The BETTER Traumatic Brain Injury Transitional Care Intervention: A Feasibility Study

Abstract

This study aimed to investigate the feasibility, acceptability, and clinical outcome measures of BETTER (Brain Injury Education, Training, and Therapy to Enhance Recovery), a culturally-tailored traumatic brain injury (TBI) transitional care intervention, among diverse younger adult patients with TBI (age 18–64) and their caregivers. Trained clinical interventionists addressed patient/family needs; established goals; coordinated post-hospital care and resources; and provided patient/family training on self- and family-management coping skills. Fifteen dyads enrolled (N=31, 15 patients, 16 caregivers). All completed baseline data; 74.2% (n=23; 10 patients, 13 caregivers) completed 8-week data; 83.8% (n=26; 13 each) completed 16-week data. Approximately 38% (N=12, 3 patients, 9 caregivers) completed acceptability data, showing positive experiences (M=9.25, range 0–10; SD=2.01). Overall and mental QOL scores did not differ over time but physical QOL scores did improve over time (baseline: 30.3, 8-weeks: 46.5, 16-weeks: 61.6; p=0.0056), which was considered to be a suitable outcome measure for a future trial. BETTER is a promising intervention with implications to improve TBI care standards. Research is needed to determine efficacy in a randomized trial.

Introduction and Background

Research suggests up to 60% of U.S. adult patients aged 18–64 years with mild-to-severe traumatic brain injury (TBI) are discharged home from acute hospital care without inpatient rehabilitation into a fragmented environment that does not bridge gaps between inpatient and outpatient settings or integrate healthcare, community, and social services.¹ Up to 12 months after acute hospital care discharge to home, patients with TBI may have significant physical, mental, and social challenges that prevent return to pre-injury levels of functioning, with worse outcomes for Black and Latino patients,² causing dependence on families.³ TBI-specific transitional care programs for diverse patients are needed to improve post-acute outcomes as patients and their families transition home from acute hospital care without inpatient rehabilitation.

Transitional care is defined as actions in the clinical encounter designed to ensure the coordination and continuity of healthcare for patients transferring between different locations or levels of care.⁴ Factors contributing to gaps in the transition from hospital to home include inadequate planning, insufficient patient/family education, and limited and fragmented access to essential services.⁵ These gaps are compounded by limited resources and lack of insurance or social support.^3,6 For non-TBI patient populations with acute events (e.g., stroke, heart failure), transitional care interventions have been shown to improve patient health and quality of life (QOL) through strategies such as individualized transitional care plans, post-discharge care coordination, and community-based service referrals.⁷ The discharge home from acute hospital care is an ideal intervention point to guide improvements in health and QOL for younger adult patients with TBI and families using transitional care interventions.⁸ However, there are no U.S. transitional care standards for TBI. The current state of “usual care” has limited provider support or engagement to help patients and families navigate and access fragmented health and community-based services.⁹

Few TBI-specific transitional care interventions exist, and existing interventions have major shortcomings, including that they do not: (1) show efficacy for racial/ethnic minorities,¹⁰ (2) have cultural tailoring to meet needs/preferences of diverse patients/families,^10–13 (3) focus on behavioral change,^10–13 or (4) address family needs.^10–13 Likewise, Black and Latino patients with TBI are underrepresented in TBI research, suggesting that interventions developed and implemented into clinical practice to date may not have been developed using inclusive or culturally-tailored strategies to adequately serve the cultural needs and preferences of this important population.¹⁴

Further, it has been well established that using the SF-36 to estimate an individual’s QOL is a reliable and valid approach to capture clinically meaningful changes in a patient’s QOL in numerous populations. Unfortunately, one gap in the knowledge base is whether the SF-36 performs well in patients with TBI. Few studies have conducted psychometric evaluations of the SF-36 with patients with TBI.¹⁵ In addition, limited data are available on early post-hospital outcomes of patients with TBI discharged home from acute hospital care. Gaining a better understanding of what defines a minimal clinically important difference on the SF-36 in the early post-acute period (≤16 weeks post-discharge) to use in establishing a baseline or expected improvement in QOL for this population is needed and warranted to inform future research.

Aims

To address these gaps, we developed a culturally-sensitive TBI transitional care intervention called BETTER (Brain Injury Education, Training, and Therapy to Enhance Recovery).^16,17 This study builds on prior reports on BETTER; companion articles are referenced throughout the manuscript to contextualize findings).^16,17 The aims of this study were to determine the: (1) feasibility, (2) acceptability, and (3) clinical outcome measures of BETTER among dyads of younger adult patients with TBI of various race/ethnicities discharged home from acute hospital care and family caregivers. Findings will be used to inform the design of a future, definitive, randomized controlled trial.

Methods

Study Design

We conducted a prospective, quasi-experimental, single center, single arm (no comparison group) feasibility study. We evaluated the feasibility of BETTER in the clinical setting and acceptability amongst younger adult patients with TBI and caregivers. We used a longitudinal explorative approach to investigate the third aim, i.e., whether BETTER will lead to improvements in SF-36 scores over time. Our design was informed by the NIH stage model for behavioral intervention development, specifically stage 1, which calls for “early-stage intervention development, refinement, and adaptation” and “real-world testing,” including without use of a control/comparison group.¹⁸ Approval from the Duke University Health System Institutional Review Board (Approval number: Pro00103181) was obtained , permitting use of written consent. The study was registered on clinicaltrials.gov (NCT04584554). Findings are reported in alignment with the CONSORT guidelines’ extension for pilot trials.¹⁹

Setting & Sample

Participants were recruited from a Southeastern U.S. level I trauma center. Patients were eligible if they were: (a) age 18–64 years; (b) diagnosed with mild, moderate, or severe TBI (admission Glasgow Coma Scale score of 3–14); (c) admitted to the participating acute care hospital; (d) planned for discharge directly home from the participating hospital (discharge to community) without inpatient rehabilitation or transfer to other setting; (e) sufficient cognitive functioning to participate at discharge, as determined by the Galveston Orientation and Amnesia Test (score ≥ 76 eligible);²⁰ (f) able to access to a smart phone or computer with internet; (g) able to appoint an eligible family caregiver who was willing to participate with them in the study; and (h) English speaking. We note that we initially sought to recruit Spanish-speaking participants but were unable to do so as our team required more time to build capacity to enroll Spanish speakers. Hospital providers (separate from our team) made the determination on each patient’s discharge disposition and timeframe. Family caregivers were eligible if they were: (a) associated with a patient who met eligibility criteria and was willing to participate in the study; (b) age ≥18 years; (c) the anticipated primary caregiver of the patient after discharge (i.e., plans to live with the patient or see them ≥10 hours/week); (d) able to access to a smart phone or computer with internet; and (e) English speaking. Patients and families were recruited and enrolled as a dyad. If the patient enrolled and the caregiver declined participation, the patient would be withdrawn from the study (or vice versa).

Intervention Description

The BETTER TBI transitional care intervention was co-created between younger adult patients with TBI, family caregivers, health care providers, and interdisciplinary researchers. We used community-engaged research methods to ensure all perspectives were captured and iteratively incorporated. Community-engaged research methods include seeking and capturing input, perspectives, and guidance from key stakeholders throughout the full research process.²¹ The intervention was informed by our team’s prior research;^{7,8,16,17,22–42} literature used to support, educate, and train patients and families in recovery;^43–46 and the Individual and Family Self-Management Theory.⁴⁷ In addition, as no U.S. TBI transitional care guidelines exist, guidelines on TBI discharge planning and follow-up from the United Kingdom⁴⁸ informed the intervention. A detailed description of BETTER (including sources informing the intervention and procedures) and strategies used to develop and culturally tailor the intervention are published elsewhere.^16,17

