Development and Feasibility of CTraC-FIT
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorVA Office of Research and Development
About this trial
Functional decline after hospitalization is a serious concern for older Veterans, often leading to loss of independence and disability. VA's nurse-led Coordinated Transitional Care (CTraC) program has demonstrated success in improving care transitions, but currently lacks targeted assessment and intervention to support Veterans' functional recovery. This project aims to develop and test a function-focused CTraC protocol (CTraC-FIT) to address this critical gap and optimize functional outcomes for Veterans transitioning from hospital to home. By integrating evidence-based functional assessment and intervention strategies into the CTraC protocol, this project aims to empower Veterans to regain and maintain their independence and improve their quality of life.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Score of > 3 on Vulnerable Elders Survey, (VES-13)
Score of 4-9 on Short Physical Performance Battery (SPPB)
Able to provide informed consent
Disqualifiers
Admitted to VA Boston for acute psychiatric are or substance abuse detoxification
Plan to discharge anywhere except home (e.g., assisted living, group home, or skilled nursing facility)
Trial design
Design model
Parallel
Treatments tested in this trial
CTraC-FIT
Other interventionThe intervention is designed to support Veterans at high risk of readmission with comprehensive transitional care that includes: Structured Follow-Ups: Regularly scheduled follow-up calls to monitor the patient's progress, address any issues, and provide ongoing support. Health Coaching: Personalized coaching to help Veterans manage their health conditions, adhere to treatment plans, and make lifestyle changes that can improve their overall health. Care Coordination: Assistance with navigating the healthcare system, facilitating appointments, and ensuring that the Veteran receives all necessary post-discharge services. The intervention arm aims to improve functional abilities and reduce hospital readmissions by providing tailored support based on the unique needs of each participant. The CTraC NCM will follow a standardized protocol to ensure consistent and effective delivery of the intervention across all participants in this group.
Enhanced Usual Care
Other interventionThe Enhanced Usual Care (EUC) arm involves participants receiving the standard care provided by their assigned Veterans Affairs Boston Healthcare System (VABHS) inpatient and outpatient teams. This includes routine medical evaluations, treatments, and follow-up appointments as typically recommended by their healthcare providers. In addition to receiving standard care, participants in the EUC group will undergo baseline, endpoint, and 3-month follow-up assessments as part of the study protocol. For participants with intermediate functional ability (SPPB score of 7-9), no additional intervention will be provided after randomization to the control group. However, for participants with low functional ability (SPPB score of 0-6), a safety protocol will be activated to notify their assigned inpatient medical team (e.g., hospitalist, social worker) about the participant's risk of functional decline, ensuring that appropriate support and referrals are provided if needed.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: CTraC-FITExperimental treatment 1 intervention
Group B: Enhanced Usual CareOther 1 intervention
Trial outcomes
Primary outcomes
1
Client Satisfaction Questionnaire
The investigators will measure Veteran satisfaction using the Client Satisfaction Questionnaire (CSQ-8), a validated tool that assesses satisfaction with various aspects of service delivery, including the quality of care, helpfulness of staff, and overall experience.
Time frame
Endpoint (Day 30)2
Perceived Characteristics of Intervention Scale
The investigators will use the Perceived Characteristics of Intervention Scale (PCIS) to understand clinicians' perspectives on the acceptability of the CTraC-FIT intervention. The PCIS is a validated tool designed to assess key factors influencing the acceptability of an intervention from the perspective of healthcare providers. Developed within VA, the scale assesses the overall acceptability of the intervention by examining whether it is perceived as beneficial, feasible, and compatible with existing practices.
Time frame
Endpoint (Day 30)3
Enrollment
Assessed by the proportion of those screened who enroll in the study, as well as the number of participants enrolled each month. This data will be sourced from the project database.
Time frame
Baseline (Day 1)4
Recruitment
Measured by the proportion of participants approached who agree to screening. This data will be sourced from the project database.
Time frame
Baseline (Day 1)Secondary outcomes
1
Performance-based Physical Function
The investigators will use the Short Physical Performance Battery (SPPB) to measure performance-based physical function over time. The SPPB's strong psychometric properties and ability to predict future disability and adverse events make it a valuable tool for evaluating the impact of the CTraC-FIT intervention on physical function and mobility.
Time frame
Baseline (Day 1), Endpoint (Day 30), 3 Month2
Self-reported Physical, Cognitive, and Social Function
The investigators will use the World Health Organization Disability Assessment Schedule (WHODAS) 2.0 to measure physical, cognitive, and social function over the past 30 days, offering a comprehensive evaluation of function and disability. This self-report tool uses a 5-point Likert scale to assess difficulties in six domains: understanding and cognition, mobility, self-care, getting along, life activities, and participation.
Time frame
Baseline (Day 1), Endpoint (Day 30), 3 Month3
Quality of Life
The investigators will use the World Health Organization Quality of Life-BREF (WHOQOL-BREF) self-report instrument to assess and produce scores representative of quality of life in the domains of physical health, psychological health, social relationships, and environment in a 2-week timeframe. The WHOQOL-BREF's strong psychometric properties and comprehensive coverage of quality-of-life domains make it a valuable tool for understanding the potential impact of the CTraC-FIT intervention.
Time frame
Baseline (Day 1), Endpoint (Day 30), 3 MonthOther outcomes
1
Functional Ability Screener
The investigators will use a self-reported measure of risk of functional decline-the Vulnerable Elders Survey and a performance-based measure of physical functional impairment-the Short Physical Performance Battery (SPPB). Veterans eligible for study participation will have both a score of ≥ 3 on the VES-13 indicating an increased risk of functional decline and a score of 4-9 on the SPPB.
Time frame
Pre-baseline - during CTraC program enrollmentSponsors and contacts
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Source ClinicalTrials.gov