TBI Care: Collaborative Care for Pain After Traumatic Brain Injury (TBI)
CompletedNot applicableNCT03523923
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- The Effectiveness of Collaborative Care Versus Usual Care for Pain After Traumatic Brain Injury
- Conditions
- Brain Injuries, Traumatic
- Chronic Pain
- Post-Traumatic Headache
- Interventions
- Behavioral: Collaborative Care
- Sponsor
- University of Washington
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Start date
- 2018-06-18
- Primary completion
- 2022-09-30
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Definitive diagnosis of mild to severe TBI based on medical chart review; * Patient has an appointment with the University of Washington/Harborview Medical Center, Department of Rehabilitation Medicine's TBI clinics or has been seen by TBI providers within the last 12 months; * Patient reports clinically significant pain, defined as having moderate or higher pain over the last 6 months (defined as an average pain score of 4-10/10 on a 0=no pain to 10=worst pain numeric rating scale); * Patient is "somewhat" or "very" willing to accept additional help with their pain as asked during screening; * Reads and English speaking (we will track non-enrollment due to other language to determine common languages) * Has access to and ability to communicate over the phone; * Aged \>18 years of age; * Provides written informed consent. Exclusion Criteria: * Answers more than one incorrect response on the Six-Item Screener; * Terminal illness or pain associated with cancer diagnosis; * Major surgery anticipated during study period (approximately 8 months); * Presence of severe psychiatric disorder as evidenced by high suicide risk, diagnosis of bipolar disorder with psychotic features or current psychotic disorder.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03523923