BETTER is a patient- and family-centered, culturally sensitive behavioral intervention for patients with TBI discharged home from acute hospital care and their families. BETTER is designed to improve patients’ QOL by 16 weeks post-discharge. Trained clinical interventionists (referred to as transitional care managers [TCMs]) were healthcare providers with experience in caring for neurological or trauma patients and had extensive training on our manualized intervention protocol. In this feasibility study, the TCMs were occupational therapists. Additional information on the training requirements of our TCMs is published elsewhere.¹⁶ TCMs were assigned to work with individual patient/family dyads to address: 1) patient/family needs; 2) establish patient goals;⁴⁴ 3) coordinate post-hospital care, services, and resources; and 4) provide patient/family training on self- and family-management coping skills. A full description of the intervention is illustrated in Figure 1. Dyads begin BETTER 24 to 72 hours pre-discharge. TCMs have ≥1 weekly contact (by phone and/or video conferencing) with each patient/family dyad until 16 weeks post-discharge. This personally tailored intervention allowed the TCM to address the unique needs of each patient/family dyad in real-time.^16,17

Figure 1.

BETTER Intervention Activities.

Recruitment

Recruitment occurred from February to July 2021. Trained research coordinators screened the electronic medical record daily to identify eligible patients. TCMs recruited the patient/family dyads. First, the TCM contacted eligible patients by phone 24 to 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. The TCM subsequently contacted the caregiver to determine interest, eligibility, and a time for the pre-discharge in-person meeting for initial study enrollment.

Data Collection

Following determination of the patient’s eligibility, the research coordinators collected outcome data by phone (due to the ongoing COVID-19 pandemic) and entered participant responses into REDCap, a secure online website for building and managing electronic surveys and databases.⁴⁹ The coordinators also collected demographic data at baseline (e.g., age, sex, race/ethnicity, insurance status, pre-injury employment); and collected feasibility and acceptability data throughout the study. Data were collected longitudinally at: 1) baseline (24–72 hours pre-discharge), 2) intervention midpoint (8 weeks post-discharge) and 3) intervention endpoint (16 weeks post-discharge). In the rare cases when the dyad was not available pre-discharge (e.g., patient in pain, tired, or discharged quickly), collection of baseline data occurred up to 3 days post-discharge. The intervention began after baseline data were collected.

When participants had limited time for data collection, we obtained a limited dataset of prioritized measures. The limited dataset for patients was the primary outcome (QOL). While most patients completed the SF-36 for the primary outcome, the SF-12 (a derivative of the SF-36) was collected if participants indicated they had limited time for data collection. For caregivers, a secondary outcome (the Preparation for Caregiving Scale) was deemed to be most important. The order of data collection for patients was SF-36 or SF-12 (SF-12 if time was limited), all other measures, and the acceptability scale (acceptability scale completed at 16 weeks post-discharge only). The order of data collection for caregivers was Preparation for Caregiving Scale, all other measures, and the acceptability scale (acceptability scale completed at 16 weeks post-discharge only). To reduce and prevent attrition, participants each received up to $130 for completion of outcome measures (participants were compensated after completion of each data collection timepoint).

Measures

Feasibility and Acceptability

For recruitment feasibility, the coordinators recorded the number of patient/family dyads eligible, approached, and consented to participate. For enrollment feasibility, the coordinators recorded the number of recruited dyads that were enrolled. For data collection feasibility, the coordinator recorded for each follow-up data collection time point: 1) number of dyads called and reached; 2) number of call attempts per dyad; 3) number of dyads reached but unable to provide information; 4) completeness of data collected; 5) length of phone call; and 6) day of week and time of day dyads participated. We assessed acceptability of the intervention using an adaptation of the Research Participant Perception Survey, using an abbreviated version of the survey with two added questions on usefulness of intervention features and materials. Patients and caregivers were asked the same questions. As this is a dyadic intervention (patients and caregivers receiving the same intervention at the same time), we combined patient and caregiver acceptability in our analysis.

