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

NCT ID: NCT03523923

Last Updated: 2022-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 158 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-18
• Study Completion Date: 2022-09-30

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.

Detailed Description

Screening

Potential participants may be referred to the study by clinical staff, self-refer based on seeing study brochures or flyers, or will be invited to participate based on review of medical records of patients scheduled for TBI clinics at Harborview Medical Center (HMC) or the University of Washington Medical Center (UWMC) Rehabilitation TBI clinics.

If a potential participant meets initial eligibility criteria of having a diagnosis of TBI and reports of chronic pain, a research staff member will contact the patient to confirm eligibility through a formalized Institutional Review Board (IRB)-approved screening questionnaire. The Six-Item Screener (a brief and reliable instrument for identifying cognitive impairment) will be used to determine if the participant is cognitively able to provide informed consent.

Once eligibility is confirmed, research staff will introduce the study using a talking points script, and if the potential participant is interested, provide a brochure and a consent form. Potential participants will be fully informed of all risks and benefits prior to giving their written informed consent and prior to enrollment in the study. They may take time to think about participating and render a decision in a subsequent call or visit. Potential participants will be asked to repeat back understanding of this material as necessary.

Research staff will also review a HIPAA authorization form with the participant that permits research staff to collect data from the participant's medical records regarding injury and medical history.

The investigators plan to enroll a total of 158 participants with the goal of outcomes assessment on 63 subjects in each arm (total of 126).

Basic Demographic Information

Basic demographic information including age, sex, and race will be collected via medical record review without consent from all patients including those who do not enroll to determine differences between enrolled patients participants and those who do not enroll to examine potential bias.

Procedures

Randomization

Once enrolled, participants will be randomized into one of two groups: usual care (UC) or Collaborative Care (CC). Those randomized to CC treatment group will work with Collaborative Care Manager (CCM) for up to 12 contacts over a 16 week treatment period, and complete a 24 week post randomization check in call with CCM.

Participants assigned to the UC arm will be informed of the assignment via phone by an un-blinded research team member. In addition, participants assigned to the UC arm will receive a letter explaining the assignment. Participants assigned to the CC arm will be contacted by the CCM to arrange the timing of their first treatment session.

Data Collection

Participants may choose to have the interview/s administered by phone or in person at either UWMC or HMC by our research staff member.

Baseline Interview:

Contact Information - Research staff will collect the following information from participants: (1) contact information; (2) best way to reach an individual if they have more than one line; best times/days to reach participant; and (3) names and contact information of people staff are allowed to contact if participant is lost to follow-up or otherwise cannot be contacted (i.e. collateral contacts). The purpose of this is to maximize the likelihood of reaching a participant to complete the study procedures. Furthermore, asking permission to leave a voicemail on at a specified contact number ensures a greater level of privacy for the participant.

Data Collection - Baseline will take approximately 30 minutes to complete and includes demographic variables, TBI variables (date of injury, TBI severity), medications and information describing participants' pain history, including pain sites, and pain duration. The Brief Pain Intensity measure (BPI), a 4 item pain intensity scale, will be asked 4 times over the course of 7 days at each assessment period.

Follow-up Interviews:

Follow-up interviews will be collected at 4-months and 8-months post-randomization and will each take approximately 45 minutes each.

Collaborative Care

Collaborative Care (CC) is a systematic and integrated approach to improving the delivery and utilization of effective treatments for chronic pain. The care will be delivered through an interdisciplinary team, organized around a CC Manager (CCM) who guides the participant through various aspects of care. The team will include a group of experts on pain and TBI. The CCM will offer all participants care management, collaborative medical management, and psychosocial treatment. If the participant declines to receive any of the components of the intervention, they may still choose to participate in the remaining components.

Usual Care Group

Participants assigned to usual care will be encouraged to consult with their TBI or primary care provider with any concerns around pain treatment. Study personnel will not make any attempts to influence usual care participants' pain management.

Because this is an effectiveness study, treatment decisions for UC participants will be left to the primary provider and may or may not include pharmacologic management, counseling, and referral to specialty services or other local resources.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Usual Care

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.).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Collaborative Care

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.

Group Type: ACTIVE_COMPARATOR

Collaborative Care

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Disability, Independent Living, and Rehabilitation Research

FED

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Jeanne Hoffman

Professor, School of Medicine: Rehabilitation Medicine:Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeanne M Hoffman, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Harborview Medical Center, TBI Clinic

Seattle, Washington, United States

University of Washington Medical Center, TBI Clinic

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39253025 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38829619 (View on PubMed)

Other Identifiers

STUDY00003847

Identifier Type: -

Identifier Source: org_study_id