why research networks?
Transcription
why research networks?
THE POWER OF RESEARCH NETWORKS Primary Care PBRNs • Define Practice-Based Research Networks (PBRNs) • Examine types of research that can be embedded into care • Present examples of prior and current CDN and N2-PBRN studies and future NYCCDRN/PCORnet studies • Discuss challenges and opportunities for scaleup and building a Learning Healthcare System The Power of Networks: Building a Learning Healthcare System with Practice-based Research Networks (PBRNs) Jonathan N. Tobin, PhD President/CEO Clinical Directors Network (CDN) Co-Director, Community Engaged Research Core The Rockefeller University Center for Clinical & Translational Science Professor, Department of Epidemiology & Population Health Albert Einstein College of Medicine of Yeshiva University • Group of ambulatory care practices • Organizational structure transcends a single research project • Link practicing clinicians with experienced investigators • Enhance research skills of network clinician members • Ongoing commitment to network activities • Mission: • Service - primary care of patients • Goal - improve quality of primary care • Investigation - questions related to community-based practice Source: AHRQ PBRN www.ahrq.gov/research/pbrn/pbrnfact.htm [email protected] www.CDNetwork.org AHRQ PBRN REGISTRY (2013) Practice-Based Research Networks (PBRNs) The Importance of Setting Models of Practice-Based Research • Top-Down – Researcher-focused – Funder-focused • Ambulatory care represents the ambient conditions under which most people present for care and under which most care (Usual Care) is provided CER/PCOR CEnR PCTs • Bottom-up – Clinician-focused (PBRN) – Patient-focused (CBPR) • PBRNs in ambulatory care settings (such as Primary Care PBRNs) represent organized practices in which care is provided and care can be studied systematically • Conduct Studies that follow Clinical Workflow in order to minimize disruption to the practices, clinicians, staff and patients • PBRNs also represent an established mechanism for the dissemination and implementation of medical innovations • Mixed Model (Bi-directional) N=155 Clinician Source: http://pbrn.ahrq.gov/pbrn-registry/pbrn-map Practice-Based Research Networks (PBRNs) MIXED MODEL PBRNS: • Can potentiate the bi-directional exchange of what is best in each model of research (lab vs. field) • Provide the venue for translating practice into research, thereby changing the pattern of information flow • Serve as both the venue for conducting research and the mechanism for disseminating research results Researcher 4 5 Types of Research Conducted in PBRNs • Descriptive • Observational • Experimental – Randomized Controlled Trials (RCTs) – Comparative Effectiveness Research (CER) – Patient Centered Outcomes Research (PCOR) – Cluster RCTs • Dissemination & Implementation (D&I) • Quality Improvement • ?Mechanistic Studies Full Spectrum of Translational Research NIH “Blue Highways” T0 Basic Science T4 Public Health Impact Source: Westfall, et al., “Practice-Based Research—‘Blue Highways’ on the NIH Roadmap” JAMA 2007; 297: 403-406 Types of T2 T3 T4 Research • PBRN • CER • PCOR Practice-based Research Networks Comparative Effectiveness Research Patient Centered Outcomes Research ------------------------------------------------------------------------------------------------------------------------------------------------------------------------- • CEnR Community-Engaged Research • CBPR Community-based Participatory Research ------------------------------------------------------------------------------------------------------------------------------------------------------------------------- • PCT Pragmatic Clinical Trials Comparative Effectiveness Research (CER) • “A rigorous evaluation of the impact of different options that are available for treating a given medical condition for a particular set of patients” (OMB) • Includes Randomized Controlled Trials (RCTs), pragmatic, and observational trials and cost analysis comparing drugs, treatments, or diagnostic tools • CER is closely related to Patient-Centered Outcomes Research (PCOR) Lauer MS. Comparative Effectiveness Research: The View From the NHLBI. Journal of the American College of Cardiology. 2010;53(12):1084-1086. MacPherson’s Key Steps in Conducting a Pragmatic Clinical Trial Pragmatic-Explanatory Continuum Indicator Summary (PRECIS) Tool 1. Appropriate research question 2. Defining the patient group 3. Identify a comparison group 4. Defining the treatment protocol 5. Ensuring adequate sample size 6. Referral, recruitment and randomisation 7. Outcomes 8. Analysis 9. Reporting and dissemination Source: MacPherson H. Pragmatic clinical trials. Complementary Therapies in Medicine. 2004. 12:136-140. WHY RESEARCH NETWORKS? Advantages: Accelerate study start-up & conduct Follow clinical workflow and embed at point of care Build shared infrastructure Facilitate data-sharing Conduct full spectrum of translational research Opportunities for dissemination & scale-up www.CDNetwork.org Four-Stage Model of Community-Engaged Research (CEnR) *CBPR One Two Researchers retain total control of the project. There is community involvement, but it is passive. Persons consulted by the researchers are at the periphery of the community. Three Community leaders are asked not only for endorsement of the project, but for guidance in hiring community residents to serve as interviewers, outreach workers, etc. Four Community members are first among equals in defining the research agenda. GOALS OF COMMUNITY-ENGAGED RESEARCH • • • Build Trust & Capacity Enlist new resources and allies Create better communication • = Improve overall health outcomes Public Health Impact Source: Hatch J, Moss N, Saran A et al. Community research: Partnership in Black communities. Am J Prev Med 1993 Nov-Dec;9(6 Suppl):27-31; discussion 32-34. Challenges for PBRNs A common aim behind Comparative Effectiveness Research (CER) and Practice-based Research Network (PBRN)-conducted research is to produce new evidence-based medical knowledge that fills gaps between primary care practice realities and findings produced by academic/tertiary-care research and clinical trials Less control over Patient characteristics Variability in practice clinical and research capacity Multiple IRBs Significant resource problems that impede research Other challenges include: selecting studies that meet network’s & practices’ priorities working within an adequate and sufficient budget developing study teams and agreements among team members training practice staff for participation Source: Thorpe KE et al. A pragmatic-explanatory continuum indicator summary tool (PRECIS): a tool to help trial designers. CMAJ 2009; 180(10):E47-57. THE POWER OF RESEARCH NETWORKS • Structure of CDN and N2-PBRN • Examples of prior and current PBRN studies conducted by CDN and N2-PBRN www.CDNetwork.org Clinical Directors Network A Practice-based Research Network (PBRN) that works with Primary Health Care Safety-net Practices ---Research Infrastructure to build a Learning Healthcare System CDN Recognition AHRQ Designated “Center of Excellence” (P30) For Practice-based Research and Learning (2012) CDN: Beginnings CDN’S OVERALL GOAL • CDN is dedicated to providing and improving comprehensive and accessible community oriented Primary and Preventative Health Care services for poor, minority, and underserved populations NIH Roadmap Initiative Designated “Best Practice” Clinical Research Network (2006) • CDN’S overall goal is to engage communities, clinicians and patients to translate clinical research into clinical practice for the elimination of health disparities US Department of Health & Human Services Award for “Outstanding Contribution Toward the Elimination of Racial and Ethnic Disparities in Health” (2001) Improving Healthcare Systems (2012) Eliminating Health Disparities (2013) Clinical Data Research Networks x2 (NYC & Chicago, 2013) CDN’S Primary Activities www.CDNetwork.org Factors Contributing to Physician Retention in FQHCs • “… while salary and benefit levels are a major variable in retention, other factors related to personal and professional satisfaction are also significant. These include workload, relationship to other staff, sense of mission, health center morale, reputation of the center and participation in decision-making within the organization.” • John Snow study of national retention rates of physicians at Community/Migrant Health Centers examined conditions which contribute to professional satisfaction or dissatisfaction. • Retention was found to be positively related to job satisfaction • Perception that the management of the health center had created a professionally satisfying environment (& connected to mission) • The most satisfying aspects of their jobs: “team-building", "diversity and versatility of their role“ "working with the community and community groups“ "taking a larger view of health care in the community“ “Clinical leadership and administrative skills” "personal commitment to the job and the mission” Sardell A. (1996) “Clinical Networks and Clinician Retention: The Case of CDN.” J Community Health. 21(6):437-51. The HRSA Primary Health Care Safety-Net (2013) Mission External Validity Generalizability Social Justice - People: Eligibility - inclusion/exclusion criteria Place: Setting - types of services available Time: Seasonality - novel/established Ideal vs. Real World: • Practice Settings • Populations • Heterogeneity Sardell A. (1996) “Clinical Networks and Clinician Retention: The Case of CDN.” J Community Health. 21(6):437-51. Grantees, Delivery Sites and FTE Clinicians (2013) USA New York Grantees Delivery Sites 1,202 9,203 57 632 Physicians 10,734 1,074 Nurses 13,278 1,326 Medical Providers 8,156 32,168 2,978 NPs, PAs, and Midwives Source: www.hrsa.gov www.healthdisparities.net • “CDN has responded to the needs articulated by clinicians at health centers…has provided managerial training and clinical education, strategies for increased involvement of clinicians in health center management and opportunities for engagement in community-based primary care research.” • Practice-based Research • Education and Training • Professional Development Peer Support: Retention/Recruitment of Clinicians into Health Centers – – – – – – • “CDN was created in 1985 by a group of community health center dental and medical directors with the encouragement and support of officials of Region II of the Public Health Service (PHS).” 578 Dentists 3,479 338 Dental Assistants, Technicians and Hygienists 8,371 627 Dental Providers 11,850 965 Mental Health Providers 5,694 524 Source: HRSA BPHC UDS, 2013– Special Tabulation Community Health Center Patients by Race/Ethnicity (2013) Patient Income Percent of Poverty Level (2013) www.CDNetwork.org Race/Ethnicity (%) National New York Asian/Pac Island 4.1 5.2 Native American 1.2 0.3 Black 20.3 26.6 White 56.2 32.1 Unknown/NR 14.9 23.0 Hispanic/Latino 34.8 35.3 Source: HRSA BPHC UDS, 2013– Special Tabulation Community Health Center Patients by Diagnosis, USA (2013) Selected Diagnoses and Services National New York Hypertension 3,642,869 216,171 (2) Immunizations 2,699,959 232,287 (1) Overweight and Obesity 2,228,089 179,258 (4) NIAID NIMH, HRSA, CDC, AmFAR, BMS, DMP, Roche MRSA NCATS HIT NIDDK, NCI CANCER PREVENTION and CONTROL NCI, AHCPR, PCORI DEPRESSION NIDA, SAMHSA, NIMH, PCORI Diabetes Mellitus 1,882,608 Pap Smear 1,787,256 158,736 (5) STRESS MANAGEMENT NIMH, CDC Depression 1,644,559 94,888 (10) HYPERTENSION NHLBI Contraception 1,221,493 102,963 (8) DIABETES HRSA, NIDDK, NIDCR 120,704 (6) ACADEMIC PARTNERS & CER/PCOR PROJECTS CDN’S RESEARCH PORTFOLIO MIXED MODEL HIV/AIDS YALE SCHOOL OF PUBLIC HEALTH • Centering Pregnancy RCT(NIMH) DARTMOUTH MEDICAL SCHOOL • Cancer Control RCT (NCI; PCORI) COLUMBIA UNVERSITY • • • • • CAATCH Hypertension in African Americans RCT (NHLBI) BP Adherence RCT (NHLBI) Cancer Caregiver Support RCT (NCI) Web-based Rx Support Tool for HIV (HRSA) Problem-Solving in Diabetes Management RCT (NIDDK) College of Physicians and Surgeons Mailman School of Public Health RAND CORP & UCLA • • PTSD Among Refugees (NIMH) PTSD Care Management RCT (NIMH) UNIVERSITY OF MICHIGAN • Periodontal Disease/Diabetes (NIDCR) • Stress Management & HIV RCT (3) (NIMH & CDC) Center for Clinical & Translational Science • • • • CA-MRSA Project (NCATS; AHRQ; PCORI) Bleeding Phenotype (NCATS) Research Participant Survey (NCATS) Hepatitis-C Screening & Treatment (NCATS; Helmsley Trust) NYU Langone School of Medicine • • Hypertension in African Americans RCT (NHLBI) Cancer Caregiver Support RCT (NCI) UNIVERSITY OF ROCHESTER • • Technology Enabled Patient Self Management (NCI, PCORI) BP Visit Intensification Study (NHLBI) ALBERT EINSTEIN COLLEGE OF MEDICINE Collaborative Cancer Care Among Low-Income Urban Women (PCORI) N2 PBRN - Network of Networks (AHRQ P30) WEILL CORNELL Medical College NYC-CDRN (PCORI) Tobacco Use Disorders 1,181,415 101,650 (9) IMMUNIZATIONS CDC, HRSA, Pharma Anxiety Disorders including PTSD 1,096,079 63,696 (12) MIGRAINE/HEADACHE Merck Asthma 1,092,389 UNIVERSITY OF MIAMI 117,516 (7) 1,079,505 ANEMIA; BLEEDING DISORDERS Ortho Biotech, NCATS Miller School Of Medicine HIV Tests ASTHMA EPA, DEP, HRSA THE ROCKEFELLER UNIVERSITY HPV SCREENING & VACCINATION NYC DOHMH 182,227 (3) Other Mental Disorders 988,999 82,583 (11) Otitis Media/Eustachian Disorders 841,327 50,483 (14) Heart Disease 602,687 42,991 (16) TEEN MENTAL HEALTH SCREENING Columbia University Dermatitis/other Eczema 599,743 51,582 (13) PALLIATIVE CARE NCI Mammogram 424,376 41,538 (17) NUTRITION/PHYSICAL ACTIVITY RWJ, NYS Atty Gen Chronic Bronchitis/Emphysema 320,862 17,633 (19) Hepatitis C Test PERIODONTAL DISEASE NIDCR 296,349 46,666 (15) Hepatitis C 145,309 GENETICS March of Dimes 11,245 (20) 115,421 19,045 (18) PREGNANCY/PRENATAL CARE NIMH Symptomatic HIV, Asymptomatic HIV Source: HRSA BPHC UDS, 2013– Special Tabulation) School of Dental & Oral Surgery & Public Health MIXED MODEL CDN RECRUITMENT EXPERIENCE 1992-Present 64,067 Patients enrolled 74 % Female 49 % African-American 40 % Latino/a Employing the Mixed Model, Significant Improvements Have Been Achieved In: CDN has successfully employed the “Mixed Model” in a variety of experimental and observational studies conducted in primary care practices serving low-income and minority communities, including : – – – – – – • • • • • • • Community/Migrant Health Centers (CHCs) Diagnostic and Treatment Centers (DTCs) Health Department Clinics (DOH) Public/Voluntary Hospitals (HOSP) Primary Care Residency Programs (PCRPs) Managed Care Organizations (MCOs) Clinical Preventive Services Disease Management Health Behavior Change Integration of Primary Care & Mental Health Quality of Life Clinical/Biological Outcomes Beginning to demonstrate Public Health Impact www.CDNetwork.org Drivers of New PBRN Growth CHALLENGES TO SUSTAINABILTY WHICH LEAD TO GROWTH OF NETWORKS Enormous financial investment Need for new markets (practices, clinicians) Saturation of existing practices Limited bandwidth & competing priorities Time Constraints Competition for funding Inconsistent, partial or poor translation of research into practice Outside demand for expertise & access Geographic diversity/diverse health needs POTENTIAL SOLUTIONS High quality data collection Simplified, less costly forms Clinicians who are engaged and serve as investigators, early adopters and disseminators Vigorous communication and discussion of efficacy and effectiveness among collaborating PBRNs Models of collaboration Accelerated model of translation Inter-operable EHR systems Drivers of Growth & Expansion: Scalable CDN N2 -PBRN : Building a Network of Safety Net PBRNs (“Network of Networks”) A collaboration among: ◦ ◦ ◦ ◦ ◦ ◦ ◦ ◦ ◦ Access Community Health Network (ACCESS) Alliance of Chicago (ALLIANCE) Association of Asian Pacific Community Health Organization (AAPCHO) Center for Community Health Education Research and Service (CCHERS) Clinical Directors Network (CDN) [Lead PBRN] Community Health Applied Research Network (CHARN) Fenway Institute (FENWAY) New York City Research and Improvement Group (NYCRING) Oregon Community Health Information Network (OCHIN) Funded by AHRQ Grant: P30 HS 021667 Principal Investigator: Jonathan N. Tobin, PhD (CDN) Project Officer: Rebecca A. Roper, MS, MPH Director, AHRQ PBRN Initiative CDN Webcast Partners • Fenway Health • Fenway Health • Chase Brexton Health Services • Beaufort-Jasper-Hampton Comprehensive Health Services • Academic Partner • University of Washington • OCHIN • Open Door Community Health Center • Virginia Garcia Memorial Health Center • Multnomah County Health Department • OHSU Family Medicine at Richmond • Academic Partner • Oregon Health and Science University(Academic Partner) < • • Alliance of Chicago Community Health Services • Alliance of Chicago Community Health Services • Erie Family Health Center, Inc. • GLIDE Health Services • Heartland Health Outreach • Howard Brown Health Center • Near North Community Health Center • North Country Healthcare • Lurie Children’s Hospital/NU • Academic Partners: • University of Michigan • Michigan Public Health Institute • Northwestern University • Kaiser Permanente Center for Health Research – Data Coordinating Center • Center for Health Research Association of Asian Pacific Community Health Organizations(AAPCHO) • Asian Health Services Community Health Center • Charles B. Wang Community Health Center • Waianae Coast Comprehensive Health Center • Waimanalo Health Center • Academic Partner • University of California, Los Angeles N2 PBRN Academic Partners Virtual Faculty • Albert Einstein College of Medicine of Yeshiva University/Montefiore Medical Center • Boston University • Columbia University • Dartmouth Medical School • Harvard University • Kaiser Permanente Center for Health Policy Research • New York University • Northwestern University • Oregon Health and Science University • RAND Corporation • • • • • • • • • • The Rockefeller University Tufts University University of California/San Francisco University of Chicago University of Illinois at Chicago University of Miami University of Michigan University of Oregon University of Washington Yale University Funded by HRSA N2 LEARNING COLLABORATIVE TRACKS Research Training for Clinical Leaders The N2 PBRN Online Training Curriculum Aims to enhance the skills of current PBRN researchers and practicing clinicians who are interested in participating in clinical research. 1. PBRN Research Management Innovations (for PBRN Senior Staff) Tracks: 2. PBRN Methods (for PBRN Senior Staff & Academic Collaborators) • Evidence-based practices and best practices demonstrated to be effective at transforming clinical research into a more clinician-engaged, accelerated research and translation model, with significant clinical and public health impact 3. Introduction to Research (for CHC Nodes Staff & New PBRN Staff) • A “Virtual Faculty” of N2 PBRN Directors and their PBRN-related research 4. PBRN Study Results (for CHC Nodes, CHC Partners, PBRN Senior Leadership & Staff, Academic Partners) • N2 PBRN Academic Partners “Virtual Faculty” and their PBRN-related research 2012-2013 • – To enable practicing clinicians to develop their research interests and skills, through didactics on the scientific and statistical aspects of study design as well as through hands-on experience in preparing and implementing a research project • Epidemiology and Biostatistics – To develop and provide oral and written research dissemination/presentation skills at local, regional and national forums • IRB/Human Subjects Protection – IRB Application – Informed Consent • • Training in research methodology for practicing clinicians who wish to become more active and engaged in practice-based research • New content added on Pragmatic Clinical Trials, CER & PCOR Research methods Study Design and Implementation Grant Writing – To provide technical assistance in grant-writing and identifying potential funding sources, including training exercises and assistance in developing budgets, staffing plans, work-scopes, and timelines • 60 CME/CNE/CDE Credits for Participation Funded in part by AHRQ Grant: P30 HS 021667 ENCORE: Community Health Center Patient Centered Outcomes Research (PCOR) Training Program (Funded by a PCORI Eugene Washington Engagement Award - NCHR 1000-30-10-10 EA-000) Key Partners: • Access Community Health Network • Association of Asian Pacific Community Health Organizations (AAPCHO) • Clinical Directors Network (CDN) [JN Tobin, PI; M Dziok, PD] • Community Health Applied Research Network (CHARN) • Institute for Community Health (ICH) at Harvard University • National Association of Community Health Centers (NACHC) [M.Proser, Co-PI] • South Carolina Primary Healthcare Association (SCPHA) ENCORE: Community Health Center Patient Centered Outcomes Research (PCOR) Training (Funded by a PCORI Eugene Washington Engagement Award NCHR 1000-30-10-10 EA-000) Goal: To adapt, enhance, and implement an existing year-long training curriculum designed to educate and engage health center teams including patients, clinical and administrative staff in PCOR Objectives: • Build infrastructure to strengthen research capacity of health centers as they develop or expand their own research infrastructure and engage in PCOR • Develop, implement, and disseminate broad innovative training content and delivery approaches • targeted to and accessible at no cost to all health centers and other primary care practices • content will prepare health center patients, staff, and researchers in the conduct of community-led PCOR • Evaluate, refine, and disseminate training resources to health centers nationally THE POWER OF RESEARCH NETWORKS CDN N2 Case Presentations of CDN & N2-PBRN Studies: • Prevention Care Management for Improving Cancer Early Detection (NCI, AHRQ, PCORI) • CA-MRSA Projects – CAMP1 ((NCATS) – CAMP/PBRN (AHRQ) – CAMP2 CER RCT (PCORI) Prevention Care Management (PCM) Projects to Improve Cancer Screening in Primary Care Framework: Prevention Care Management (PCM) Projects (2000-2012) Efficacy PCM1 CONSORT: Health Centers Recruitment Timeline: PCM1, PCMT, PCM2 –MMCO & PCM3-MH Projects November 2001 October 2002 Principal Investigator: Allen Dietrich, MD Geisel School of Medicine at Dartmouth Follow-up: Co-Principal Investigator: Jonathan N. Tobin, Ph.D. Clinical Directors Network (CDN) Funded by: NCI Grants R01-CA87776 (PCM1, PCMT) & R01-CA119014 (PCM2) PCORI IH-12-11-4522 AHRQ 1 P30-HS-021667 Efficacy Effectiveness Dissemination & Implementation PCM1 (2000-2004) PCMT (2003-2005) PCM2 (2006-2012) 18 months after recruitment; all follow-up completed by April 2004 Dietrich AJ, Tobin JN, Cassells A, Robinson CM, Greene MA, Sox CH, Beach ML, DuHamel KN, Younge, RG. Telephone Care Management To Improve Cancer Screening among Low-Income Women. Ann Intern Med. 2006; 144:563-571. Funded by NCI Grants R01-CA87776 & RO1-CA119014 (A. Dietrich, PI; J.N. Tobin, Co-PI) Dissemination & Implementation Effectiveness PCMT CONSORT: MMCO (n=1) Screening Outcomes PCM1 PCM2 CONSORT: MMCO (n=3) 18 months: Up-to-Date Pap, mammogram 1 Year HFOBT 5 Years: Sigmoid 10 Years: Colonoscopy By Chart Review Efficacy PCMT 8 months: Up-to-Date Pap, mammogram 1 Year HFOBT 5 Years: Sigmoid Barium Enema 10 Years: Colonoscopy PCM2 18 months: Up-to-Date 1 Year HFOBT 5 Years: Sigmoid Barium Enema 10 Years: Colonoscopy By MMCO Claims Data Effectiveness By MMCO Claims Data Dietrich AJ, Tobin JN, Cassells A, Robinson CM, Reh M, Romero KA, Flood AB, Beach ML. Translation of an Efficacious Cancer-Screening Intervention to Women Enrolled in a Medicaid Managed Care Organization. Ann Fam Med. 2007; 5:320-327. Dissemination & Implementation Dietrich AJ, Tobin JN, Robinson CM, Cassells A, Greene MA, Dunn VH, Falkenstern KM, De Leon R, Beach ML. Telephone Outreach to Increase Colon Cancer Screening in Medicaid Managed Care Organizations: A Randomized Controlled Trial. Ann Fam Med. 2013; 335-343. PCM Intervention Delivery PCM Intervention Components Organizational Characteristics Intervention Implementation Organizational Characteristics PCM1 Total Number of Participants N (%) Reached PCMT PCM2 696 663 562 633 (91%) 268 (40%) 340 (60%) PCM1 Study Period Mail clinician recommendation letter to patient 18 months Research Staff at CDN 8 months Health Plan Staff 18 months Heath Plan Staff Targeted Cancers Breast, Cervical and Colorectal Breast, Cervical and Colorectal Breast, Cervical and Colorectal* Identification of Eligible Participants • Medical records review • Administrative claims data • Administrative claims data Mail activation card to patient (excluded women who were up-to-date for breast, cervical and colorectal cancer screening) Mean # of calls (range) Average call length (support was given in no more than 3 calls) Subsequent 17(6-48) − 14 (1-53) 14(1-62) − 7(1-21) √ √ Schedule screening appointments √ Reminder calls √ Reminder letters 52 √ √ [# minutes (range)] Initial √ Confirmed and updated screening dates 3 PCMT PCM2 2000-2004 2003-2005 2006-2012 Medicaid 80 100 100 Medicare 21 - - Employer/other 9 - - No Insurance 5 0 0 Insurance of Study Participants (%) Mail screening test-specific educational material to patient Discuss and provide support on barriers using script Phone Calls PCM1 PCM2 Intervention Components Intervention Period Staff 4 (range 1 to 20) PCMT √ − − − √ √ √ Practice Types Involved (%) √ Community Health Center (publicly funded) √ √ √ − √ (as needed) − √ − √ 100 100 45 Diagnostic & Treatment Center (publicly funded) 0 0 37 Private Practice 0 0 18 Primary Care Clinicians at All Centers per Study Total Clinicians, n 116 - 364 Family Practitioners (%) 26 - 12 General Internists (%) 35 - 35 Nurse Practitioners and Physician's Assistants (%) 39 - 15 “-” = data not available 53 54 Patient Characteristics PCM1 PCMT 1390 1316 2240 Age Inclusion Criteria 50-69 40-69 50-63 Age at Baseline - Mean 58.1 50.0 English 36.9% 49.6% 69.3% Spanish 62.8% 9.4% 24.8% Other 0.3% 0.5% 6.0% <3 28.5% 57.8% >3 68.3% 42.2% - Unknown 3.2% 0.0% - Diabetes 37.8% - 29.0% Hypertension 70.9% - 60.8% High Cholesterol 39.6% - 37.5% Current 17.6% - 18.6% Former 13.0% - 13.8% Never 63.9% - 67.6% Primary Language (%) Meta-analysis of Odds Ratios from 3 CDN PCM RCTs Statistical Methods for Meta-Analysis of 3 PCM RCTs PCM2 Total Number of Participants 55.8 * • Unadjusted Comparisons of the main effects for the three PCM RCTs • Random effects meta-analysis • Random effects meta-regression model using the aggregate level data on the log scale was used to estimate a decrease in effectiveness over the three trials Years Receiving Care at CHC/Practice (%) - Comorbidities at Baseline (%) Smoking Status (%) 32 - 30 Normal (%) 11.4% - 20.0% Overweight (%) 27.3% - 34.6% Obese (%) 51.3% - 44.9% PCM1 PCMT – More complete data were available for PCM1 and PCM2 – PCM1 & PCM2 were combined to provide a covariate-adjusted estimate using logistic regression models Body Mass Index Mean kg/m2 Forest Plot PCM2 • p-value < 0.05 (2-tailed) statistical significance • 95% confidence intervals are reported - = data unknown/not available I2 = 54.8%, p =0.109 55 56 57 Odds Ratios Stratified by Language: Proportion of Spanish Speakers Interpretation Heterogeneity of Treatment Effects • While the effect sizes for PCM1 versus PCM2 appear to be different, they are not Proportion of Spanish Speakers - PCM1 vs PCM2 • The distribution for Spanish and English speakers differs between PCM1 (64%) and PCM2 (27%) 70 60 64% • This language effect drives the difference in ORs % Spanish Speakers 50 • The difference between 1.69 (PCM2) versus 1.31 (PCM1) is best explained by language differences 40 • This represents Simpson’s Paradox: 30 • 27% 20 • 10 NS: PCM1 vs. PCM2 Sig: Eng vs. Span • 0 PCM1 PCM2 + P <0.10 * P < 0.05 ** P <0.01 *** P<0.001 The possibility that a measure of association may reverse direction upon stratification by a third variable Simpson's paradox can occur in meta-analysis because the sum of the data or results from a number of different studies may be affected by confounding variables that have been excluded by design features from some studies but not others It is an extreme extreme violation of COLLAPSIBILITY, in which results of the data analysis in every mutually exclusive stratum or subgroup are the opposite of the crude results. (see also CONFOUNDING BIAS)" 58 Source: M. Porta, A Dictionary of Epidemiology (University Press, 2008) SCALE-UP NYC DOHMH Colo-rectal Cancer Screening Patient Navigator Program Source: 2008 C5 SCALE-UP NYC DOHMH Colo-rectal Cancer Screening Patient Navigator Program Source: 2008 C5 Source: 2008 C5 Source: 2014 C5 P30 Curriculum, Web Portals and Resource Library Development For Patients and Clinicians www.CDNetwork.org/RussianCRC Funding: NYC DOHMH, NYS DOH, CDC Next Steps: Using Collaborative Care to Reduce Depression and Increase Cancer Screening Among Low-Income Urban Women Project NYC Colonoscopy Screening Data Booklet, 2010 Community Health Survey, C5 Source: 2008 C5 Source: 2014 C5 Collaborative Care to Reduce Depression and Increase Cancer Screening Among Low-Income Urban Women Project (PCM3-MH) A collaboration among: Clinical Directors Network (CDN) - Jonathan N. Tobin, PhD, Andrea Cassells, MPH, TJ Lin MPH Albert Einstein College of Medicine - Elisa Weiss, PhD, Nan Xue, PhD Montefiore Family Care Center - Elisabeth Ihler, MD Morris Heights Health Center - Alison Maling, LCSW Urban Health Plan - Alejandra Morales, PsyD NYCRING – Claudia Lechuga, MPH BronxWorks - John Weed, LMSW Good Shepherd Services - Ellen O’Hara-Cicero, LCSW Geisel School of Medicine at Dartmouth University – Allen Dietrich, MD Bronx Partners N2 PBRN: NYCRING • The New York City Research and Improvement Networking Group is a partnership of thirty-five practices • Exclusively focuses on the urban underserved • NYCRING provides visits to over 600,000 low income, minority primary care patients • Access to research, data, clinical and administrative resources made available through the Albert Einstein College of Medicine and Montefiore Medical Center Funding: PCORI IH-12-11-4522 AHRQ 1 P30-HS-021667 www.nycring.org Prevention Care Management – PCM Bronx Partners 1 Montefiore Family Care Center 2 Morris Heights Health Center 3 Urban Health Plan 4 BronxWorks 5 Good Shepherd Services 6 Albert Einstein College of Medicine Goals and Objectives • To determine whether addressing and reducing depression are necessary steps to increase rates of cancer screening among low-income depressed women ages 50-64 across 3 Bronx health centers • We implemented a CER/PCOR study comparing the effectiveness of two year-long interventions for: – 756 women ages 50-64 – screen positive for depression (PHQ-9 > 8) – have not completed recommended screenings for cervical, breast, and/or colorectal cancer (Comparison Arm) • In the PCM condition, the Care Manager will focus on cancer screening, providing – – – Education Patient navigation Motivational support to overcome screening barriers and form favorable attitudes towards screening • Patients in the PCM condition will be referred to their primary care clinicians for their depression, if they are not in treatment CDN Online Tools: Staff Intervention Training Resources at NCI/SAMHSA Cancer Control Planet RTIPS • Comparing the Effectiveness of: 1) Collaborative Care Intervention (CCI) that addresses Depression and Cancer Screening needs simultaneously 2) Prevention Care Management (PCM) Patient Navigation Cancer Screening Intervention http://rtips.cancer.gov/rtips http://rtips.cancer.gov/rtips/viewProduct.do?viewMode=product&prod uctId=295815 CDN Online Tools: Clinician Training Resources (CME) Collaborative Care Intervention (CCI) • Collaborative Care Intervention facilitates decision-making and action to engage in screening AND reduce depression. A Care Manager (CM) will: – educate patients about cancer screening and depression; – provide patient navigation to improve access to and use of cancer screening services, and connect patients to outside services – provide depression care management and motivational support (includes addressing barriers) for self-care with respect to screening, depression, and other conditions and – act as a critical link between primary care, mental health care provider, and the patients, helping to develop and implement a treatment plan www.CDNetwork.org PCM1 1 Year HFOBT 5 Years: Sigmoid 10 Years: Colonoscopy Three Component Model (TCM) Screening Outcomes 18 months: Up-to-Date Pap, mammogram By Chart Review Efficacy PCMT 8 months: Up-to-Date Pap, mammogram 1 Year HFOBT 5 Years: Sigmoid Barium Enema 10 Years: Colonoscopy By MMCO Claims Data Effectiveness http://prevention.mt.gov/suicideprevention/13macar thurtoolkit.pdf PCM2 18 months: Up-to-Date Pap, mammogram 12 months: Up-to-Date Pap, mammogram By MMCO Claims Data 1 Year HFOBT 5 Years: Sigmoid 10 Years: Colonoscopy Dissemination & Implementation WWW.CDNetwork.org CME accredited through AAFP PCM3 1 Year HFOBT 5 Years: Sigmoid Barium Enema 10 Years: Colonoscopy By Electronic Health Records (2012-2015) 75 Pragmatic Clinical Trial: All EHR-based Cancer Screening, Mental Health, Treatment Data, Process and Outcomes Measures – Past history of medication use for mental health – Past history of psychotherapy – Present medication use (names and reported side effects) – Barriers to medication or psychtherapy use – Present psychotherapy/counseling and frequency – Initiation of medication or psychotherapy while enrolled Results and Lessons Learned CONCLUSIONS Results Prevention Care Management (PCM) intervention • Both FQHCs and Community Based Organizations (CBOs) are now significantly engaged in project implementation activities • Key facilitators to study implementation include presence of a study champion, a robust Electronic Health Record (EHR) system and a multi-disciplinary team • Challenges include bureaucratic systems that slow the hiring of study staff, competing priorities and lack of a central IRB 1. 2. 3. 4. 5. 6. Conclusions 7. • This study is designed to increase our understanding of integrating mental health and cancer screening in primary care, and how to best support this population in making screening decisions Addresses multi-level barriers to screening Effective at increasing CRC screening rates Impact is greater for the Latina population Can be translated and implemented successfully across a wide range of clinical settings in medically underserved communities Is robust and transferable across CHC, DTC and MMCO settings Is an important strategy to be implemented in primary care systems to be effective and sustainable May need to add CCI components added to address depression and other mental health, but care management framework may enhance outcomes for both mental health and cancer screening 78 Policy Implications Examples 1. CHCs, DTCs, PCPs and other primary care practices with large numbers of Spanish speaking patients can benefit from the PCM intervention 2. PCM is an innovative and effective strategy that can be implemented in MCOs, ACOs, and PCMHs to enhance CRC screening rates and reduce cancer health disparities 3. PCM is transferrable and can be adapted into cancer early detection Quality Improvement (QI) Initiatives 4. PCM can be generalized to address mental health needs of underserved populations ? CDN N2 79 Case Presentations of CDN & N2-PBRN Studies • Prevention Care Management for Cancer Early Detection (NCI, AHRQ, PCORI) • CA-MRSA Project (NCATS, AHRQ, PCORI) www.CDNetwork.org The Rockefeller University Center for Clinical and Translational Science Clinical Directors Network CHC Partnership Conducting CER/PCOR with Embedded Mechanistic Studies Supported in part by grant # UL1 TR000043 from the National Center for Advancing Translational Sciences (NCATS, National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program PCORI CER 1402 10800 The Community-Associated Methicillin-Resistant Staphylococcus aureus (CA-MRSA) Project (CAMP1): Establishing a CA-MRSA Surveillance Network Translational Science Embedded Mechanistic Studies Comparative Effectiveness Research (CER) / Patient Centered Outcomes Research (PCOR) Dissemination and Implementation Research A collaboration among: Public Health The Rockefeller University Center for Clinical & Translational Science (CCTS) BRONX Impact Effectiveness Research CA-MRSA Project (CAMP1) Team Rockefeller-Clinical Directors NetworkCommunity Health Centers Clinical Directors Network (CDN) Community Health Centers (CHCs) Efficacy Research Pre-Clinical/Phase I & II Research Funded by The Rockefeller University Center for Clinical and Translational Science (CCTS) Pilot Grants and an NIH Administrative Supplement (NIH-NCATS Grant #8 UL1 TR000043) and AHRQ Grant # P30 HS 021667 Stakeholder Engagement and Study Design Diagnosis Total Average # per Year Average # per Month Average # over 6 Months 50% Consent / recruitment Internist 20% Nutritionist 1% 2. EHR Extraction of Prevalence data (2008 – 2010): Inflammatory Disease of Breast Carbuncle and furuncle Cellulitis and abscess of finger and toe Cellulitis/abscess Impetigo Infection of skin/subcutaneous NOS Folliculitis Hydaradenitis Other skin and soft tissue infections Pediatrician 16% Nurse Nurse 5% practitioner 26% Optometrist 1% Family physician 9% Podiatrician 1% Obstetricia ns & Gynecologi sts 3% Cumulative # Diagnoses (2008-2010) from 3 CHCs Urban Health Open Door Family ICD-9-CM code Total Plan Health Center 373 139 130 611 680 18 18 0 681 77 77 0 682.8 31 0 0 791 0 487 684 267 110 45 686.9 642 0 320 704.8 705.83 333 208 50 683 (acute lymphadenitis), 686 (pyoderma),728 (myosistis), 771.4 (omphalitis of the newborn), 771.5 (neonatal infective mastitis) Hudson River Health Care 104 0 0 31 304 112 322 75 88 1 0 87 2620 873 73 437 553 184 1032 344 1035 345 15 92 46 29 172 86 29 173 86 218 Workflow Exercise Worksheet Dentist 3% Laboratory/Microbiological Results: S. aureus clones (n=129) CAMP1 Results • – – – – – – Lesion Location (n=152) • – – – – – – – – Retrospective Recurrence: History of SSTIs /MRSA before enrollment T1: Recurrent Infection 42 MRSA isolates ST8-USA 300 (28 wounds + 14 colonization sites) 3 MRSA isolates ST30-USA 1100 “SouthWest Pacific clone” (2 wounds + 1 colonization site) 2 MRSA isolates ST8-NY cloneV (2 colonization site) 1 MRSA isolate ST5-USA 100 “NewYork/Japan clone” (1 wound) 1 MRSA isolate ST 72 (1 wound) 5 MRSA isolates to be typed 37 MSSA isolates ( 17 wounds + 20 colonization sites) T1: Received treatment of this lesion from other doctors before Wound and colonizing isolates share identical phenotypes of heterogeneous beta-lactam resistance 7 MSSA isolates ST8-USA 300 (4 wounds + 3 colonization sites) 8 MSSA isolates ST30-USA 1100 “SouthWest Pacific clone” (4 wounds + 4 colonization sites) 2 MSSA isolates ST8-NY cloneV (1 wound + 1 colonization site) 4 MSSA isolates ST5-USA 100 “NewYork/Japan clone” (2 wounds + 2 colonization sites) 7 MSSA isolates ST15 (2 wounds + 5 colonization sites) 2 MSSA isolates ST121 (1 wound + 1 colonization site) 1 MSSA isolate USA 400 (1 colonization site) 1 MSSA isolate to be typed UHP/CAMP-016— wound spa type MLST mecA SCCmec pvl ACME Wound t008 ST 8 + IVa + type I Nasal t008 ST 8 + IVa + type I UHP/CAMP-016-nasal-homo* UHP/CAMP-016-wound-homo* 1.00E+10 UHP/CAMP-016-w UHP/CAMP-016-n 1.00E+11 1.00E+09 UHP-16-w-homo*1 1.00E+10 UHP-016-n-homo*1 1.00E+08 UHP-16-w-homo*2 1.00E+09 UHP-016-n-homo*2 1.00E+07 UHP-16-w-homo*3 1.00E+06 UHP-16-w-homo*4 1.00E+05 UHP-16-w-homo*5 1.00E+04 1.00E+03 1.00E+02 UHP-016-n-homo*3 1.00E+07 UHP-016-n-homo*4 1.00E+06 UHP-016-n-homo*5 1.00E+05 UHP-16-w-homo*6 1.00E+04 UHP-16-w-homo*7 1.00E+03 UHP-16-w-homo*8 1.00E+01 1.00E+08 UHP-016-n-homo*6 UHP-016-n-homo*7 1.00E+02 UHP-016-n-homo*8 1.00E+01 UHP-16-w-homo*9 1.00E+00 0 0.75 1.5 3 6 12.5 25 Oxacillin (µg/ml) 50 100 200 400 800 UHP-16-w-homo*10 UHP-016-n-homo*9 1.00E+00 0 0.75 1.5 3 6 12.5 25 50 100 200 400 800 UHP-016-n-homo*10 Oxacillin (µg/ml) T3: Previously documented MRSA infection or colonization Prospective Recurrence: Subsequent incident of SSTIs/MRSA after enrollment T3: Re-occurring complaint of SSTI at more recent primary care visit USA 300 UHP/CAMP-016— nasal Inclusion Criteria Exclusion Criteria •The patient presents with signs and symptoms of a SSTI •7 to 70 years of age •Fluent in English or Spanish •Plans to receive care in this community health center during the next year •The patient is unwilling to provide informed consent •The patient is acutely sick (for example, crying, wheezing, bleeding, screaming or shaken) and unable to participate in a discussion about the study •The patient is unable to understand the information shared about the study Treatment and Recurrence of Staph aureus cases (n=75) 54 MRSA isolates ( 36 wounds + 18 colonization sites) CFU/ml 5 CHCs; 