跳至主要内容
临床试验/NCT03157999
NCT03157999已完成不适用

A Pragmatic Effectiveness-implementation Trial to Evaluate a Hospital-to-home Transitional Care Intervention Compared to Usual Care for Older Adults With Multiple Chronic Conditions and Depression

McMaster University6 个研究点 分布在 1 个国家目标入组 127 人开始时间: 2017年7月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
127
试验地点
6
主要终点
Change in mental functioning of the older adult study participant

研究概览

简要总结

The aim of this study is to test a support program for older adults with symptoms of depression and other chronic health problems after they are discharged home from hospital. The study will be conducted in three communities in Ontario (Sudbury, Burlington, and Hamilton) and the program will be implemented with input from community members. The program will be delivered by a Registered Nurse, who will provide support to patients via home visits and telephone calls. The nurse's role will involve linking patients and their caregivers with needed services and supports, reviewing medications that the patients are taking, assessing patients' health, building the skills of patients in problem-solving and managing their care, and providing education to patients and their caregivers.

详细描述

Implementing transitional care interventions for older adults with depressive symptoms and multiple chronic conditions (MCC) is a pressing concern since older adults with depression face persistent health disparities. The Community Assets Supporting Transitions (CAST) research team seeks to address these health inequities, and improve health outcomes in this vulnerable and under-served population by developing and implementing an intervention that will improve patients' self-management ability, support their families and caregivers, and build capacity for primary care and other health and non-health providers to collaborate in delivering home and community services. The proposed study builds on our pilot study that evaluated a nurse-led intervention for older adult home care clients with MCC and depressive symptoms and demonstrated that the intervention was feasible and effective in reducing depressive symptoms.

The overall aim of the study is to improve care transitions in older adults with MCC and depressive symptoms. The project will address three research questions:

  1. What is the effect of a new, nurse-led hospital-to-home transitional care intervention compared to usual care on health outcomes and costs for older adults with MCC and depressive symptoms?
  2. How is a care transition intervention adapted and implemented in diverse settings?
  3. What is required to sustain and scale up the intervention? We hypothesize that the intervention will improve health outcomes and reduce use of expensive health services compared to usual care at no additional cost, from a societal perspective.

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
Double (Participant, Outcomes Assessor)

盲法说明

The Research Assistant who will be collecting the outcome measures will be blinded to group allocation (intervention vs. control) for the duration of data collection.

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Is an adult, age 65 or older;
  • Is planned for discharge from hospital to the community (this includes retirement homes and transitional care beds);
  • Self-reports having a diagnosis of at least two chronic conditions;
  • Is experiencing depressive symptoms, assessed using the 2-item version of the Patient Health Questionnaire (PHQ-2);
  • Lives within one of the study regions (Sudbury, Burlington, or Hamilton), and is not planning to move out of the region during the trial (defined as a one-year period);
  • Is capable of providing informed consent, or has a substitute decision-maker who is able to provide informed consent on his/her behalf; and
  • Is competent in English, or has an interpreter who is competent in English.

排除标准

  • Is being discharged from the hospital to a long-term care home or tertiary care.

结局指标

主要结局

Change in mental functioning of the older adult study participant

时间窗: T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization

Measured by the mental component summary (MCS) score of the Veterans RAND 12 item Health Survey (VR-12).

次要结局

  • Change in health-related quality of life of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).(T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization)
  • Change in depressive symptoms of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).(T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization)
  • Change in utilization of health and social services by the: 1) older adult study participant, 2) family/friend caregiver of the older adult study participant.(T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization)
  • Change in mental functioning of the family/friend caregiver of older adult participant (if applicable).(T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization)
  • Change in physical function of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).(T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization)
  • Change in unmet care needs of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).(T1 = Baseline data collection; T2 = 6 months after randomization)
  • Change in anxiety of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).(T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization)
  • Change in caregiver strain of the family/friend caregiver of the older adult study participant (if applicable)(T1 = Baseline data collection; TT2 = 6 months after randomization; T3 = 12 months after randomization)
  • Change in utilization of health services by the older adult study participant(T2 = 6 months after randomization; T3 = 12 months after randomization)
  • Change in patient-reported experience (CCCQ) for the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).(T1 = Baseline data collection; T2 = 6 months after randomization)
  • Change in patient-provider communication of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).(T1 = Baseline data collection; T2 = 6 months after randomization)
  • Change in patient-reported experience (IC-PREMs) for the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).(T1 = Baseline data collection; T2 = 6 months after randomization)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maureen Markle-Reid

Professor and Canada Research Chair in Aging, Chronic Disease and Health Promotion Interventions

McMaster University

研究点 (6)

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