Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03523923
Recruitment Status : Recruiting
First Posted : May 14, 2018
Last Update Posted : June 27, 2018
Sponsor:
Collaborator:
National Institute on Disability, Independent Living, and Rehabilitation Research
Information provided by (Responsible Party):
Jeanne Hoffman, University of Washington

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.


Condition or disease Intervention/treatment Phase
Brain Injuries, Traumatic Chronic Pain Post-Traumatic Headache Behavioral: Collaborative Care Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: The Effectiveness of Collaborative Care Versus Usual Care for Pain After Traumatic Brain Injury
Actual Study Start Date : June 18, 2018
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: 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.).
Active Comparator: 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.
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.




Primary Outcome Measures :
  1. Change from enrollment to end of treament (month 4) in Pain Interference Scale from the Brief Pain Inventory [ Time Frame: Collected at 0-14 days of enrollment, Month 4 ]
    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).


Secondary Outcome Measures :
  1. Patient Health Questionnaire-9 (PHQ-9)-Change is being assessed. [ Time Frame: Collected at 0-14 days of enrollment, Month 4, Month 8 ]
    A measure of depression severity that parallels DSM-5 criteria and has established reliability, validity, and sensitivity to change in people with TBI.

  2. Generalized Anxiety Disorder 7 item (GAD-7) - Change is being assessed. [ Time Frame: Collected at 0-14 days of enrollment, Month 4, Month 8 ]
    A measure of general anxiety.

  3. Pittsburgh Sleep Quality Inventory (PSQI) - Change is being assessed. [ Time Frame: Collected at 0-14 days of enrollment, Month 4, Month 8 ]
    The PSQI contains 19 items covering 7 dimensions of sleep plus a composite score.

  4. Brief Pain Intensity- 4 (BPI-4) - Change is being assessed. [ Time Frame: Collected 4 times in one week over the course of 7 days at enrollment period, Month 4, Month 8 ]
    A 4-item pain intensity scale in past week (current, worst, average, least).

  5. Patient Global Assessment of Treatment Satisfaction (PGATS) - Change is being assessed. [ Time Frame: Collected at Month 4, Month 8 ]
    A 3 item measure that rates satisfaction with care received.

  6. Participation Assessment with Recombined Tools - Objective 17 - Change is being assessed. [ Time Frame: Collected at 0-14 days of enrollment, Month 4, Month 8 ]
    The PART-O-17 is a patient-reported measure of involvement in life situations at the societal level as reflected in fulfillment of developmentally and culturally appropriate roles such as worker, student, spouse, parent, or citizen.

  7. Cornell Service Index (CSI) - Change is being assessed. [ Time Frame: Collected at 0-14 days of enrollment, Month 4, Month 8 ]
    A standardized measure of the quantity and characteristics (for example, site and provider) of health services used.

  8. Visits To Regional Emergency Departments (ED) - Change is being assessed. [ Time Frame: Collected at 0-14 days of enrollment, Month 4, Month 8 ]
    Count of visits to regional emergency departments in the last 4 months.

  9. Change from enrollment to 4 months post randomization (month 8) in Pain Interference Scale from the Brief Pain Inventory [ Time Frame: Collected at 0-14 days of enrollment, Month 8 ]
    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).

  10. Chronic Pain Acceptance Questionnaire (CPAQ-8) [ Time Frame: Collected at 0-14 days of enrollment, Month 4, Month 8 ]
    An 8-item measure looking at the acceptance of chronic pain

  11. DFAQ-CU Inventory [ Time Frame: Collected at 0-14 days of enrollment, Month 4, Month 8 ]
    DFAQ-CU is a 4-item measure and stands for daily sessions, frequency, age of onset, and quantity of cannabis use.

  12. AUDIT-C [ Time Frame: Collected at 0-14 days of enrollment, Month 4, Month 8 ]
    A 3-item alcohol screen that can help identify persons who have active alcohol use disorders.

  13. The two-Item Conjoint Screen (TICS) [ Time Frame: Collected at 0-14 days of enrollment, Month 4, Month 8 ]
    A two-Item Conjoint Screen, is composed of two questions on alcohol/drug use in the past year and feeling the need to cut down on this use.

  14. Patient Global Impression of Change (PGIC) [ Time Frame: Collected at 0-14 days of enrollment, Month 4, Month 8 ]
    A self-report measure which reflects a patient's belief about the efficacy of treatment.

  15. Pain Quality Assessment Scale (PQAS) [ Time Frame: Collected at 0-14 days of enrollment, Month 4, Month 8 ]
    Measures different types of pain people may experience.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03523923


Contacts
Layout table for location contacts
Contact: Laurie Research Coordinator 2067443607 lpeabody@uw.edu
Contact: Leslie Kempthorne 2065430219 ette@uw.edu

Locations
Layout table for location information
United States, Washington
Harborview Medical Center, TBI Clinic Recruiting
Seattle, Washington, United States, 98104
Contact: Laurie Research Coordinator    206-744-3607    lpeabody@uw.edu   
Contact: Leslie Kempthorne    206-543-0219    ette@uw.edu   
Principal Investigator: Jeanne M Hoffman, PhD         
University of Washington Medical Center, TBI Clinic Recruiting
Seattle, Washington, United States, 98195
Contact: Laurie Research Coordinator    206-744-3607    lpeabody@uw.edu   
Principal Investigator: Jeanne M Hoffman, PhD         
Sponsors and Collaborators
University of Washington
National Institute on Disability, Independent Living, and Rehabilitation Research
Investigators
Layout table for investigator information
Principal Investigator: Jeanne M Hoffman, PhD University of Washington

Layout table for additonal information
Responsible Party: Jeanne Hoffman, Professor, School of Medicine: Rehabilitation Medicine:Psychology, University of Washington
ClinicalTrials.gov Identifier: NCT03523923     History of Changes
Other Study ID Numbers: STUDY00003847
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jeanne Hoffman, University of Washington:
Collaborative Care
Effectiveness Study

Additional relevant MeSH terms:
Layout table for MeSH terms
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Post-Traumatic Headache
Brain Diseases
Craniocerebral Trauma
Trauma, Nervous System
Chronic Pain
Headache
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Headache Disorders, Secondary
Headache Disorders