Equity Using Interventions for Pain and Depression - Pilot Study

Not Applicable

Completed

Conditions: Chronic Pain
Health Equity
Depression

Registration Number: NCT05695209

Lead Sponsor: Indiana University

Brief 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 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 randomized 30 Black patients with comorbid chronic musculoskeletal pain and depression in primary care from an urban safety-net health system. After the baseline assessment, patients randomized to the intervention were asked to participate in 4 coaching sessions over approximately 12 weeks. Sessions used 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 were integrated into these sessions, which facilitated discussion of these options with their PCP. The first 3 sessions ideally took place prior to the patient's next scheduled PCP visit; the final session occurred after this visit. Assessments were conducted at baseline, 3 months (i.e., after completing the final coaching session), and 6 months.

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

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 or African American,
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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change From Baseline Brief Pain Inventory (BPI) Interference Scale at 3 Months	3 months	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.
Change From Baseline Brief Pain Inventory (BPI) Interference Scale at 6 Months	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline Altarum Consumer Engagement (ACE) Measure at 6 Months	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. Each item is assessed on a 5-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree) with a total score ranging from 0 to 48. Higher scores indicate greater engagement.
Change From Baseline Use of Nonpharmacological and Self-Care Approaches (NSCAP) at 3 Months	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.
Change From Baseline Use of Nonpharmacological and Self-Care Approaches (NSCAP) at 6 Months	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.
Change From Baseline Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) at 3 Months	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. Higher scores indicate greater communication self-efficacy. The scale uses ratings from 0 (not at all confident) to 10 (extremely confident) for each item with a total score ranging from 0 to 50.
Change From Baseline Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) at 6 Months	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. Higher scores indicate greater communication self-efficacy. The scale uses ratings from 0 (not at all confident) to 10 (extremely confident) for each item with a total score ranging from 0 to 50.
Change From Baseline CollaboRATE at 3 Months	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. The CollaboRATE scale uses a 5-point Likert scale, ranging from "No effort was made (0)" to "Every effort was made (4)" for each item with a total score ranging from 0 to 12. Higher scores indicate higher provider effort from the patient's perspective to engage in shared-decision making.
Change From Baseline CollaboRATE at 6 Months	6 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. The CollaboRATE scale uses a 5-point Likert scale, ranging from "No effort was made (0)" to "Every effort was made (4)" or each item with a total score ranging from 0 to 12. Higher scores indicate higher provider effort from the patient's perspective to engage in shared-decision making.
Change From Baseline Working Alliance Inventory (WAI) Client Short Form at 3 Months	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. The scale uses ratings from 1 (Never) to 7 (Always) for each item with a total score ranging from 12 to 84. Higher scores indicate greater alliance between patient and provider.
Change From Baseline Working Alliance Inventory (WAI) Client Short Form at 6 Months	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. The scale uses ratings from 1 (Never) to 7 (Always) or each item with a total score ranging from 12 to 84. Higher scores indicate greater alliance between patient and provider.
Change From Baseline Patient Health Questionnaire (PHQ)-8 at 3 Months	3 months	The PHQ-8 is a widely-used, validated 8-item measure of depression severity. The PHQ-8 is scored by assigning a value of 0 (not at all) to 3 (nearly every day) to each of the 8 items, with a total score ranging from 0 to 24. Higher scores indicate worse depression severity.
Change From Baseline Patient Health Questionnaire (PHQ)-8 at 6 Months	6 months	The PHQ-8 is a widely-used, validated 8-item measure of depression severity. The PHQ-8 is scored by assigning a value of 0 (not at all) to 3 (nearly every day) to each of the 8 items, with a total score ranging from 0 to 24. Higher scores indicate worse depression severity.
Change From Baseline Generalized Anxiety Disorder Scale (GAD-7) at 3 Months	3 months	Anxiety will be measured with the 7 item Generalized Anxiety Disorder Scale (GAD-7). The GAD-7 is scored by assigning a value of 0 to 3 to each of the seven items, with a total score ranging from 0 to 21. The total score indicates the severity of anxiety symptoms (higher scores indicating a worse outcome).
Change From Baseline Generalized Anxiety Disorder Scale (GAD-7) at 6 Months	6 months	Anxiety will be measured with the 7 item Generalized Anxiety Disorder Scale (GAD-7). The GAD-7 is scored by assigning a value of 0 to 3 to each of the seven items, with a total score ranging from 0 to 21. The total score indicates the severity of anxiety symptoms (higher scores indicating a worse outcome).
Change From Baseline Pain Catastrophizing Scale at 3 Months	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) for each item with a total score ranging from 0 to 52. Higher scores indicate a worse outcome.
Change From Baseline Pain Catastrophizing Scale at 6 Months	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) for each item with a total score ranging from 0 to 52. Higher scores indicate a worse outcome.
Change From Baseline Altarum Consumer Engagement (ACE) Measure at 3 Months	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. Each item is assessed on a 5-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree) with a total score ranging from 0 to 48. Higher scores indicate greater engagement.

Trial Locations

Locations (1): Eskenazi Health Primary Care
🇺🇸
Indianapolis, Indiana, United States
Eskenazi Health Primary Care
🇺🇸Indianapolis, Indiana, United States