Communication and activation in pain to enhance relationships and treat pain with equity (COOPERATE): a randomized clinical trial.

ABSTRACT: Racialized disparities in chronic pain care are well-documented and persist despite national priorities focused on health equity. Similar disparities have been observed in patient activation (ie, having the knowledge, confidence, and skills to manage one's health). As such, interventions targeting patient activation represent a novel approach to addressing and reducing disparities in pain care. Communication and Activation in Pain to Enhance Relationships and Treat Pain with Equity is a randomized controlled trial of a 6-session telephone-delivered intervention to increase patient activation for Black patients with chronic pain. Two hundred fifty Black patients from a Midwestern Veterans Affairs medical center were randomized to the intervention or attention control. The primary outcome was patient activation; secondary outcomes included communication self-efficacy, pain, and psychological functioning. Outcomes were assessed at baseline and at 3 (primary endpoint), 6, and 9 months (sustained effects). Analyses used an intent-to-treat approach. Compared with baseline, patient activation increased 4.6 points at 3 months (versus +0.13 in control group, 95% CI: 0.48, 7.34; P = 0.03). These improvements in the intervention group were sustained, with +7 from baseline at 6 months and +5.77 at 9 months, and remained statistically significant from the control group. Communication self-efficacy increased significantly relative to the control group from baseline to 3 months. Pain intensity and interference improved at 3 months, but differences were not significant after adjusting for multiple comparisons. Most other secondary outcomes improved, but group differences were not statistically significant after controlling for multiple comparisons. Results suggest that increasing patient activation is a potentially fruitful path toward improving pain management and achieving health equity.

Feasibility and Acceptability of Music Imagery and Listening Interventions for Analgesia: Protocol for a Randomized Controlled Trial.

BACKGROUND: Chronic pain and access to care are identified as critical needs of the Veterans Health Administration. Music imagery and music listening interventions have shown promise as effective nonpharmacological options for pain management. However, most studies have focused on acute pain, passive music experiences, and in-person delivery. OBJECTIVE: In this study, we aimed to examine the feasibility and acceptability of 2 music interventions delivered through telehealth for chronic musculoskeletal pain, trial design, and theoretical model before conducting a fully powered efficacy or comparative effectiveness trial. METHODS: FAMILIA (Feasibility and Acceptability of Music Imagery and Listening Interventions for Analgesia) is a 3-arm, parallel group, pilot trial. A total of 60 veterans will be randomized to one of the three conditions: music imagery, music listening, or usual care. Aim 1 is to test the feasibility and acceptability of a multicomponent, interactive music imagery intervention (8-weekly, individual sessions) and a single-component, minimally interactive music learning intervention (independent music listening). Feasibility metrics related to recruitment, retention, engagement, and completion of the treatment protocol and questionnaires will be assessed. Up to 20 qualitative interviews will be conducted to assess veteran experiences with both interventions, including perceived benefits, acceptability, barriers, and facilitators. Interview transcripts will be coded and analyzed for emergent themes. Aim 2 is to explore the effects of music imagery and music listening versus usual care on pain and associated patient-centered outcomes. These outcomes and potential mediators will be explored through changes from baseline to follow-up assessments at 1, 3, and 4 months. Descriptive statistics will be used to describe outcomes; this pilot study is not powered to detect differences in outcomes. RESULTS: Recruitment for FAMILIA began in March 2022, and as of July 2022, 16 participants have been enrolled. We anticipate that enrollment will be completed by May 2023. We expect that music imagery and music listening will prove acceptable to veterans and that feasibility benchmarks will be reached. We hypothesize that music imagery and music listening will be more effective than usual care on pain and related outcomes. CONCLUSIONS: FAMILIA addresses four limitations in music intervention research for chronic pain: limited studies in veterans, evaluation of a multicomponent music intervention, methodological rigor, and internet-based delivery. Findings from FAMILIA will inform a fully powered trial to identify putative mechanisms and test efficacy. TRIAL REGISTRATION: ClinicalTrials.gov NCT05426941; https://tinyurl.com/3jdhx28u. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/38788.

Effectiveness of the VA-Geriatric Resources for Assessment and Care of Elders (VA-GRACE) program: An observational cohort study.

BACKGROUND: As the Department of Veterans Affairs (VA) healthcare system seeks to expand access to comprehensive geriatric assessments, evidence-based models of care are needed to support community-dwelling older persons. We evaluated the VA Geriatric Resources for Assessment and Care of Elders (VA-GRACE) program's effect on mortality and readmissions, as well as patient, caregiver, and staff satisfaction. METHODS: This retrospective cohort included patients admitted to the Richard L. Roudebush VA hospital (2010-2019) who received VA-GRACE services post-discharge and usual care controls who were potentially eligible for VA-GRACE but did not receive services. The VA-GRACE program provided home-based comprehensive, multi-disciplinary geriatrics assessment, and ongoing care. Primary outcomes included 90-day and 1-year all-cause readmissions and mortality, and patient, caregiver, and staff satisfaction. We used propensity score modeling with overlapping weighting to adjust for differences in characteristics between groups. RESULTS: VA-GRACE patients (N = 683) were older than controls (N = 4313) (mean age 78.3 ± 8.2 standard deviation vs. 72.2 ± 6.9 years; p < 0.001) and had greater comorbidity (median Charlson Comorbidity Index 3 vs. 0; p < 0.001). VA-GRACE patients had higher 90-day readmissions (adjusted odds ratio [aOR] 1.55 [95%CI 1.01-2.38]) and higher 1-year readmissions (aOR 1.74 [95%CI 1.22-2.48]). However, VA-GRACE patients had lower 90-day mortality (aOR 0.31 [95%CI 0.11-0.92]), but no statistically significant difference in 1-year mortality was observed (aOR 0.88 [95%CI 0.55-1.41]). Patients and caregivers reported that VA-GRACE home visits reduced travel burden and the program linked Veterans and caregivers to needed resources. Primary care providers reported that the VA-GRACE team helped to reduce their workload, improved medication management for their patients, and provided a view into patients' daily living situation. CONCLUSIONS: The VA-GRACE program provides comprehensive geriatric assessments and care to high-risk, community-dwelling older persons with high rates of satisfaction from patients, caregivers, and providers. Widespread deployment of programs like VA-GRACE will be required to support Veterans aging in place.

