Measuring the Context of Healing in Chronic Pain Treatment

Study Overview
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Brief Summary
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This project focuses on whether nonspecific factors as well as patient characteristics contribute to treatment outcome differences. The project uses assessment instruments, computerized adaptive tests (CATs), from the Patient-Reported Outcomes Measurement Information System (PROMIS®). The research team has recently developed and tested (using PROMIS methods) a set of instruments to assess non-specific factors in healing from the patient's perspective. These instruments, the Healing Encounters and Attitudes Lists (HEAL) assess the Patient-Provider Connection, Treatment Expectancy, views of the Healthcare Environment, Positive and Negative Attitudes, Spirituality, and Attitude toward Complementary and Alternative Medicine (CAM). HEAL CAT's, like other PROMIS CATs, are brief, easy to use and understand, and are designed to apply to a broad spectrum of treatments and health conditions. In this project, the investigators aim to 1) evaluate whether HEAL predicts chronic pain treatment outcomes, 2) examine heterogeneity of treatment effects based upon HEAL and PROMIS scores in integrative and conventional medicine settings, and 3) interview patients and their clinicians regarding the utility of HEAL, PROMIS and a Pain Log for enhancing communication. The investigators will administer HEAL CATs and other PROMIS CATs (depression, anxiety, sleep disturbance, fatigue and physical function) to 200 patients who are starting treatment for chronic pain in integrative medicine and conventional medicine settings. Follow-up assessments will be completed 2 and 4 months after baseline testing. The investigators will evaluate factors that may predict which patients judge themselves to be improved, the same, or worsened. Some of the possible factors that may contribute to improvement include HEAL scores, emotional distress, or the preference for CAM or conventional treatment. The investigators are also interested in learning whether patients find the assessments to be clear and useful. A subset of 50 patients and approximately 10 clinicians will complete interviews about the HEAL and PROMIS questions, and about the Pain Log developed by a patient advocacy group partner, the American Chronic Pain Association. By interviewing patients and their healthcare providers, the investigators hope to determine the clarity and acceptability of the HEAL and other assessments, and to learn whether HEAL and PROMIS summaries enhance patient-provider communication in the clinical partnership.

Official Title
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Measuring the Context of Healing: Using PROMIS in Chronic Pain Treatment

Conditions
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Chronic Pain

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years and older able to read and understand English able to answer questionnaires on a computer starting a new treatment for chronic pain or having just started a new treatment within the past month expecting to continue their course of treatment Exclusion Criteria: psychotic disorders substance abuse by self report

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Integrative Medicine (Complementary /Alternative)Group<br>Patients receiving chiropractic care, acupuncture, massage therapy, or meditation training for chronic pain | |
| Conventional Medicine Group<br>Patients receiving conventional medicine care (physical therapy, medication management, injections, etc.) for chronic pain. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS Pain Intensity | PROMIS Pain Intensity is a three item scale measuring the severity of pain at its worst (past week), average (past week), and current level using a five-point Likert-type scale (i.e., no pain=1, mild=2, moderate=3, severe=4, very severe=5). Scores on the 3 items are summed to create a raw score, which can range from 3 to 15. The raw score is converted to a T-score metric in which 50 is the mean of the relevant reference population and 10 is the standard deviation (SD) of that population.(see http://www.healthmeasures.net/promis-scoring-manuals for details ). | 6-8 weeks | 
| PROMIS Pain Interference | Computerized adaptive test measuring interference of pain in everyday functioning using five-point Likert-type scales with two types or response options (i.e., not at all=1, a little bit=2, somewhat=3, quite a bit=4, very much=5, and never=1, rarely=2, sometimes=3, often=4, always=5). Scores on the items are summed to create a raw score. The raw score is converted to a T-score metric in which 50 is the mean of the relevant reference population and 10 is the standard deviation (SD) of that population.(see http://www.healthmeasures.net for details of CAT administration and scoring). | 6-8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression of Change (CGI) | Patient's rating of current symptom level compared to baseline assessment using a five-point bipolar scale: Much better(2), Somewhat better(1), No change(0), Somewhat worse(-1), Much worse(-2) | 6-8 weeks |