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Cooperative Pain Education and Self-management (COPES)

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ClinicalTrials.gov Identifier: NCT02724930
Recruitment Status : Recruiting
First Posted : March 31, 2016
Last Update Posted : August 8, 2018
Sponsor:
Collaborator:
VA Office of Research and Development
Information provided by (Responsible Party):
VA Connecticut Healthcare System

Brief Summary:
This study will test the effectiveness of using enhanced facilitation strategies on implementation of an automated Interactive Voice Response (IVR) system as a means to remotely deliver in-home self-management support to Veterans with chronic pain. The implementation intervention uses an enhanced facilitation approach paired with automated case finding and direct patient outreach to encourage uptake of Cooperative Pain Education and Self-management (COPES). A nested effectiveness study will measure pre-post differences in pain-relevant outcomes (pain intensity, physical functioning and physical activity). The investigators will use a stepped wedge cluster design in which clusters will be randomized to the timing of the introduction of enhanced COPES implementation. Investigators will assess the efficacy of the facilitation based implementation strategy by evaluating COPES uptake in the implementation settings.

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Behavioral: Enhanced facilitation of COPES Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1488 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Veterans COPES:

  1. Back-pain-related International Classification of Diseases (ICD)-9 diagnosis
  2. Pain intensity rating of ≥4 (indicating moderate pain) on the 0-10 Numerical Rating Scale on at least two separate outpatient encounters at a CBOC in the prior year
  3. CBOC patient at VA Boston, VA Palo Alto or Roudebush VA

Veterans Interviews:

  1. Those who are eligible for COPES, but who have not been asked to enroll (pre-implementation period)
  2. Those who participate in COPES (post-implementation)
  3. Those who decline enrollment in COPES (post-implementation)
  4. CBOC patients at VA Boston, VA Palo Alto or Roudebush VA

Admin, Champion, Provider Interviews:

1. Employed at the project implementation sites

Exclusion Criteria:

Veterans (COPES & Interviews):

  1. Diagnosis of cancer, dementia, schizophrenia, and active alcohol or substance abuse
  2. Psychiatric hospitalization in the past 30 days
  3. Patients who are designated as fall risks and/or have active diabetic foot ulcers

Admin, Champion, Provider Interviews:

1. Not employed at the project implementation sites


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): NCT02724930


Contacts
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Contact: Kathryn LaChappelle, MPH 203-932-5711 ext 2812 kathryn.lachappelle@va.gov
Contact: Rebecca A Czlapinski, BA MA 203-932-5711 ext 3357 rebecca.czlapinski@va.gov

Locations
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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    amanda.midboe@va.gov   
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    mbair@iupui.edu   
United States, Massachusetts
VA Boston Healthcare System Recruiting
Brockton, Massachusetts, United States, 02301
Contact: Diana Higgins, PhD    508-583-4500    diana.higgins2@va.gov   
Sponsors and Collaborators
VA Connecticut Healthcare System
VA Office of Research and Development
Investigators
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Principal Investigator: Alicia A Heapy, PhD VA Connecticut Healthcare System
Principal Investigator: John D Piette, PhD VA Ann Arbor Healthcare System

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Responsible Party: VA Connecticut Healthcare System
ClinicalTrials.gov Identifier: NCT02724930     History of Changes
Other Study ID Numbers: 0012
First Posted: March 31, 2016    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by VA Connecticut Healthcare System:
low back pain, chronic pain, cognitive behavior therapy

Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms