Measuring the Context of Healing in Chronic Pain Treatment

NCT02873429 | Completed Results

• 1 other identifier: ME-1402-10114
• Study Type: observational
• Target: 218
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Clinical Global Impression of Change (CGI)

  6-8 weeks

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• psychotic disorders
• substance abuse by self report

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Carol M. Greco, Associate Professor of Psychiatry
• Organization: University of Pittsburgh

grecocm@upmc.edu

412-623-6873

Study Officials

• Carol M Greco, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: August 12, 2016
• First Posted: August 19, 2016
• Study Start: February 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2017
• Last Updated: August 2, 2017
• Results First Posted: August 2, 2017

Record last verified: 2017-04

Locations

US (1)