Dataset Information

Weight loss in primary care: A pooled analysis of two pragmatic cluster-randomized trials.

ABSTRACT:

Objective

The aim of this study was to report the results of five weight-loss interventions in primary care settings in underserved patients and to compare the level of pragmatism across the interventions using the Pragmatic Explanatory Continuum Indicator Summary (PRECIS-2) tool.

Methods

Data from 54 primary care clinics (2,210 patients) were pooled from the Promoting Successful Weight Loss in Primary Care in Louisiana (PROPEL) and Rural Engagement in Primary Care for Optimizing Weight Reduction (REPOWER) cluster-randomized trials. Clinics were randomized to one of five comparators: PROPEL usual care, PROPEL combination of in-clinic and telephone visits, REPOWER in-clinic individual visits, REPOWER in-clinic group visits, or REPOWER telephone group visits.

Results

At 24 months, weight loss (kilograms) was -0.50 (95% CI: -1.77 to 0.76), -3.05 (-4.10 to -2.01), -4.30 (-5.35 to -3.26), -4.79 (-5.83 to -3.75), and -4.80 (-5.96 to -3.64) in the PROPEL usual care, REPOWER in-clinic individual visits, REPOWER telephone group visits, REPOWER in-clinic group visits, and PROPEL in-clinic and telephone visits arms, respectively. At 24 months, percentage of weight loss was -0.360 (-1.60 to 0.88), -3.00 (-4.02 to -1.98), -4.23 (-5.25 to -3.20), -4.67 (-5.69 to -3.65), and -4.69 (-5.82 to -3.56), respectively, in the five arms. The REPOWER in-clinic individual visits intervention was the most pragmatic and reflects the current Centers for Medicare and Medicaid Services funding model, although this intervention produced the least weight loss.

Conclusions

Clinically significant weight loss over 6 months in primary care settings is achievable using a variety of lifestyle-based treatment approaches. Longer-term weight-loss maintenance is more difficult to achieve.

SUBMITTER: Katzmarzyk PT

PROVIDER: S-EPMC9520994 | biostudies-literature | 2021 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Weight loss in primary care: A pooled analysis of two pragmatic cluster-randomized trials.

Katzmarzyk Peter T PT Apolzan John W JW Gajewski Byron B Johnson William D WD Martin Corby K CK Newton Robert L RL Perri Michael G MG VanWormer Jeffrey J JJ Befort Christie A CA

Obesity (Silver Spring, Md.) 20211029 12

<h4>Objective</h4>The aim of this study was to report the results of five weight-loss interventions in primary care settings in underserved patients and to compare the level of pragmatism across the interventions using the Pragmatic Explanatory Continuum Indicator Summary (PRECIS-2) tool.<h4>Methods</h4>Data from 54 primary care clinics (2,210 patients) were pooled from the Promoting Successful Weight Loss in Primary Care in Louisiana (PROPEL) and Rural Engagement in Primary Care for Optimizing ...[more]

PMID: 34714976

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Project description:BackgroundObesity is a major risk factor behind some of the most common problems encountered in primary care. Although effective models for obesity treatment have been developed, the 'reach' of these interventions is poor and only a small fraction of primary care patients receive evidence-based treatment. The purpose of this study is to identify factors that impact the uptake (reach) of an evidence-based obesity treatment program within the context of a pragmatic cluster randomized controlled trial comparing three models of care delivery.MethodsRecruitment and reach were evaluated by the following measures: 1) mailing response rates, 2) referral sources among participants contacting the study team, 3) eligibility rates, 4) participation rates, and 5) representativeness based on demographics, co-morbid conditions, and healthcare utilization of 1432 enrolled participants compared to > 17,000 non-participants from the clinic-based patient populations. Referral sources and participation rates were compared across study arms and level of clinic engagement.ResultsThe response rate to clinic-based mailings was 13.2% and accounted for 66% of overall program recruitment. An additional 22% of recruitment came from direct clinic referrals and 11% from media, family, or friends. Of those screened, 87% were eligible; among those eligible, 86% enrolled in the trial. Participation rates did not vary across the three care delivery arms, but were higher at clinics with high compared to low provider involvement. In addition, clinics with high provider involvement had a higher rate of in clinic referrals (33% versus 16%) and a more representative sample with regards to BMI, rurality, and months since last clinic visit. However, across clinics, enrolled participants compared to non-participants were older, more likely to be female, more likely to have had a joint replacement but less likely to have CVD or smoke, and had fewer hospitalizations.ConclusionsA combination of direct patient mailings and in-clinic referrals may enhance the reach of primary care behavioral weight loss interventions, although more proactive outreach is likely necessary for men, younger patients, and those at greater medial risk. Strategies are needed to enhance provider engagement in referring patients to behavioral weight loss programs.Trial registrationclnicialtrials.gov NCT02456636. Registered May 28, 2015, https://www.clinicaltrials.gov/ct2/results?cond=&term=RE-POWER&cntry=&state=&city=&dist=.

