Care Outcomes for Chiropractic Outpatient Veterans Aim 3-pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 8
- 主要终点
- Duration of Study Recruitment
研究概览
简要总结
The primary objectives of this pilot trial are to evaluate the feasibility, safety and acceptability of an integrative care pathway that includes chiropractic care, for the coordinated care for Veterans Administration (VA) patients with chronic low back pain (cLBP), with an emphasis on those with mental health comorbidity, in preparation for the conduct of an appropriately powered multi-site randomized controlled trial (RCT). The secondary objectives are to collect study outcomes at the baseline visit (BV) and at weeks 3, 5, 7, and 10 to: 1) assess the success of collecting outcomes; 2) determine the outcome measures to use in a future RCT; and 3) determine preliminary intervention effect sizes and variability to aid in sample size determination for a future RCT. The investigators hypothesize that chiropractic care offers relief for pain and mental health symptoms through the direct effects of treatment-focused CMT, as well as through the indirect, non-specific effects of the team-based relationship with the clinician.
This pilot study is a single-arm trial. All participants will be asked to complete study outcomes which include the Roland Morris Disability Questionnaire (RMDQ), LBP intensity and interference as measured by the Defense and Veterans Pain Rating Scale (DVPRS), as well as the Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder 7-item Scale (GAD-7), Alcohol Use Disorders Identification Test (AUDIT), Post-traumatic Stress Disorder Checklist-Civilian Version (PLC-C), self-care behaviors, Keele Start Back Screening Tool (STarT Back), Healing Encounters and Attitudes Lists (HEAL), Expectations for Complementary and Integrative Treatments Questionnaire (EXPECT), and Pain Intensity, Enjoyment of Life, General Activity Assessment Tool (PEG) questionnaires, and the Pain Assessment Screening Tool and Outcomes Registry (PASTOR) assessment, which includes measures of pain, disability, mental health, quality of life enjoyment and satisfaction. All participants will receive up to 10 weeks of chiropractic care and will complete outcome assessments at weeks 3, 5, 7, and 10 of the study.
详细描述
The coinciding problems of chronic pain and mental illness are of great concern for patients seeking care within the Department of Veterans Affairs (VA) healthcare facilities. Of the 5.7 million veterans treated in VA facilities in 2012, more than half reported chronic pain syndromes, including chronic low back pain (cLBP). Veterans also experience many mental health comorbidities, such as depression, anxiety, post-traumatic stress disorder (PTSD), and substance abuse. Veterans in pain are often managed using prescription drugs, including opioids, psychotropic medications, and sleep agents. Non-pharmacological treatments for chronic pain, which also may provide relief of mental health symptoms, may be welcomed complementary therapies for veterans suffering from these conditions.
Patients with musculoskeletal (MSK) pain and pain at multiple locations often report depression, anxiety and other mental health symptoms. Chronic pain may perpetuate mental health comorbidity as these conditions share common pathophysiological pathways. Research has shown that the non-specific effects of empathetic doctor communication and therapeutic alliance improves clinical outcomes. The investigators hypothesize that chiropractic care offers relief for pain and mental health symptoms through the direct effects of treatment-focused chiropractic manipulative therapy (CMT), as well as through the indirect, non-specific effects of the team-based relationship with the clinician.
However, chiropractic care is not delivered in isolation from other treatments within the VA. Thus, the investigators will test a feasible, effective, patient-centered, guideline-based, integrative care model that integrates chiropractic into VA Patient Aligned Care Teams (PACTs). This integrative care pathway will involve primary care providers, mental health professionals, and doctors of chiropractic (DCs) engaged in the treatment of veterans with cLBP, with or without mental health comorbidity. While DCs are providing services within VA in increasing numbers over the past 13 years, as with any new service, adoption and appropriate placement faces challenges. Many VA providers may know little about the clinical approaches used by DCs. Similarly, DCs may not be fully aware of the processes involved in the delivery of primary care services within VA or the healthcare needs of veterans with mental illness. The purpose of this pilot clinical trial is to evaluate the feasibility, safety and patient perceptions of an integrative care pathway, developed through a consensus-based process, for the coordinated care for VA patients with cLBP and mental health comorbidity.
As this is a pragmatic trial, chiropractic care will consist of usual chiropractic procedures for the management chronic low back pain (cLBP). Treatment approaches will be based on clinical evaluation, which may include diagnostic testing, to determine a working diagnosis, rule out pathology, and/or to screen for conditions requiring referral or other co-management. The investigators anticipate that chiropractic care often will include some form of chiropractic manipulative therapy (CMT). DCs will likely also recommend rehabilitative exercise, stretching, or nutritional and lifestyle advice based upon clinical findings and patient goals/preferences. The investigators will evaluate treatments through electronic health records (EHR) data abstraction following completion of chiropractic care at Week 10. As per typical VA care, DCs will monitor the participant's health status throughout the trial and initiate referrals as clinically indicated. Referrals to primary care and mental health providers will be consistent with the chiropractic integrated care pathway developed during a prior phase of the study. The investigators anticipate the most common communication and referral methods will occur through note-review and countersign procedures, which are already established among VA providers using the VA electronic health record, but may also occur in person or via phone conversations. Chiropractic care will be administered by licensed DCs who are current employees of the Iowa City VA Health Care System (ICVAHCS).
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Veterans age 18 years or older
- •Self-reported chronic LBP
- •Ability to sign informed consent form
排除标准
- •Use of chiropractic care within the past 90 days
- •Impaired cognitive ability
- •Not a candidate for chiropractic care
- •Not able to attend chiropractic appointments
- •Identified as at risk for suicide
结局指标
主要结局
Duration of Study Recruitment
时间窗: From date of first participant enrolled to date last participant is enrolled, up to 8 months.
As part of the feasibility assessment, the investigators will monitor the amount of time it takes to complete study recruitment and enrollment, and data collection. The investigators will monitor this through a data capture program.
Diversity of Patient Demographics
时间窗: Screening through baseline
As part of the recruitment plan, investigators are trying to target female and minority veterans. Historically these groups have been underrepresented in veteran research. The investigators will review EHR data for participant demographics.
Number of Participants Engaged in Use of MyHealthEVet
时间窗: 10 weeks from Baseline
As part of the feasibility assessment, investigators will monitor the number of study participants who enroll in and have at least one communication with MyHealthEVet. MyHealthEVet is an online communication tool designed to partner veterans and the veteran's health care team. It provides information on the veteran's health record and health topics as well as allows messaging communication between veterans and health care providers. Usage reports generated by MyHealthEVet will be analyzed to determine number of study participants engaged.
Percentage of Participants Who Did Not Attend the Initial Chiropractic Visit, Withdrew, or Are Lost to Follow-up
时间窗: 10 weeks from Baseline
As part of the feasibility assessment and ability to calculate a sample size for a full scale trial with subgroup analysis, investigators will monitor the percentage of missing data. This will include the percentage of participants who did not attend the initial chiropractic visit and withdraw or are lost to follow-up.
Acceptability
时间窗: At Week 10 of the study
Acceptability will be assessed by conducting structured, qualitative exit interviews with participants and providers.
Number of Participants With Reported Adverse Events
时间窗: 10 weeks from Baseline
Safety for this study will be assessed by the number of adverse events counted and recorded.
次要结局
- Roland Morris Low Back Pain Disability Questionnaire (RMDQ)(Baseline visit and weeks 5 and 10)
- Patient Health Questionnaire (PHQ-9)(Baseline visit and week 10)
- Alcohol Use Disorders Identification Test (AUDIT)(Baseline visit and week 10)
- Pain Assessment Screening Tool and Outcomes Registry (PASTOR)(Baseline visit and weeks 5 and 10)
- STarT Back Screening Tool(Baseline visit and week 10)
- Self-Efficacy for Managing Symptoms (SF8a)(Baseline visit and week 10)
- Generalized Anxiety Disorder-7 (GAD-7)(Baseline visit and week 10)
- PTSD Checklist-Civilian (PCL-C)(Baseline visit and week 10)
- Healing Encounters and Attitudes Lists (HEAL)(After the initial chiropractic visit)
- Pain, Enjoyment, and General Activity (PEG)(Week 3 and Week 7)
