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Recruiting NCT07132944

Development and Feasibility of CTraC-FIT

No phase Interventional Functional Impairment Functional Performance

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CTraC-FIT, Enhanced Usual Care.
Who it may be relevant to
Registry conditions: Functional Impairment, Functional Performance. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Development and Feasibility of a Function-focused Transitional Care Intervention to Support Functional Recovery in Older Veterans

Overview

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.

Detailed description

Nearly two-thirds of older adults experience significant functional decline after hospital discharge, resulting in loss of independence, institutionalization, and even death. Functional decline (i.e., loss of physical or cognitive ability that makes it difficult or impossible to perform activities of daily living) often occurs after hospital discharge due to a complex interplay between pre-existing health conditions, physiological stressors, and reduced mobility and activity levels during hospitalization. Veterans are at particular risk of functional decline as they experience a disproportionate burden of physical and psychological conditions compared to their non-Veteran peers. Transitions from hospital to home serve as critical junctures to address Veterans' functional needs, but many patients are discharged without a comprehensive functional evaluation. Even when evaluation occurs, discharge plans often fail to translate into effective care delivery, creating a concerning gap between planned and actual support after hospitalization.

The Coordinated Transitional Care (CTraC) program is a potential foundation on which to build a protocol that meets Veterans' rehabilitative care needs during and after discharge. CTraC is a nurse-led transitional care program developed to improve Veterans' transitions to the community after hospitalization. CTraC aims to address key components of transitional care: (1) care planning and communication; (2) medical follow-up; (3) education on symptom management; and (4) medication safety/management. In this model, the CTraC nurse identifies and meets Veterans at high risk of readmission, helps optimize their discharge planning, and then delivers a protocolized phone-based intervention for up to 30 days. CTraC has demonstrated significant benefits to VA, including a 50% reduction in readmissions, resolution of medication discrepancies for more than half of enrolled patients, and cost savings. Yet, the existing CTraC protocol misses a critical opportunity to include functional assessment and intervention to support Veterans' functional recovery.

The goal of this CDA-2 proposal is to develop and test a function-focused protocol for VA's CTraC program. The aim is to leverage CTraC's established success and infrastructure to comprehensively address Veterans' rehabilitation needs after hospitalization and optimize their functional recovery and independence during the transition from hospital to home. Specifically, this project aims to:

Aim 1: Develop \& refine CTraC-FIT (Functional Independence aT home) for Veterans at risk of functional decline transitioning from hospital to home. (1a) Develop CTraC-FIT to support Veterans' functional recovery based on input from clinicians (n=15) across hospital and outpatient settings (e.g., CTraC NCMs, inpatient providers, primary care providers, physical therapists, and occupational therapists). (1b) Conduct a nonrandomized, preliminary pilot of the CTraC-FIT intervention (n=5 Veterans) and collect qualitative feedback from Veterans and the CTraC NCM to refine the intervention protocol and study procedures, as well as address any unanticipated barriers before pilot testing.

Aim 2: Examine the feasibility and acceptability of CTraC-FIT in a pilot randomized controlled trial via randomization of n=40 Veterans to either CTraC-FIT (n=20) or an enhanced usual care condition (n=20). The primary outcomes will be feasibility and acceptability of the intervention protocol and study procedures. Feasibility and acceptability of the intervention protocol will be measured via survey and qualitative interviews with Veterans, and surveys with clinicians (n\~20). Feasibility of the study procedures will be assessed via data logs (e.g., recruitment, enrollment, retention, adherence, randomization, and fidelity). Secondary outcomes will include Veterans' self-reported quality of life, social and cognitive function as well as self-reported and performance-based physical function measured at baseline, post-intervention, and 3-months post-intervention.\]

Interventions

  • Other CTraC-FIT
    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 navigatin
  • Other Enhanced Usual Care
    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.

Primary outcome measures

  • Client Satisfaction Questionnaire [Time frame: Endpoint (Day 30)]
  • Perceived Characteristics of Intervention Scale [Time frame: Endpoint (Day 30)]
  • Enrollment [Time frame: Baseline (Day 1)]
  • Recruitment [Time frame: Baseline (Day 1)]
  • Retention [Time frame: Endpoint (Day 30); 3-Month]
  • Adherence [Time frame: Endpoint (Day 30); 3 Month]
  • Fidelity [Time frame: Endpoint (Day 30)]
Secondary outcome measures (3)
  • Performance-based Physical Function [Time frame: Baseline (Day 1), Endpoint (Day 30), 3 Month]
  • Self-reported Physical, Cognitive, and Social Function [Time frame: Baseline (Day 1), Endpoint (Day 30), 3 Month]
  • Quality of Life [Time frame: Baseline (Day 1), Endpoint (Day 30), 3 Month]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

United States · 1 center
  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA — Boston

Identifiers

NCT: NCT07132944 · RRD9-002-24W · 1IK2RD000454-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