Development and Feasibility of a Function-focused Transitional Care Intervention to Support Functional Recovery in Older Veterans
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Client Satisfaction Questionnaire
研究概览
简要总结
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.
详细描述
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.]
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 65 Years 至 —(Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Score of > 3 on Vulnerable Elders Survey, (VES-13)
- •Score of 4-9 on Short Physical Performance Battery (SPPB)
- •Able to provide informed consent
排除标准
- •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)
研究组 & 干预措施
CTraC-FIT
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.
干预措施: CTraC-FIT (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.
干预措施: Enhanced Usual Care (Other)
结局指标
主要结局
Client Satisfaction Questionnaire
时间窗: Endpoint (Day 30)
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.
Adherence
时间窗: Endpoint (Day 30); 3 Month
The investigators 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.
Enrollment
时间窗: Baseline (Day 1)
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.
Retention
时间窗: Endpoint (Day 30); 3-Month
Proportion of enrolled participants who complete the endpoint assessment and the 3-month follow-up. This data will be sourced from the project database.
Perceived Characteristics of Intervention Scale
时间窗: Endpoint (Day 30)
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.
Recruitment
时间窗: Baseline (Day 1)
Measured by the proportion of participants approached who agree to screening. This data will be sourced from the project database.
Fidelity
时间窗: Endpoint (Day 30)
Assessed by compliance with the CTraC-FIT fidelity checklist. This data will be sourced from the project database.
次要结局
- 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)
