Implementing a Case-management Intervention for Frequent Users of the Emergency Department in French-speaking Switzerland

NCT03641274 | Unknown

• 1 other identifier: 407440_167341-FNS
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Frequent Users of Emergency Department (FUEDs)

Keywords

Vulnerable populations; Emergency department

Outcome Measures

Primary Outcomes (9)

• Adoption rate as assessed by the number of hospitals included in the research project divided by the number of hospitals invited to participate

  In total, 22 hospitals will be invited to participate therefore the number of hospitals included will be divided by 22

  An average of 6 months

• Reach as assessed by the number of patients receiving the CM intervention divided by the total number of eligible patients at the operation phase

  An average of 18 months

• Reach as assessed by the number of patients receiving the CM intervention divided by the total number of eligible patients at the sustainability phase

  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]

  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.

  An average of 18 months

• Level of the CM intervention integration as assessed with the Normalization MeAsure Development survey (NoMad) at the sustainability phase [5]

  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.

  An average of 36 months

• 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

  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.

  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

  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.

  An average of 36 months

• 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

  Number of ED visits over the past 12 months will be extracted from medical records.

  Baseline and 12-month follow-up assessments

• 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).

  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

  Baseline, 3-, 6- and 12-month follow-up assessments

Secondary Outcomes (10)

• 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

• 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

• 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

• 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

• 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

Other Outcomes (6)

• Change in levels of acceptability of the CM intervention in staff involved with the implementation between the preparation and the operation phase as assessed with the Acceptability Intervention Measure (AIM) [13]

  An average of 12 and 18 months

• Change in levels of the CM intervention appropriateness perception in staff involved with the implementation between the preparation and the operation phase as assessed with the Appropriateness Measure (IAM) [13].

  An average of 12 and 18 months

• Change in levels of the CM intervention feasibility perception in staff involved with the implementation between the preparation and the operation phase as assessed with the Feasibility of the Intervention Measure (FIM) [13]

  An average of 12 and 18 months

Study Arms (1)

Frequent users of emergency departement

FUEDs receiving the CM intervention in sites participating in the research project will be assessed over time on clinical variables (see inclusion and exclusion criteria)

Other: Case-management intervention for frequent users of the emergency department

Interventions

Case-management intervention for frequent users of the emergency department OTHER

The CM intervention to be implemented is an evidence-based practice. It consists of individualized services based on a detailed baseline evaluation using validated scales to identify all of the social and medical needs of each FUED. The CM team provides counseling and education on health care utilization, substance abuse and the social determinants of health directly to the FUEDs, using skills such as motivational interviewing and cross-cultural competences. Additionally, the CM team provides concrete services including, referral to psychiatric or substance abuse treatment, or medical services (such as a GP or medical specialist), on a case-by-case basis. Another key element of the CM intervention is to connect all health care or social service providers within the hospital or in the community, promoting continuity of care and improving the FUEDs' ability to navigate the complex health care system.

Frequent users of emergency departement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Frequent users of the emergency departments (i.e., FUEDs; reporting 5 or more ED visits in the past year) \[17\] are in need of targeted attention from clinicians, public health advisors and researchers. FUEDs disproportionately access ED services, and contribute to ED overcrowding (i.e., FUEDs account for 3 to 8% of all patients and 12 to 28% of all ED visits) \[18-20\]. Driving this high use of health care services is the fact that FUEDs are often affected by multiple chronic medical diseases (e.g., heart disease, cancer) \[21-23\], as well as psychiatric, substance use and social problems (e.g., unemployment or social isolation) \[18, 24-26\].

You may qualify if:

• Being a community or academic public hospital in French-speaking Switzerland
• Being interested in implementing the CM intervention

You may not qualify if:

• Clinical part of the study:
• 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
• 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

Sponsors & Collaborators

• University of Lausanne Hospitals: lead

Study Sites (8)

Hôpital du Jura Bernois

Saint-Imier, Canton of Bern, 2610, Switzerland

RECRUITING

Hôpital du Jura

Delémont, Canton of Jura, 2800, Switzerland

RECRUITING

Hôpital Intercantonal de la Broye (HIB)

Payerne, Canton of Vaud, 1530, Switzerland

RECRUITING

Etablissements hospitaliers du Nord Vaudois (eHnv)

Yverdon-les-Bains, Canton of Vaud, 1400, Switzerland

RECRUITING

Hôpital du Valais

Sion, Valais, 1951, Switzerland

RECRUITING

Hôpital Fribourgeois

Fribourg, 1708, Switzerland

RECRUITING

Hôpitaux Universitaires de Genève (HUG)

Geneva, 1205, Switzerland

RECRUITING

Hôpitaux Neuchâtelois (HNE)

Neuchâtel, 2000, Switzerland

RECRUITING

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MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Patrick Bodenmann, MD MSc

  University of Lausanne Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Bodenmann, MD, MSc

CONTACT

0041213144937; patrick.bodenmann@hospvd.ch

Veronique S Grazioli, PhD

CONTACT

1141 21 314 23 72; veronique.grazioli@chuv.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Vulnerable Populations Centre, Principal Investigator

Study Record Dates

• First Submitted: July 13, 2018
• First Posted: August 21, 2018
• Study Start: November 20, 2018
• Primary Completion: November 20, 2018
• Study Completion: October 1, 2020
• Last Updated: April 26, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (8)