Pragmatic implementation of a fully automated online obesity treatment in primary care.
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ABSTRACT: Objective
Behavioral obesity treatment implemented in primary care is efficacious but typically involves face-to-face or phone contact. This study evaluated enrollment, engagement, and 12-week weight loss in a fully automated online behavioral weight-loss intervention implemented pragmatically in a primary care network.Methods
As part of routine primary care, providers and nurse care managers offered a no-cost online obesity treatment program to 1,721 patients. Of these, 721 consented and were eligible (aged 18-75 years with BMI ≥ 25 kg/m2 and internet access), and 464 started the program. The program included 12 weekly online lessons, a self-monitoring platform, and automated feedback.Results
More than one-quarter of patients who were offered the program (26%) initiated treatment. In intent-to-treat analyses using all data available, mean 12-week weight change was -5.10% (SE = 0.21). Patients who submitted their weights on all 12 weeks (37% of 464) lost an estimated 7.2% body weight versus 3.4% in those submitting less frequently.Conclusions
This fully automated online program, implemented into the routine workflow of a primary care setting without any human counseling or researcher involvement, produced clinically meaningful short-term weight loss. Greater program engagement was associated with greater weight loss; efforts are needed to understand barriers to engagement.
SUBMITTER: Thomas JG
PROVIDER: S-EPMC9335894 | biostudies-literature | 2022 Aug
REPOSITORIES: biostudies-literature
Publications
Pragmatic implementation of a fully automated online obesity treatment in primary care.
Thomas J Graham JG Panza Emily E Espel-Huynh Hallie M HM Goldstein Carly M CM O'Leary Kevin K Benedict Noah N Puerini Albert J AJ Wing Rena R RR
Obesity (Silver Spring, Md.) 20220801 8
<h4>Objective</h4>Behavioral obesity treatment implemented in primary care is efficacious but typically involves face-to-face or phone contact. This study evaluated enrollment, engagement, and 12-week weight loss in a fully automated online behavioral weight-loss intervention implemented pragmatically in a primary care network.<h4>Methods</h4>As part of routine primary care, providers and nurse care managers offered a no-cost online obesity treatment program to 1,721 patients. Of these, 721 cons ...[more]
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Project description:ImportanceBehavioral weight loss interventions have achieved success in primary care; however, to our knowledge, pragmatic implementation of a fully automated treatment that requires little researcher oversight has not been tested. Moreover, weight loss maintenance remains a challenge.ObjectiveTo evaluate the long-term effectiveness of an automated, online, behavioral obesity treatment program (Rx Weight Loss [RxWL]) at 12 months (primary end point) and 24 months when delivered pragmatically in primary care and to compare the effectiveness of 3 weight loss maintenance approaches.Design, setting, and participantsThis randomized clinical trial of RxWL, an online weight loss program, recruited patients from a Rhode Island primary care network with approximately 60 practices and 100 physicians. Eligible participants were primary care patients aged 18 to 75 years with overweight or obesity who were referred by their nurse care manager and enrolled between 2018 and 2020. All participants were included in the intention-to-treat analysis, whereas only those who engaged with maintenance intervention were included in the per-protocol analysis. Data were analyzed from August 2022 to September 2023.InterventionsAll participants were offered the same 3-month weight loss program, with randomization to one of three 9-month maintenance programs: control intervention (monthly online newsletters), monthly intervention (9 monthly video lessons and 1 week of self-monitoring per month), or refresher intervention (an introductory session and two 4-week periods of lessons and self-monitoring at 7 and 10 months).Main outcomes and measuresThe primary outcome was weight change at 12 months using height and weight data collected from electronic medical records through 24 months.ResultsAmong the 540 participants (mean [SD] age, 52.8 [13.4] years; 384 females [71.1%]) in the intention-to-treat analysis, mean estimated 3-month weight loss was 3.60 (95% CI, -4.32 to -2.88) kg. At the 12-month primary end point, the amount of weight regained in the monthly (0.37 [95% CI, -0.06 to 0.81] kg) and refresher (0.45 [95% CI, 0.27 to 0.87] kg) maintenance groups was significantly less than that in the newsletter control maintenance group (1.28 [95% CI, 0.85 to 1.71] kg; P = .004). The difference in weight regain between the monthly and refresher maintenance groups was not statistically significant. This pattern persisted at 24 months. In the per-protocol analysis of 253 participants, mean weight loss at the end of the initial 3-month intervention was 6.19 (95% CI, -7.25 to -5.13) kg. Similarly, at 12 months there was less weight regain in the monthly (0.61 kg) and refresher (0.96 kg) maintenance groups than in the newsletter control maintenance group (1.86 kg).Conclusions and relevanceResults of this randomized clinical trial indicate that pragmatic implementation of a 12-month automated, online, behavioral obesity treatment that includes 9 months of active maintenance produces clinically significant weight loss over 2 years in primary care patients with overweight or obesity. These findings underscore the importance of providing ongoing maintenance intervention to prevent weight regain.Trial registrationClinicalTrials.gov Identifier: NCT03488212.
| S-EPMC10928540 | biostudies-literature
Project description:BackgroundCurrent guidelines recommend behavioral intervention to achieve a modest weight loss (e.g., 3-5%) as a first-line obesity treatment. Online behavioral obesity treatment, delivered via the Rx Weight Loss (RxWL) program, produces clinically significant initial weight losses. However, the program's pragmatic utility in routine medical care has yet to be tested. Further, additional research is needed to determine how best to extend the RxWL program to facilitate weight loss maintenance. This paper summarizes methods for a pragmatic trial aimed at identifying optimal methods for implementation of RxWL in primary care and evaluating relative effectiveness of two approaches to weight loss maintenance.Study designRxWL will be implemented in a network of approximately 60 primary care clinics. Implementation outcomes (program uptake and completion metrics) will be compared between a Basic Implementation Intervention consisting primarily of access to RxWL, and an Enhanced Implementation Intervention with additional training in strategies for motivating and supporting patients in their use of RxWL and online clinician support tools for tracking patient progress. Second, two intervention approaches (Monthly Lessons versus Refresher Courses) within the RxWL patient platform will be tested against an educational control condition, and effects on 1-year weight loss maintenance will be compared.ConclusionThis study will provide essential information about the feasibility and utility of online obesity treatment in primary care. It will provide novel information on two approaches to weight loss maintenance for patients in this setting. This project fills key gaps in evidence regarding best practices for obesity treatment in primary care.
| S-EPMC6606329 | biostudies-literature
Project description:Online behavioral obesity treatment is a promising first-line approach to weight management in primary care. However, little is known about contextual influences on implementation. Understand qualitative contextual factors that affect the implementation process, as experienced by key primary care stakeholders implementing the program. Online behavioral obesity treatment was implemented across a 60-clinic primary care practice network. Patients were enrolled by nurse care managers (NCMs; N = 14), each serving 2-5 practices. NCMs were randomized to one of two implementation conditions-"Basic" (standard implementation) or "Enhanced" (i.e., with added patient tracking features and more implementation strategies employed). NCMs completed qualitative interviews guided by the Consolidated Framework for Implementation Research (CFIR). Interviews were transcribed and analyzed via directed content analysis. Emergent categories were summarized by implementation condition and assigned a valence according to positive/negative influence. Individuals in the Enhanced condition viewed two aspects of the intervention as more positively influencing than Basic NCMs: Design Quality & Packaging (i.e., online program aesthetics), and Cost (i.e., no-cost program, clinician time savings). In both conditions, strongly facilitating factors included: Compatibility between intervention and clinical context; Intervention Source (from a trusted local university); and Evidence Strength & Quality supporting effectiveness. Findings highlight the importance of considering stakeholders' perspectives on the most valued types of evidence when introducing a new intervention, ensuring the program aligns with organizational priorities, and considering how training resources and feedback on patient progress can improve implementation success for online behavioral obesity treatment in primary care.
