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This study explores the implementation context in rural primary care settings for an obesity treatment trial. It examines the challenges and lessons learned in patient and stakeholder engagement, implementation decisions and adaptations, and adoption and reach. The study also highlights the key factors affecting obesity treatment in primary care and provides insights into improving patient outcomes.
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Implementation Context in Rural Primary Care Settings:Lessons learned from an obesity treatment trial Christie Befort, PhD UNMC Dissemination and Implementation Science Workshop 8-7-18
Overview • RE-POWER trial design • Patient and stakeholder engagement • Implementation decisions and adaptations • Adoption and reach • Local context
Obesity treatment in primary care falls short • Only 20-40% of patients get diagnosed and counseled • Wide variation in counseling methods • Training gap for PCPs and auxiliary health professionals • Reimbursement may be insufficient
Behavioral obesity treatment trials in primary care Wadden et al., JAMA 2014
Intensive Behavior Therapy for Obesity Medicare Claims • Authorized by CMS in 2011 • Provided by PCP or incident to physician’s service • Face-to-face, 15 minutes, ~$27/session • 14 sessions in 6 months • If > 3 kg loss, continue with monthly sessions • <1% of eligible beneficiaries received IBT for Obesity • Average 2 sessions per patient Source: Kaiser Health News, USA Today, 2013
PCORI 2014 RFA Obesity Treatment Options Set in Primary Care for Underserved Populations • Comparative effectiveness pragmatic trial testing alternatives against Medicare-reimbursable IBT model • Two funded trials • University of Kansas Medical Center • Pennington (Louisiana)
Rural Obesity Disparity • 4 out of 10 rural Americans • Drivers: • Cultural eating patterns • Low leisure-time activity levels • Less environmental support for PA • Less access to weight control programs Befort et al., 2012 NHANES 2005-2008
BMI 30-45 kg/m2 Age 20-75 years PCP clearance Primary Outcome: Weight change at 2 years Secondary Outcomes: Quality of life, metabolic syndrome, implementation process measures
Very explanatory • Rather explanatory • Equally pragmatic/explanatory • Rather pragmatic • Very pragmatic
Patient and provider engagement • Study design phase • Patient focus group and formation of Patient Advisory Board • Interviews with provider stakeholders • Study implementation • Engagement kick-off meeting • Central training + 2-3 site visits to launch study locally • 1-2 clinic site visits per year • Monthly phone meetings • Weekly Weigh-In Newsletter • Facebook and website • Joint presentations at national and state meetings
Patient-Centered Engagement Principles Shared vision and mission Informal, everyone on first name basis Hard work acknowledged and celebrated Input on budget and payments Sharing of experiences across providers and patients Patients are experts in communication, consenting, and retention
Intervention behavioral targets Energy Deficit • ↓ caloric intake • 1200-1800 kcal/day • High FV, optional prepackaged meals • ↑ physical activity • Moderate intensity • 225 min/week Knowledge Behavioral Modification • Self-monitoring • Goal-setting • Stimulus control • Cognitive reframing • Problem-solving Self-regulation Goal: 10% weight loss, minimize regain
PAB helped tailor materials to rural setting • Participated in mock sessions and reviewed all materials • 6th grade reading level • Shopping on a budget • Recipes and meal plans • Access barriers for PA facilities and fresh produce • Prayer incorporated as stress management strategy • Alternative home-based physical activities when conditions not conducive to walking
Fee-for-Service Counseling Visits Year 1 20 visits Year 2 12 visits
PCMH vs. DM CounselingVisits Year 1 24 visits Year 2 12 visits
Implementation Decisions Pragmatic...but how do these factors influence outcomes? • Counselor selection • Provider training • ‘Fidelity’ monitoring • Clinic workflow and care coordination • Practice payments
Local counselor selection • Chosen locally • Our criteria: available, willing, interested • 25% reported some prior training in health behavior coaching/counseling • 32% reported some prior training in nutrition or exercise science • <1% (2) with prior experience in weight loss counseling
Group counselors use simplified tracking and self-assessment
Local clinic process and care coordination • Optional EMR documentation for sessions • Variable level of PCP participation and coordination with treating PCP • Usual workflow for session reminders • Optional billing for Medicare patients (FFS) • Group visit adaptations (PCMH) • Session times (requested before/after hours) • Location of meeting space • Option of phone group meetings after first 14 sessions • Local activities (potluck meals, exercise and cooking demonstrations, PCP guest speakers)
How and how much to pay the practices? • Paid via monthly invoices based on visit documentation in REDCap • Interventionist payment model determined locally
Adoption by practices • 77 clinics approached • 39 contracts; 3 dropped • 1 MD illness (FFS) • 1 lost staff (PCMH) • 1 VA clinic IRB issues (FFS) • 36 enrolled • 21 KU Medical Center • 10 Marshfield Clinic • 5 UN Medical Center
Adoption: Reasons for participating • Pre-implementation interviews at KS sites • 17 Lead PCPs • 17 Practice liaisons * MDs more likely to rate financial incentives as Very Important (8 MDs vs 1 practice liaison)
Patient Recruitment • Clinic referrals and targeted mailings • Patient registries (zip, age, BMI, date of last visit) • Process highly variable by clinic • Advertisements left up to local clinics
Recruitment response • Patients opt-in by contacting study line • 2466 patient contacts • 56% from mailing • Response rate by clinic: median 12% (range 2-27%) • 20% from provider referral • 7% family/friend referral • 17% other/unknown • 1931 completed screening
Eligibility criteria • Not excluding: weight loss medications, recent weight loss, current depression, binge eating disorder, serious mental illness, insulin-dependent diabetes, planned joint replacements, inability to walk, uncontrolled hypertension or hyperlipidemia, cardiovasular or cancer history outside 6 month window, dietary restrictions
Reach: Eligibility and participation rates 138 BMI 52 medical
Participant characteristics (n = 1432) • 76.7% female • 54.6 ± 11.9 years-old • 95.8% White non-Hispanic • 47% isolated rural; 18% small rural; 34% large rural (RUCA) • Medical conditions • 46% hypertension • 34% arthritis • 24% diabetes • 11% cancer • 39% depression (32% current psychotropic meds) • Patients enrolled vs those mailed to: • Women (77% vs 56%) • White non-Hispanic (96% vs 85%) • Older (54.6 vs 50.9 years old)
Broad eligibility associated with high number of SAEs • 207 SAEs (3 deaths, 204 hospitalizations) • 46 cardiovascular • 64 orthopedic (unplanned) • 22 GI • 75 other • 3 possibly-probably related • orthopedic, syncope
Mixed methods evaluation of context, barriers and facilitators • Pre, mid, post surveys and structured interviews • 2 providers per site • Field notes/ observations Consolidated Framework for Implementation Research (CFIR)
Other provider/clinic-level measures Potential predictors of patient attendance and satisfaction • Counselor-level: • prior training and experience • self-assessed and observed competencies • Clinic-level: • history of offering weight management services
Opportunities and challenges for implementation • Representativeness: how do we reach those who need it most? • Clinical integration for addressing co-morbid medical needs • Importance of local tailoring • Rural access barriers and culture • Regional and racial/ethnic variation • Local in-person vs. entirely remote • Local capacity, training strategy • Optimal amount of face-to-face contact
Problems must be solved in work and in place, with particular knowledge, fidelity, and care, by people who will suffer the consequences of their mistakes. There is no theoretical or ideal practice. Practical advice or direction from people who have no practice may have some value, but its value is questionable and is limited. -Wendell Berry, Solving for Pattern, 1981
Collaborators Co-Investigators • Edward Ellerbeck, MD • Allen Greiner, MD • Kim Kimminau, PhD • Byron Gajewski, PhD • Jeff VanWormer, PhD • Terry Huang, PhD • Cyrus DeSouza, MD • Mike Perri, PhD Provider Stakeholders • Jen Brull, MD • Bob Kraft, MD • Cindie Wolff, MD • Greg Thomas, MD • Doug Gruenbacher, MD • Krista Postai, CEO • Gregg Wenger, MD • Bryon Bigham, MD • Bethany Enoch, MD • Beth Oller, MD • Jen McKenney, MD • Libby Hineman, MD • Heather Harris, MD Staff, students • Stacy McCrea-Robertson, MS • Danny Kurz, MPH • Leigh Quarles, MPH • Susan Ahlstedt, LCSW • Nick Thompson, MPH • Lara Bennett, MS, RD • Eryen Nelson, MPH • Nick Marchello, RD • Stephanie Punt, MS • Fatima Rahman