Scaling-Up Integrative Pain Management in Federally-Qualified Health Centers
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Fidelity
研究概览
简要总结
Chronic pain impacts about 20% of US Adults. Though non-pharmacologic, integrative pain management therapies are now considered first-line treatment by clinical guidelines, these therapies are still rarely covered by health insurance and therefore inaccessible to lower-income individuals. The Integrative Medical Group Visit (IMGV) program was developed to offer low-income, diverse patients with chronic pain an introduction to integrative pain management approaches, through a model that is covered by health insurance under existing billing codes. An initial pragmatic randomized control trial found that IMGV led to significant improvement in mental health related quality of life and lower use of high-cost care. However, there has been little research investigating the implementation of IMGV, and none in Federally-Qualified Health Centers (FQHCs), where the program was initially designed to be implemented. In this study, the investigators test strategies to implement IMGV in FQHCs, including training and coaching clinic staff, and measure the effectiveness of the IMGV on health outcomes for patients with chronic pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Staff and clinicians at each clinic who are involved in implementation of the IMGV.
- •Only patients who have enrolled in the Integrative medical group visit (IMGV) programs for patients with chronic pain at their Federally Qualified Health Center will be eligible for enrollment in the study. Physicians at each clinical site will determine enrollment criteria for their IMGV program specific to their clinical site--patients who are enrolled in the program will then be invited to participate in the research study.
排除标准
- •All staff, clinicians, and patients who are not involved in the IMGV at the specific clinical sites are excluded from participation.
研究组 & 干预措施
Training, Coaching, and Orientation
Clinic personnel will receive training for delivering integrative medicine group visits (IMGV) and ongoing coaching in delivering IMGV for patients with chronic pain. Clinic patients will participate in orientation and the 9-week IMGV.
干预措施: Integrative Medicine Group Visit (Behavioral)
Training, Coaching, and Orientation
Clinic personnel will receive training for delivering integrative medicine group visits (IMGV) and ongoing coaching in delivering IMGV for patients with chronic pain. Clinic patients will participate in orientation and the 9-week IMGV.
干预措施: Implementation Strategies (Other)
结局指标
主要结局
Fidelity
时间窗: Through completion of IMGV delivery, a total of up to two years
Score on the Integrative Medical Group Visit (IMGV) Fidelity rating scale, measuring the extent to which core functions of the IMGV were delivered as intended by the clinic personnel. The scale includes 5 questions using a 0-3 point scale. Questions measure the constructs: fostering a safe and positive environment, fostering social support through the group, providing evidence-based medical advice, fostering collaboration, and providing access to integrative therapy experiential practice. Total range is from 0-15 with 0 representing the lowest and 15 representing the highest possible fidelity.
Maintenance: 12 months
时间窗: Twelve months after the first IMGV session at clinic
Number of IMGV sessions held at the clinic at 12 months since the first IMGV session at that clinic.
Cost: Clinic Perspective
时间窗: within 1 month of final IMGV session participation, approximately 10 weeks
Total cost of implementation in the IMGV from the perspective of the clinic (ie total cost of staff time to implement the program, material costs).
Maintenance: 6 months
时间窗: Six months after the first IMGV session at clinic
Number of IMGV sessions held at the clinic at 6 months since the first IMGV session at that clinic.
Reach: Total Patients Reached
时间窗: through study completion, a total of up to 3 years
Number of patients who enroll in IMGV at each clinical site.
Reach: Ethnicity of Patients Reached
时间窗: through study completion, a total of up to 3 years
Ethnicity of patients who enroll in IMGV at each clinical site.
Cost: Patient Perspective
时间窗: within 1 month of final IMGV session participation, approximately 10 weeks
Total cost of participation in the IMGV from the perspective of patients (ie total cost of time, accessing technology, childcare, out-of-pocket costs).
Reach: Age of Patients Reached
时间窗: through study completion, a total of up to 3 years
Age of patients who enroll in IMGV at each clinical site.
Reach: Race of Patients Reached
时间窗: through study completion, a total of up to 3 years
Race of patients who enroll in IMGV at each clinical site.
Reach: Gender of Patients Reached
时间窗: through study completion, a total of up to 3 years
Gender of patients who enroll in IMGV at each clinical site.
Adoption
时间窗: through study completion, a total of up to 3 years
Number of clinic staff willing to form an implementation team to participate in delivering and implementing the IMGV at each clinical site.
Acceptability: Patients
时间窗: within 1 month of final IMGV session participation, approximately 10 weeks
Number of patients who perceive the IMGV to be acceptable based on qualitative data analysis.
Acceptability: Clinic Personnel
时间窗: within 1 month of final IMGV session participation, approximately 10 weeks
Number of clinic personnel who perceive the implementation of IMGV to be acceptable based on qualitative data analysis.
次要结局
- Change in Physical Function(Pre-assessments will be conducted within 4 weeks of the first IMGV session, Post assessments will be conducted within 4 weeks of the final IMGV session.)
- Change in Pain Medication Use(Assessments will be conducted within 4 weeks of the final IMGV session.)
- Change in Depression(Pre-assessments will be conducted within 4 weeks of the first IMGV session, Post assessments will be conducted within 4 weeks of the final IMGV session.)
- Change in Ability to Participate in Social Roles and Activities(Pre-assessments will be conducted within 4 weeks of the first IMGV session, Post assessments will be conducted within 4 weeks of the final IMGV session.)
- Change in Pain Intensity(Pre-assessments will be conducted within 4 weeks of the first IMGV session, Post assessments will be conducted within 4 weeks of the final IMGV session.)
- Change in Anxiety(Pre-assessments will be conducted within 4 weeks of the first IMGV session, Post assessments will be conducted within 4 weeks of the final IMGV session.)
- Change in Fatigue(Pre-assessments will be conducted within 4 weeks of the first IMGV session, Post assessments will be conducted within 4 weeks of the final IMGV session.)
- Change in Sleep Disturbance(Pre-assessments will be conducted within 4 weeks of the first IMGV session, Post assessments will be conducted within 4 weeks of the final IMGV session.)
- Change in Pain Interference(Pre-assessments will be conducted within 4 weeks of the first IMGV session, Post assessments will be conducted within 4 weeks of the final IMGV session.)