Equity Using Interventions for Pain and Depression
NCT Number: NCT06500780
Acronym: EQUIPD
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Pain|Musculoskeletal Pain|Depression|Health Equity
Interventions: BEHAVIORAL: Coaching and Decision Aid
Sponsor: Indiana University
Collaborators: National Institute of Nursing Research (NINR)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 304
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-08
Completion Date: 2027-05-31
Locations: Eskenazi Health Primary Care, Indianapolis, Indiana, 46254, United States

Summary:
This project is part of the NIH Helping to End Addiction Long-term (HEAL) initiative (https://heal.nih.gov/). This pilot randomized controlled trial (RCT) is phase 2 of a two-phase, 5-year project with the overarching goal of testing a decision aid (DA)/coaching intervention, tailored to Black patients with comorbid chronic pain and depression, to encourage use of and adherence to nonpharmacological pain treatments (NPTs).

This 2-arm pilot trial will aim to enroll up to 355 Black patients with comorbid chronic musculoskeletal pain and depression in primary care from an urban safety-net health system (Eskenazi) in order to randomize at least 304 patients. After the baseline assessment, patients randomized to the intervention will be asked to participate in 4 coaching sessions over approximately 12 weeks. Sessions will use Motivational Interviewing principles to foster openness to NPTs and self-efficacy by helping patients identify their goals and priorities, understand their NPT options, prepare them to discuss and choose options with their primary care providers (PCPs), and reinforce these choices to foster maintenance of these changes. DA contents will be integrated into these sessions, which will facilitate discussion of these options with their PCP. The first 3 sessions take place prior to the patient's next scheduled PCP visit; the final session occurs after this visit. Assessments will be conducted at baseline, 3 months (i.e., after completing the final coaching session), and 6 months.

Patients randomized to the wait-list control group will receive usual care (in addition to study assessments at baseline, 3 months, and 6 months). After completing the final assessment, they will then be given the DA and offered a 20-minute coaching session to walk them through it.

