Equity Using Interventions for Pain and Depression - Pilot Study (EQUIPD-Pilot)

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 part of phase 1 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 40 Black patients with comorbid chronic musculoskeletal pain and depression in primary care from an urban safety-net health system with the end goal of at least 30 patients completing the trial. 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 along with a 20-minute coaching session to walk them through it (patients may decline the coaching session or schedule for a future time).

The pain interference score averages seven ratings, 0 (does not interfere) to 10 (interferes completely), of interference with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.

The pain interference score averages seven ratings, 0 (does not interfere) to 10 (interferes completely), of interference with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.

This pain intensity scale has 4 items with ratings from 0 (no pain) to 10 (pain as bad as you can imagine).

This pain intensity scale has 4 items with ratings from 0 (no pain) to 10 (pain as bad as you can imagine).

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).

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).

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.

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.

This is a single question asking about the number of hours and minutes of actual sleep in the last month.

This is a single question asking about the number of hours and minutes of actual sleep in the last month.

The Pain Catastrophizing Scale is a 13-item scale that assesses catastrophizing-a cognitive-emotional factor that predicts poor treatment response.

The Pain Catastrophizing Scale is a 13-item scale that assesses catastrophizing-a cognitive-emotional factor that predicts poor treatment response.

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.

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.

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.

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.

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.

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.

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.

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.

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

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

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.

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.

We will measure perceived discrimination in healthcare settings with the 7-item "Perceived Discrimination in Healthcare" Scale.

We will measure satisfaction with the coaching sessions and coach with 2 questions using a 5-item Likert scale ranging from Very Dissatisfied to Very Satisfied.

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.

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.

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.

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.

Inclusion Criteria: Eligible patients must: have musculoskeletal pain in the low back, cervical spine, or extremities (hip, knee, shoulder) for ≥3 months, have at least moderate pain intensity and interference with function, defined by a score ≥4 (possible range: 0-10) on the Pain, Enjoyment of Life and General Activity scale (PEG), a 3-item measure of pain intensity, interference with enjoyment of life, and interference with general activity, have at least mild depression, defined as PHQ-8 score ≥5, identify as Black, have consistent access to a telephone, indicate openness to new pain treatments, and have a scheduled appointment with their PCP in the next approximate 2-4 months Exclusion Criteria: Patients are excluded: if previously participated in the PI's past pilot study (IRB #12885) or participation as a Patient Engagement Panel member for this project, if medical records indicate severe medical conditions likely precluding participation (e.g., NY Heart Association Class III or IV heart failure), or if the eligibility screener reveals (1) active suicidal ideation, or (2) severe hearing/speech or cognitive impairment.

NIH intends to maximize the impact of HEAL Initiative-supported projects through broad and rapid data sharing. All HEAL Initiative award recipients, regardless of the amount of direct costs requested for any one year, are required to comply with the HEAL Public Access and Data Sharing Policy, which also aligns with the NIH Policy for Data Management and Sharing (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-013.html). HEAL award recipients must following all requirements and timelines developed through the HEAL Initiative Data Ecosystem, as described in HEAL's compliance guidance (https://heal.nih.gov/data/complying-heal-data-sharing-policy).