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临床试验/NCT04330365
NCT04330365已完成不适用

Implementation of a Pragmatic Trial of Whole Health Team vs. Primary Care Group Education to Promote Non-Pharmacological Strategies to Improve Pain, Functioning, and Quality of Life in Veterans

San Francisco Veterans Affairs Medical Center9 个研究点 分布在 1 个国家目标入组 793 人开始时间: 2020年9月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
793
试验地点
9
主要终点
Improved pain interference

研究概览

简要总结

The overarching goal of this Pain Management Collaboratory Demonstration project is to test a new Whole Health paradigm for chronic pain care, emphasizing non-pharmacological pain self-management that is hypothesized to reduce pain symptoms and improve overall functioning and quality of life in Veterans. In UH3 Aim 1, the investigators will conduct a 12-month pragmatic effectiveness trial at 6 VA sites across the country to test whether veterans with moderate to severe chronic pain randomized to receive the Whole Health Team (WHT) intervention are more likely than those receiving Primary Care Group Education (PC-GE) to: Hypothesis 1: Experience improved pain interference (primary outcome), pain intensity, functioning and quality of life (secondary outcomes); Hypothesis 2: Decrease use of higher-risk pain medications, including opioids, or high-risk combinations; Hypothesis 3: Engage in a greater number of non-pharmacological pain management activities; and Hypothesis 4: Experience improved mental health-related symptoms, including sleep problems and suicidality. In addition, both the WHT and PC-GE arms will be compared to a third group of veterans randomized to Usual Primary Care (UPC, Control) on the same primary and secondary outcomes above. After the baseline assessment, masked telephone assessments will be administered to participants at 3, 6, 9, and 12 months. UH3 Aim 2 is to conduct a process evaluation of the two active interventions (WHT and PC-GE) and a budget impact analysis that includes costs to implement and execute the two active interventions as well as the control condition (UPC) to inform the development of an implementation toolkit for scaling and dissemination. Eligible participants are veterans reporting moderate to severe chronic pain present every day or nearly every day for ≥ 6 months. The total sample size for the population is based on our main study aim/hypothesis and is N=764. This breaks down to n=343 in the WHT intervention, n=339 in the PC-GE intervention, and N=82 in the Usual Primary Care arm (Control). Results of this UG3/UH3 Pain Management Collaboratory Demonstration project will contribute to the overall mission of the NIH/VA/DoD initiative to build national-level infrastructure that supports non-pharmacologic pain management in veterans and military service personnel.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants must meet the following inclusion criteria to be enrolled in the study:
  • Assigned to a VA PCP;
  • Report pain present every day or nearly every day for ≥ 6 months using a phone eligibility screener; and
  • PEG score of ≥ 5 (including at baseline assessment)

排除标准

  • Candidates with any of the exclusion criteria at baseline will be excluded from study participation:
  • Moderate or severe cognitive impairment as determined by a failed 6-item, validated cognitive screener on initial phone screening (See Appendix A: Telephone Eligibility Screen/Script);
  • Active suicidality as determined by medical record review, standardized assessment (PHQ-9) and/or is unable to attend study visits because of an unstable or severe psychiatric or medical condition or is receiving palliative or hospice care; or
  • Any other factors that would interfere with study participation including inability to communicate by telephone, VTEL or VVC; being a non-English speaker; plans to relocate within 12 months and concurrent participation in another pain-related study.

研究组 & 干预措施

Whole Health Team (WHT) Intervention Arm

Active Comparator

The WHT intervention arm includes four core elements: 1) An interdisciplinary WHT collaborating with primary care; 2) Personalized Health Planning with prioritization of multi-modal non-pharmacological and CIH pain management approaches; 3) Whole Health Coaching sessions to assist patients in developing and implementing a Personalized Health Plan for chronic pain care; and 4) the web/mobile Whole Health Resource Directory provided to patient participants (in addition to their providers) to support non-pharmacologic/CIH chronic pain care.

干预措施: Whole Health Team (WHT) Intervention Arm, Primary Care Group Education (PC-GE) Intervention Arm, Usual Primary Care (UPC) Arm (Behavioral)

Primary Care Group Education (PC-GE) Intervention Arm

Active Comparator

Primary Care Group Education (PC-GE) is the comparator arm, which is an abbreviated form of Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) adapted for group use in primary care.

干预措施: Whole Health Team (WHT) Intervention Arm, Primary Care Group Education (PC-GE) Intervention Arm, Usual Primary Care (UPC) Arm (Behavioral)

Usual Primary Care (UPC) Arm

Placebo Comparator

In VA, patient-aligned care teams (PACTs) or primary care is step 1 of VA's Stepped Care Model in the treatment of chronic pain. PCPs are expected to possess the requisite skill set for management of common chronic pain-causing conditions, which includes biopsychosocial assessment, multi-modal treatment, and coordination of specialty pain care after shared-decision making that incorporates patient preferences and values. Participants randomized to this arm will continue to have their PCP and PACT serve in this role.

干预措施: Whole Health Team (WHT) Intervention Arm, Primary Care Group Education (PC-GE) Intervention Arm, Usual Primary Care (UPC) Arm (Behavioral)

结局指标

主要结局

Improved pain interference

时间窗: 12 months

The total Brief Pain Inventory (BPI) interference sub-scale score is our primary outcome measure.

次要结局

  • Improved pain intensity(12 months)
  • Decreased use of higher-risk pain medications, including opioids or high-risk combinations of pain medications (i.e., co-prescription of opioids and benzodiazepines)(12 months)
  • Engagement in a greater number of non-pharmacological pain management activities(12 months)
  • Improvement in mental health-related symptoms, including sleep problems and suicidality(12 months)
  • Functioning and quality of life(12 months)

研究者

发起方
San Francisco Veterans Affairs Medical Center
申办方类型
Fed
责任方
Principal Investigator
主要研究者

Karen Seal

Chief of Integrative Medicine

San Francisco Veterans Affairs Medical Center

研究点 (9)

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