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

NCT03523923 | Completed

• 1 other identifier: STUDY00003847
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Collaborative Care; Effectiveness Study

Outcome Measures

Primary Outcomes (1)

• Change from enrollment to end of treament (month 4) in Pain Interference Scale from the Brief Pain Inventory

  A 7-item scale which measures pain interference with general activity, mood, walking, work (outside or in home), relationships, sleep, and enjoyment of life on numerical rating scales (NRS) from 0 (does not interfere) to 10 (interferes completely).

  Collected at 0-14 days of enrollment, Month 4

Secondary Outcomes (15)

• Patient Health Questionnaire-9 (PHQ-9)-Change is being assessed.

  Collected at 0-14 days of enrollment, Month 4, Month 8

• Generalized Anxiety Disorder 7 item (GAD-7) - Change is being assessed.

  Collected at 0-14 days of enrollment, Month 4, Month 8

• Pittsburgh Sleep Quality Inventory (PSQI) - Change is being assessed.

  Collected at 0-14 days of enrollment, Month 4, Month 8

• Brief Pain Intensity- 4 (BPI-4) - Change is being assessed.

  Collected 4 times in one week over the course of 7 days at enrollment period, Month 4, Month 8

• Patient Global Assessment of Treatment Satisfaction (PGATS) - Change is being assessed.

  Collected at Month 4, Month 8

Study Arms (2)

Usual Care

NO INTERVENTION

If assigned to the Usual Care (UC) arm, participants receive the same care as they would normally received from the HMC or UWMC outpatient TBI clinics, which could include similar types of treatment (medication changes, referral to specialists, etc.).

Collaborative Care

ACTIVE COMPARATOR

If assigned to the Collaborative Care (CC) arm, participants receive up to 12 sessions (45-60 minutes) of scheduled contacts with a Collaborative Care Manager (CCM) over 16 weeks of treatment. The CCM meets weekly for supervision with a team of experts to determine appropriate care.

Behavioral: Collaborative Care

Interventions

Collaborative Care BEHAVIORAL

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.

Collaborative Care

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead
• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator

Study Sites (2)

Harborview Medical Center, TBI Clinic

Seattle, Washington, 98104, United States

Location

University of Washington Medical Center, TBI Clinic

Seattle, Washington, 98195, United States

Location

Related Publications (2)

• Curran MC, Lucas S, Fann JR, Zumsteg JM, Hoffman JM. Chronic pain after traumatic brain injury: a collaborative care approach. Front Rehabil Sci. 2024 Aug 26;5:1398856. doi: 10.3389/fresc.2024.1398856. eCollection 2024.

  PMID: 39253025 DERIVED

• Hoffman JM, Curran M, Barber J, Lucas S, Fann JR, Zumsteg JM. Collaborative Care for Chronic Pain After Traumatic Brain Injury: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jun 3;7(6):e2413459. doi: 10.1001/jamanetworkopen.2024.13459.

  PMID: 38829619 DERIVED

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Headache Disorders, Secondary; Headache Disorders

Study Officials

• Jeanne M Hoffman, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This study uses masked outcome assessments; research staff members who collect outcome data from participants at 4 and 8 months must be unaware of participants' treatment group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Medicine: Rehabilitation Medicine:Psychology

Model Details: Randomized, 1:1 controlled trial effectiveness study comparing Collaborative Care (CC) to usual care (UC) to reduce pain interference among outpatients in our UW Medicine TBI clinics who have chronic pain, including headache, and meet other eligibility criteria.

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: May 14, 2018
• Study Start: June 18, 2018
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: November 1, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)