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Project description:BackgroundDespite the overwhelming prevalence and health implications of obesity, it is rarely adequately addressed in a health care setting. PATHWEIGH is a pragmatic approach to weight management that uses tools built into the electronic medical record to overcome barriers and guide care. Implementation strategies are employed to facilitate adoption and use of the PATHWEIGH tools and processes. The current study will compare the effectiveness of PATHWEIGH versus standard of care (SOC) on patient weight loss in primary care and explore factors for its successful implementation.MethodsA stepped wedge cluster randomized trial design will be used within an effectiveness-implementation hybrid study. Adult patient weight loss and weight loss maintenance will be compared in PATHWEIGH versus SOC in 57 family and internal medicine clinics in a large health system in Colorado, USA. Effectiveness will be evaluated using generalized linear mixed models to determine statistical differences in weight loss and weight loss maintenance at 6, 12, and 18 months. Patient-, provider-, and clinic-level predictors will be identified using mediator and moderator analyses. Conceptually guided by the Practical, Robust, Implementation and Sustainability Model (PRISM), a mixed methods approach including quantitative (practice surveys, use tracking) and qualitative (interviews, observations) data collection will be used to determine factors impeding and facilitating adoption, implementation, and maintenance of PATHWEIGH and evaluate specified implementation strategies. A cost analysis of the practice and system costs and resources required by PATHWEIGH relative to the reimbursement collected will be performed.DiscussionThe effectiveness and implementation of PATHWEIGH, and their interrelatedness, for patient weight loss are collectively the focus of the current trial. Findings from this study are expected to serve as a blueprint for available and effective weight management in primary care medical practice.Trial registrationClinicalTrials.gov NCT04678752 . Registered on December 21, 2020.

Project description:BackgroundEfforts to improve primary care diabetes management have assessed strategies across heterogeneous groups of patients and practices. However, there is substantial variability in how well practices implement interventions and achieve desired outcomes.ObjectiveTo examine practice contextual features that moderate intervention effectiveness.DesignSecondary analysis of data from a cluster randomized trial of three approaches for implementing the Chronic Care Model to improve diabetes care.ParticipantsForty small to mid-sized primary care practices participated, with 522 clinician and staff member surveys. Outcomes were assessed for 822 established patients with a diagnosis of type 2 diabetes who had at least one visit to the practice in the 18 months following enrollment.Main measuresThe primary outcome was a composite measure of diabetes process of care, ascertained by chart audit, regarding nine quality measures from the American Diabetes Association Physician Recognition Program: HgA1c, foot exam, blood pressure, dilated eye exam, cholesterol, nephropathy screen, flu shot, nutrition counseling, and self-management support. Data from practices included structural and demographic characteristics and Practice Culture Assessment survey subscales (Change Culture, Work Culture, Chaos).Key resultsAcross the three implementation approaches, demographic/structural characteristics (rural vs. urban + .70(p = .006), +2.44(p < .001), -.75(p = .004)); Medicaid: < 20 % vs. ≥ 20 % (-.20(p = .48), +.75 (p = .08), +.60(p = .02)); practice size: < 4 clinicians vs. ≥ 4 clinicians (+.56(p = .02), +1.96(p < .001), +.02(p = .91)); practice Change Culture (high vs. low: -.86(p = .048), +1.71(p = .005), +.34(p = .22)), Work Culture (high vs. low: -.67(p = .18), +2.41(p < .001), +.67(p = .005)) and variability in practice Change Culture (high vs. low: -.24(p = .006), -.20(p = .0771), -.44(p = .0019) and Work Culture (high vs. low: +.56(p = .3160), -1.0(p = .008), -.25 (p = .0216) were associated with trajectories of change in diabetes process of care, either directly or differentially by study arm.ConclusionsThis study supports the need for broader use of methodological approaches to better examine contextual effects on implementation and effectiveness of quality improvement interventions in primary care settings.

Dataset Information

Weight loss in primary care: A pooled analysis of two pragmatic cluster-randomized trials.

Objective

Methods

Results

Conclusions

Publications

Weight loss in primary care: A pooled analysis of two pragmatic cluster-randomized trials.

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