Primary Outcome Measures: Change from Baseline Brief Pain Inventory (BPI) Interference Scale at 3 months, The pain interference score averages seven ratings, 0 (does not interfere) to 10 (completely interferes)., 3 months|Change from Baseline Brief Pain Inventory (BPI) Interference Scale at 6 months, The pain interference score averages seven ratings, 0 (does not interfere) to 10 (completely interferes)., 6 months|Change from Baseline Patient Health Questionnaire (PHQ)-8 at 3 months, The Patient Health Questionnaire (PHQ)-8 is a widely-used, validated 8-item measure of depression severity that uses a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day)., 3 months|Change from Baseline Patient Health Questionnaire (PHQ)-8 at 6 months, The Patient Health Questionnaire (PHQ)-8 is a widely-used, validated 8-item measure of depression severity that uses a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day)., 6 months
Secondary Outcome Measures: Change from Baseline Brief Pain Inventory (BPI) Intensity Scale at 3 months, This pain intensity scale has 4 items with ratings from 0 (no pain) to 10 (pain as bad as you can imagine)., 3 months|Change from Baseline Brief Pain Inventory (BPI) Intensity Scale at 6 months, This pain intensity scale has 4 items with ratings from 0 (no pain) to 10 (pain as bad as you can imagine)., 6 months|Change from Baseline Generalized Anxiety Disorder (GAD)-7 at 3 months, Anxiety will be measured with the 7 item Generalized Anxiety Disorder (GAD)-7 that uses a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day)., 3 months|Change from Baseline Generalized Anxiety Disorder (GAD)-7 at 6 months, Anxiety will be measured with the 7 item Generalized Anxiety Disorder (GAD)-7 that uses a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day)., 6 months|Change from Baseline Pain Catastrophizing Scale at 3 months, The Pain Catastrophizing Scale is a 13-item scale that assesses catastrophizing-a cognitive-emotional factor that predicts poor treatment response. The scale uses a 5-point Likert scale ranging from 0 (not at all) to 4 (all the time)., 3 months|Change from Baseline Pain Catastrophizing Scale at 6 months, The Pain Catastrophizing Scale is a 13-item scale that assesses catastrophizing-a cognitive-emotional factor that predicts poor treatment response. The scale uses a 5-point Likert scale ranging from 0 (not at all) to 4 (all the time)., 6 months|Change from Baseline Altarum Consumer Engagement (ACE) Measure at 3 months, Patient engagement will be measured with the 12-item Altarum Consumer Engagement (ACE) Measure, which has 3 subscales: 1) commitment to manage one's health, 2) informed choice, and 3) confidence to participate in treatment decisions. Items are assessed on a 5-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree)., 3 months|Change from Baseline Altarum Consumer Engagement (ACE) Measure at 6 months, Patient engagement will be measured with the 12-item Altarum Consumer Engagement (ACE) Measure, which has 3 subscales: 1) commitment to manage one's health, 2) informed choice, and 3) confidence to participate in treatment decisions. Items are assessed on a 5-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree)., 6 months|Change from Baseline Decisional Conflict Scale (DCS) at 3 months, Decisional conflict will be measured with the 16-item Decisional Conflict Scale that measures personal perceptions of a) uncertainty in choosing options, b) modifiable factors contributing to uncertainty, and c) effective decision making on a 5-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree)., 3 months|Change from Baseline Decisional Conflict Scale (DCS) at 6 months, Decisional conflict will be measured with the 16-item Decisional Conflict Scale that measures personal perceptions of a) uncertainty in choosing options, b) modifiable factors contributing to uncertainty, and c) effective decision making on a 5-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree)., 6 months|Change from Baseline CollaboRATE at 3 months, Shared decision making will be measured with CollaboRATE, a 3-item measure assessing provider effort from the patient's perspective to engage in shared-decision making during a recent appointment., 3 months|Change from Baseline Pain Self-Efficacy Questionnaire (PSEQ) at 3 months, This self efficacy questionnaire, developed to assess the confidence people with ongoing pain have in performing activities while in pain, has 10 items with ratings from 0 (not at all confident) to 6 (completely confident)., 3 months|Change from Baseline Pain Self-Efficacy Questionnaire (PSEQ) at 6 months, This self efficacy questionnaire, developed to assess the confidence people with ongoing pain have in performing activities while in pain, has 10 items with ratings from 0 (not at all confident) to 6 (completely confident)., 6 months|Change from Baseline Use of Nonpharmacological and Self-Care Approaches (NSCAP) at 3 months, The NSCAP asks about 9 nonpharmacological treatment (NPT) modalities and assesses details of use such as frequency, location/source of service, and patients' judgments of effectiveness. Space is also provided for other NPTs that are used but not listed. The number of modalities for which patients answer "yes" will be summed for analyses., 3 months|Change from Baseline Use of Nonpharmacological and Self-Care Approaches (NSCAP) at 6 months, The NSCAP asks about 9 nonpharmacological treatment (NPT) modalities and assesses details of use such as frequency, location/source of service, and patients' judgments of effectiveness. Space is also provided for other NPTs that are used but not listed. The number of modalities for which patients answer "yes" will be summed for analyses., 6 months|Change from Baseline Working Alliance Inventory (WAI) Client Short Form at 3 months, The Working Alliance Inventory (WAI) Client Short Form assesses patient-provider agreement on treatment goals, collaboration to achieve these goals, and degree of emotional bond (liking and trust) between patients and providers. Items are assessed using a 7-point Likert scale ranging from 1 (never) to 7 (always)., 3 months|Change from Baseline Working Alliance Inventory (WAI) Client Short Form at 6 months, The Working Alliance Inventory (WAI) Client Short Form assesses patient-provider agreement on treatment goals, collaboration to achieve these goals, and degree of emotional bond (liking and trust) between patients and providers. Items are assessed using a 7-point Likert scale ranging from 1 (never) to 7 (always)., 6 months|Perceived Discrimination in Healthcare Scale, Perceived discrimination in healthcare settings will be measured with the 7-item "Perceived Discrimination in Healthcare" Scale. Items are assessed using a 5-point Likert scale ranging from 0 (never) to 4 (always)., Baseline|Coaching Satisfaction, Satisfaction with the coaching sessions and coach will be measured with 2 questions using a 5-item Likert scale ranging from Very Dissatisfied to Very Satisfied., 3 months|Change from Baseline Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) measure at 3 months, Tobacco, alcohol, and drug use, as well as prescription medication misuse will be assessed using this 4-item screening tool., 3 months|Change from Baseline Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) measure at 6 months, Tobacco, alcohol, and drug use, as well as prescription medication misuse will be assessed using this 4-item screening tool., 6 months|Change from Baseline PROMIS Physical Function Short Form 6b at 3 months, Physical functioning will be assessed with the PROMIS Physical Function Short Form 6b which assesses universal physical functioning with a 6-item, self-report scale. Four items use a 5-point Likert scale ranging from 5 (without any difficulty) to 1 (unable to do). Two items use a 5-point Likert scale ranging from 5 (not at all) to 1 (cannot do)., 3 months|Change from Baseline PROMIS Physical Function Short Form 6b at 6 months, Physical functioning will be assessed with the PROMIS Physical Function Short Form 6b which assesses universal physical functioning with a 6-item, self-report scale. Four items use a 5-point Likert scale ranging from 5 (without any difficulty) to 1 (unable to do). Two items use a 5-point Likert scale ranging from 5 (not at all) to 1 (cannot do)., 6 months|Change from Baseline Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form at 3 months, The PROMIS Sleep Disturbance Short Form assesses self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep using 6 items with varying 5 point Likert scales \[scores ranging from 5 (very poor) to 1 (very good), and 5 (not at all) to 5 (very much)\]., 3 months|Change from Baseline Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form at 6 months, The PROMIS Sleep Disturbance Short Form assesses self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep using 6 items with varying 5 point Likert scales \[scores ranging from 5 (very poor) to 1 (very good), and 5 (not at all) to 5 (very much)\]., 6 months|Change from Baseline Sleep Duration at 3 months, This is a single question asking about the number of hours and minutes of actual sleep in the last month., 3 months|Change from Baseline Sleep Duration at 6 months, This is a single question asking about the number of hours and minutes of actual sleep in the last month., 6 months|Change from Baseline Patient Global Impression of Change (PGIC) at 3 months, Patient-reported impression of change will be measured using the PGIC which is a one-item measure reflecting a patient's perception of change after the start of an intervention using a 7-point Likert scale ranging from 0 (very much improved) to 6 (very much worse)., 3 months|Change from Baseline Patient Global Impression of Change (PGIC) at 6 months, Patient-reported impression of change will be measured using the PGIC which is a one-item measure reflecting a patient's perception of change after the start of an intervention using a 7-point Likert scale ranging from 0 (very much improved) to 6 (very much worse)., 6 months
Other Outcome Measures: Change from Baseline Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) at 3 months, Communication self-efficacy will be measured with this 5-item scale that measures patients' self-efficacy in obtaining medical information and getting their most important health concern discussed in a clinic visit. The scale uses ratings from 0 (not at all confident) to 10 (extremely confident)., 3 months|Change from Baseline Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) at 6 months, Communication self-efficacy will be measured with this 5-item scale that measures patients' self-efficacy in obtaining medical information and getting their most important health concern discussed in a clinic visit. The scale uses ratings from 0 (not at all confident) to 10 (extremely confident)., 6 months