Implementing a Case Management Intervention for Frequent Users of the Emergency Department: An Effectiveness-Implementation Hybrid Trial Study Protocol
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 8
- 主要终点
- Level of normalization of the CM intervention as assessed with the Measure of Inner Context Sustainment (MICS; in development and testing) at the operation phase
研究概览
简要总结
Background. Emergency department (ED) overcrowding represents a significant public health problem in developed countries. Frequent users of the emergency departments (FUEDs; reporting 5 or more ED visits in the past year) are often affected by medical, psychological, social, and substance use problems and account for a disproportionately high number of ED visits. Past research indicates that the case management (CM) intervention is a promising way to reduce ED overcrowding and improve FUEDs' quality of life. There is, however, very limited knowledge about how to disseminate and implement this intervention on a large scale to diverse clinical settings, including community hospitals and non-academic centers. This research project aims to implement a CM intervention tailored to FUEDs in the public hospitals with ED in the French-speaking region of Switzerland and to evaluate both the implementation process and effectiveness of the CM intervention. Methods. This research project will examine both implementation and clinical outcomes. The implementation part of the study will describe quantitatively and qualitatively factors that influence the implementation process; the investigators will also examine implementation effectiveness (i.e., whether the implementation of the CM intervention in the ED was successful or not). The clinical part of the study will evaluate participants' trajectories on clinical variables (e.g., quality of life, ED use) after receiving the CM intervention. Discussion. This research project will contribute to implementation science by providing key insights into the processes for implementing CM into broader practice. This research project is also likely to have both clinical and public health implications.
详细描述
Frequent users of the emergency departments (FUEDs) and other health care services are of much interest to clinicians, administrators and researchers. Emergency department (ED) overuse is linked to ED overcrowding, which in turn has a negative impact on patients and health system outcomes. There are over 1.4 million annual ED visits in Switzerland, with 84% of EDs reporting overcrowding. FUEDs made up 4.4% of the patient population and made 12.1% of all visits at the Lausanne University Hospital ED. Driving this high use of health care services is the fact that FUEDs often suffer from chronic medical diseases, including heart disease, pulmonary disease and cancer, at high rates, in addition to mental illness and substance use disorders. CM has been shown to be a promising intervention to reduce ED overuse by frequent users in research settings; however, there is limited knowledge about how to disseminate and implement a CM intervention for FUEDs on a large scale to diverse clinical settings, including community hospitals and non-academic centers.
The research project has the following three specific aims:
- Develop and disseminate a practical CM intervention for FUEDs to several hospitals in the French-speaking region of Switzerland.
- Study the process of implementation of the intervention.
- Study FUEDs' trajectories on health outcomes (e.g., ED use, health care reorientation and quality of life) after receiving the CM intervention.
This research project is an observational study with a hybrid study design, measuring both implementation variables and clinical outcomes relating to the dissemination and implementation of the CM intervention. The implementation part of the study uses a mixed methods design (i.e., using both qualitative and quantitative analyses) to describe both qualitatively and quantitatively factors that may influence implementation process. The clinical part of the study uses a within-subject (pre-post intervention) design to evaluate participants' trajectories after receiving the CM intervention.
The whole research project will take place over five phases.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Being a community or academic public hospital in French-speaking Switzerland
- •Being interested in implementing the CM intervention
- •No exclusion Criteria:
- •Clinical part of the study:
- •Inclusion Criteria:
- •Being ≥18 years
- •Being able to communicate in a language that is spoken by the local team or a professional interpreter
- •Reporting ≥5 visits in the ED in the past 12 months
排除标准
- •Presenting less than two vulnerability dimensions in addition to ED recurrent use [17]
- •Being unable to provide informed consent
- •Planning to stay in Switzerland less than 18 months
- •Being not expected to survive at least 18 months
- •Awaiting for incarceration or being currently incarcerated
- •Having a family member already enrolled in the study
结局指标
主要结局
Level of normalization of the CM intervention as assessed with the Measure of Inner Context Sustainment (MICS; in development and testing) at the operation phase
时间窗: An average of 18 months
Participants (i.e., staff involved in the CM intervention implementation) are asked to indicate to which extent they agree with 22 statements related to the CM intervention normalization using a 5-point Likert scale, where 0 = not at all and 4 = to a very great extent. Descriptive statistics (means, percentages) will be computed for each item. Higher scores will indicate higher levels of agreement from the sample.
Reach as assessed by the number of patients receiving the CM intervention divided by the total number of eligible patients at the operation phase
时间窗: An average of 18 months
Level of normalization of the CM intervention as assessed with the Measure of Inner Context Sustainment (MICS; in development and testing) at the sustainability phase
时间窗: An average of 36 months
Participants (i.e., staff involved in the CM intervention implementation) are asked to indicate to which extent they agree with 22 statements related to the CM intervention normalization using a 5-point Likert scale, where 0 = not at all and 4 = to a very great extent. Descriptive statistics (means, percentages) will be computed for each item. Higher scores will indicate higher levels of agreement from the sample.
Reach as assessed by the number of patients receiving the CM intervention divided by the total number of eligible patients at the sustainability phase
时间窗: An average of 36 months
Level of the CM intervention integration as assessed with the Normalization MeAsure Development survey (NoMad) at the operation phase [5]
时间窗: An average of 18 months
The NoMad survey includes 20 items organized around four subscales (coherence, cognitive participation, collective action and reflexive monitoring). Participants (i.e., staff involved in the CM intervention implementation) are asked to indicate the degree to which they agree or disagree with 20 statements related to the CM intervention integration, using a 5-point Likert-scale, where 1 = strongly disagree and 5 = strongly agree. Descriptive statistics (means and percentages) will be computed for each item. Higher scores will indicate higher agreement from the sample.
Change in the number of emergency department visits between baseline and 12 months follow-up assessments over the 12 months study period among FUEDs receiving the CM intervention
时间窗: Baseline and 12-month follow-up assessments
Number of ED visits over the past 12 months will be extracted from medical records.
Adoption rate as assessed by the number of hospitals included in the research project divided by the number of hospitals invited to participate
时间窗: An average of 6 months
In total, 22 hospitals will be invited to participate therefore the number of hospitals included will be divided by 22
Level of the CM intervention integration as assessed with the Normalization MeAsure Development survey (NoMad) at the sustainability phase [5]
时间窗: An average of 36 months
The NoMad survey includes 20 items organized in four subscales (coherence, cognitive participation, collective action and reflexive monitoring). Participants (i.e., staff involved in the CM intervention implementation) are asked to indicate the degree to which they agree or disagree with 20 statements related to the CM intervention integration, using a 5-point Likert-scale, where 1 = strongly disagree and 5 = strongly agree. Descriptive statistics (means and percentages) will be computed for each item. Higher scores will indicate higher agreement from the sample.
Trajectories in quality of life over the 12 months study period among FUEDs receiving the CM intervention as assessed with the World Health Organization Quality of Life - Bref scale (WHOQOL-BREF) [6] (among FUEDs receiving the CM intervention).
时间窗: Baseline, 3-, 6- and 12-month follow-up assessments
The WHOQOL-BREF includes 22 items assessing four domains of quality of life (4 subscales): physical health, psychological health, social relationships and environment. Each question refers to the last past two week and uses a 5-point Likert scale (where 1 = very unsatisfied and 5 = very satisfied, 1= never and 5 = always or 1 = strongly disagree and 5 = strongly agree depending on item content. Following the instrument guideline, percentage ratings within each domain will be computed ranging from 0 to 100, where 0 = lowest quality of life and 100 = highest quality of life
次要结局
- Costs salary required for the research team to assist the CM intervention implementation as assessed with an adapted version of the Stages of Implementation Completion Tool (SIC) [8](An average of 36 months)
- Number of implementation stages completed as assessed with an adapted version of the Stages of Implementation Completion tool [7] (in hospitals included in the study)(An average of 36 months)
- Costs salary required for staff implementing the CM intervention as assessed with an adapted version of the Stages of Implementation Completion Tool (SIC) [8](An average of 36 months)
- Proportion of activities completed on each stage as assessed with an adapted version of the Stages of Implementation Completion Tool (SIC)(An average of 36 months)
- Trajectories in empowerment over the 12 months study period among FUEDs receiving the CM intervention as assessed with the Health Care Empowerment Informed, Committed, Collaborative and Engaged subscales of the Health Care Empowerment Inventory [9].(Baseline, 3, 6 and 12-months follow-up assessments)
- Trajectories in precursors of alcohol use changes over the 12-months study period among FUEDs receiving the CM intervention as assessed with four single-item visual analog rulers [12].(Baseline, 3, 6 and 12-months follow-up assessments)
- Time spent in each implementation stage as assessed with an adapted version of the Stages of Implementation Completion Tool (SIC)(An average of 36 months)
- Trajectories in health-care reorientations over the 12 months study period among FUEDs receiving the CM intervention(Baseline, 3, 6 and 12-months follow-up assessments)
- Trajectories in self-efficacy over the 12 months study period among FUEDs receiving the CM intervention as assessed with the General Self-Efficacy scale [10].(Baseline, 3, 6 and 12-months follow-up assessments)
- Trajectories in health literacy over the 12 months study period among FUEDs receiving the CM intervention using the European Health Literacy Project Questionnaire [11](Baseline, 3, 6 and 12-months follow-up assessments)
研究者
Patrick Bodenmann
Head of Vulnerable Populations Centre, Principal Investigator
University of Lausanne Hospitals