Background: Nearly 20% of the US population lives in rural communities. Rural residents experience obesity disproportionally and have less access to effective weight loss programs than do residents of other areas. Primary care has the potential to fill an important need in treating obesity in rural America. Primary care is traditionally provided on a fee-for-service (FFS) model with 15-minute individual office visits, as is reimbursed by Medicare under the intensive behavioral therapy for obesity (IBT) benefit, which was approved in 2011 as the first benefit billed under an obesity diagnosis code. However, alternative models may be better suited for behavioral obesity treatment especially in the rural setting, where having fewer available clinic staff may limit capacity for frequent individual visits.
Methods: We conducted a pragmatic cluster randomized trial comparing the Medicare IBT FFS model delivered via in-clinic individual visits with 2 alternative models: (1) in-clinic group visits delivered by practice-employed providers modeled after patient-centered medical home (PCMH) principles, and (2) phone-based group visits delivered by centralized personnel. A total of 36 rural primary care practices were randomized 1:1:1 to the 3 study arms (12 practices per arm). Participants (N = 1407 adults aged 20-75 years who resided in a rural area) were enrolled at participating practices. All participants received a high-intensity lifestyle intervention with the same core components that differed by delivery model: in-clinic individual visits, in-clinic group visits, or phone-based group visits. The primary outcome was 24-month weight change. Secondary outcomes included cardiometabolic risk factors, quality of life (QOL), sleep, and stress. In addition, both quantitative and qualitative measures were used to evaluate RE-AIM measures (ie, reach, adoption, implementation, and maintenance).
Results: Of the 36 included practices, 22 were located in isolated or small rural areas, and 13 were in large rural areas; 10 were rural health clinics, and 12 were Federally Qualified Health Centers. Participants (N = 1407) had a mean (SD) age of 54.7 (11.8) years and mean (SD) body mass index (BMI) of 36.7 (4.0); 76.8% were female, 96.2% were White non-Hispanic, and 46.8% were from an isolated rural area. The trial retained 87% of participants at 24 months. Weight loss at 24 months was −4.43 kg (95% CI, −5.48 to −3.39 kg) in the PCMH arm (in-clinic group visits); −3.92 kg (95% CI, −4.98 to −2.87 kg) in the disease management (DM) arm (phone-based group visits); and −2.56 kg (95% CI, −3.63 to −1.49 kg) in the FFS arm (in-clinic individual visits). Compared with FFS, there was a net difference of −1.87 kg (97.5% CI, −3.51 to −0.23 kg; P = .01) for PCMH and −1.36 kg (97.5% CI, −3.00 to 0.29 kg; P = .06) for DM. The pattern of results across study arms was similar for most subpopulations, except that greater weight loss in DM than in FFS was observed only among participants with an annual income of ≥$50 000. The results for secondary outcomes showed greater improvements in triglyceride levels and physical activity in the PCMH arm than in the FFS arm. All arms showed statistically significant (P <.05) and meaningful improvements through 24 months in physical activity, dietary measures, weight-related QOL, and sleep.
Participant-level implementation measures showed that participants in the FFS arm had the highest attendance, whereas participants in the DM arm had the lowest attendance and worst ratings of experience of care. Participants in the PCMH arm reported the highest overall satisfaction. Analysis of reach revealed a high enrollment rate among eligible participants (86%), with no statistical differences between arms. Mixed-method findings among practice personnel revealed that most perceived the intervention across all arms to be easy to implement, effective, and compatible with what their patients wanted, although for some, the perceived effectiveness declined from midintervention to postintervention. Practice personnel in the DM arm reported lower perceived effectiveness than did those in the FFS and PCMH arms, which some related to lack of care integration. The major barriers to maintaining the intervention across arms were cost and counselor staffing, and these concerns were particularly evident among counselors in the PCMH arm.
Conclusions: The PCMH arm with in-clinic group visits produced greater weight loss than did the FFS arm with in-clinic individual visits. The combined participant and practice personnel implementation measures highlighted downsides to the DM model, which had slightly worse results than those from the PCMH model, including patients' difficulty developing accountability and cohesiveness, lack of support from local peers, and lack of care integration within local practices. Thus, the magnitude of the additional weight loss in the DM arm compared with the FFS arm needs to take into account the less-positive experiences of care. Overall, the PCMH model resulted in the most favorable outcomes; however, to be a sustainable model, implementation strategies are needed to determine financial viability based on reimbursement options across different payers and to address staffing shortages. The findings have implications for policies related to treatment of obesity in primary care, particularly in rural and other medically underserved areas.
Limitations: The sample was predominantly female and White non-Hispanic, and the rural cultural and geographical context of the trial may affect the generalizability of the findings to urban and more racially/ethnically diverse populations. Because the study was designed to compare current care delivery models under pragmatic conditions, it did not control for the potential impact of different professional backgrounds or training of the counselors. Finally, by design, the study was not limited to older adults covered by Medicare; thus, replication of the IBT provision is needed in a Medicare-insured population.
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