Clinic variation in recruitment metrics, patient characteristics and treatment use in a randomized clinical trial of osteoarthritis management.

Abstract

Background

The Patient and PRovider Interventions for Managing Osteoarthritis (OA) in Primary Care (PRIMO) study is one of the first health services trials targeting OA in a multi-site, primary care network. This multi-site approach is important for assessing generalizability of the interventions. These analyses describe heterogeneity in clinic and patient characteristics, as well as recruitment metrics, across PRIMO study clinics.

Methods

Baseline data were obtained from the PRIMO study, which enrolled n = 537 patients from ten Duke Primary Care practices. The following items were examined across clinics with descriptive statistics: (1) Practice Characteristics, including primary care specialty, numbers and specialties of providers, numbers of patients age 55+, urban/rural location and county poverty level; (2) Recruitment Metrics, including rates of eligibility, refusal and randomization; (3) Participants' Characteristics, including demographic and clinical data (general and OA-related); and (4) Participants' Self-Reported OA Treatment Use, including pharmacological and non-pharmacological therapies. Intraclass correlation coefficients (ICCs) were computed for participant characteristics and OA treatment use to describe between-clinic variation.

Results

Study clinics varied considerably across all measures, with notable differences in numbers of patients age 55+ (1,507-5,400), urban/rural location (ranging from "rural" to "small city"), and proportion of county households below poverty level (12%-26%). Among all medical records reviewed, 19% of patients were initially eligible (10%-31% across clinics), and among these, 17% were randomized into the study (13%-21% across clinics). There was considerable between-clinic variation, as measured by the ICC (>0.01), for the following patient characteristics and OA treatment use variables: age (means: 60.4-66.1 years), gender (66%-88% female), race (16%-61% non-white), low income status (5%-27%), presence of hip OA (26%-68%), presence both knee and hip OA (23%-61%), physical therapy for knee OA (24%-61%) and hip OA (0%-71%), and use of knee brace with metal supports (0%-18%).

Conclusions

Although PRIMO study sites were part of one primary care practice network in one health care system, clinic and patient characteristics varied considerably, as did OA treatment use. This heterogeneity illustrates the importance of including multiple, diverse sites in trials for knee and hip OA, to enhance the generalizability and evaluate potential for real-world implementation.

Trial registration

Clinical trial registration number

NCT 01435109.

Department

Description

Provenance

Citation

Published Version (Please cite this version)

10.1186/1471-2474-15-413

Publication Info

Allen, Kelli D, Hayden B Bosworth, Ranee Chatterjee, Cynthia J Coffman, Leonor Corsino, Amy S Jeffreys, Eugene Z Oddone, Catherine Stanwyck, et al. (2014). Clinic variation in recruitment metrics, patient characteristics and treatment use in a randomized clinical trial of osteoarthritis management. BMC musculoskeletal disorders, 15(1). p. 413. 10.1186/1471-2474-15-413 Retrieved from https://hdl.handle.net/10161/29991.

This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.

Scholars@Duke

Allen

Kelli Dominick Allen

Adjunct Professor in the Department of Medicine
  • Improving care and outcomes for individuals with osteoarthritis and other musculoskeletal conditions with an emphasis on non-pharmacological therapies including physical activity, weight management, rehabilitation services, and pain coping
    * Understanding rand reducing disparities in musculoskeletal conditions
    * Musculoskeletal conditions in U.S. military Veterans
    * Pragmatic clinical trials
    * Adaptive interventions
Bosworth

Hayden Barry Bosworth

Professor in Population Health Sciences

Dr. Bosworth is a health services researcher and Deputy Director of the Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT)  at the Durham VA Medical Center. He is also Vice Chair of Education and Professor of Population Health Sciences. He is also a Professor of Medicine, Psychiatry, and Nursing at Duke University Medical Center and Adjunct Professor in Health Policy and Administration at the School of Public Health at the University of North Carolina at Chapel Hill. His research interests comprise three overarching areas of research: 1) clinical research that provides knowledge for improving patients’ treatment adherence and self-management in chronic care; 2) translation research to improve access to quality of care; and 3) eliminate health care disparities. 

Dr. Bosworth is the recipient of an American Heart Association established investigator award, the 2013 VA Undersecretary Award for Outstanding Achievement in Health Services Research (The annual award is the highest honor for VA health services researchers), and a VA Senior Career Scientist Award. In terms of self-management, Dr. Bosworth has expertise developing interventions to improve health behaviors related to hypertension, coronary artery disease, and depression, and has been developing and implementing tailored patient interventions to reduce the burden of other chronic diseases. These trials focus on motivating individuals to initiate health behaviors and sustaining them long term and use members of the healthcare team, particularly pharmacists and nurses. He has been the Principal Investigator of over 30 trials resulting in over 400 peer reviewed publications and four books. This work has been or is being implemented in multiple arenas including Medicaid of North Carolina, private payers, The United Kingdom National Health System Direct, Kaiser Health care system, and the Veterans Affairs.

Areas of Expertise: Health Behavior, Health Services Research, Implementation Science, Health Measurement, and Health Policy

Chatterjee

Ranee Chatterjee

Associate Professor of Medicine
Coffman

Cynthia Jan Coffman

Professor of Biostatistics & Bioinformatics
Corsino

Leonor Corsino

Associate Professor of Medicine

Dr. Leonor Corsino is a Board- Certified Adult Endocrinologist, an experienced physician-scientist, and an organizational and health professional education leader. She offers an extensive and diverse leadership background with successfully implementing innovative clinical, research, and workforce development and education programs. Her expertise and strengths lie in her diverse portfolio that expands from basic science to clinical and community-engaged research, innovative curriculum development, successful clinical program implementation, and collaborations.

Dr. Corsino's research focuses on diabetes, obesity, and related complications and health disparities, with a particular interest in Hispanic/Latino populations. She has successfully led and extensively collaborated with investigators locally, nationally, and internationally. Her research and contribution have been recognized locally and nationally with many awards, including the NIH/NIDDK Network of Minority Health Research Investigators medallion.

Dr. Corsino has extensive leadership experience, including her current roles as a member of the Executive Committee Member and Associate Director of the Duke School of Medicine Masters of Biomedical Sciences (MBS), Co-Director for the Duke Clinical and Translational Science Institute - Community Engagement Core / Community-Engaged Research Initiative (CERI) and Associate Dean for Students Affairs/Advisory Dean Duke School of Medicine MD program.

She is the former Co-Director, Education and Training Sub-core of the Duke Center for REsearch to AdvanCe Healthcare Equity, Director of the Duke Population Health Improvement Initiative Program, Associate Chair for the Department of Medicine Minority Recruitment and Retention Committee, and Associate Director for the Duke School of Medicine Office of Faculty Mentoring Training.

Dr. Corsino's leadership led to the successful development and implementation of unique and innovative programs, including the Duke MBS program selective curriculum, the REACH Equity Summer Undergraduate Research Program, the CTSI/CERI Population Health Improvement Award, E-library, consultation services, and the interactive platform for the Duke Population Health Improvement Program.

Her visionary and innovative initiatives have enhanced patient care, population health, and the recruitment, training, development, and support of health professions students, residents, fellows, and junior faculty, having a significant, palpable, impact on the diversity of health profession workforce and health disparities research.

 

 

Oddone

Eugene Zaverio Oddone

Professor Emeritus of Medicine

I am a health services researcher whose primary research interests are: 1) evaluating the effectiveness of primary care with an emphasis on chronic disease, 2) assessing the reasons and testing interventions to reduce racial variation in access the health care and utilization of health services, 3) determining appropriate interventions to improve blood pressure control for hypertensive patients treated in primary care. I have research expertise in racial variation, blood pressure control, disease management, and tele-medicine. I also have methodologic expertise in designing and testing health services interventions in multi-site clinical trials.

Key words: primary care, racial variation, quality of care, hypertension

Yancy

William Samuel Yancy

Professor of Medicine

Impact of obesity on health, health care delivery, quality of life.
Diet and other weight loss interventions
Preventive medicine

Dolor

Rowena Joy Dolor

Professor of Medicine

Rowena J. Dolor, MD, MHS did her medical training and internal medicine residency at Duke University Medical Center. She completed the Ambulatory Care/Health Services Research fellowship at the Durham VA Medical Center in 1996 and obtained her Masters in Health Sciences degree in Biometry (renamed MHS in Clinical Research) from the Duke University School of Medicine in 1998. Dr. Dolor was a staff physician in the Ambulatory Care Service at the Durham VA Medical Center and Research Associate at the Center for Health Services Research in Primary Care at the Durham VAMC from 1995-2012.  She is currently an investigator of several federally-funded projects conducted in the community-based setting. Dr. Dolor served as a member of the AHRQ PBRN Resource Center Steering Committee and co-chaired the NAPCRG PBRN conference from 2012-2016.

Since 1996, Dr. Dolor has been the director of the Primary Care Research Consortium (PCRC), a network of primary care practices in the Duke University Health System and outlying communities. The PCRC has participated in over 100 industry- and investigator-initiated studies on hypertension, hyperlipidemia, asthma, otitis, obesity, diabetes, depression, anticoagulation, and vaccines. In 2002, the Duke PCRC received grant funding from the Agency for Healthcare Research and Quality (AHRQ) for Primary Care Practice-based Research Networks (PBRNs). The focus of her research pertains to primary care clinical and outcomes research. She has helped lead a number of comparative effectiveness studies and large, pragmatic trials in the primary care setting.   In addition, Dr. Dolor has led or co-led networks in otolaryngology and integrative medicine.

Dr. Dolor has contributed to the development and methodology of Practice-based Research Networks (PBRNs). She has served as a co-investigator on three online resources to help researchers conduct multi-center research in the primary care practice-based setting – (1) A toolkit for building and sustaining health research partnership with practices and communities, http://www.researchtoolkit.org/index.php (2) Toolkit for Developing and Conducting Multi-site Clinical Trials in Practice Based Research Networks, http://www.dartnet.info/ClinicalTrialsPBRNToolkit.htm ; and (3) PBRN Research Good Practices (PRGP), http://www.napcrg.org/PBRNResearchGoodPractice

From July 2009-June 2012, she served as the Associate Director for the Duke EPC. She worked closely with the Director, Gillian Sanders PhD, in overseeing the day-to-day functioning of EPC projects and supervising EPC personnel.  The Duke EPC was awarded a contract entitled “American Recovery and Reinvestment Act of 2009: Comprehensive EPC Comparative Effectiveness Reviews for Effective Health Care” to serve within a core group of EPCs to focus on a comprehensive approach to comparative effectiveness review (CER) and evidence synthesis. The Duke EPC area of concentration was cardiovascular and pulmonary disorders.

She previously served as the principal investigator for the systematic literature review for the AHA Scientific Statement: Evidence-based guidelines for cardiovascular disease prevention in women published in 2004 and updated in 2007. She was the PI of four CER projects on “Noninvasive Technologies for the Diagnosis of Coronary Artery Disease in Women” and “Treatment Strategies for Women with CAD”, “PAD”, and “UA/NSTEMI” as well as upcoming CER topics on pulmonary arterial hypertension, peripheral artery disease and unstable angina/non-ST elevation myocardial infarction. 

Within the Duke Clinical and Translational Institute (CTSI), Dr. Dolor directs the collaboration with CTSI researchers on community-based PBRN projects. From 2011- 2014, she was co-chair of the CTSA PBRN Collaboration Workgroup, and a member of the Community Engagement Key Function Committee, the CTSA Strategic Goal 4 Combined Networking Group committee, and the CTSA Comparative Effectiveness Research Key Function Committee (CER KFC). Since September 2016, she serves as a Co-chair of the Dissemination, Implementation and Knowledge Transfer Workgroup within the Collaboration Engagement Domain Task Force.

In the fall of 2014, Dr. Dolor joined Vanderbilt part-time as a Consultant/Adjunct Associate Professor of Medicine within the Division of General Internal Medicine. Her role is to assist in the formation of the Meharry-Vanderbilt Clinical Research Network, a PBRN in the mid-Tennessee region.  In addition, she is a co-investigator on the Mid-South Clinical Data Research Network, a PCORnet awardee, to build the partnership with the community practices for comparative effectiveness studies that will utilize the electronic health records/information system infrastructure of the CDRN. 




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