Impact of a Novel Community-Based Biobehavioral Chronic Pain Team Training Program (4PCP) on Practitioner and Patient Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,188
- 试验地点
- 12
- 主要终点
- Change in Patient Participant Pain, Enjoyment of Life and General Activity (PEG-3)
研究概览
简要总结
Reducing opioid prescribing and improving outcomes in patients with chronic pain would benefit our nation. Neither addiction nor chronic pain spares any race, gender, or particular socio-economic status. This study is investigating a potentially inexpensive way of providing a previously costly service (the intensive chronic pain rehabilitation program), which is why insurers stopped covering it. Although it is unusual for an application from an academic institution to include a startup company (PainSTakers, LLC) as the curriculum provider, this is actually a long-term strength of this program, and the reason NIH recommended this route. It ensures that 4PCP will ultimately sustain itself rather than require government support for its continuation. Support for this application is not to provide the curriculum, but to determine if it is effective in the outcomes expected to be found. The curriculum is being provided freely only as an incentive for practitioners to participate in the research portion of the study. If the study is able to demonstrate its clinical effectiveness, the next step will be to show a positive economic impact for health care institutions and for health insurers who may then wish to support the program for their practitioners and their patients.
详细描述
Practitioner procedures:
After the completion of informed consent, practitioners will be sent their first set of surveys (Baseline).
1 week before the first day of the practitioner's course, they will be sent a second set of surveys (Time 0).
6 months after course completion, practitioners will be sent their next set of surveys (Follow Up 1).
6 months after the distribution of Follow Up Survey 1, practitioners will be sent their next set of surveys (Follow Up 2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Practitioner Inclusion:
- •General practitioners
- •Part of a practice that has their own identifiable patient population including patients with chronic pain
- •Able to fully answer questionnaires
- •Able to attend 4PCP course
- •English speaking
- •Patient inclusion:
- •Age 14-80
- •Self-report of chronic non-malignant pain > 3 months
- •No foreseeable or planned surgeries for chronic pain
- •Has attended at least 2 established visits in the enrolled practitioner's practice
- •English speaking
- •Practitioner
排除标准
- •Pain specialists
- •Unable to fully answer questionnaires
- •Unable to attend the 4PCP course
- •Non-English speaking
- •Patient exclusion:
- •Unable to answer questionnaires (e.g. stroke, dementia, developmental delay, etc.)
- •Followed in a specialty pain clinic (PCP not managing pain care)
- •Sickle cell disease
- •Prisoners
- •Non-English speaking
研究组 & 干预措施
4PCP Course (for practitioners only)
All enrolled practitioners will be assigned to take the 4PCP course as the intervention. Patients will not be assigned to the course and will only be completing surveys before and after their practitioner completes 4PCP.
干预措施: 4PCP Course (Behavioral)
结局指标
主要结局
Change in Patient Participant Pain, Enjoyment of Life and General Activity (PEG-3)
时间窗: Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation
Pain, Enjoyment of Life and General Activity will be assessed using the PEG-3 which is a self-report, 3 item survey which asks patient participants to rate their experiences on a 10 point Likert scale.
Change in Practitioner Chronic Pain Physician Perspectives Questionnaire (CPPP)
时间窗: Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation
Practitioner chronic pain perspectives will be assessed using the CPPP, which is a self-report 26 item survey that asks practitioners to rate feelings related chronic pain on a 6 point Likert scale.
Number of Patient Participants whose opioid dose tapered
时间窗: Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation
Opioid Morphine milligram equivalents (MME) MME will be calculated from medical record/state prescription monitoring data to determine changes in patient opioid use. Based on MME changes, number of patients whose dose is tapered by at least 5% over 6 months will be counted.
次要结局
- Change in Patient Participant Pain Interference (PI)(Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation)
- Change in Patient Participant Pain Catastrophizing Scale (PCS)(Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation)
- Change in Patient Participant Quality of Life (QoL)(Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation)
- Practitioner Burn-Out(Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation)
- Change in Practitioner Chronic Pain Attitudes and Beliefs Questionnaire (PABS-PT)(Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation)
- Change in Patient Participant Generalized Anxiety Disorder (GAD-7)(Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation)
- Change in Practitioner Health Care Providers' Pain and Impairment Relationship Scale (HC-PAIRS)(Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation)
- Change in Patient Participant Patient Health Questionnaire (PHQ-9)(Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation)
- Change in Practitioner Burn-Out (Mini Z)(Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation)