The Effectiveness of Collaborative Care Versus Usual Care for Pain After Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 158
- 试验地点
- 4
- 主要终点
- Change from enrollment to end of treament (month 4) in Pain Interference Scale from the Brief Pain Inventory
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change from enrollment to end of treament (month 4) in Pain Interference Scale from the Brief Pain Inventory
时间窗: 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).
次要结局
- Visits To Regional Emergency Departments (ED) - Change is being assessed.(Collected at 0-14 days of enrollment, Month 4, Month 8)
- AUDIT-C(Collected at 0-14 days of enrollment, Month 4, Month 8)
- Pain Quality Assessment Scale (PQAS)(Collected at 0-14 days of enrollment, Month 4, Month 8)
- Patient Health Questionnaire-9 (PHQ-9)-Change is being assessed.(Collected at 0-14 days of enrollment, Month 4, Month 8)
- The two-Item Conjoint Screen (TICS)(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)
- Patient Global Assessment of Treatment Satisfaction (PGATS) - Change is being assessed.(Collected at Month 4, Month 8)
- Participation Assessment with Recombined Tools - Objective 17 - Change is being assessed.(Collected at 0-14 days of enrollment, Month 4, Month 8)
- Cornell Service Index (CSI) - Change is being assessed.(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(Collected at 0-14 days of enrollment, 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)
- Chronic Pain Acceptance Questionnaire (CPAQ-8)(Collected at 0-14 days of enrollment, Month 4, Month 8)
- DFAQ-CU Inventory(Collected at 0-14 days of enrollment, Month 4, Month 8)
- Patient Global Impression of Change (PGIC)(Collected at 0-14 days of enrollment, Month 4, Month 8)
研究者
Jeanne Hoffman
Professor, School of Medicine: Rehabilitation Medicine:Psychology
University of Washington