Brain Injuries, TraumaticNCT03523923
TBI Care: Collaborative Care for Pain After Traumatic Brain Injury (TBI)
A study testing Collaborative Care in people with Brain Injuries, Traumatic and Chronic Pain, run by University of Washington at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injuries, Traumatic, Chronic Pain, Post-Traumatic Headache
- What is being tested?
- Collaborative Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Jun 2018to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Harborview Medical Center, TBI Clinic
Seattle, Washington, 98104
University of Washington Medical Center, TBI Clinic
Seattle, Washington, 98195
About this study
Official title: The Effectiveness of Collaborative Care Versus Usual Care for Pain After Traumatic Brain Injury
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.
Read the 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.
- Being tested
- Collaborative Care
- Keywords
- Collaborative Care, Effectiveness Study
- Medical subject headings
- Brain Injuries, Traumatic, Chronic Pain, Post-Traumatic Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Collaborative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Collected at 0-14 days of enrollment, Month 4
Secondary outcomes (15)
Patient Health Questionnaire-9 (PHQ-9)-Change is being assessed.
A measure of depression severity that parallels DSM-5 criteria and has established reliability, validity, and sensitivity to change in people with TBI.
Measured: Collected at 0-14 days of enrollment, Month 4, Month 8
Generalized Anxiety Disorder 7 item (GAD-7) - Change is being assessed.
A measure of general anxiety.
Measured: Collected at 0-14 days of enrollment, Month 4, Month 8
Pittsburgh Sleep Quality Inventory (PSQI) - Change is being assessed.
The PSQI contains 19 items covering 7 dimensions of sleep plus a composite score.
Measured: Collected at 0-14 days of enrollment, Month 4, Month 8
Brief Pain Intensity- 4 (BPI-4) - Change is being assessed.
A 4-item pain intensity scale in past week (current, worst, average, least).
Measured: 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.
A 3 item measure that rates satisfaction with care received.
Measured: Collected at Month 4, Month 8
Participation Assessment with Recombined Tools - Objective 17 - Change is being assessed.
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.
Measured: Collected at 0-14 days of enrollment, Month 4, Month 8
Cornell Service Index (CSI) - Change is being assessed.
A standardized measure of the quantity and characteristics (for example, site and provider) of health services used.
Measured: Collected at 0-14 days of enrollment, Month 4, Month 8
Visits To Regional Emergency Departments (ED) - Change is being assessed.
Count of visits to regional emergency departments in the last 4 months.
Measured: Collected at 0-14 days of enrollment, Month 4, Month 8
Change from enrollment to 4 months post randomization (month 8) 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).
Measured: Collected at 0-14 days of enrollment, Month 8
Chronic Pain Acceptance Questionnaire (CPAQ-8)
An 8-item measure looking at the acceptance of chronic pain
Measured: Collected at 0-14 days of enrollment, Month 4, Month 8
DFAQ-CU Inventory
DFAQ-CU is a 4-item measure and stands for daily sessions, frequency, age of onset, and quantity of cannabis use.
Measured: Collected at 0-14 days of enrollment, Month 4, Month 8
AUDIT-C
A 3-item alcohol screen that can help identify persons who have active alcohol use disorders.
Measured: Collected at 0-14 days of enrollment, Month 4, Month 8
The two-Item Conjoint Screen (TICS)
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.
Measured: Collected at 0-14 days of enrollment, Month 4, Month 8
Patient Global Impression of Change (PGIC)
A self-report measure which reflects a patient's belief about the efficacy of treatment.
Measured: Collected at 0-14 days of enrollment, Month 4, Month 8
Pain Quality Assessment Scale (PQAS)
Measures different types of pain people may experience.
Measured: Collected at 0-14 days of enrollment, Month 4, Month 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start18 Jun 2018
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Brain Injuries, TraumaticStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Responsible party
- Principal investigator, Jeanne Hoffman, University of Washington
- Investigators
- Jeanne M Hoffman, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03523923
- Sponsor's protocol ID
- STUDY00003847
- Status last verified
- Oct 2022
- First submitted
- 17 Apr 2018
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39253025Hoffman 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.
PubMed 38829619
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Collaborative Care Versus Usual Care for Pain After Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT03523923
- Acronym / sponsor ID
- STUDY00003847
- Keywords
- Collaborative Care, Effectiveness Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Study start
- 18 Jun 2018 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 14 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Collaborative CareIf 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collaborative CareUp 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. | Behavioural | Collaborative Care |
Primary outcome
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).
15 secondary outcomes
Patient Health Questionnaire-9 (PHQ-9)-Change is being assessed.
Time frame: Collected at 0-14 days of enrollment, Month 4, Month 8
Generalized Anxiety Disorder 7 item (GAD-7) - Change is being assessed.
Time frame: Collected at 0-14 days of enrollment, Month 4, Month 8
Pittsburgh Sleep Quality Inventory (PSQI) - Change is being assessed.
Time frame: Collected at 0-14 days of enrollment, Month 4, Month 8
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
Patient Global Assessment of Treatment Satisfaction (PGATS) - Change is being assessed.
Time frame: Collected at Month 4, Month 8
Participation Assessment with Recombined Tools - Objective 17 - Change is being assessed.
Time frame: Collected at 0-14 days of enrollment, Month 4, Month 8
Cornell Service Index (CSI) - Change is being assessed.
Time frame: Collected at 0-14 days of enrollment, Month 4, Month 8
Visits To Regional Emergency Departments (ED) - Change is being assessed.
Time frame: Collected at 0-14 days of enrollment, Month 4, Month 8
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
Chronic Pain Acceptance Questionnaire (CPAQ-8)
Time frame: Collected at 0-14 days of enrollment, Month 4, Month 8
DFAQ-CU Inventory
Time frame: Collected at 0-14 days of enrollment, Month 4, Month 8
AUDIT-C
Time frame: Collected at 0-14 days of enrollment, Month 4, Month 8
The two-Item Conjoint Screen (TICS)
Time frame: Collected at 0-14 days of enrollment, Month 4, Month 8
Patient Global Impression of Change (PGIC)
Time frame: Collected at 0-14 days of enrollment, Month 4, Month 8
Pain Quality Assessment Scale (PQAS)
Time frame: Collected at 0-14 days of enrollment, Month 4, Month 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Derived from this study: PubMed 39253025Curran 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.
- Derived from this study: PubMed 38829619Hoffman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeanne M Hoffman, PhD principal investigator
University of Washington
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collaborative Care in people with Brain Injuries, Traumatic and Chronic Pain, run by University of Washington at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03523923, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.