Implementing Family Participation Training in Tertiary Hospital Care in Bangladesh: a Stepped-wedge Realist Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,029
- 试验地点
- 1
- 主要终点
- Family Caregiver: Strain
研究概览
简要总结
The goal of this trial is to evaluate whether a family participation training intervention can reduce caregiver strain and health worker workload, and improve patient outcomes and collaboration in the medicine wards of Chittagong Medical College Hospital (CMCH).
General objectives:
- To assess the effect of a family participation training intervention on the medicine wards of CMCH. (Stepped-wedge)
- To examine how, for whom and under what circumstances a family participation training intervention works. (Realist evaluation)
Specific objectives:
- To examine the implementation of a family participation training intervention.
- To investigate the acceptability and feasibility of a family participation training intervention.
The study will use a step-by-step roll-out, introducing training at different times in three wards, to see if it improves care compared to usual practice.
Study participants will include adult patients, their family caregivers, nurses, doctors, ward assistants, and hospital administrators. Health workers will be trained to deliver sessions to family caregivers of hospitalised patients on hospital introduction, basic care tasks, warning sign detection, oral medication administration, caregiver handover, and discharge preparedness.
详细描述
Background:
In many resource-limited settings, understaffed hospitals rely on the families of patients to provide care during admission. Family participation in hospital care may include washing, toileting, feeding, administering medication, and detecting warning signs. Family participation in hospital care is commonplace at Chittagong Medical College Hospital (CMCH) and other hospitals in Bangladesh. These care tasks are often performed informally, untrained, and unsupported, resulting in a high mental and physical burden of care for family caregivers, unknown effects on patient outcomes and potentially an even higher workload for health workers. This study proposes to implement and evaluate a family participation training intervention in the general medicine wards of CMCH. Building on prior preparatory research, the intervention aims to reduce family caregiver strain, lower health workers' workloads, enhance patient outcomes and improve collaboration between family caregivers and health workers.
Objective The primary objectives of the study are to assess the effect of a family participation training intervention on the medicine wards of CMCH and to examine how, for whom and under what circumstances a family participation training intervention works.
Methods The study employs a stepped-wedge realist trial over six months in the CMCH medicine wards (13, 14, and 16). It involves adult patients, family caregivers, health workers (nurses, doctors, and ward assistants), and hospital administrators. Family caregivers will receive training to support their participation in hospital care, while nurses and doctors will be trained to deliver these sessions. The training will include an introduction to the hospital, basic hospital care, oral medication administration, detection of warning signs, handover between family caregivers, and discharge preparation. The primary outcomes are reduced family caregiver strain and lower health worker workload. Patient-family caregiver dyads will be followed daily for up to five days during admission and one call after discharge. Health workers will be followed throughout the study period. In addition, ward-level, implementation, feasibility, and acceptability outcomes will be collected. Some patients, family caregivers, health workers, and hospital administrators will be included in realist interviews or focus group discussions. The analysis will integrate mixed-effects modelling with a realist evaluation approach.
Discussion This study will add a foundational piece of research to the family participation field, in resource-limited and -rich settings. It builds on the shared journey of this growing international research collaboration. No such previous research has been performed. It will be the first to test a co-created family participation training intervention in hospital care. In addition, it suggests new research methods by integrating a stepped-wedge design with a realist evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
Unable to mask a training intervention.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All study parts
- •Patient: admitted to one of the three medicine ward
- •Family caregiver: caregiver providing care for a patient on one of the three medicine wards
- •Health worker: nurse, doctor or ward assistant working on one of the three medicine wards
- •Hospital administrator: professors or administrators responsible for or directly involved in policymaking or have operational oversight on one of the three medicine wards
- •- Age: ≥18 years
- •Data collection specific Patient and family caregiver data collection - Patient & family caregiver dyad: admitted for ≤24 hours on the medicine wards
- •Health worker data collection
- •- Employment: working on one of the medicine wards for at least one week
- •Interviews, focus group discussions and observations
- •Patient: admitted ≥24 hours on the medicine wards
- •Family caregiver: caring for the patient ≥24 hours on the medicine wards
- •During the intervention period
- •Patient: family caregiver of the patient has received the training
- •Family caregiver: has received the training
排除标准
- •Language - Unable to speak Bengali, Chittagonian or English
- •No consent given
- •Unable to give consent
- •Duplicates: Previously enrolled in the study
- •Data collection specific Patient and family caregiver data collection
- •- Patient: Planned discharge ≤24 hours of admission to the medicine ward
研究组 & 干预措施
Standard care
Control: Hospital care as usual.
Family Caregiver Training
Intervention: Family Caregiver Training in hospital.
干预措施: Family Caregiver Training (Behavioral)
结局指标
主要结局
Family Caregiver: Strain
时间窗: During 5 day hospital follow-up
Measured with Care-related Quality of Life (CarerQOL), ranging from 0 (worst care situation) to 100 (best care situation)
Health Worker: Workload
时间窗: Assessed from inclusion till study end for at least once per study period across four periods, spanning five months in total
Nasa Task Load Index, ranging from 0 (low workload) to 10 (high workload)
Refined Programme Theories from the Realist Evaluation
时间窗: Continuous refinement from start of the intervention till end of the study, spanning four months in total
The refined programme theories will be developed through iterative analysis of qualitative and quantitative data, outlining what works in the intervention, for whom, and under what circumstances.
次要结局
- Family Caregiver: Workload(During 5 day hospital follow-up)
- Family Caregiver: Caregiving Tasks Performed During Hospitalisation(During 5 day hospital follow-up)
- Family Caregiver: Readiness for Discharge(During 5 day hospital follow-up)
- Family Caregiver: Satisfaction with Hospital Care(During 5 day hospital follow-up and at 14 day call)
- Health Worker: Families' Importance in Nursing Care(Assessed from inclusion till study end for at least once per study period across four periods, spanning five months in total)
- Health Worker: Interruptions(Assessed from inclusion till study end for at least once per study period across four periods, spanning five months in total)
研究者
Michele van Vugt
Professor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