Primary and Secondary Outcomes

The primary outcome was patient QOL (SF-36), which has two subscales, physical and mental component summaries.⁵⁰ The SF-12 (a derivative of the SF-36) was collected if participants indicated they had limited time for data collection, thus we have calculated both SF-36 and SF-12 for primary outcome.⁵¹

In addition, although the intervention was designed to improve patient QOL, we had numerous secondary outcomes, some of which were overlapping for the patient and caregiver. Secondary outcomes included: (1) caregiver preparation (Preparedness for Caregiving Scale),⁵² (2) caregiver QOL (SF-36/SF-12),^50,51 (3) caregiver strain (Modified Caregiver Strain Index),⁵³ (4) patient and caregiver depressive symptoms (Patient Health Questionnaire-9 [PHQ-9]),⁵⁴ (5) patient and caregiver self-efficacy (Self-Efficacy for Management of Chronic Conditions),⁵⁵ and (6) patient health service utilization (transitional care survey developed by team).

Sample Size Justification

Our proposed sample size was 15 patient/family dyads (30 participants). To determine this sample size, we referred to the literature, using recommendations of at least 12 participants per group for pilot/feasibility studies.⁵⁶ The sample was selected to demonstrate the feasibility of recruiting, enrolling, and data collection for this intervention with the intention to use findings to inform design of a future, definitive randomized controlled trial.

Data Analysis

To determine feasibility, we initially performed a descriptive analysis of the flow of respondents from recruitment to enrollment, and the response rates for completing instruments. We also performed a descriptive analysis detailing the investment (i.e., number of contact attempts, amount of time spent for data collection) as a measure of data collection feasibility. To describe patients’ and caregivers’ perspectives on acceptability, we also used descriptive analyses. Finally, for the clinical outcome measures aim, although no control group was used, repeated measures ANOVA techniques were used to test if QOL scores (and the Preparedness for Caregiving Scale for caregivers) changed over time.

Results

Sample Characteristics

Of the 15 patients enrolled, 73.33% were men (n = 11) with a mean age of 39.07 (Range: 18–61; SD: 15.15). The racial distribution of patients included 60% Black (n = 9), 33% White (n = 5), and 6.67% American Indian/Alaska Native (n = 1). Of the 16 caregivers enrolled, 87.5% were women (n = 14) with a mean age of 43.38 (Range: 26–64; SD: 10.45). For caregivers’ racial distribution, 50% were Black (n = 8), 43.75% were White (n = 7), and 6.25% were American Indian/Alaska Native (n = 1). All injury severities were included (mild: n = 6 [40.0%]; moderate n = 4 [26.7%]; severe: n = 5 [33.3%]). Additional information about characteristics of participants enrolled are published elsewhere.¹⁶

Feasibility and Acceptability

Recruitment and Enrollment Feasibility

There were 438 patients with TBI admitted during the recruitment period and 139 met inclusion criteria. Of these, 124 were not enrolled due to language barriers, being discharged before being approached, scheduling issues, or declining participation. Of the 139 eligible, 26 patients (18.7% of eligible) were approached to participate and 11 declined due to lack of interest in participating, pain, or fatigue. As such, 16 (61.5% of those approached) were recruited, and ultimately 15 patients and their associated caregivers enrolled (N=31; 15 total dyads; 15 patients, 16 caregivers). The number of patients and caregivers enrolled are unequal because one patient was administratively removed after they changed their mind about enrollment, however, their caregiver had already enrolled.

Investment to Collect Data

Table 1 displays descriptive data regarding investment to collect data. Response rates were high for patients at both 8- and 16-weeks post-discharge, but were lower for caregivers. The number of attempts to reach patients and caregivers increased over time while the length of the calls decreased over time. Patients and caregivers were most commonly reached to complete data collection on weekdays (vs. weekends) in the afternoon (vs. morning or evening).

Table 1.

