Comparing Approaches to Helping People With Chronic Traumatic Brain Injury Manage Their Health Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Patient Priorities Care (PPC), Resource Education.
- Who it may be relevant to
- Registry conditions: Traumatic Brain Injury, Traumatic Brain Injury (TBI) Patients, TBI. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The goal of this double-masked, randomized control trial is to learn about the potential benefits of two different strategies at helping people with traumatic brain injury who see a brain injury physician be more engaged in their healthcare and feel more confident in managing their health. The main questions it aims to answer are: * When comparing the two strategies, which will result in high participant-reported health empowerment assessed approximately 7 - 21 days of completing the approach? * When comparing the two strategies, which will result in high participant-reported health engagement assessed approximately 7 - 21 days of completing the approach? Participants will: * complete baseline assessments about their health, daily activities, and their attitudes about healthcare and their treatment. These will be done over the phone and/or online survey. * have one virtual session with a health professional to discuss their health and wellness. * 7-21 days after the session with a health professional, participants will complete an online survey about their attitudes about healthcare and their treatment. * Some participants may be invited to complete an additional interview about their study participation around 3 months after their session with the health professional.
Detailed description
Phase II trial of PPC for persons with TBI versus resource education control; and qualitative input from selected participants. The study uses mixed methods including double-masked (neither participants nor researchers/assessors know which approach participants are receiving), parallel-group randomized, controlled trial (RCT) using a person-centered approach, Patient Priorities Care (PPC) to enhance health empowerment/self-efficacy and engagement, as compared to a resource education approach (control). Additionally, qualitative interviews will be conducted with selected participants to assess the experience (impact, satisfaction, barriers, and facilitators) of participating in the PPC approach among select adults with chronic TBI randomized to that approach arm.
Interventions
- Behavioral Patient Priorities Care (PPC)
A health professional will conduct a 30-minute interview with the participant to: identify what matters most to them (their values); establish realistic, specific, and actionable healthcare goals they want to accomplish; identify the symptom or problem preventing the participant from reaching their goals; and establish one goal (the one thing) they want to focus on achieving with their healthcare providers that is aligned with the participant's values. - Behavioral Resource Education
A health professional will conduct a 30-minute education session with the participant about resources on living with brain injury available on the Brain Injury Association of America website (https://biausa.org/). The interaction will exclude PPC-specific elements (health priorities identification and care alignment).
Primary outcome measures
- Elder's Health Empowerment Scale (EHES) [Time frame: collected at baseline and post-approach (approximately 7 - 21 days).]
- Patient Activation Measure (PAM) [Time frame: collected at baseline and post-approach (approximately 7 - 21 days).]
Eligibility criteria
Inclusion criteria
- community dwelling adult (>18 years at enrollment)
- ≥1-year post-TBI that resulted in loss of consciousness based on The Ohio State University-TBI Identification Method
- followed by a brain injury physician for TBI care who refers them to the study
- must have sufficient comprehension, communication, sensorimotor function, and English proficiency (due to outcome measures not being validated in languages other than English)
- must provide informed consent and have webcam and Internet access for assessments and approach
Additionally, meet 1 or more of the following criteria:
- 2 or more current chronic conditions (including chronic TBI)
- 5 or more medications
- 3 or more emergency department visits within the past 12 months
- 1 or more hospital admissions within the past 12 months
- Under care of 2 or more specialists (non-primary care), including physicians, midlevel providers, therapists, mental health professionals) with visits with these providers in the past 12 months
Exclusion criteria
- non-community dwelling
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Health services research
Study locations
United States · 1 center
- Indiana University School of Medicine — Indianapolis
Identifiers
NCT: NCT07483528 · 30315 · 90DPHF0017