NCT04168437

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 331 (actual)
• Sponsor: University of North Texas Health Science Center · Academic / Other
• Sex: All
• Age: 21 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Chronic Low Back Pain

Interventions

Type	Name	Description
OTHER	Health-Related Quality of Life Report	Two page report and interpretation guide based on SPADE cluster scores

Timeline

• Start date: 2019-11-26
• Primary completion: 2021-08-31
• Completion: 2021-10-31
• First posted: 2019-11-19
• Last updated: 2022-05-19

Locations

1 site across 1 country: United States