PCORI has identified the need for large studies that look at real-life questions facing diverse patients, caregivers, and clinicians. In 2014, PCORI launched the Pragmatic Clinical Studies initiative to support large-scale comparative effectiveness studies focusing on everyday care for a wide range of patients. The Pragmatic Clinical Studies initiative funded this research project.
This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.
What is the research about?
Bumps or jolts to the head can damage the brain, resulting in traumatic brain injury, or TBI. TBI can cause headaches, sleep problems, dizziness, mood changes, and tiredness. People with TBI may have trouble thinking clearly, and their memory may be affected. Some of these problems may not go away quickly, and people with TBI may have a hard time returning to their daily routine. About half of people whose moderate to severe TBI requires a hospital stay have a long-term disability.
Although TBI is common, not all healthcare professionals are equipped to care for TBI-related health problems or are familiar with the education or services patients may need after leaving the hospital. The research team wants to compare different approaches to connect patients and their caregivers to education or services to help patients continue to recover from TBI after they leave the hospital.
Who can this research help?
Results of this study can help doctors and patients with TBI and their caregivers plan for the patients’ recovery after a hospital stay.
What is the research team doing?
The team is working with six hospitals that offer TBI inpatient rehabilitation treatment to recruit 900 patients being treated for moderate to severe TBI. Before patients leave the hospital for home or another facility, the team is assigning them, by chance, to one of two groups.
One group is getting the care patients and families usually receive to help plan for recovery after a hospital stay. This care includes education, advice, and a plan based on the patient’s needs. A care manager from the hospital calls the patient at home within three days to follow up.
The other group is also getting usual care. But in addition, patients and families in this group are receiving help from a TBI care manager for the first six months after leaving the hospital. Care managers contact patients and families by phone. They help patients and families stay on their care plans and connect them to education or services if needed. Patients and families also have access to a helpline, or they can e-mail or text the care managers for help.
The team is following up with patients every three months for one year to find out if patients are returning to their normal daily activities and to ask about their quality of life. Follow-up questions ask about caregiver burden and how often patients use healthcare services. The team is also looking at how much work it is for the TBI care managers to help connect patients and caregivers to services and what services are available.
Patients with TBI and their families helped plan the study and decide what results to measure. They are contributing to all phases of the study.
Research methods at a glance
|Design||Randomized controlled trial|
|Population||Adult patients who have been hospitalized for treatment of moderate to severe TBI|
Primary: Participation Assessment with Recombined Tools-Objective 17 (PART-O), Quality of Life after Brain Injury Scale (QoLIBRI)
Secondary: healthcare utilization; caregiver burden; quality of life for caregiver including personal quality of life and time spent in caregiving; process variables, including time it takes for the TBI care manager to connect patients and caregivers with healthcare, education, and services
|6-month follow-up for primary outcomes|