Trial Outcomes & Findings for Enhancing the Transition From Hospital to Home for Patients With Traumatic Brain Injury and Families (NCT NCT04584554)

Results Overview

The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scores on each item are summed and averaged (range: 0=worst to 100=best).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

31 participants

Primary outcome timeframe

Baseline (24-72 hours pre-discharge) and 16-weeks post-discharge

Results posted on

2024-11-15

Participant Flow

Trained research coordinators screened the electronic medical record daily to determine eligible patients. TCMs recruited the patient/family dyads. First, the TCM contacted eligible patients by phone 24-72 hours before discharge to determine interest in participating and obtain additional eligibility information. Interested and eligible patients were asked to identify the caregiver they preferred to participate with them and to share the caregiver's name and contact information.

15 patient-caregiver dyads started the study.

Participant milestones

Participant milestones
Measure	Intervention Patient-Caregiver Dyad - Patient BETTER Transitional Care Intervention: Patient and family will receive pre- and post-discharge support and education from interventionist.	Intervention Patient-Caregiver Dyad - Caregiver BETTER Transitional Care Intervention: Patient and family will receive pre- and post-discharge support and education from interventionist.
Overall Study STARTED	15	16
Overall Study COMPLETED	13	14
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention Patient-Caregiver Dyad - Patient BETTER Transitional Care Intervention: Patient and family will receive pre- and post-discharge support and education from interventionist.	Intervention Patient-Caregiver Dyad - Caregiver BETTER Transitional Care Intervention: Patient and family will receive pre- and post-discharge support and education from interventionist.
Overall Study Withdrawal by Subject	2	2

Baseline Characteristics

Enhancing the Transition From Hospital to Home for Patients With Traumatic Brain Injury and Families

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Patient-Caregiver Dyad - Patient n=15 Participants BETTER Transitional Care Intervention: Patient will receive pre- and post-discharge support and education from interventionist.	Intervention Patient-Caregiver Dyad - Family Caregivers n=16 Participants BETTER Transitional Care Intervention: Family will receive pre- and post-discharge support and education from interventionist.	Total n=31 Participants Total of all reporting groups
Age, Continuous	39.07 years STANDARD_DEVIATION 15.15 • n=99 Participants	43.38 years STANDARD_DEVIATION 10.45 • n=107 Participants	41.25 years STANDARD_DEVIATION 12.8 • n=206 Participants
Sex: Female, Male Female	5 Participants n=99 Participants	6 Participants n=107 Participants	11 Participants n=206 Participants
Sex: Female, Male Male	10 Participants n=99 Participants	10 Participants n=107 Participants	20 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=99 Participants	16 Participants n=107 Participants	31 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	9 Participants n=99 Participants	8 Participants n=107 Participants	17 Participants n=206 Participants
Race (NIH/OMB) White	5 Participants n=99 Participants	7 Participants n=107 Participants	12 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment United States	15 Participants n=99 Participants	16 Participants n=107 Participants	31 Participants n=206 Participants

PRIMARY outcome

Timeframe: Baseline (24-72 hours pre-discharge) and 16-weeks post-discharge

Population: Younger adults (age 18-64) with mild, moderate, or severe TBI discharged home from acute hospital care without inpatient rehabilitation. Not collected on caregivers.

The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scores on each item are summed and averaged (range: 0=worst to 100=best).

Outcome measures

Outcome measures
Measure	Intervention Patient-Caregiver Dyad - Patient n=15 Participants BETTER Transitional Care Intervention: Patient and family will receive pre- and post-discharge support and education from interventionist.
Change in Quality of Life as Measured by the Short Form-36 (SF-36)	47.97 score on a scale Standard Deviation 24.93

SECONDARY outcome

Timeframe: Baseline (24-72 hours pre-discharge) and 16-weeks post-discharge

Population: Family caregivers of patients with TBI. Not collected on patients.

The CPS is a caregiver self-rated instrument that consists of eight items that asks caregivers how well prepared they believe they are for multiple domains of caregiving. Responses are rated on a 5 point scale with scores ranging from 0 (not at all prepared) to 4 (very well prepared). Total score range is 0 to 32, where a higher score indicates the caregiver feels more prepared for caregiving.

Outcome measures

Outcome measures
Measure	Intervention Patient-Caregiver Dyad - Patient n=16 Participants BETTER Transitional Care Intervention: Patient and family will receive pre- and post-discharge support and education from interventionist.
Change in Preparedness for Caregiving Scale (CPS)	25.75 score on a scale Standard Deviation 8.02

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tolu Oyesanya, PI of study

Duke University School of Nursing

Phone: 919-684-5292

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place