Investment to Collect Data

Patients (n = 15)	Baseline	8 weeks	16 weeks
Number of patients called and reached, n (%)	15 (100.0%)	13 (86.7%)	13 (86.7%)*
Number of call attempts per patient, mean (SD)	3.5 (2.5)	5.1 (2.9)	6.6 (6.9)
Length of phone call, mean (SD), in minutes	33 (16.5)	20 (15.6)	25 (25.7)
Date of week reached
Weekday (Monday-Friday)	86.7%	84.6%	100%
Weekend (Saturday-Sunday)	13.3%	15.4%	0%
Time of day reached
Morning (6 AM-11:59 AM)	20%	38.5%	41.7%
Afternoon (12 PM-5:59 PM)	73.3%	61.5%	41.7%
Evening (6–9 PM)	6.7%	0%	16.6%
Family caregivers (n= 16)	Baseline	8 weeks	16 weeks
Number of family caregivers called and reached, n (%)	16 (100.0%)	10 (66.7%)	13 (86.7%)
Number of call attempts per family caregiver, mean (SD)	2.9 (1.1)	7.0 (6.3)	6.3 (4.6)
Length of phone call, mean (SD), in minutes	36 (18.0)	24 (16.0)	23 (15.0)
Date of week reached
Weekday (Monday-Friday)	93.8%	80.8%	100.0%
Weekend (Saturday-Sunday)	6.2%	20.0%	0.0%
Time of day reached
Morning (6 AM-11:59 AM)	18.8%	30.0%	23.1%
Afternoon (12 PM-5:59 PM)	62.5%	60.0%	69.2%
Evening (6–9 PM)	18.7%	10.0%	7.7%

Note:

^*one individual was reached but did not provide information

Data Collection Feasibility

Table 2 displays descriptive data regarding data collection feasibility for patients and family caregivers. For patients, those who were reached by phone completed a QOL instrument, with a majority completing the SF-36 (compared to SF-12) at baseline, 8, and 16 weeks post-discharge. Most patients completed a SF-36 (73%) or SF-12 (80%) for all time points, demonstrating availability of data for completing longitudinal analysis. For caregivers, all those reached by phone completed a Preparedness for Caregiving Scale at baseline and at 16 weeks post-discharge. There was a monotonic decrease in the proportion of caregivers who completed an SF-36 (compared to SF-12) over time. A total of 4 (26.7%) caregivers completed the SF-36 or SF-12 (30.4%) for all time points.

Table 2.

Data Collection Feasibility

Patients	Baseline n=15 (%)	8 Weeks n=13 (%)	16 Weeks n=12 (%)
Completed ≥1 Instrument	15 (100.0%)	13 (100.0%)	12 (100.0%)
Instruments Completed
SF-36	13 (86.7%)	11 (84.6%)	11 (91.7%)
SF-12*	2 (13.3%)	2 (15.4%)	1 (8.3%)
PHQ-9	7 (46.67%)	0 (0%)	1 (8.3%)
Self-efficacy for managing chronic conditions scale	9 (60.0%)	3 (23.1%)	2 (16.7%)
Health care utilization#	N/A	7 (53.85%)	2 (16.67%)
Caregivers	Baseline n=16 (%)	8 Weeks n=10 (%)	16 Weeks n=13 (%)
Completed ≥1 Instrument	16 (100.0%)	10 (100.0%)	13 (100.0%)
Instruments Completed
Preparedness for Caregiving Scale	16 (100.0%)	8 (80.0%)	13 (100.0%)
SF-36	16 (100.0%)	9 (90.0%)	4 (80.0%)
SF-12*	0 (0.0%)	1 (10.0%)	1 (20.0%)
Modified Caregiver Strain Index	15 (93.75%)	3 (20.0%)	2 (15.4%)
PHQ-9	15 (93.75%)	3 (20.0%)	2 (15.4%)
Self-efficacy for managing chronic conditions scale	15 (93.75%)	3 (20.0%)	2 (15.4%)
Health care utilization# (proxy for patient)	N/A	5 (33.3%)	2 (15.4%)

Notes:

^*SF-12 alone collected if participant indicated they had limited time for data collection;

^#health care utilization was only asked at the 8- and 16-weeks post-discharge follow-up time frames, not at baseline.

Acceptability of the Intervention

Table 3 displays descriptive data regarding acceptability of the intervention, including item-wise responses. A total of 12 participants (3 patients, 9 caregivers) completed acceptability information at the intervention endpoint (16 weeks post-discharge). Three-fourths of respondents felt information and discussions provided prior to participating in the study prepared them for their experience. The respondents always felt the research team listened to them and treated them with courtesy and respect. More than half of respondents expressed research team members always respected their cultural background and one-third indicated they had no cultural issues. All respondents found the study materials were helpful. Two respondents considered leaving the study. Mean ratings for the overall study experience were very high.

Table 3.

Acceptability of the Intervention (n=12)

Acceptability Questions Asked of Patients and Caregivers	n (%)
Did the information and discussions you had before participating in the research study prepare you for your experience in the study?  No  Somewhat  Mostly  Completely	1 (8.3%) 2 (16.7%) 6 (50.0%) 3 (25.0%)
Did the research team members listen carefully to you?  Never  Sometimes  Usually  Always	0 (0.0%) 0 (0.0%) 1 (8.3%) 11 (91.7%)
Did the research team members treat you with courtesy and respect?  Never  Sometimes  Usually  Always	0 (0.0%) 1 (8.3%) 0 (0.0%) 11 (91.7%)
Did the research staff respect your cultural background (e.g. language, religion, ethnic group)?  Never  Sometimes  Usually  Always  No Cultural Issues	0 (0.0%) 0 (0.0%) 1 (8.3%) 7 (58.3%) 4 (33.3%)
Were the study materials helpful?  Yes  No	12 (100.0%) 0 (0.0%)
Did you ever consider leaving the study?  Yes  No	2 (16.7%) 10 (83.33%)
Overall experience in the study (0–10 scale), mean (SD)	9.25 (2.01)

Primary and Secondary Outcomes

Table 4 displays data on clinical outcome measures. Scores on the SF-36/SF-12 did not differ over time in overall QOL or mental QOL. However, scores in physical QOL did improve over time. Role limitations due to the physical health sub-domain significantly improved over time for both the SF-12 and the SF-36. The pain sub-domain significantly improved over time for both the SF-12 and the SF-36. Scores on the Preparedness for Caregiving Scale did not differ over time for caregivers.

Table 4.

Changes in Patients’ Quality of Life Over Time (SF-12 and SF-36) and Caregivers’ Preparedness of Caregiving

