Care Outcomes for Chiropractic Outpatient Veterans — COCOV  

Depression Clinical Trial

Official title: Care Outcomes for Chiropractic Outpatient Veterans Aim 3-pilot Trial

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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). ;

Related Conditions & MeSH terms

• Anxiety
• Back Pain
• Depression
• Low Back Pain
• PTSD

• NCT number: NCT03254719
• Study type: Interventional
• Source: Palmer College of Chiropractic
• Status: Completed
• Phase: N/A
• Start date: February 19, 2018
• Completion date: November 5, 2018