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

Brief summary (registry, in English)

In 2023, Cleveland Clinic was accepted into a national program, the Patient-Centered Outcomes Research Institute Health Systems Implementation Initiative (PCORI HSII) which aims to improve implementation of prior published PCORI-funded research evidence into real-world practice. The investigators first received funding to build organizational capacity to participate in health system implementation projects. This protocol describes activities for our first implementation project for which the investigators have received funding from the PCORI HSII program. The investigator's project seeks to expand the availability of shared medical appointments (SMAs) for obesity treatment in all 56 primary care practices of the Cleveland Clinic health system in Northeast Ohio. The proposed project, to be implemented as part of routine healthcare delivery, will adapt aspects of a prior study funded by the PCORI that generated evidence that group visits such as SMAs can help with obesity treatment. All primary care patients in Northeast Ohio with obesity (body mass index (BMI) \>/=30) and aged between 20 and 75 years will be potentially eligible for enrollment in the SMAs. Primary care providers will offer patients entry into the SMAs as part of usual clinical care during office visits. In addition, information about these SMAs will also be available to the patients through the "MyChart" patient portal in EPIC. Implementation of the SMAs will happen in three phases (pre-implementation, active implementation, and maintenance) over 42 months. During its implementation, the project intends to reach over 140,000 patients. Quantitative and qualitative methods will be used to evaluate implementation and effectiveness outcomes associated with the SMAs. Electronic medical records and patient surveys will be the key data sources for the quantitative evaluation. Qualitative data collection methods will include semi-structured interviews, field observations, and periodic reflections. As this implementation project will be part of routine care delivery, the investigators emphasize that the risks (physical, psychological, social, legal, financial, or other) associated with participation in SMAs for obesity will not be greater than minimal or those posed by any SMAs as currently configured for the delivery of other healthcare services within the Cleveland Clinic healthcare system. The potential benefits associated with participation in these SMAs include weight loss, improvements in cardiovascular risk factors, and reduced utilization of acute healthcare services.

What you commit to

• Study type: Observational
• Planned participants: 3600
• From 1 Dec 2024 to the primary completion date, Feb 2028
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 20 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.