	Baseline Mean (SD)	8 weeks post-discharge Mean (SD)	16 weeks post-discharge Mean (SD)	Change between baseline and 16 weeks	p-value
Domains of SF-12 (Patients Only)	(n = 15)	(n = 13)	(n = 13)
Total score (SF-12)	42.34 (27.10)	54.79 (32.13)	63.11 (26.19)	20.77 (26.70)	0.0555
Physical Component Summary (PCS)	23.33 (24.49)	48.56 (30.10)	57.81 (27.19)	34.48 (25.71)	0.0019 *
Physical functioning (Q4,6)	30.00 (41.40)	65.38 (42.74)	70.83 (39.65)	40.83 (40.64)	0.0156 *
Role limitations due to physical health (Q14, 15)	10.00 (28.03)	30.77 (43.49)	41.67 (41.74)	31.67 (34.74)	0.0268 *
Pain (Q22)	21.67 (33.89)	57.69 (40.03)	66.67 (26.83)	45.00 (30.98)	0.0009 **
General health (Q1)	31.67 (24.03)	40.38 (29.82)	52.08 (31.00)	20.42 (27.32)	0.0651
Mental Component Summary (MCS)	61.36 (39.74)	61.03 (38.45)	68.42 (29.56)	7.06 (35.62)	0.6133
Role limitations due to emotional problems (Q18, 19)	46.67 (44.19)	50.00 (45.64)	37.50 (43.30)	−9.17 (43.80)	0.5937
Energy/fatigue (Vitality) (Q27)	37.33 (32.83)	44.62 (35.73)	45.00 (29.70)	7.67 (31.49)	0.5353
Emotional well-being (Mental health) (Q26,28)	54.67 (29.97)	59.23 (34.27)	69.17 (22.75)	14.50 (27.03)	0.6065
Social functioning (Q32)	45.40 (39.86)	29.23 (37.16)	53.58 (41.32)	8.18 (40.51)	0.1783
Domains of SF-36 (Patients Only)	(n = 13)	(n = 11)	(n = 11)
Total score (SF-36)	47.97 (24.93)	54.15 (31.44)	68.86 (29.08)	20.89 (26.90)	0.0712
Physical Component Summary (PCS)	30.29 (22.70)	46.53 (24.29)	61.65 (27.41)	31.36 (24.95)	0.0056 *
Physical functioning	31.92 (34.85)	57.75 (28.40)	64.55 (33.35)	32.62 (34.18)	0.0294 *
Role limitations due to physical health	9.62 (28.02)	18.18 (29.77)	52.27 (39.46)	42.66 (33.70)	0.0054 *
Pain	23.85 (28.11)	53.86 (34.50)	62.95 (29.93)	39.11 (28.95)	0.0033 *
General health	55.77 (25.97)	56.36 (20.87)	66.82 (22.28)	11.05 (24.36)	0.2802
Mental Component Summary (MCS)	65.65 (36.22)	61.76 (42.81)	76.07 (32.68)	10.42 (34.66)	0.4710
Role limitations due to emotional problems	48.72 (42.20)	42.42 (42.40)	42.42 (44.95)	−6.29 (43.47)	0.7271
Energy/fatigue (Vitality)	40.77 (25.65)	48.18 (36.90)	50.45 (32.28)	9.69 (28.85)	0.4214
Emotional well-being (Mental health)	59.38 (26.87)	53.82 (36.55)	72.00 (17.06)	12.62 (22.94)	0.1932
Social functioning	48.08 (31.81)	40.86 (26.34)	63.32 (23.28)	15.24 (28.25)	0.2014
Preparedness for Caregiving Scale (Caregivers Only)	(n = 16)	(n = 15)	(n = 13)
Total score	25.75 (8.02)	25.63 (6.59)	25.38 (9.68)	−0.37 (8.80)	0.9123

Note:

^*= p<.05;

^**= p<.01

Discussion

The aims of this study were to determine the: (1) feasibility, (2) acceptability, and (3) clinical outcome measures of BETTER among dyads of younger adult patients with TBI of various races and ethnicities discharged home from acute hospital care and their family caregivers. Findings suggest recruitment and enrollment in our study were feasible. Data collection was appropriate given the length of follow up, suggesting that time points and the time period for follow-up were feasible. Regarding clinical outcome measures, although overall and mental component QOL scores did not significantly improve over time, physical component QOL scores did significantly improve over time. Finally, participants who completed the acceptability scale indicated an overall very high experience.

Recruitment and enrollment rates for this study are in alignment with rates for patients with TBI recruited from trauma settings.¹⁴ We believe our recruitment process and sample are comparable to the types of patients with TBI hospitalized for acute care in the U.S.^1,57 Transitional care interventions designed to improve patient QOL among younger adult patients without TBI have similar recruitment and enrollment rates.⁷ As only 18.7% of eligible patients were approached to participate in this study, findings suggest recruitment from the participating hospital was feasible and will likely be feasible for a larger study. The same inclusion/exclusion criteria will be used for BETTER in future studies. Unfortunately, limited information on feasibility of data collection in prospective TBI studies has been published for comparison, as most publications only describe outcome data.

Within this feasibility study, we encountered challenges with data collection and diversity of primary language spoken by participants. Regarding data collection, we invested more time collecting data from participants than initially expected, with increasing numbers of call attempts to collect data as the study went on; there was an average of six call attempts at the last data collection timepoint (16 weeks-post-discharge) for patients and family caregivers. We will need to account for this challenge in the future trial, developing new strategies to increase efficiency of data collection. Furthermore, although our sample was diverse with participants from multiple racial groups enrolled, we also sought to recruit a sample diverse in primary language spoken. However, we encountered difficulty recruiting Spanish-speaking patients and families as our team did not have the capacity to offer the intervention in Spanish as initially planned. Since completion of this study, our team has spent multiple years building capacity to enroll Spanish-speakers, including through translation of all study materials (e.g., consents, workbooks, data collection measures and scripts, manualized intervention protocol) from English to Spanish. Next steps in preparation to enroll Spanish-speakers into our future trial include hiring and training bilingual study staff, including trained clinical interventionists and research coordinators. We hope these changes will increase the success of recruiting and enrolling participants diverse in race and ethnicity and primary language spoken (English- and Spanish-speakers) in our future trial.