Communication and Activation in Pain to Enhance Relationships and Treat Pain with Equity (COOPERATE): Rationale, study design, methods, and sample characteristics.

BACKGROUND: Chronic pain is associated with profound negative effects, and racial disparities are well-documented in chronic pain treatment. In addition, Black patients report poorer communication with providers and exhibit lower levels of patient activation (self-management self-efficacy) than White patients. Although the causes of healthcare disparities are complex and require intervention at multiple levels, empowering patients is one critical path to achieving health equity. The current study is a coaching intervention focused on increasing patient activation and building communication skills for Black patients with chronic pain. METHODS: In this randomized controlled trial, 250 Black patients with chronic pain were randomized to either the coaching intervention or an attention control arm. Intervention patients attended 6 telephone-delivered individual coaching sessions over 12 weeks. Coaching focused on clarifying and prioritizing goals and on communication skills, such as agenda setting. The primary outcome is patient activation. Secondary outcomes include communication self-efficacy, pain intensity and interference, and psychological functioning. DISCUSSION: Having the knowledge and confidence to participate in one's pain care, coupled with the skills needed to effectively communicate with providers, is essential to optimize chronic pain care. This is particularly important for Black patients who often experience lower quality pain care. Interventions such as COOPERATE hold promise for helping patients to acquire the requisite tools to take greater control of their chronic pain care. TRIAL REGISTRATION: clinicaltrials.gov, # NCT03562793.

Peer Support for Self-Management of Chronic Pain: the Evaluation of a Peer Coach-Led Intervention to Improve Pain Symptoms (ECLIPSE) Trial.

BACKGROUND: Pain self-management is an effective, evidence-based treatment for chronic pain. Peer support, in which patients serve as coaches for other patients, has been effective in other chronic conditions and is a potentially promising approach to implementing pain self-management programs using fewer clinical resources. OBJECTIVE: To test a peer coach-delivered pain self-management program for chronic pain. DESIGN: Randomized controlled trial. PARTICIPANTS: Veterans with chronic musculoskeletal pain. INTERVENTION: Intervention patients were assigned a trained peer coach for 6 months. Coaches, who were volunteers, were asked to contact their assigned patients, either by phone or in person, twice per month. Coaches and patients were given an intervention manual to guide sessions. The control group was offered a 2-hour pain self-management class. MAIN MEASURES: The primary outcome was total pain, assessed by the Brief Pain Inventory (BPI). Secondary outcomes were anxiety, depression, pain catastrophizing, self-efficacy, social support, patient activation, health-related quality of life, and healthcare utilization. Outcomes were measured at baseline, 6 months, and 9 months. KEY RESULTS: Two hundred fifteen patients enrolled (120 intervention, 95 control). Adherence to intervention protocol was low, with only 13% of patients reporting having at least the recommended 12 peer coach meetings over the 6-month intervention. BPI total decreased from baseline to 6 months and baseline to 9 months in both groups. At 9 months, this change was statistically significant (intervention, - 0.40, p = 0.018; control, - 0.47, p = 0.006). There was not a statistically significant difference between groups on BPI at either time point. No secondary outcomes improved significantly in either group after adjusting for multiple comparisons. CONCLUSIONS: Patients randomized to peer support did not differ from control patients on primary and secondary outcomes. Other peer support models that do not rely on volunteers might be more effective. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02380690.

Evaluation of a peer coach-led intervention to improve pain symptoms (ECLIPSE): Rationale, study design, methods, and sample characteristics.

Chronic pain is prevalent, costly, and a leading cause of disability. Pain self-management (i.e., employing self-management strategies including behavioral modifications) is an effective, evidence-based treatment. However, implementation and delivery of a pain self-management model is challenging because of time and resources. Peer supported pain self-management offers a promising approach to implementing pain self-management programs using fewer clinical resources. Evaluation of a Peer Coach-Led Intervention for the Improvement of Pain Symptoms (ECLIPSE) is a randomized controlled trial testing effectiveness of peer coach-delivered pain self-management intervention versus controls receiving a class on pain and pain self-management. ECLIPSE is a Hybrid Type 1 study testing effectiveness while examining implementation factors. ECLIPSE enrolled 215 veterans randomly assigned to the peer coaching (N = 120) or control (N = 95) arm. The peer coaching intervention lasts 6 months, with patient-peer coach pairs instructed to talk twice per month. Coaches attend initial training, are provided a detailed training manual, and attend monthly booster sessions. Outcomes are assessed at baseline, 6 months, and 9 months. The primary outcome is overall pain (intensity and interference), measured by the Brief Pain Inventory (BPI). Secondary outcomes are self-efficacy, social support, pain catastrophizing, patient activation, health-related quality of life, and health care utilization. To maximize implementation potential of pain self-management, innovative delivery methods are needed that do not require additional resources from healthcare teams. A novel and promising approach is a peer-coaching model, in which patients who are successfully managing their pain offer information, ongoing support, and advice to other patients with pain. Clinical Trials Registration: NCT02380690.