Cooperative Pain Education and Self-management (COPES)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02724930|
Recruitment Status : Recruiting
First Posted : March 31, 2016
Last Update Posted : August 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Low Back Pain||Behavioral: Enhanced facilitation of COPES||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1488 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Cooperative Pain Education and Self-management|
|Actual Study Start Date :||June 25, 2018|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||December 2020|
No Intervention: Standard Implementation
Standard COPES implementation consists of provider education including brief in-person presentations and written material.
Experimental: Implementation Facilitation
Enhanced facilitation of COPES implementation.
All clusters start in the standard implementation group and cross-over from the control group to the intervention group in a randomized stepped-wedge fashion at 7 time points over the course of the 33 week implementation.
Behavioral: Enhanced facilitation of COPES
Enhanced facilitation of COPES implementation consists of promotional meetings, automated case finding and proactive outreach to recruit patients, marketing and educational materials, local champion, and academic detailing.
- Patient enrollment [ Time Frame: Baseline, 6 months post-facilitation, and study end (up to 30 months) ]Patient enrollment measured as the probability an eligible patient enrolls in Cooperative Pain Education and Self-management (COPES).
- Provider referrals [ Time Frame: Baseline, 6 months post-facilitation, and study end (up to 30 months) ]Provider referrals to COPES measured as the total number of provider referrals and the number of referrals per provider by: site, time point, and overall.
- Pain-related interference [ Time Frame: Baseline, 6 months post-facilitation, and study end (up to 30 months) ]Pain-related interference will be assessed using the interference items of the "PEG 3 A Three-Item Scale Assessing Pain Intensity and Interference" (PEG-3) which assesses interference with general activity and enjoyment of life.
- Pain intensity [ Time Frame: Baseline, 6 months post-facilitation, and study end (up to 30 months) ]Pain intensity will be assessed using the pain intensity question of the PEG-3.
- Physical activity [ Time Frame: Baseline, 6 months post-facilitation, and study end (up to 30 months) ]Physical activity will be assessed by pedometer-measured step count.
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): NCT02724930
|Contact: Kathryn LaChappelle, MPH||203-932-5711 ext firstname.lastname@example.org|
|Contact: Rebecca A Czlapinski, BA MA||203-932-5711 ext email@example.com|
|United States, California|
|VA Palo Alto Healthcare System||Not yet recruiting|
|Menlo Park, California, United States, 94025|
|Contact: Amanda M Midboe, PhD 650-493-5000 ext 27829 firstname.lastname@example.org|
|United States, Indiana|
|Richard L. Roudebush VA Medical Center||Not yet recruiting|
|Indianapolis, Indiana, United States, 46202|
|Contact: Matthew J Bair, MD MS 317-692-2323 email@example.com|
|United States, Massachusetts|
|VA Boston Healthcare System||Recruiting|
|Brockton, Massachusetts, United States, 02301|
|Contact: Diana Higgins, PhD 508-583-4500 firstname.lastname@example.org|
|Principal Investigator:||Alicia A Heapy, PhD||VA Connecticut Healthcare System|
|Principal Investigator:||John D Piette, PhD||VA Ann Arbor Healthcare System|