Cooperative Pain Education and Self-management

NCT02724930 | Completed

• 1 other identifier: 0012
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 3

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.

Conditions

Chronic Low Back Pain

Keywords

low back pain, chronic pain, cognitive behavior therapy

Outcome Measures

Primary Outcomes (1)

• Patient enrollment

  Patient enrollment measured as the probability an eligible patient enrolls in Cooperative Pain Education and Self-management (COPES).

  Baseline, 6 months post-facilitation, and study end (up to 30 months)

Secondary Outcomes (1)

• Provider referrals

  Baseline, 6 months post-facilitation, and study end (up to 30 months)

Other Outcomes (3)

• Pain-related interference

  Baseline, 6 months post-facilitation, and study end (up to 30 months)

• Pain intensity

  Baseline, 6 months post-facilitation, and study end (up to 30 months)

• Physical activity

  Baseline, 6 months post-facilitation, and study end (up to 30 months)

Study Arms (2)

Standard Implementation

NO INTERVENTION

Standard COPES implementation consists of provider education including brief in-person presentations and written material.

Implementation Facilitation

EXPERIMENTAL

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

Interventions

Enhanced facilitation of COPES BEHAVIORAL

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.

Implementation Facilitation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veterans COPES:
• Back-pain-related International Classification of Diseases (ICD)-9 diagnosis
• 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
• CBOC patient at VA Boston, VA Palo Alto or Roudebush VA
• Veterans Interviews:
• Those who are eligible for COPES, but who have not been asked to enroll (pre-implementation period)
• Those who participate in COPES (post-implementation)
• Those who decline enrollment in COPES (post-implementation)
• CBOC patients at VA Boston, VA Palo Alto or Roudebush VA
• Admin, Champion, Provider Interviews:
• \. Employed at the project implementation sites

You may not qualify if:

• Veterans (COPES \& Interviews):
• Diagnosis of cancer, dementia, schizophrenia, and active alcohol or substance abuse
• Psychiatric hospitalization in the past 30 days
• Patients who are designated as fall risks and/or have active diabetic foot ulcers
• Admin, Champion, Provider Interviews:
• \. Not employed at the project implementation sites

Sponsors & Collaborators

• VA Connecticut Healthcare System: lead
• VA Office of Research and Development: collaborator

Study Sites (3)

VA Palo Alto Healthcare System

Menlo Park, California, 94025, United States

Location

Richard L. Roudebush VA Medical Center

Indianapolis, Indiana, 46202, United States

Location

VA Boston Healthcare System

Brockton, Massachusetts, 02301, United States

Location

MeSH Terms

Conditions

Low Back Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alicia A Heapy, PhD

  VA Connecticut Healthcare System

  PRINCIPAL INVESTIGATOR

• John D Piette, PhD

  VA Ann Arbor Healthcare System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2016
• First Posted: March 31, 2016
• Study Start: June 25, 2018
• Primary Completion: August 27, 2020
• Study Completion: August 27, 2020
• Last Updated: September 22, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)