| S-EPMC8849001 | biostudies-literature
Project description:BackgroundMost people with opioid use disorder (OUD) never receive treatment. Medication treatment of OUD in primary care is recommended as an approach to increase access to care. The PRimary Care Opioid Use Disorders treatment (PROUD) trial tests whether implementation of a collaborative care model (Massachusetts Model) using a nurse care manager (NCM) to support medication treatment of OUD in primary care increases OUD treatment and improves outcomes. Specifically, it tests whether implementation of collaborative care, compared to usual primary care, increases the number of days of medication for OUD (implementation objective) and reduces acute health care utilization (effectiveness objective). The protocol for the PROUD trial is presented here.MethodsPROUD is a hybrid type III cluster-randomized implementation trial in six health care systems. The intervention consists of three implementation strategies: salary for a full-time NCM, training and technical assistance for the NCM, and requiring that three primary care providers have DEA waivers to prescribe buprenorphine. Within each health system, two primary care clinics are randomized: one to the intervention and one to Usual Primary Care. The sample includes all patients age 16-90 who visited the randomized primary care clinics from 3 years before to 2 years after randomization (anticipated to be > 170,000). Quantitative data are derived from existing health system administrative data, electronic medical records, and/or health insurance claims ("electronic health records," [EHRs]). Anonymous staff surveys, stakeholder debriefs, and observations from site visits, trainings and technical assistance provide qualitative data to assess barriers and facilitators to implementation. The outcome for the implementation objective (primary outcome) is a clinic-level measure of the number of patient days of medication treatment of OUD over the 2 years post-randomization. The patient-level outcome for the effectiveness objective (secondary outcome) is days of acute care utilization [e.g. urgent care, emergency department (ED) and/or hospitalizations] over 2 years post-randomization among patients with documented OUD prior to randomization.DiscussionThe PROUD trial provides information for clinical leaders and policy makers regarding potential benefits for patients and health systems of a collaborative care model for management of OUD in primary care, tested in real-world diverse primary care settings. Trial registration # NCT03407638 (February 28, 2018); CTN-0074 https://clinicaltrials.gov/ct2/show/NCT03407638?term=CTN-0074&draw=2&rank=1.
| S-EPMC7849121 | biostudies-literature
Project description:BackgroundThere is a need for new strategies to improve the success of obesity treatment within the primary care setting.ObjectiveTo determine if patients offered low out-of-pocket cost weight management tools achieved more weight loss compared to usual care.DesignTwelve-month pragmatic clinical weight loss trial with a registry-based comparator group performed in primary care clinics of an urban safety-net hospital.ParticipantsFrom a large clinical registry, we randomly selected 428 patients to have the opportunity to receive the intervention.InterventionsMedical weight management tools-partial meal replacements, recreation center vouchers, pharmacotherapy, commercial weight loss program vouchers, and a group behavioral weight loss program-for $5 or $10 monthly. Patients chose their tools, could switch tools, and could add a second tool at 6 months.Main measuresThe primary outcome was the proportion of intervention-eligible patients who achieved ≥ 5% weight loss. The main secondary outcome was the proportion of on-treatment patients who achieved ≥ 5% weight loss.Key resultsOverall, 71.3% (305 of 428) had available weight measurement data/PCP visit data to observe the primary outcome. At 12 months, 23.3% (71 of 305) of intervention-eligible participants and 15.7% (415 of 2640) of registry-based comparators had achieved 5% weight loss (p < 0.001). Of the on-treatment participants, 34.5% (39 of 113) achieved 5% weight loss. Mean percentage weight loss was - 3.15% ± 6.41% for on-treatment participants and - 0.30% ± 6.10% for comparators (p < 0.001). The initially preferred tools were meal replacements, pharmacotherapy, and recreation center passes.ConclusionsAccess to a variety of low out-of-pocket cost weight management tools within primary care resulted in ≥ 5% body weight loss in approximately one quarter of low-income patients with obesity.Trial registrationhttps://clinicaltrials.gov/ct2/show/NCT01922934.
| S-EPMC6848318 | biostudies-literature
Project description:ObjectiveOnline behavioral treatment for obesity produces clinically-meaningful weight losses among many primary care patients. However, some patients experience poor outcomes (i.e., failure to enroll post-referral, poor weight loss, or premature disengagement). This study sought to understand primary care clinicians' perceived utility of a clinical decision support system (CDSS) that would alert clinicians to patients' risk for poor outcome and guide clinician-delivered rescue interventions to reduce risk.MethodsQualitative formative evaluation was conducted in the context of an ongoing pragmatic clinical trial implementing online obesity treatment in primary care. Interviews were conducted with 14 nurse care managers (NCMs) overseeing patients' online obesity treatment. Interviews inquired about the potential utility of CDSS in primary care, desired alert frequency/format, and priorities for alert types (non-enrollment, poor weight loss, and/or early disengagement). We used matrix analysis to generate common themes across interviews.ResultsNearly all NCMs viewed CDSS as potentially helpful in clinical practice. Alerts for patients at risk for disengagement were of highest priority, though all alert types were generally viewed as desirable. Regarding frequency and delivery mode of patient alerts, NCMs wanted to balance the need for prompt patient intervention with minimizing clinician burden. Concerns about CDSS emerged, including insufficient time to respond promptly and adequately to alerts and the need to involve other support staff for patients requiring ongoing rescue intervention.ConclusionsNCMs view CDSS for online obesity treatment as potentially feasible and clinically useful. For optimal implementation in primary care, CDSS must minimize clinician burden and facilitate collaborative care.
| S-EPMC8555757 | biostudies-literature
Project description:BACKGROUND:There is a pressing need for greater attention to patient-centered health behavior and psychosocial issues in primary care, and for practical tools, study designs and results of clinical and policy relevance. Our goal is to design a scientifically rigorous and valid pragmatic trial to test whether primary care practices can systematically implement the collection of patient-reported information and provide patients needed advice, goal setting, and counseling in response. METHODS:This manuscript reports on the iterative design of the My Own Health Report (MOHR) study, a cluster randomized delayed intervention trial. Nine pairs of diverse primary care practices will be randomized to early or delayed intervention four months later. The intervention consists of fielding the MOHR assessment--addresses 10 domains of health behaviors and psychosocial issues--and subsequent provision of needed counseling and support for patients presenting for wellness or chronic care. As a pragmatic participatory trial, stakeholder groups including practice partners and patients have been engaged throughout the study design to account for local resources and characteristics. Participatory tasks include identifying MOHR assessment content, refining the study design, providing input on outcomes measures, and designing the implementation workflow. Study outcomes include the intervention reach (percent of patients offered and completing the MOHR assessment), effectiveness (patients reporting being asked about topics, setting change goals, and receiving assistance in early versus delayed intervention practices), contextual factors influencing outcomes, and intervention costs. DISCUSSION:The MOHR study shows how a participatory design can be used to promote the consistent collection and use of patient-reported health behavior and psychosocial assessments in a broad range of primary care settings. While pragmatic in nature, the study design will allow valid comparisons to answer the posed research question, and findings will be broadly generalizable to a range of primary care settings. Per the pragmatic explanatory continuum indicator summary (PRECIS) framework, the study design is substantially more pragmatic than other published trials. The methods and findings should be of interest to researchers, practitioners, and policy makers attempting to make healthcare more patient-centered and relevant. TRIAL REGISTRATION:Clinicaltrials.gov: NCT01825746.
| S-EPMC3694031 | biostudies-literature
Project description:BACKGROUND:In primary care, multiple priorities and system pressures make closing the gap between evidence and practice challenging. Most implementation studies focus on single conditions, limiting generalisability. We compared an adaptable implementation package against an implementation control and assessed effects on adherence to four different evidence-based quality indicators. METHODS AND FINDINGS:We undertook two parallel, pragmatic cluster-randomised trials using balanced incomplete block designs in general practices in West Yorkshire, England. We used 'opt-out' recruitment, and we randomly assigned practices that did not opt out to an implementation package targeting either diabetes control or risky prescribing (Trial 1); or blood pressure (BP) control or anticoagulation in atrial fibrillation (AF) (Trial 2). Within trials, each arm acted as the implementation control comparison for the other targeted indicator. For example, practices assigned to the diabetes control package acted as the comparison for practices assigned to the risky prescribing package. The implementation package embedded behaviour change techniques within audit and feedback, educational outreach, and computerised support, with content tailored to each indicator. Respective patient-level primary endpoints at 11 months comprised the following: achievement of all recommended levels of haemoglobin A1c (HbA1c), BP, and cholesterol; risky prescribing levels; achievement of recommended BP; and anticoagulation prescribing. Between February and March 2015, we recruited 144 general practices collectively serving over 1 million patients. We stratified computer-generated randomisation by area, list size, and pre-intervention outcome achievement. In April 2015, we randomised 80 practices to Trial 1 (40 per arm) and 64 to Trial 2 (32 per arm). Practices and trial personnel were not blind to allocation. Two practices were lost to follow-up but provided some outcome data. We analysed the intention-to-treat (ITT) population, adjusted for potential confounders at patient level (sex, age) and practice level (list size, locality, pre-intervention achievement against primary outcomes, total quality scores, and levels of patient co-morbidity), and analysed cost-effectiveness. The implementation package reduced risky prescribing (odds ratio [OR] 0.82; 97.5% confidence interval [CI] 0.67-0.99, p = 0.017) with an incremental cost-effectiveness ratio of £1,359 per quality-adjusted life year (QALY), but there was insufficient evidence of effect on other primary endpoints (diabetes control OR 1.03, 97.5% CI 0.89-1.18, p = 0.693; BP control OR 1.05, 97.5% CI 0.96-1.16, p = 0.215; anticoagulation prescribing OR 0.90, 97.5% CI 0.75-1.09, p = 0.214). No statistically significant effects were observed in any secondary outcome except for reduced co-prescription of aspirin and clopidogrel without gastro-protection in patients aged 65 and over (adjusted OR 0.62; 97.5% CI 0.39-0.99; p = 0.021). Main study limitations concern our inability to make any inferences about the relative effects of individual intervention components, given the multifaceted nature of the implementation package, and that the composite endpoint for diabetes control may have been too challenging to achieve. CONCLUSIONS:In this study, we observed that a multifaceted implementation package was clinically and cost-effective for targeting prescribing behaviours within the control of clinicians but not for more complex behaviours that also required patient engagement. TRIAL REGISTRATION:The study is registered with the ISRCTN registry (ISRCTN91989345).
| S-EPMC7048270 | biostudies-literature
Project description:ObjectiveTo evaluate the effectiveness of a clinical decision support system (CDSS) in improving the use of guideline accordant antihypertensive treatment in primary care settings in China.DesignPragmatic, open label, cluster randomised trial.Setting94 primary care practices in four urban regions of China between August 2019 and July 2022: Luoyang (central China), Jining (east China), and Shenzhen (south China, including two regions).Participants94 practices were randomised (46 to CDSS, 48 to usual care). 12 137 participants with hypertension who used up to two classes of antihypertensives and had a systolic blood pressure <180 mm Hg and diastolic blood pressure <110 mm Hg were included.InterventionsPrimary care practices were randomised to use an electronic health record based CDSS, which recommended a specific guideline accordant regimen for initiation, titration, or switching of antihypertensive (the intervention), or to use the same electronic health record without CDSS and provide treatment as usual (control).Main outcome measuresThe primary outcome was the proportion of hypertension related visits during which an appropriate (guideline accordant) treatment was provided. Secondary outcomes were the average reduction in systolic blood pressure and proportion of participants with controlled blood pressure (<140/90 mm Hg) at the last scheduled follow-up. Safety outcomes were patient reported antihypertensive treatment related events, including syncope, injurious fall, symptomatic hypotension or systolic blood pressure <90 mm Hg, and bradycardia.Results5755 participants with 23 113 visits in the intervention group and 6382 participants with 27 868 visits in the control group were included. Mean age was 61 (standard deviation 13) years and 42.5% were women. During a median 11.6 months of follow-up, the proportion of visits at which appropriate treatment was given was higher in the intervention group than in the control group (77.8% (17 975/23 113) v 62.2% (17 328/27 868); absolute difference 15.2 percentage points (95% confidence interval (CI) 10.7 to 19.8); P<0.001; odds ratio 2.17 (95% CI 1.75 to 2.69); P<0.001). Compared with participants in the control group, those in the intervention group had a 1.6 mm Hg (95% CI -2.7 to -0.5) greater reduction in systolic blood pressure (-1.5 mm Hg v 0.3 mm Hg; P=0.006) and a 4.4 percentage point (95% CI -0.7 to 9.5) improvement in blood pressure control rate (69.0% (3415/4952) v 64.6% (3778/5845); P=0.07). Patient reported antihypertensive treatment related adverse effects were rare in both groups.ConclusionsUse of a CDSS in primary care in China improved the provision of guideline accordant antihypertensive treatment and led to a modest reduction in blood pressure. The CDSS offers a promising approach to delivering better care for hypertension, both safely and efficiently.Trial registrationClinicalTrials.gov NCT03636334.
| S-EPMC11265211 | biostudies-literature
Project description:Rigorous evaluation of eHealth interventions is acutely needed but can be challenging to execute in a cost- and time-efficient way. The purpose of this study is to describe a randomized controlled trial carried out as part of an approach that evaluates and informs product development throughout an intervention's life cycle. We present the methodological case of a pragmatic randomized controlled trial evaluating the effectiveness of the web-based intervention "Daily Challenge." We conducted the trial entirely online and leveraged existing resources to implement it quickly and within budget. One thousand five hundred three participants were recruited in 49 days (17.1 % of candidates assessed for eligibility). Then, 68.7 % of participants were reached for follow-up at 30 days and 62.5 % at 90 days. Data collection (baseline to 90-day follow-up) was completed within 5 months. Rigorous trials can be conducted efficiently and in a timely manner, enabling evaluation on a continuous basis. Development should include ongoing empirical input to inform product iterations.
| S-EPMC3771016 | biostudies-literature