The present study demonstrates the promising potential for BETTER to improve patient QOL for younger adult patients with TBI as findings will be used to inform a future, definitive randomized controlled trial, which we do intend to conduct. While findings indicating no improvement in overall and mental QOL may be an artifact of the small sample size, we also speculate that mental QOL scores may not have significantly improved because of stress incurred by participants during the COVID-19 pandemic, compounded by typical TBI-related lifestyle and role changes.³ Limited TBI research is available starting from discharge home from acute hospital care and following patients through their natural recovery trajectory, including on QOL (via SF-12 or SF-36), to use as a basis of comparison to the present study’s findings. As such, one goal of our study was to understand the degree of change on the SF-36 to inform design of a future trial. Our findings show differences in QOL scores are larger than minimal clinically important difference scores reported in the neurological literature.⁵⁸ While evidence from this study is strong, there is a lack of a control group without sufficient power to determine differences, limiting our ability to establish causation.

Comparison of primary outcome findings from the present study to existing TBI transitional care interventions^10–13 is not possible due to differences in design and primary outcomes. Similar to the present study, transitional care interventions designed to improve patient QOL (measured by SF-36) among younger adult patients without TBI showed variations in QOL scores, including no improvements or improvements in either physical or mental component summary scores.⁷ Although these non-TBI transitional care interventions used SF-36 as their primary outcome and had findings similar to this study, their designs (i.e., randomized controlled trials) and sample sizes (i.e., 28–486 participants across groups) limit comparison to our study (quasi-experimental, single arm, 31 total participants).⁷

The current study was conducted to fill a void in TBI transitional care literature, with implications for research and practice. Existing TBI transitional care interventions had multiple shortcomings, as they do not: (1) focus on or improve patient QOL as a sole primary outcome, ^10–13 (2) show efficacy for racial/ethnic minorities,¹⁰ (3) have cultural tailoring to meet needs and/or preferences of diverse patients and families,^10–13 (4) focus on behavioral change or goal setting,^10–13 or (5) address family needs, or caregiver health and capacity to support the patient.^10–13 The present study makes novel contributions to the literature by demonstrating the feasibility, acceptability, and clinical outcome measures of a culturally-tailored transitional care intervention designed to: (1) improve patient QOL, (2) address needs and preferences of racial/ethnic minority patients with TBI, (3) address family needs, and (4) address behavioral changes and patient goal setting. Research is needed to determine the efficacy of this novel intervention.

This study has multiple strengths, including intervention co-creation between patients, caregivers, providers, and researchers; use of a culturally-tailored intervention to address needs and preferences of patients with TBI of various races/ethnicities and caregivers; and recruitment of a diverse sample (61% of participants were racial/ethnic minorities; more information on participant characteristics is published elsewhere¹⁶). However, this study is not without limitations, including in design (single-arm, quasi-experimental study with no control group); setting (single center); sample (N=31); language (English-speaking participants only); and in low response rates on the acceptability scale, particularly for patients. Regardless of these limitations, findings provide foundational knowledge useful for informing subsequent testing and future research and practice.

Conclusions

BETTER, a patient- and family-centered, culturally sensitive, TBI transitional care intervention designed to improve patient QOL among younger adult patients with TBI of various races/ethnicities and caregivers is feasible and acceptable. QOL scores did not differ over time in overall or mental QOL but did improve over time in physical QOL, suggesting promising potential to work in a large randomized controlled trial. Finally, there is a critical need to measure TBI patient recovery and care transitions directly following discharge home from acute hospital care.