Optimizing Chronic Pain Management Through Patient Engagement With Quality of Life Measures (OPTIQUAL)

Optimizing Chronic Pain Management Through Patient Engagement With Quality of Life Measures: A Randomized Controlled Trial

This study evaluates the use of a health-related quality of life report based on the SPADE cluster (sleep disturbance, pain interference with activities, anxiety, depression, and low energy/fatigue) derived from the PROMIS-29 instrument in patients with chronic low back pain. Half of the participants will receive the report, while the other half will not.

Study Overview

• Status: Completed
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: Other: Health-Related Quality of Life Report

Detailed Description

The health-related quality of life report provides participants with an overall score on the SPADE cluster and scores on each of its five component scales. The recently released Federal Pain Research Strategy states that pain cannot be measured in isolation, but rather should be assessed in conjunction with other outcome measures in 'non-pain domains,' such as quality of life. It recognizes that pain may be affected by, and affect, such patient attributes as sleep, mood, cognition, function, and quality of life. Further, the report states that improvement in pain without concomitant improvement in other domains may not constitute a clinically meaningful outcome. This study primarily aims to assess the utility of a health-related quality of life report in improving quality of life, back pain intensity, and back-related disability in participants with chronic low back pain. Another aspect of the study will be to determine how the health-related quality of life report may impact the physician-patient interaction. This will be assessed using validated measures of physician interpersonal manner, empathy, and communication style, as well as end-of-trial survey data acquired from participants assigned to the experimental group. The survey will include an overall assessment of the report, as well as specific actions attributed to the report.

• Study Type: Interventional
• Enrollment (Actual): 331
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Worth, Texas, United States, 76107
      • University of North Texas Health Science Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Chronic Low Back Pain AND SPADE Cluster Score ≥ 55

Exclusion Criteria:

• Absence of Chronic Low Back Pain OR SPADE Cluster Score < 55

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Health-Related Quality of Life Report; Participants randomized to this arm will receive the 2- page Health-Related Quality of Life Report.	Other: Health-Related Quality of Life Report; Two page report and interpretation guide based on SPADE cluster scores
No Intervention: Wait List to Receive the Report; Participants randomized to this arm will receive the 2- page Health-Related Quality of Life Report following completion of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS-29 Quality of Life Measures	SPADE Cluster Scores (population mean, 50)	3 Months Post-Randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Low Back Pain Intensity	Numerical Rating Scale for Pain (0-10)	3 Months Post-Randomization
Back-Related Disability	Roland-Morris Disability Questionnaire (0-24)	3 Months Post-Randomization

Collaborators and Investigators

• Sponsor: University of North Texas Health Science Center
• Investigators: Principal Investigator: John C Licciardone, DO, MS, MBA, University of North Texas Health Science Center

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2019
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): October 31, 2021

Study Registration Dates

• First Submitted: November 15, 2019
• First Submitted That Met QC Criteria: November 18, 2019
• First Posted (Actual): November 19, 2019

Study Record Updates

• Last Update Posted (Actual): May 19, 2022
• Last Update Submitted That Met QC Criteria: May 18, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Quality of Life; Back Pain; PROMIS-29; PRECISION Pain Research Registry
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Chronic Pain
• Other Study ID Numbers: 2015-169

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No