Development and Feasibility of CTraC-FIT

NCT07132944 | Not Yet Recruiting

• 2 other identifiers: RRD9-002-24W1IK2RD000454-01A1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Functional Impairment; Functional Performance

Keywords

Physical function; Transitional care; Function-focused care; Function; Care Transition; Physical performance; Functional performance; Health care transition; Transition of care

Outcome Measures

Primary Outcomes (7)

• Client Satisfaction Questionnaire

  We 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.

  Endpoint (Day 30)

• Perceived Characteristics of Intervention Scale

  We 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.

  Endpoint (Day 30)

• 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.

  Baseline (Day 1)

• Recruitment

  Measured by the proportion of participants approached who agree to screening. This data will be sourced from the project database.

  Baseline (Day 1)

• Retention

  Proportion of enrolled participants who complete the endpoint assessment and the 3-month follow-up. This data will be sourced from the project database.

  Endpoint (Day 30); 3-Month

• Adherence

  We will use a combination of metrics to determine adherence, including: The proportion of completed phone or VVC (Video Visit Communication) calls The proportion of participants who establish functional goals The proportion of participants who achieve at least 50% of their goals The proportion of participants with a documented functional recovery care plan within 72 hours post-discharge This data will be sourced from the project database.

  Endpoint (Day 30); 3 Month

• Fidelity

  Assessed by compliance with the CTraC-FIT fidelity checklist. This data will be sourced from the project database.

  Endpoint (Day 30)

Secondary Outcomes (3)

• Performance-based Physical Function

  Baseline (Day 1), Endpoint (Day 30), 3 Month

• Self-reported Physical, Cognitive, and Social Function

  Baseline (Day 1), Endpoint (Day 30), 3 Month

• Quality of Life

  Baseline (Day 1), Endpoint (Day 30), 3 Month

Other Outcomes (1)

• Functional Ability Screener

  Pre-baseline - during CTraC program enrollment

Study Arms (2)

CTraC-FIT

EXPERIMENTAL

The intervention arm involves participants receiving a structured transitional care intervention (CTraC-FIT) administered by a trained nurse case manager via phone or VA Video Connect, aimed at improving functional abilities and reducing hospital readmissions.

Other: CTraC-FIT

Enhanced Usual Care

OTHER

The 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.

Other: Enhanced Usual Care

Interventions

CTraC-FIT OTHER

The 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.

Also known as: Coordinated Transitional Care

CTraC-FIT

Enhanced Usual Care OTHER

The 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.

Also known as: EUC

Enhanced Usual Care

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age \> or = 65 years
• Score of \> 3 on Vulnerable Elders Survey, (VES-13)
• Score of 4-9 on Short Physical Performance Battery (SPPB)
• Able to provide informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130-4817, United States

Location

Study Officials

• Caroline Madrigal, PhD

  VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline Madrigal, PhD

CONTACT

(401) 273-7100; Caroline.Madrigal@va.gov

Jane Driver, MD

CONTACT

(857) 364-2560; Jane.Driver@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Given the nature of the intervention, it is not feasible to use double blinding where both participants and assessors are unaware of group assignments. Instead, a single-blind design will be employed where the participants are not aware of their specific group assignments.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: The investigators will conduct a pilot randomized controlled trial (RCT) to evaluate the feasibility, acceptability, and preliminary effects of the CTraC-FIT protocol. Participants will be randomized into two groups: CTraC-FIT intervention and control group receiving enhanced usual care (EUC).

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 20, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)