CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 218 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Key inclusion· 5
  • Age 18 years or older
  • Able to read and understand English
  • Able to complete questionnaires on a computer
  • Starting a new treatment for chronic pain or within the past month of starting
Key exclusion· 2
  • Psychotic disorders
  • Self-reported substance abuse

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02873429
NCT02873429N/ACompleted

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

University of Pittsburgh·observational·Posted Aug 19, 2016·Updated Aug 2, 2017

In Brief

An observational study for Chronic Pain. Completed, enrolled 218 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Pain
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 19, 2016
Enrollment StartFeb 1, 2015
Primary CompletionDec 1, 2016
Study CompletionJan 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 9.9 years ago