Measuring the Context of Healing in Chronic Pain Treatment (HEALpain)

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain

• Study Type: Observational
• Enrollment (Actual): 218

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who have ongoing pain (> / = 3 months) who are beginning a treatment for their pain.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Integrative Medicine (Complementary /Alternative)Group; Patients receiving chiropractic care, acupuncture, massage therapy, or meditation training for chronic pain
Conventional Medicine Group; Patients receiving conventional medicine care (physical therapy, medication management, injections, etc.) for chronic pain.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: Carol M Greco, PhD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: August 12, 2016
• First Submitted That Met QC Criteria: August 16, 2016
• First Posted (Estimate): August 19, 2016

Study Record Updates

• Last Update Posted (Actual): August 2, 2017
• Last Update Submitted That Met QC Criteria: April 21, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: ME-1402-10114

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED