Clinical trial NCT03523923: TBI Care: Collaborative Care for Pain After Traumatic Brain Injury (TBI)
Official title: The Effectiveness of Collaborative Care Versus Usual Care for Pain After Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injuries, Traumatic
Chronic Pain
Post-Traumatic Headache
Keywords: Collaborative Care
Effectiveness Study
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Disability, Independent Living, and Rehabilitation Research
First posted: 2018-05-14
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from enrollment to end of treament (month 4) in Pain Interference Scale from the Brief Pain Inventory
timeFrame: Collected at 0-14 days of enrollment, Month 4
Secondary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)-Change is being assessed.
timeFrame: Collected at 0-14 days of enrollment, Month 4, Month 8
measure: Generalized Anxiety Disorder 7 item (GAD-7) - Change is being assessed.
timeFrame: Collected at 0-14 days of enrollment, Month 4, Month 8
measure: Pittsburgh Sleep Quality Inventory (PSQI) - Change is being assessed.
timeFrame: Collected at 0-14 days of enrollment, Month 4, Month 8
measure: Brief Pain Intensity- 4 (BPI-4) - Change is being assessed.
timeFrame: Collected 4 times in one week over the course of 7 days at enrollment period, Month 4, Month 8
measure: Patient Global Assessment of Treatment Satisfaction (PGATS) - Change is being assessed.
timeFrame: Collected at Month 4, Month 8
measure: Participation Assessment with Recombined Tools - Objective 17 - Change is being assessed.
timeFrame: Collected at 0-14 days of enrollment, Month 4, Month 8
measure: Cornell Service Index (CSI) - Change is being assessed.
timeFrame: Collected at 0-14 days of enrollment, Month 4, Month 8
measure: Visits To Regional Emergency Departments (ED) - Change is being assessed.
timeFrame: Collected at 0-14 days of enrollment, Month 4, Month 8
measure: Change from enrollment to 4 months post randomization (month 8) in Pain Interference Scale from the Brief Pain Inventory
timeFrame: Collected at 0-14 days of enrollment, Month 8
measure: Chronic Pain Acceptance Questionnaire (CPAQ-8)
timeFrame: Collected at 0-14 days of enrollment, Month 4, Month 8
measure: DFAQ-CU Inventory
timeFrame: Collected at 0-14 days of enrollment, Month 4, Month 8
measure: AUDIT-C
timeFrame: Collected at 0-14 days of enrollment, Month 4, Month 8
measure: The two-Item Conjoint Screen (TICS)
timeFrame: Collected at 0-14 days of enrollment, Month 4, Month 8
measure: Patient Global Impression of Change (PGIC)
timeFrame: Collected at 0-14 days of enrollment, Month 4, Month 8
measure: Pain Quality Assessment Scale (PQAS)
timeFrame: Collected at 0-14 days of enrollment, Month 4, Month 8
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Harborview Medical Center, TBI Clinic
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center, TBI Clinic
state: Washington
Study officials:
affiliation: University of Washington
name: Jeanne M Hoffman, PhD
role: PRINCIPAL_INVESTIGATOR
References: