Improving Transition From Acute to Post-Acute Care Following Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,555
- 试验地点
- 6
- 主要终点
- Participation Assessment With Recombined Tools - Objective 17 (PART-O-17)
研究概览
简要总结
Each year, about 2.8 million people sustain a traumatic brain injury (TBI) in the United States, and at least 25 percent of these injuries are classified as moderate to severe. Nearly half of those hospitalized for TBI have long-term disability. Most have psychological, physical, social, or work-related problems, which often become chronic. By talking with patients and family members, we found that returning to daily activities and regaining quality of life are major concerns. Outcomes are affected by the type and severity of the TBI, but the type of treatment someone with TBI receives is also important. What resources are available, whether providers are experienced with the problems associated with TBI, and how much treatment is available can affect outcomes as well.
Currently, inpatient rehabilitation professionals are told to give people with TBI information, reassurance, advice, and referral resources. Some promising ways of helping people with TBI include using telephone and other mobile devices to reach patients after they leave the hospital, to regularly assess their individual needs and help them coordinate their health care, and to provide the information and resources that they need. These new strategies may lead to earlier return to activities and improved quality of life. No studies have compared the standard approach to discharge care with an approach that uses telecare to provide information and care coordination after discharge from inpatient rehabilitation for TBI.
The main goal of this project is to find out how improving the transition from the hospital to outpatient care can improve the lives of people with moderate to severe TBI and achieve better results that are important to patients with TBI, their families, and healthcare providers. In this study, patients with TBI who are discharged from inpatient rehabilitation at one of six national TBI Model Systems sites (University of Washington, Indiana University, Ohio State University, Mount Sinai Hospital, Moss Rehabilitation, and Baylor Institute for Rehabilitation) will be randomized (like the flip of a coin) to either the standard discharge plan or the standard discharge plan with additional telephone follow up from a TBI care manager for the first 6 months after discharge. The project team will compare patient and caregiver functioning and quality of life at 3, 6, 9, and 12 months after hospital discharge in these two groups.
详细描述
Screening
The screening process involves a review of medical records by our research staff for patients with a diagnosis of TBI, or suspected TBI, (see inclusion/exclusion for further detail) who are admitted to the inpatient rehabilitation unit at the study sites.
Recruitment
Patient Participants: If a potential participant meets eligibility criteria based on medical record review, research staff will approach him/her on the inpatient rehabilitation unit to determine whether the patient is cognitively capable of providing consent by administering a measure of orientation/ emergence from PTA. If the patient is deemed oriented, the research staff will introduce the study using a talking points script, and if the potential participant is interested, provide him/her with a brochure and a consent form.
Research staff will initiate the informed consent process if: a) the patient is deemed oriented per definition above, and b) the patient expresses interest in participating. Research staff will visit the patient on a subsequent day and re-administer the orientation test prior to consent if needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
This study uses masked outcome assessment, which means study researchers will make every effort to ensure that staff members who collect outcomes data from both patient and caregiver participants at 3-, 6-, 9- and 12 months are unaware of patient 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
- •Hospitalized with a moderate-to-severe TBI defined by TBIMS and this study as damage to brain tissue caused by an external mechanical force as evidenced by medically documented loss of consciousness or post-traumatic amnesia (PTA) due to brain trauma or by objective neurological findings that can be reasonably attributed to TBI on physical examination or mental status examination. Potential participants must meet at least one of the following criteria to be considered experiencing a moderate-to-severe TBI:
- •PTA>24 hours;
- •Trauma related intracranial neuroimaging abnormalities;
- •Loss of consciousness exceeding 30 minutes (unless due to sedation or intoxication); or
- •Glasgow Coma Scale in the emergency department of less than 13 (unless due to intubation, sedation, or intoxication).
- •English speaking (we will track non-enrollment due to other language to determine common languages and have consumer dissemination materials translated for more broad use if time and resources permit.);
- •At least 18 years old;
- •Will be discharged from inpatient rehabilitation to community (private residence, adult home, hotel, homeless) or facility (nursing home, subacute care i.e. skilled nursing facility);
- •Current admission to inpatient rehabilitation considered their first comprehensive rehabilitation experience, or extension thereof for most recent TBI (e.g. admitted to inpatient rehabilitation, discharged to acute care, then returns to inpatient rehabilitation to complete their initial stay);
- •Able to provide informed consent, or if unable to provide consent have family or legal guardian to provide informed consent for the patient.
- •Inclusion Criteria- Caregiver Participants:
- •Individuals who will have primary care giving responsibility post rehabilitation care discharge of enrolled patient participants;
- •English speaking (we will track non-enrollment due to other language to determine common languages and have consumer dissemination materials translated for more broad use if time and resources permit.);
- •At least 18 years old;
- •Able to provide informed consent.
排除标准
- •Exclusion criteria- Patient Participants:
- •We will not enroll individuals who are in law enforcement custody at admission to the designated rehabilitation unit or who are taken into custody prior to discharge from the designated rehabilitation unit due to federal restrictions on inclusion of prisoners in research.
- •We will not enroll individuals who do not have access to a phone.
- •We will not enroll individuals who are unable to complete study procedures due to cognitive/verbal limitations AND do not have a proxy to assist with study procedures.
- •Exclusion criteria- Caregiver Participants:
- •We will not enroll individuals who are in law enforcement custody due to federal restrictions on inclusion of prisoners in research.
- •We will not enroll individuals who do not have access to a phone.
研究组 & 干预措施
Rehabilitation Discharge Plan
Commission on Accreditation of Rehabilitation Facilities (CARF) standards for discharge following an inpatient rehabilitation stay for a traumatic brain injury, including patient and family education, written discharge care instructions, and telephone follow up from a clinical provider.
干预措施: Rehabilitation Discharge Plan (Other)
Rehabilitation Transition Plan
Approximately 12 scheduled contacts from a TBI care manager 6 months following discharge in addition to the CARF standards for discharge.
干预措施: Rehabilitation Transition Plan (Other)
结局指标
主要结局
Participation Assessment With Recombined Tools - Objective 17 (PART-O-17)
时间窗: This outcome will be assessed via self-report instrument from the patient participant 6 months after discharge from inpatient rehabilitation care.
The Participation Assessment with Recombined Tools - Objective 17 (PART-O-17) assesses participation in usual roles and social activities. There are 17 items with 0-5 response scales. Those items are combined and averaged into three domain subscale scores that range from 0-5: Productivity (3 items), Social Relations (7 items), and Out and About (7 items). The Averaged Total score, used here, is calculated by averaging the three domain scores. Higher values represent a better outcome.
Quality of Life After Brain Injury Scale (QoLIBRI)
时间窗: This outcome will be assessed via self-report instrument from the patient participant 6 months after discharge from inpatient rehabilitation care.
A patient-reported instrument specifically created to measure the patient's perception of their health-related quality of life following TBI. The QOLIBRI scores are reported on a 0-100 scale, where 0=worst possible quality of life and 100=best possible quality of life.
次要结局
- Cornell Services Index(This outcome will be assessed via self-report instrument from the patient participant 3, 6, 9 and 12 months after discharge from inpatient rehabilitation care.)
- Bakas Caregiving Outcomes Scale(This outcome was assessed via self-report instrument from the caregiver participant at 3, 6, 9 and 12 months after the patient is discharged from inpatient rehabilitation care. This is reporting the 6-month outcomes.)
- Zarit Burden Interview(This outcome was assessed via self-report instrument from the caregiver participant at 3, 6, 9 and 12 months after the patient is discharged from inpatient rehabilitation care. This is reporting the 6-month outcomes.)
- Short Form 12-Item Measure (SF-12)(This outcome was assessed via self-report instrument from the caregiver participant at 3, 6, 9 and 12 months after the patient is discharged from inpatient rehabilitation care. This is reporting the 6-month outcomes.)
- PROMIS (Patient-Reported Outcomes Measurement Information System) Satisfaction With Social Roles and Activities 8a(This outcome was assessed via self-report instrument from the caregiver participant at 3, 6, 9 and 12 months after the patient is discharged from inpatient rehabilitation care. This is reporting the 6-month outcomes.)
- Time Spent Caregiving - Required Assistance(This outcome was assessed via self-report instrument from the caregiver participant at 3, 6, 9 and 12 months after the patient is discharged from inpatient rehabilitation care. This is reporting the 6-month outcomes.)
- Participation Assessment With Recombined Tools - Objective 17 (PART-O-17)(This outcome will be assessed longitudinally via self-report instrument from the patient participant 3,6, 9 and 12 months after discharge from inpatient rehabilitation care.)
- Quality of Life After Brain Injury Scale (QoLIBRI)(This outcome will be assessed via self-report instrument from the patient participant 3, 6, 9 and 12 months after discharge from inpatient rehabilitation care.)
- Satisfaction With Care(This outcome will be assessed via self-report instrument from the patient participant 6 and 12 months after discharge from inpatient rehabilitation care. 6-month outcomes are reported.)
- RTP Satisfaction Survey(This outcome was assessed via self-report instrument from both patient and caregiver participants (if applicable) randomized to the RTP group 6 months after discharge from inpatient rehabilitation care (if they consented to complete the survey).)
- Time Spent Caregiving - Reason for Assistance(This outcome was assessed via self-report instrument from the caregiver participant at 3, 6, 9 and 12 months after the patient is discharged from inpatient rehabilitation care. This is reporting the 6-month outcomes.)
研究者
Jeanne Hoffman
Professor, School of Medicine: Rehabilitation Medicine:Psychology
University of Washington