Group Medical Appointments for Intensive Lifestyle Treatment for Obesity in Cleveland Clinic Primary Care Practices

The objective of this implementation effort is to optimize the availability of intensive lifestyle treatment of obesity in the adult population of patients who receive care within the Cleveland Clinic health system in Northeast Ohio primary care practices as part of routine clinical practice. Utilizing the group visit model from the evidence generated from the Befort et al Patient-Centered Outcomes Research (PCORI) funded study,(5) the investigators will significantly expand current health system obesity treatment resources and build on our model of SMAs led by multidisciplinary teams to deliver the intervention. Through a coordinated health system-wide implementation effort in all primary care practices, the investigators aim to improve the health of our patients with obesity through developing a successful obesity treatment program, improving upon current health system programs, with the goal of long-term impact in reducing patient comorbidities, cardiovascular risk, and promoting sustainable weight loss. The investigators propose to implement group visits for intensive lifestyle intervention for obesity utilizing the SMA model. Implementation of the Obesity SMAs will be in all 56 Cleveland Clinic primary care practices in Northeast Ohio.

Specific Aims

Aim 1. To prepare for implementation of Obesity Treatment SMAs across all Northeast Ohio Primary Care Practices (Pre-Implementation)

Pre-Implementation Phase (9 months)

* Adaptation of Obesity SMA Training Materials for Primary Care Providers with input from Continuous Improvement Specialists regarding practice change principles * Delivery of Education Sessions, including topic of implementation outcomes * Quantitative Assessment of Practice Variation in Obesity Treatment Patterns * Qualitative Assessment of Barriers and Facilitators to Obesity Treatment at Primary Care Practice Level * Creation of Clinical Decision Support Tool for SMA referral * Creation of Patient and Employee Advisory Panel

Aim 2. To Implement Obesity Treatment SMAs across all Northeast Ohio Primary Care Practices (Active Implementation)

Active Implementation Phase (18 months)

* Implementation of Clinical Decision Support at Implementation Sites * Delivery of Additional Educational Materials to Implementation Sites to refresh learning * Practice Facilitation at Implementation Sites * Delivery of Obesity SMA Intervention * Qualitative and Survey Data Collection regarding- Patient and Provider Implementation Outcomes of acceptability, feasibility, appropriateness * Quantitative Data Collection of Implementation Outcomes of adoption, fidelity, effectiveness, implementation cost * Patient and Employee Advisory Panel Input into Implementation Evaluation

Aim 3: To monitor and evaluate the maintenance of the Obesity Treatment SMAs across all Northeast Ohio Primary Care Practices (Maintenance \& Sustainment)

Maintenance \& Sustainment Phase (15 months)

* Quantitative Data Collection of Implementation Outcomes- adoption, fidelity, effectiveness, cost- with comparison to active implementation phase * Capture Practice Level adaptations with comparison to active implementation phase.

Study Population (Potential Eligible / Intended Reach) Potentially eligible patients: Utilizing electronic medical record data, the investigators determined across the 56 outpatient primary care practices, the total patient population ages 20-75 with a body mass index (BMI) \>/= 30 who have had a primary care visit within the past 18 months is 170,087 patients.

Intended reach: The intended reach will exclude patients with a history of bariatric surgery, current pregnancy and post-partum within 180 days, current cancer diagnosis or cognitive impairment diagnosis. Exclusion criteria are based upon unique clinical situations affecting BMI as well as conditions that may affect SMA participation. Prior obesity SMA participation will not be an exclusion. The intended reach includes 141,735 potentially eligible patients ages 20 to 75, with an office visit within 18 months, BMI \>/=30, with exclusion of history of bariatric surgery, pregnancy, current cancer diagnosis or cognitive impairment diagnosis. Through navigator support, the investigators will assess demographic distribution of patients with uptake of the program and will ensure representation from groups with higher Area Deprivation Index (ADI). If this is not the case, the investigators will conduct outreach to eligible patients outside of an office visit, through the MyChart portal or telephone outreach. Scripts will be created as part of routine clinical care during the pre-implementation phase.

Entry Into SMAs Entry into the obesity treatment program will be offered by a patient's primary care provider as part of usual clinical care and can be offered at the time of an office visit. In addition, the clinical and project teams will create flyers describing the program to be available to primary care practices. This information will also be available through our MyChart patient portal in the EPIC(6) electronic medical record. Scripts will be created as part of routine clinical care during the pre-implementation phase.

Once the referral to the program is made, the patient will complete an individual appointment, offered as both in-person or virtual, with either an obesity-trained primary care provider, an endocrinology provider, or a Wellness Medicine provider from the Primary Care Institute. This individual appointment will be focused on discussion of the diagnosis of obesity and treatment options, including the SMA program. If the patient accepts the referral to the SMA, the first appointment will be scheduled. The program will include options of scheduling both the initial individual appointment and the SMA through the primary care practice office or an opportunity for self-scheduling through our MyChart patient portal. Throughout the study, the investigators will have primary care navigator support to ensure outreach to underrepresented groups.

• Weight Loss [Срок оценки: Baseline, every 6 months during intervention, and 6 months post-intervention]
• Outcome measure type: Reach [Срок оценки: Timing and frequency of measurement is every 3 months.]
• Outcome measure type: Effectiveness [Срок оценки: Hospitalizations and emergency department visits - every 6 months]
• Outcome measure type: Effectiveness [Срок оценки: Baseline and end of intervention]
• Patient Reported Outcomes- PROMIS10 Global Health Survey [Срок оценки: Baseline, every month during the SMA intervention and 6 months post-intervention.]
• Provider Bias Related to Patients with Obesity survey [Срок оценки: Administered at baseline and at end of intervention period.]
• Provider views of Acceptability, Appropriateness, Feasibility survey [Срок оценки: Administered to primary care providers every 6 months starting baseline throughout active implementation & maintenance.]
• Outcome Measure: Adoption (Actual) [Срок оценки: Every 3 months during the intervention period]
• Outcome measure: SMA Leader Adoption [Срок оценки: Every 3 months during intervention period.]
• Formal Qualitative Assessment of context of high referral and low referral practices: Pre-implementation [Срок оценки: Pre-implementation]
• Formal Qualitative Assessment: Observations of Employee and Patient Advisory Panels [Срок оценки: Quarterly meetings throughout pre- and active implementation.]
• Formal Qualitative Assessment: Semi-structured Interviews with Patients at High/Low Referral Sites [Срок оценки: Baseline, 6 months, 12 months during active implementation]