跳至主要内容
临床试验/NCT04403295
NCT04403295已完成不适用

Collaborative Specialty Care for Gulf War Illness

VA Office of Research and Development1 个研究点 分布在 1 个国家目标入组 281 人开始时间: 2020年8月24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
入组人数
281
试验地点
1
主要终点
Roland Morris Disability Scale

研究概览

简要总结

Gulf War Veterans (GWVs) with Gulf War Illness (GWI) do not receive the care they should in the Veterans Affairs (VA). The investigators' data show 70% of GWVs with Gulf War Illness (GWI) do not receive treatment recommendations for their GWI and 78% are NOT very satisfied with their care. The quality of care GWVs receive must improve. VA and DoD have invested hundreds of millions of dollars to develop new treatments for GWVs, without effective delivery methods GWVs will not benefit. This study will be the first study to examine the best model of care to deliver treatments to GWVs with GWI. Determining the best model of care to translate research into practice is a key goal of the VA Gulf War Strategic Plan and a specific aim of this Request for Applications.

详细描述

There is a quality chasm between the care Gulf War Veterans (GWVs) should receive and the care they do receive. The investigators' data show 70% of GWVs with Gulf War Illness (GWI) do not receive treatment recommendations for their GWI and 78% are NOT very satisfied with their care. Reducing this quality chasm is essential. The VA and DoD have invested hundreds of millions of dollars to develop new treatments, including the second largest clinical trial for GWVs which is finding health coaching and problem-solving treatment both reduce the disability of GWI. Without effective models of healthcare to implement these treatments, GWVs will not benefit. In the current model of care, GWVs receive care locally through VA's primary care patient aligned care teams (PACTs). The VA War Related Illness and Injury Study Center (WRIISC) supports the current model of care by increasing local knowledge of the skills and treatments needed to manage GWI through national education efforts and electronic consultation (e-consultation) on difficult cases. The WRIISC and other stakeholders are currently questioning whether improving local knowledge of skills and treatments for GWI is enough to address the quality chasm, or if GWI is too complex to be treated in primary care without additional support from specialists in GWI. A potentially useful model of care for GWI is collaborative specialty care where specialists work with PACTs to synergistically treat patients. The local PACT is the lead of the team with the specialist providing some direct care to the patient (through tele-health) and also consulting with the PACT about other aspects of care. Collaborative specialty care is effective for other complex conditions (e.g., depression) with over 40 studies documenting its efficacy. The goal of this proposal is to conduct a hybrid type 1 randomized effectiveness/implementation trial for GWVs with GWI (n=220). The primary aim is to determine the effectiveness of tele-CSC as compared to e-consultation. In tele-CSC, the investigators' specialty provider team will deliver health coaching and problem-solving treatment to GWVs and recommend the PACT make monthly optimization of analgesics. In e-consultation the specialty provider team will make a onetime recommendation to the PACT that the GWV locally receive health coaching and problem-solving treatment and analgesic optimization. The secondary aim is to understand implementation outcomes. This information will be used to guide a future randomized (by VISN) multi-site implementation study. Throughout, an advisory committee of operations partners will be convened to ensure that the results of the study are able to directly and immediately improve care. Determining the best model of care to translate research into practice for GWVs with GWI is a key goal of the VA Gulf War Strategic Plan and a specific aim of this Request for Applications.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

The study coordinator conducting the randomization and study providers will not be blinded. Other staff and investigators (including the Principal Investigator) will be blind to study assignment.

入排标准

性别
All
接受健康志愿者

入选标准

  • deployed to Operation Desert Shield/Storm
  • meets Kansas City (Steele) definition of GWI (which excludes conditions that may account for GWI)
  • rates their activity limitations from pain at least 3 on a 0 to 10 point scale
  • has a VA primary care provider

排除标准

  • suicidal intent
  • previous evaluation at the WRIISC or participated in our clinical trial for GWVs with GWI

研究组 & 干预措施

collaborative specialty care

Experimental

In specialty collaborative care, the specialty provider team will deliver health coaching and problem-solving treatment to GWVs and recommend the primary care team make monthly optimization of analgesics.

干预措施: Collaborative Specialty Care (Behavioral)

e-consultation

Active Comparator

In e-consultation the specialty provider team will make a onetime recommendation to the primary care team that the GWV locally receive health coaching and problem-solving treatment and analgesic optimization.

干预措施: e-consultation (Behavioral)

结局指标

主要结局

Roland Morris Disability Scale

时间窗: 6 months

Pain disability will be assessed with the RMDS a 24 item scale of disability from pain. The RMDS is a core outcome measure for patients with chronic pain. A change of 2-3 points is considered clinically significant. Pain is present in 99% of GWVs with GWI and previous collaborative care trials in the VA have used this measure. Scores range from 0-24 with higher scores = greater disability.

World Health Organization Disability Schedule

时间窗: 6 months

The WHO-DAS 2.0 measures disability which is due to physical and mental health conditions. The WHO-DAS 2.0 is a 40 item measure that assesses 6 life tasks. The composite score will be used as the dependent variable. The items of the WHO-DAS have a factor loading on composite score of 0.82 to 0.98. The WHO-DAS was the primary outcome in our previous trial of problem-solving treatment and captures all over health disability. Scores range from 0-100 with higher scores equaling greater disability.

次要结局

  • Brief Pain Inventory - Interference Scale(9 month)
  • Patient Activation Measure(9 month)
  • Patient Health Questionnaire Somatic Symptom Scale - 15(9 month)
  • Satisfaction: Patient Satisfaction Questionnaire(9 month)
  • Roland Morris Disability Scale(9 month)
  • World Health Organization Disability Schedule(9 month)
  • Brief Pain Inventory - Interference Scale(6 months)
  • Patient Health Questionnaire Somatic Symptom Scale - 15(6 months)
  • Patient Activation Measure(6 months)
  • Satisfaction: Patient Satisfaction Questionnaire(6 month)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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