72 attendees Elements: • Active discussions between scientists & healthcare providers • Agreed incision & drainage of infection site is a simple & effective treatment • Emphasized importance of community hygiene Challenges recognized: • Tracking infected patients • Therapy commonly used for CA-MRSA in a CHC setting Other 7% CFU/ml Medical Assistant 4% Physician Assistant School 4% Health 1. Continuing Medical Education (CME) accredited sessions: Stakeholder Engagement and Study Design CHC CME Attendees Study Start-Up: Fisher’s Exact Test: P= 2.206E-04 p-value = 0.0040 CAMP Dissemination Hospital-Acquired MRSA (HA-MRSA) Pilot Project: Expanding the CA-MRSA Surveillance Network Practice Based Research Networks Conduct the Full Spectrum of Translational Research Studies of CA-MRSA Treatment and Recurrence in Community Health Centers Goals: • To study the clinical and microbiological characteristics of HA-MRSA in the same communities as the CHCs, in order to allow for simultaneous phenotypic and genotypic comparisons of both HA-MRSA and CA-MRSA clones • To understand the increasing occurrence of CA-MRSA strains in nosocomial settings and HA-MRSA strains appearing in individuals who are not exposed to hospitals Received Special Recognition during the Poster Tour Session on Returning Travelers. Presented at the 2014 PBRN Conference held by the North American Primary Care Research Group, June 30 – July 1, Bethesda, MD by: Maria Pardos de la Gandara, MD, PhD Postdoctoral Associate Laboratory of Microbiology and Infectious Diseases The Rockefeller University 1) Lincoln Medical Center, Bronx, NY 2) Lutheran Medical Center, Brooklyn, NY Presented at SCTS Translational Science Conference 2013, (Washington, DC ) by: • Shirish Balachandra, MD Section Head, Walk-In Dept. Urban Health Plan, Inc. • Presented by: Nancy Jenks, FNP Director of Internal Medicine Hudson River Community Health Scott Salvato, PA Clinical Coordinator Urban Health Plan, Inc. Expanding the Study of SSTIs/CA-MRSA To Barbershops and Beauty Salons in NYC Recurrent Furunculosis in a Community-Acquired S. aureus Infection Caused by a Strain Belonging to the USA300 Clone of MRSA • Previous studies have shown the receptiveness of male barbershop owners, employees, and patrons to learning more about disease prevention and occupational safety and health • SSTIs/lesions are often observed on face, scalp, head, neck, arms, hands • About 20% of CAMP participants’ lesions presented in these locations • Barbers and their clients were highly receptive to inquiries and information about MRSA • Barbers welcome an in-depth public health education in the barbershop setting Clinical Directors Network (CDN) South Texas Ambulatory Research Network (STARNet) + Hudson Brookdale Open Urban River Family Care Door Health Family Plan Center Health Health Care Center Section Head, Walk-In Dept. Urban Health Plan, Inc. Key: Maria Pardos de la Gandara, MD, PhD Postdoctoral Associate Laboratory of Microbiology and Infectious Diseases The Rockefeller University CHC CHC CHC CHC CHC CHC Brooklyn Family Care Center Hudson River Health Care Manhattan’s Physician Group 95 St. Manhattan’s Physician Group 125 St. Urban Health Plan n=2 n=34 n=6 n=14 Open Door Family Health Center n=23 CHCs n=12 PATIENTS n=159 SPECIMENS n=318 • Protocol • Consent oEnglish oSpanish • Methods • Database • Ontology • Biospecimen Repository Hair Braiding Eyebrow Threading Cosmetics Infection Prevention Knowledge: Paired T-Test (p-value) Baseline to T1: 2.59 (0.0135) Baseline to T2: 4.12 (0.0003) N2 PBRN: STARNet San Antonio TX CDN (New York) CAMP Nail Salon Unisex Beauty Salon Waxing CDN PBRN2 PBRNs n=4 Barberhop MRSA Knowledge: Paired T-Test (p-value) Baseline to T1: 6.81 (<.0001) Baseline to T2: 6.25 (<.0001) n=50 StarNet ACCESS LFHC* (Texas) (Chicago) (New York) CHC CHC CHC CHC CHC CHC Treviño Family Clinic University Health System Kling Adult Medicine Madison Adult Medicine LFHC (Family Physician) LFHC (Park Slope) n=8 n=7 n=0 n=0 n=0 n=8 *Incubator PBRN CAMP Incision/ Drainage Specimens & Nasal Specimens BioReference Labs (Culture & Sensitivity) (Antibiograms) (Purified Sub-Cultures) (+) MRSA & MSSA Rockefeller/ Tomasz Lab for Molecular EPI & Whole Genome Seq • The South Texas Ambulatory Research Network is composed of small group practices or solo clinicians. • Members are primary care physicians, clinical staff, medical students who provide service for patients from the San Antonio area to the Lower Rio Grande Valley and Corpus Christi communities. PBRN Pilot Local Clinical Labs (Culture & Sensitivity) https://iims.uthscsa.edu/STARNet/home Manhattan’s Physician Group 95th Street Manhattan’s Physician Group 125th Street 4 PBRNs 12 CHCs 159 Patients 318 Specimens University Health System CAMP Lutheran Family Health Centers (LFHCs) Incubator PBRN Access Community Health Network (ACCESS) + Trevino Family Clinic Community Health Centers Hospitals Presented at SCTS Translational Science Conference 2013, (Washington, DC) by: • Shirish Balachandra, MD Maria Pardos de la Gandara, MD, PhD Postdoctoral Associate Laboratory of Microbiology and Infectious Diseases The Rockefeller University N2 PBRN: Network of Networks Community-Engaged Research Pilot Project: CAMP Dissemination • Recurrent Furunculosis in a Community-Acquired S. aureus Infection Caused by a Strain Belonging to the USA300 Clone of MRSA Presented at the 13th Conference of the International Society of Travel Medicine, May 19-23, 2013, Maastricht, The Netherlands, Method: To engage and recruit two hospitals in the Greater New York Metropolitan Area to enroll in-patient (HA-MRSA) and out-patient (CA-MRSA) patients for clinical and microbiological analyses, and expand our CA-MRSA Surveillance Network to a wider range of healthcare providers Participating Hospitals: CAMP Dissemination Cases of Community-Acquired MRSA (CA-MRSA) Among Immigrants Seen in NYC Community Health Centers + Kling Adult Medicine Madison Family Health Incision/ Drainage Specimens & Nasal Specimens BioReference Labs (Culture & Sensitivity) (Antibiograms) (Purified Sub-Cultures) (+) MRSA & MSSA Park Slope LFHC Family Physician LFHC PBRN Pilot Local Clinical Labs (Culture & Sensitivity) Rockefeller/ Tomasz Lab for Molecular EPI & Whole Genome Seq Funded in part by AHRQ Grant: P30 HS 021667 N2 PBRN: Access Community Health CHICAGO IL • Composed of 40 health centers that provide preventive care, chronic disease management, and support services to underserved communities • Advance a continuum of care by partnering healthcare providers with outreach staff, case managers, social workers, and substance abuse counselors • Largest provider of primary care for Medicaid beneficiaries in Illinois http://www.accesscommunityhealth.net/ N2 PBRN: Lutheran Family Health Centers Network CAMP Town Halls & Focus Groups: BROOKLYN NY (incubator PBRN) Qualitative Findings Demonstrated Convergence of CER/PCOR Interests • The Lutheran Family Health Centers (LFHC) network provides high quality, affordable outpatient primary health care and support services close to home. • As one of the largest Federally Qualified Health Center (FQHC) networks in the nation, LFHC includes 9 primary care sites, 28 school based health/dental clinics and numerous social support services. With approximately 86,000 patients, the LFHC network handles nearly 530,000 visits annually Pragmatic Clinical Trial Infrastructure (PCTi) Use Case: CA-MRSA RECURRENCE PREVENTION CER/PCOR Study To compare outcomes, for patients presenting with SSTIs and diagnosed with CAMRSA, randomized to one of two interventions: • Patients: Responses from the RPPS patient focus group indicated that many patients participated in the CAMP study in order to contribute to knowledge about CA-MRSA transmission and recurrence. Outcomes that patients were most concerned about include: recurrence, pain and inability to work. [1] Standard CDC-Guidelines Directed Usual Care, including incision, drainage, and oral antibiotics • Clinicians: “[It is assumed that] colonization is ongoing, because we’ve had patients return with recurrent infections. …If you just use systemic antibiotics, the nasal colonization persists. Another question to consider is if the source is in the house. We can take all measures to decolonize the person but if the infection is still in the house (pet, towel, sheets, etc), then it’s a huge factor.” – Dr. Balachandra [2] CDC-Guidelines-directed Usual Care combined with interventions conducted in the home setting to reduce re-infection and transmission to family/household members • Laboratory Investigators: “Does the MRSA recurrent phenotype reflect a single or multiple genotypes? https://www.lutheranhealthcare.org • Clinical Investigators: 31% of MRSA+ wounds and 28% of MSSA+ wounds are recurrent Funded by PCORI CER 1402 10800 (01/01/2015) CAMP2 Specific Aims & Logic Model Team Grant-writing Tasks Each Team consisted of: – CHC Clinician – Rockefeller Investigator – CDN PBRN Staff Member Group Discussion (30 minutes) – – – – Brainstorming and writing Discussion, Review Editing References added by CDN Staff CDN Efficacy Reach Effectiveness N2 Effectiveness Dissemination & Implementation CDN N2 PCORnet Task One: Home Assessment 1. Community Health Worker Training Module 2. Identifying Household Members 3. Approach and Consent 4. Conducting Patient Education Task Two: Home Intervention 1. Administering Questionnaire 2. Self-Sampling for CA-MRSA Carriage 3. Environmental Sampling for MRSA Contamination 4. Specimen Transport NYC-CDRN Dissemination & Implementation Scale-Up PCORnet Scale-Up Sustainability CDN PBRN & N2 -PBRN • Adaptation of Existing Templates • Models of Stakeholder Engagement – – – – – Aim 1: To evaluate the comparative effectiveness of a CHW/Promotora-delivered home intervention (Experimental Group) as compared to Usual Care (Control Group) on the primary patient-centered and clinical outcome (SSTI recurrence rates) and secondary patient-centered and clinical outcomes (pain, depression, quality of life, care satisfaction) using a two-arm randomized controlled trial (RCT). Aim 2: To understand the patient-level factors (CA-MRSA infection prevention knowledge, self-efficacy, decision-making autonomy, prevention behaviors/adherence) and environmental-level factors (household surface contamination, household member colonization, transmission to household members) that are associated with differences in SSTI recurrence rates. Aim 3: To understand interactions of the intervention with bacterial genotypic and phenotypic variables on decontamination, decolonization, SSTI recurrence, and household transmission. Aim 4 [Exploratory]: To explore the evolution of stakeholder engagement and interactions among patients and other community stakeholders with practicing community-based clinicians and academic laboratory and clinical investigators over the duration of the study period. • Scalability www.CDNetwork.org Building a Learning Healthcare System Requires Designing Studies with these Principles: • Analyzing, reviewing & providing feed-back of EHR data to practices and clinicians at multiple levels: – patient – clinician – practice • Disseminating and implementing research on evidencebased (EB)/effective interventions and best practices • Linking routine workflow with EB-interventions • Carrying this out within each clinical practice nested within multiple Healthcare Systems • Aligning incentives Communities Clinicians Patients Researchers Policy-makers NYC-CDRN Key Collaborators Health Systems • • • • • • • PI: Clinical Directors Network (CDN) Columbia/P&S Montefiore/Einstein Mount Sinai/Icahn New York-Presbyterian NYU/Langone Weill Cornell (Lead Organization) Rainu Kaushal, MD MPH Weill Cornell Medical College Co-PI: Jonathan N. Tobin, PhD CDN/Rockefeller University Co-PI: George Hripcsak, MD MS Columbia University Key Scientific/Technical Partners • The Rockefeller University Hospital • NY Genome Center (NYGC) • Biomedical Research Alliance of NY (BRANY) • HealthIX • Bronx RHIO (BRIC) Clinical Research Data • Demographics • Diagnoses • Procedures • Medications • Test Results (Labs, Radiologic Scans) • Health Insurance Claims • Omics • Patient-Reported Outcomes Successful PBRNs = Power of Connectivity Implications for Clinical Care, Teaching, Research & Public Health • • • Acceleration of study conduct and implementation of results Integration of all activities across the full translational research spectrum Development of high performing workforce, including • • • • PCORnet Organizational Structure • 109 Exploring the Use of Social Network Analysis to Measure Stakeholder Engagement: CAMP Team Connectivity Source: “Introducing PCORnet: The National Patient-Centered Clinical Research Network,” http://pcornet.org/resource-center/other-resources/ CDN eLearning • CDN weekly listserv course announcements reaches 25,135 Clinicians, Clinical Researchers and Healthcare Policy-makers • As of February 2015: – 815 Webcasts – 640 Hours of CME/CDE CECH/CESW Credits awarded – 30,110 Total Participants Each dot (node) represents one individual and the line (edge) between them represents a connection between those individuals. The darkness of the edges between nodes indicates a stronger connection between the two nodes. The strongest connections between individuals are clustered in the center of the graph, and include stakeholders representing The Rockefeller University, CDN and the CHCs. This network visualization includes data from a period of three years, and represents the cumulative total of opportunities for the network of stakeholders to build connections to each other (since interim communications, such as those via small-group face-to-face, telephone and email are not represented, the densities may actually underestimate the level of connectivity across stakeholders). Summary: Participating in PBRNs and Learning Healthcare Initiatives • 20,200 Live Participants • 9,910 Library Participants new types of clinician-investigators who spend most of their career seeing patients in practice-based settings carrying out research in practice-based settings engaging clinicians as investigators who design, conduct, analyze, disseminate and implement studies Real-time flow of data and information extracted from care settings used for population health planning and evaluation, as well as individual patient treatment Increasing patient engagement in decision-making and governance Summary: Learning Healthcare Initiatives Why Efforts are Working • Strong Academic-PBRN Partnerships • Strong Community-PBRN Partnerships • Strong PBRN-PBRN Partnerships Keys to Success • Diverse topic offerings • Protocol specific topic offerings • Offer timely, relevant Continuing Education (CME, CNE, CDE, CECH, CESW) Key Barriers • • • • Clinical demands/productivity protected time Competing Priorities (JCAHO, PCMH, MU, ACO) ACA Uncertainties Lack of clear linkage between QI & Research Jonathan N. Tobin, Ph.D. President/CEO CLINICAL DIRECTORS NETWORK, INC. (CDN) Enhances Retention and Recruitment Professional Development Training and Education Role Diversification Job Satisfaction Improves Clinical Skills Clinical Guidelines and Best Practices Adoption Clinical Quality Decreases Implementation Time Stress & Burnout Co-Director for Community Engaged Research & Adjunct Professor Allen and Frances Adler Laboratory of Blood and Vascular Biology Center for Clinical and Translational Science THE ROCKEFELLER UNIVERSITY Professor, Department of Epidemiology & Population Health ALBERT EINSTEIN COLLEGE OF MEDICINE OF YESHIVA UNIVERSITY Clinical Directors Network (CDN) 5 West 37th Street, 10th Floor New York, NY 10018 USA TEL 212-382-0699 ext. 234 FAX 212-382-0669 [email protected] www.CDNetwork.org www.eClinician.org TRANSLATING RESEARCH INTO PRACTICETM WWW.CDNETWORK.ORG Clinical Directors Network, Inc. (CDN) is dedicated to the continuing training and education of clinicians in Health Centers and other practices serving low-income and minority populations. Winter/Spring 2015 Free CME-Accredited Programs available to everyone via webcast at www.CDNetwork.org To register for a live webcast, visit Upcoming Webcasts To view an on-demand webcast, click on Webcast Library and use our tracks to choose from hundreds of archived webcasts March 2015 WEBCASTS The 2015 Beatrice Renfield Lecture in Research Nursing NextGen Health Care: The Stars are Aligned Presented by: Afaf I. Meleis, PhD, Dr. P.S. (hon), FAAN, Dean Emerita and Professor of Nursing and Sociology at University of Pennsylvania School of Nursing Sponsored by: The Beatrice Renfield Foundation and The Rockefeller University University Center for Clinical and Translational Science Tuesday, March 3, 2015, 6:00-7:00 PM EST Discovering the Microbiome of New York City Presented by: Christopher Mason, PhD, Principal Investigator at Mason Labs, Assistant Professor of Physiology and Biophysics and an Assistant Professor in the Institute for Computational Biomedicine at Weill Cornell Medical College Sponsored By: The Rockefeller University Center for Clinical and Translational Science, N2 PBRN Virtual Training Series (AHRQ, Grant No. 1 P30-HS-021667), Patient-centered CER Study of Home-based Interventions to Prevent CA-MRSA Infection Recurrence (CAMP-2) ( PCORI, Grant No. CER 1402 10800) Wednesday, March 4 2015, 11:30 AM – 12:30 PM EST April 2015 WEBCASTS Engaging Patients to Inform Community Health Research within a Practice Based Research Network Presented By: Kay Dickerson, BA, Patient Engagement Panel Co-Founder, Lynn Robbins, Patient Engagement Panel Co-Founder Kathy Norman, MS, Patient Engagement Panel Co-Founder, Nate Warren, MPH, Patient Engagement Coordinator Sponsored By: N2 PBRN Virtual Training Series (AHRQ, Grant No. 1 P30-HS-021667) featuring the Oregon Community Health Information Network (OCHIN) Wednesday, April 8, 2015, 4:00-5:00 PM EST RECENT WEBCASTS Viral Hepatitis and Opportunities for Action Presented By: Nicole Smith, PhD, MPH, MPP CAPT US Public Health Service, Associate Director, Policy Office, Division of Viral Hepatitis, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention Sponsored by: N2 PBRN Virtual Training Series (AHRQ, Grant No. 1 P30-HS-021667) A Multi-Level Community Engaged Study Exploring Barriers to Clinical Trials and Cancer Care Among Black Bostonians Presented by: Linda Sprague Martinez, PhD, Assistant Professor, Public Health and Community Medicine, Research Director, Center for Community Health Education Research and Service, Inc. (CCHERS), Elmer R. Freeman, MSW, Executive Director, Center for Community Health, Chidinma Osuagwa, B.A.Sc., Research Assistant, CCHERS, Elizabeth Ann Powell, MPH, Program Manager , Cancer Care Equity Program at Massachusetts General Hospital, Karen M. Winkfield, MD, PhD, Assistant Professor, Department of Radiation Oncology, Harvard Medical School, Director, Hematologic Services, Radiation Oncology, Massachusetts General Hospital Sponsored by: N2 PBRN Virtual Training Series, (AHRQ, Grant No. 1 P30-HS-021667) Using Technology for Patient Engagement: Examples from the Charles B. Wang Community Health Center Presented by: Lynn Sherman, CFO, Charles B. Wang Community Health Center Sponsored by: N2 PBRN Virtual Training Series (AHRQ, Grant No. 1 P30-HS-021667) featuring the Association of Asian Pacific Community Health Organizations (AAPCHO) THE ROCKEFELLER UNIVERSITY CENTER FOR CLINICAL AND TRANSLATIONAL SCIENCE (CCTS) WEBCAST SERIES Diet Versus Bariatric Surgery In Obesity And Type 2 Diabetes Treatment Presented by: Ana Emiliano, MD, Instructor in Clinical Investigation, The Rockefeller University Programmable Bacteria for Cancer Diagnostics and Therapy Presented by: Tal Danino PhD, MIT, Bhatia Koch Institute for Integrative Cancer Research Lab Understanding the Research Participant’s Experience: Outcome Measures to Improve Clinical Research Presented by: Rhonda G. Kost, MD, Clinical Research Officer, The Rockefeller University Center for Clinical and Translational Science (CCTS) Maximizing the Effectiveness of Therapy against Hepatitis C Infection Presented by: Donald Kotler, MD, Chief of the Division of Gastroenterology and Liver Disease at St. Luke's-Roosevelt Hospital Visit www.CDNetwork.org/Rockefeller. Funded by The National Institutes of Health - National Center for Advancing Translational Sciences (NIH-NCATS) Grant No. 8 UL1 TR000043 and the 2011 CTSA Administrative Supplement Award. Contents are solely the responsibility of the authors and do not necessarily represent the official view of NIH or NCATS. CDN can help you disseminate your research, conduct your own web-based training, and provide Continuing Education accreditation. Call us at (212) 382 0699 x 243. WEBCAST SERIES The Rockefeller University Center for Clinical and Translational Science (CCTS) Series www.rockefeller.edu/ccts/communityengagement www.CDNetwork.org/Rockefeller AIDS Education and Training Center National Multicultural Center Howard University College of Medicine www.CDNetwork.org/AETCNMC RCHN Community Health Foundation Webcast Series Hospital Community Benefit Obligations: Implications Centers and Communities www.rchnfoundation.org www.CDNetwork.org/RCHN National Association of Community Health Centers (NACHC) Risk Management Series www.NACHC.com www.CDNetwork.org/NACHC Health Care Acquired Infection (HAI) Prevention Training for Ambulatory Surgical Centers (ASCs) & Train-the-Trainer Workshop www.CDNetwork.org/HAI HIV/HEPATITIS C WEBCAST LIBRARY Further webcasts on these topics are available in our Webcast Library at www.CDNetwork.org Taking a History of Sexual Health- Opening the Door to Effective HIV Prevention and Care Presented by: Harvey J. Makadon MD, Director, National LGBT Health Education Center, The Fenway Institute, Fenway Health, Clinical Professor of Medicine, Harvard Medical School Sponsored by: N2 PBRN Virtual Training Series (AHRQ, Grant No. 1 P30-HS-021667) Ending LGBT Invisibility in Health Care: Obtaining Data on Sexual Orientation and Gender Identity in Clinical Settings Presented by: Harvey J. Makadon MD, Director, National LGBT Health Education Center, The Fenway Institute, Fenway Health, and Clinical Professor of Medicine, Harvard Medical School Sponsored by: N2 PBRN Virtual Training Series (AHRQ, Grant No. 1 P30-HS-021667) Young African American Men and HIV: An Interactive Response to a Community Health Issue Presented by: John Schneider, MD, MPH, Infectious Disease, Access Grand Blvd. Health and Specialty Center, Milton “Mickey” Eder, PhD, Director of Research and Evaluation, Access Community Health Network Sponsored by: N2 PBRN Virtual Training Series (AHRQ, Grant No. 1 P30-HS-021667) Maximizing the Effectiveness of Therapy Against Hepatitis C Infection Presented by: Donald Kotler, MD, Chief of the Division of Gastroenterology and Liver Disease at St. Luke's-Roosevelt Hospital Sponsored by: The Rockefeller University Center for Clinical and Translational Science (CCTS) and N2 PBRN Virtual Training Series (AHRQ, Grant No. 1 P30-HS-021667) ENHANCING COMMUNITY HEALTH CENTER PCORI ENGAGEMENT (EnCoRE) This work was partially supported through a Patient-Centered Outcomes Research Institute (PCORI) Program Award (NCHR 1000-30-10-10 EA-0001). With support from: N2PBRN – Building a Network of Safety Net PBRNs Funded by: Agency for Healthcare Research and Quality (AHRQ) Grant # 1 P30 HS 021667. Session 3: Community Engagement in Research Presenters: Michelle Jester, Research Manager, National Association of Community Health Centers Rosy Chang Weir, Director of Research, Association of Asian Pacific Community Health Organizations (AAPCHO) Session 4: Measurement, Measurement Error, and Descriptive Statistics Presenter: Vicki M. Young PhD, Chief Operating Officer, South Carolina Primary Health Care Association Session 5: Sample Size, Power and Sampling Methods Presenters: Jonathan N. Tobin, PhD, FACE, FAHA, President/CEO, Clinical Directors Network, Inc., Professor, Department of Epidemiology & Population Health, Albert Einstein College of Medicine of Yeshiva University; MaryAnn McBurnie, PhD Senior Investigator, Kaiser Permanente Center for Health Research Steering Committee Chair, Community Health Applied Research Network (CHARN) For more information on the EnCoRE curriculum and to view new additions to the Live Session Library, visit www.CDNetwork.org/EnCoRE Clinical Directors Network, Inc. (CDN) 5 West 37th St. 10th FL. • New York, NY 10018 USA • TEL 212-382-0699 ext. 242 • FAX 212-382-0669 [email protected] www.CDNetwork.org www.eClinician.org