Resource Education vs PPC for Traumatic Brain Injury

(2BeHealthy Trial)

MO
RR
Overseen ByRebecca Runkel
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Indiana University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two strategies to help people with traumatic brain injuries (TBI) become more involved and confident in managing their healthcare. Participants will either attend a session focused on understanding resources for living with a brain injury (Resource Education) or a session tailored to identifying their personal health priorities (Patient Priorities Care, PPC). Researchers aim to determine which method better empowers and engages participants in their health journey. This trial suits those living in the community who have had a TBI for over a year, see a brain injury doctor, and face challenges like managing multiple health conditions or frequent medical visits. As an unphased trial, this study offers a unique opportunity for participants to contribute to innovative approaches in TBI care.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your medications, but it's best to confirm with the trial coordinators.

What prior data suggests that these strategies are safe for participants with traumatic brain injury?

Research has shown that both Patient Priorities Care (PPC) and Resource Education are safe and well-received methods for individuals with traumatic brain injury (TBI). These approaches do not involve physical procedures and aim to empower individuals in managing their healthcare.

PPC primarily involves conversations to identify personal health goals, and there is no specific data on negative effects. Previous studies emphasize the importance of supporting TBI survivors without mentioning any safety issues.

Resource Education focuses on providing information and resources, suggesting it is very safe. Reports of negative effects are absent, and education-based methods generally carry very low safety risks.

This trial is categorized as "Not Applicable," indicating it likely involves behavioral or educational methods rather than new drugs, further suggesting it is very safe.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative approaches to managing traumatic brain injury (TBI) through personalized care and resource education. Unlike traditional treatments that focus primarily on medical interventions, the Patient Priorities Care (PPC) approach centers on identifying individual patient priorities in a 30-minute session, potentially leading to more tailored and effective care plans. Meanwhile, the Resource Education method provides patients with valuable information on living with a brain injury, empowering them to take an active role in their recovery. These methods emphasize patient engagement and personalized care, which could enhance overall treatment outcomes for individuals with TBI.

What evidence suggests that this trial's strategies could be effective for traumatic brain injury?

This trial will compare the Patient Priorities Care (PPC) approach with Resource Education for individuals with traumatic brain injury. Research has shown that the PPC approach helps patients by focusing on what is most important to them, which can enhance their involvement in healthcare. Studies have found that PPC can create more personalized care plans that align with patient goals, potentially increasing their engagement and satisfaction.

Conversely, Resource Education aims to provide individuals with the knowledge and tools to better manage their brain injury. Effective education programs have empowered patients, helping them handle their conditions with greater confidence. Both strategies have shown promise in boosting patient involvement and confidence in managing health, although their specific effects on traumatic brain injury require further study.12467

Who Is on the Research Team?

FH

Flora Hammond, MD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have had a traumatic brain injury at least one year ago, live in the community, are under care of a brain injury doctor, can communicate in English, and meet certain health criteria like having multiple chronic conditions or recent hospital visits. Participants need internet access.

Inclusion Criteria

≥1-year post-TBI of any severity 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)
See 3 more

Exclusion Criteria

Non-community dwelling

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Participants complete baseline assessments about their health, daily activities, and attitudes about healthcare and treatment over the phone and/or online survey

1 week
1 virtual visit

Intervention

Participants have one virtual session with a health professional to discuss their health and wellness

1 day
1 virtual session

Post-Intervention Assessment

Participants complete an online survey about their attitudes about healthcare and treatment 7-21 days after the session with a health professional

2-3 weeks

Follow-up

Some participants may be invited to complete an additional interview about their study participation around 3 months after their session with the health professional

3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Patient Priorities Care (PPC)
  • Resource Education

Trial Overview

The study compares two ways to help people with chronic traumatic brain injury manage their healthcare: Resource Education and Patient Priorities Care (PPC). Participants are randomly assigned to one approach and complete virtual sessions and surveys about their experiences.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Patient Priorities Care (PPC)Experimental Treatment1 Intervention
Group II: Resource EducationActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials
1,063
Recruited
1,182,000+

Citations

Patient Experiences of and Priorities for Traumatic Brain Injury ...

To learn patient perspectives about health care in a level I trauma center for traumatic brain injury (TBI) that inform the design of better TBI systems of ...

Comparing Approaches to Helping People With Chronic ...

The PPC approach consists of one 30 minute session with a health professional to identify patient priorities. Intervention/Treatment, Behavioral ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40584562/

Patient Experiences of and Priorities for Traumatic Brain ...

Objective: To learn patient perspectives about health care in a level I trauma center for traumatic brain injury (TBI) that inform the ...

4.

patientprioritiescare.org

patientprioritiescare.org/publications/

Publications

Patient Priorities Care (PPC) is aligned with the Age-Friendly Health Systems 4Ms Framework. Starting with what Matters, PPC also guides Medication, Mentation ...

traumatic brain injury - research priorities

CDC seeks to set a clearer path to improving TBI prevention and management generally, including focusing on at-risk populations. Addressing these research gaps ...

Assessing Patient Experiences and Priorities in Traumatic ...

Weighted results indicated that 35% of participants were unaware of their TBI diagnosis, 39% desired more follow-up care, and 50% reported still experiencing ...

Traumatic Brain Injury Categories Should Be Updated and ...

The report recommends the creation of an updated TBI classification system to better guide patient care and inform research across the phases of ...