TBI Care: Collaborative Care for Pain After Traumatic Brain Injury (TBI)

NCT03523923 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2022-11-01

No results posted yet for this study

Summary

The purpose of this study is to (1) test the benefits of the patient-centered collaborative care treatment approach for persons who have had a TBI and who have pain, including headache; and also (2) test whether this approach improves quality of life, patient satisfaction, adherence to other treatments, and quality of care in the TBI care system.

This project uses the contextual paradigm of disability to analyze and improve outpatient treatment of pain, including headache, in people who have had a TBI. Issues of restricted access and health care system complexity likely contribute to sub-optimal treatment of chronic pain. Therefore, the investigators seek to enhance real-world outpatient healthcare delivery through a patient-centered, collaborative care approach to treating chronic pain. The intervention is structured to reduce pain interference directly and indirectly through improved management of pain and comorbid conditions (e.g., depression, anxiety, and sleep difficulties) that can amplify pain perception and disability. In addition, change in the system of care may reduce burden on the emergency department. The investigators have heard from our clinician and patient partners that poor pain management often leads to emergency department visits, and this has also been reported in the literature.

Conditions

  • Brain Injuries, Traumatic
  • Chronic Pain
  • Post-Traumatic Headache

Interventions

BEHAVIORAL

Collaborative Care

Up to 12 phone sessions over 16 weeks from Collaborative Care Manager (CCM). Session 1: Establish rapport, perform structured clinical assessment explain the rationale and parameters of the intervention, provide brief education on pain and together with the participant create an overall treatment plan and detailed follow-up plan. Sessions 2-12 Components: * Care Management Weekly monitoring of response to treatment using standardized measures. * Collaborative Medical Management: Optimized management of problem areas. Medication recommendations will follow evidence-based treatment algorithms with consultation of supervisors. * Psychosocial Treatment: Evidence based, focus on pain self-management skills/education, initially on foundational skills including: (1) pain education; (2) relaxation skills training; (3) behavioral activation and goal setting; 4) importance of physical activity and (5) motivational interviewing to promote adherence to healthcare and goals.

Sponsors & Collaborators

  • National Institute on Disability, Independent Living, and Rehabilitation Research

    collaborator FED
  • University of Washington

    lead OTHER

Principal Investigators

  • Jeanne M Hoffman, PhD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-18
Primary Completion
2022-09-30
Completion
2022-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03523923 on ClinicalTrials.gov