跳至主要内容
临床试验/NCT05787379
NCT05787379招募中不适用

Leveraging Knowledge of Chronic Multisymptom Illness to Improve Care for Veterans Post-COVID

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 348 人开始时间: 2025年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
348
试验地点
2
主要终点
Concordant Care Practice Change

研究概览

简要总结

The evidence-based Concordant Care approach involves engaging in processes that: 1) validate the patient's experience, 2) develop a shared understanding of the condition, and 3) create a patient-centered, whole health-oriented action plan to manage the condition. This is consistent with published expert opinion that Concordant Care underlies patients' (and clinicians') positive experiences of care for poorly understood conditions. Despite strong evidence supporting this care approach, there are no interventions to train clinicians on practices to provide Concordant Care for Veterans with poorly understood conditions such as Long-COVID. Part 1 of the study will optimize and test if a Concordant Care training improves VA clinicians' engagement in recommended practices to provide Concordant Care (i.e., validate, shared understanding, action plan) for Veterans with Long-COVID. This study will adapt and refine Concordant Care training for Long-COVID. Part 2 of this study will determine if Concordant Care training increases clinicians' engagement in recommended practices to provide Concordant Care and will explore the effectiveness of Concordant Care on care outcomes including satisfaction, adherence to care, & disability for Veterans with Long-COVID. Veterans treated by clinicians receiving Concordant Care training will report their clinician more frequently engaged in recommended conversations (i.e., ask about Long-COVID, validate experience with Long-COVID, create a shared understanding and action plan), and Veterans will perceive greater shared understanding of Long-COVID with their clinicians than Veterans treated by clinicians in the control arm.

详细描述

This is a two-part study. Part 1 of the study will optimize and test if a Concordant Care training improves VA clinicians' engagement in recommended practices to provide Concordant Care (i.e., validate, shared understanding, action plan) for Veterans with Long-COVID. The evidence-based Concordant Care approach involves engaging in processes that: 1) validate the patient's experience, 2) develop a shared understanding of the condition, and 3) create a patient-centered, whole health-oriented action plan to manage the condition. Concordant Care will be adapted through interviews and focus groups with Veterans with Long-COVID (estimated n=9) and primary care providers (estimated n=21). Feedback from the participants will help refine and test Concordant Care training. Part 2 of this study will determine if Concordant Care training increases clinicians' engagement in recommended practices to provide Concordant Care and will explore the effectiveness of Concordant Care on care outcomes including satisfaction, adherence to care, & disability for Veterans with Long-COVID. Part 2 will be a randomized parallel cluster trial with primary care clinicians (n=60) separated into a Concordant Care training group and an education packet control group. Veterans (n=240) who have an upcoming appointment with their primary care provider who is a participant in the study will be recruited. The Veterans will be assessed at baseline before their appointment and approximately 3-months later after their appointment. Veterans treated by clinicians receiving Concordant Care training will report their clinician more frequently engaged in recommended conversations (i.e., ask about Long-COVID, validate experience with Long-COVID, create a shared understanding and action plan), and Veterans will perceive greater shared understanding of Long-COVID with their clinicians than Veterans treated by clinicians in the control arm.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Part 1 and Part 2, English-speaking VA primary care providers will be included.
  • Part 1, Veterans who self-identify as having Long-COVID will be included.
  • Part 2, Veterans who meet criteria for Long-COVID assessed with modified DePaul Symptom Questionnaire version 2 will be included; --Part 2, Veterans must also have a scheduled appointment with one of the participating clinicians within one to six months of the clinician being consented.

排除标准

  • Part 1 and Part 2, clinicians who have already taken Concordant Care training will be excluded.
  • Part 1, Veterans will be excluded if they are not receiving care in the VA.
  • Part 2, Veterans will be excluded if they were in the Intensive Care Unit (ICU) for COVID-19.

结局指标

主要结局

Concordant Care Practice Change

时间窗: Baseline and 3-months

Concordant Care practices will be measured with the 11-item measure that asks the patient if the clinician talked with them about multiple dimensions of their understanding of the health condition (i.e., cause, consequence, treatment). Participants answer yes or no to each question. Scores range from 0 to 11 with a higher score = more Concordant Care practices.

Concordance of Illness Perceptions Questionnaire Change

时间窗: Baseline and 3-months

Shared Understanding will be captured with the concordance of illness perceptions questionnaire, a 6-item validated measure of shared understanding of the 5 components of illness perception between patients and clinicians. Veterans respond on a 5-point Likert scale. Scores range from 6 to 30 with higher scores = greater concordant understanding.

次要结局

  • Patient Satisfaction Questionnaire (PSQ-III)(Baseline and 3-months)
  • Medical Outcomes Survey Adherence Scale(Baseline and 3-months)
  • Veterans Rand (VR-12)(Baseline and 3-months)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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