Group Medical Appointments for Intensive Lifestyle Treatment for Obesity in Cleveland Clinic Primary Care Practices
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 3,600
- 试验地点
- 1
- 主要终点
- Weight Loss
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient population ages 20-75 with a body mass index (BMI) >/= 30 who have had a primary care visit within the past 18 months
排除标准
- •history of bariatric surgery, current pregnancy and post-partum within 180 days, current cancer diagnosis or cognitive impairment diagnosis
结局指标
主要结局
Weight Loss
时间窗: Measured at baseline, every 6 months during the intervention, and 6 months post-intervention.
Change in body weight as measured in kg compared to baseline weight.
次要结局
- Weight Loss(Baseline, every 6 months during intervention, and 6 months post-intervention)
- Patient Reported Outcomes- PROMIS10 Global Health Survey(Baseline, every month during the SMA intervention and 6 months post-intervention.)
- Provider Bias Related to Patients with Obesity survey(Administered at baseline and at end of intervention period.)
- Outcome measure: SMA Leader Adoption(Every 3 months during intervention period.)
- Outcome measure type: Reach(Timing and frequency of measurement is every 3 months.)
- Outcome measure type: Effectiveness(Baseline, every 6 months during intervention, and 6 months post-intervention)
- Outcome Measure: Adoption (Actual)(Every 3 months during intervention period)
- Formal Qualitative Assessment of context of high referral and low referral practices: Pre-implementation(Pre-implementation)
- Formal Qualitative Assessment: Observations of Employee and Patient Advisory Panels(Quarterly meetings throughout pre- and active implementation.)
- Formal Qualitative Assessment: Semi-structured Interviews with Patients at High/Low Referral Sites(Baseline, 6 months, 12 months during active implementation)
- Formal Qualitative Assessment: Periodic Reflections with Agents of Implementation(Monthly or bimonthly throughout active implementation and maintenance.)
- Provider views of Acceptability, Appropriateness, Feasibility survey(Administered to primary care providers every 6 months starting baseline throughout active implementation & maintenance.)
- Patient Reported Outcomes - Obesity history, diabetes/hypoglycemia history if relevant, diet, exercise Survey(Baseline, then follow-up survey every month during AMS intervention.)
- Outcome Measure: SMA Leader Adoption(Every 3 months during intervention period)
- Outcome measure type: Reach (Other)(At 18 months post intervention start time of Practice Group 1, then every 3 months until end of study.)
- Outcome measure type: Effectiveness(Hospitalizations and emergency department visits - every 6 months)
- Outcome measure type: Effectiveness(Baseline and end of intervention)
- Outcome Measure: Adoption (Actual)(Every 3 months during the intervention period)
- Outcome measure type: Effectiveness(Every 6 months)
研究者
Anita Misra-Hebert
Professor of Medicine, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University; Staff, Department of Internal Medicine; Director, Healthcare Delivery and Implementation Science Center
The Cleveland Clinic