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

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ClinicalTrials.gov Identifier: NCT02873429
Recruitment Status : Completed
First Posted : August 19, 2016
Results First Posted : August 2, 2017
Last Update Posted : August 2, 2017
Sponsor:
Information provided by (Responsible Party):
Carol Greco, University of Pittsburgh

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.

Condition or disease
Chronic Pain

Study Type : Observational
Actual Enrollment : 218 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Measuring the Context of Healing: Using PROMIS in Chronic Pain Treatment
Study Start Date : February 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

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.



Primary Outcome Measures :
  1. PROMIS Pain Intensity [ Time Frame: 6-8 weeks ]
    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 ).

  2. PROMIS Pain Interference [ Time Frame: 6-8 weeks ]
    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).


Secondary Outcome Measures :
  1. Clinical Global Impression of Change (CGI) [ Time Frame: 6-8 weeks ]
    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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have ongoing pain (> / = 3 months) who are beginning a treatment for their pain.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02873429


Locations
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Carol M Greco, PhD University of Pittsburgh

Responsible Party: Carol Greco, Associate Professor of Psychiatry, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02873429     History of Changes
Other Study ID Numbers: ME-1402-10114
First Posted: August 19, 2016    Key Record Dates
Results First Posted: August 2, 2017
Last Update Posted: August 2, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms