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| ID | Type | Description | Link |
|---|---|---|---|
| 4R33NR020845-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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This project is part of the NIH Helping to End Addiction Long-term (HEAL) initiative (https://heal.nih.gov/). This 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 trial will randomize 304 patients with comorbid chronic musculoskeletal pain and depression in primary care from an urban safety-net health system (Eskenazi). 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coaching and Decision Aid | Experimental | Intervention group (Individual coaching sessions and Decision Aid) |
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| Control | No Intervention | Wait-list control group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coaching and Decision Aid | Behavioral | Four (4) coaching sessions over approximately 12 weeks with integration of Decision Aid contents |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Eligible patients must
Exclusion Criteria:
Patients are excluded:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Research Specialist | Contact | 317-274-9402 | equipd@regenstrief.org | |
| Jennifer Garabrant | Contact | 317-278-2510 | jwilkers@iu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Adam T Hirsh, PhD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eskenazi Health Primary Care | Recruiting | Indianapolis | Indiana | 46254 | United States |
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).
At the time of publication of the primary manuscript
Implementation of the plan will follow the HEAL Public Access and Data Sharing Policy.
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D059352 | Musculoskeletal Pain |
| D003863 | Depression |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003661 | Decision Support Techniques |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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Baseline assessments are conducted prior to randomization (Baseline assessor will not know the randomization assignment).
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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 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 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 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 |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |