Evaluation of a Case-management Program for Frequent Emergency Department Users (DAUM)

June 3, 2026 updated by: CHOUIHED Tahar, Central Hospital, Nancy, France

The DAUM Case-management Program for Frequent Users of the Nancy University Hospital Emergency Department: Evaluation Protocol

The DAUM case-management program for frequent users (FUs) of emergency department was developed to improve FUs identification and management. FUs were eligible if they had four ED visits or more in the previous year, and attended the ED between November, 2022 and October, 2023. Patients were identified in the ED and addressed to the territorial support platform. A personalized health coordination plan which included a care plan (care objectives) and a support plan (social objectives) was co-constructed by the support platform, the patient, their caregiver(s), and their GP. Follow-up assessments at three to six months and at one year evaluated whether individual objectives were achieved. The primary outcomes were participants' mean number of ED visits during their year of participation in the program compared to the previous year, and the incremental cost-effectiveness ratio (ICER), expressed as the cost per ED visit avoided. Secondary outcomes included reach, adoption, implementation, and maintenance indicators.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
153

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nancy, France
        • Nancy University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • adults
  • who visited the ED of Nancy University Hospital between November 7th, 2022, and October 6th, 2023
  • with at least four ED visits during the preceding year
  • residing in Nancy or the surrounding urban areas

Exclusion Criteria:

  • homeless patients
  • patient refusal to participate
  • patient's GP refusal to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Case-management program
Patients included in the case-management program
Behavioral: Case-management program

FUs patients were identified by the admission nurse through an alert generated by the ED information system. The ED physician explained the DAUM program to the patient and notified the Territorial Support Platform (TSP). The TSP team contacted the patient and his/her GP to present the DAUM program, obtain their agreement to participate and collect additional information.

Once the patient included in the DAUM program, a Personalized Health Coordination Plan (PHCP) was co-constructed by the TSP team, in collaboration with the patient, hi/her GP, and other caregiver(s). The PHCP is divided into a care plan (with care objectives) and a support plan (with social obectives). Once the objectives of the care and support plans were identified for a patient, specific actions and timeframes were established for each objective. Follow-up assessments were conducted at three to six months from the inclusion and at one year.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Effectiveness
Time Frame: Before-after comparison between the mean number of ED visits during the year of program participation and the mean number of ED visits in the preceding year
Mean number of ED visits among included patients
Before-after comparison between the mean number of ED visits during the year of program participation and the mean number of ED visits in the preceding year
Cost-effectiveness
Time Frame: One year
Incremental cost-effectiveness ratio in cost per ED visit avoided
One year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Indicator Reach 1 - Percentage of patients who consented to participate in the DAUM program among eligible patients
Time Frame: One year
[number of patients who consented to participate in the DAUM program / number of eligible patients] x 100
One year
Indicator Reach 2 - Percentage of patients who consented to participate in the program among patients to whom the program was proposed
Time Frame: One year
[number of patients who consented to participate in the DAUM program / number of patients to whom the DAUM program was proposed] x 100
One year
Indicator Reach 3 - Percentage of patients who effectively participated in the program
Time Frame: One year
[number of patients who effectively participated in the DAUM program (PHCP validated) / number of included patients] x 100
One year
Indicator Adoption 1 - Percentage of patients notified to the TSP by ED physicians
Time Frame: One year
[number of patients notified to the TSP by ED physicians / number of potentially eligible patients (i.e., patients identified as FU who visited the ED during the study period)] x 100
One year
Indicator Adoption 2 - Percentage of patients who had been informed about the program during their ED visit
Time Frame: One year
[number of patients who had been informed about the DAUM program during their ED visit / number of patients to whom the DAUM program was proposed by the TSP] x 100
One year
Indicator Implementation 1 - Percentage of patients notified to the TSP by ED physicians within three days of their ED visit
Time Frame: One year
[number of patients notified to the TSP by ED physicians within three days of their ED visit / number of patients notified to the TSP by ED physicians] x 100
One year
Indicator Implementation 2 - Percentage of patients whose GP was contacted within 48 hours of the notification by an ED physician
Time Frame: One year
[number of patients whose GP was contacted within 48 hours of the notification by an ED physician / number of eligible patients] x 100
One year
Indicator Implementation 3 - Percentage of patients contacted by the TSP team within seven days of the notification by an ED physician
Time Frame: One year
[number of patients contacted by the TSP team within seven days of the notification by an ED physician / number of patients to whom the DAUM program was proposed] x 100
One year
Indicator Implementation 4 - Percentage of patients for whom a PHCP was validated within a month of the first contact between the TSP team and the patient
Time Frame: One year
[number of patients for whom a PHCP was validated within a month of the first contact (between the TSP team and the patient) / number of patients who had a PHCP] x 100
One year
Indicator Implementation 5 - Percentage of patients who benefited from the first actions of the PHCP within two weeks of the PHCP validation
Time Frame: One year
[number of patients who benefited from the first actions of the PHCP within two weeks of the PHCP validation / number of patients who had a PHCP validated] x 100
One year
Indicator Implementation 6 - Percentage of patients with a 3- to 6-month assessment
Time Frame: 3 and 6 months
[number of patients with a 3-to 6-month assessment / number of patients who had a PHCP validated] x 100
3 and 6 months
Indicator Implementation 7 - Percentage of patients with a 1-year assessment
Time Frame: One year
[number of patients with a 1-year assessment / number of patients not dead or lost to follow-up during the year] x 100
One year
Indicator Implementation 8 - Percentage of patients for whom all the PHCP actions were implemented as planned at the 1-year assessment
Time Frame: One year
[number of patients for whom all the PHCP actions were implemented as planned at the 1-year assessment / number of patients followed-up at 1 year] x 100
One year
Indicator Maintenance R1 - Percentage of patients who consented to participate in the DAUM program among eligible patients
Time Frame: One year
[number of patients who consented to participate in the DAUM program / number of eligible patients] x 100, calculated each month
One year
Indicator Maintenance R2 - Percentage of patients who consented to participate in the program among patients to whom the program was proposed
Time Frame: One year
[number of patients who consented to participate in the DAUM program / number of patients to whom the DAUM program was proposed] x 100, calculated each month
One year
Indicator Maintenance R3 - Percentage of patients who effectively participated in the program
Time Frame: One year
[number of patients who effectively participated in the DAUM program (PHCP validated) / number of included patients] x 100, calculated each month
One year
Indicator Maintenance A1 - Percentage of patients notified to the TSP by ED physicians
Time Frame: One year
[number of patients notified to the TSP by ED physicians / number of potentially eligible patients (i.e., patients identified as FU who visited the ED during the study period)] x 100, calculated each month
One year
Indicator Maintenance A2 - Percentage of patients who had been informed about the program during their ED visit
Time Frame: One year
[number of patients who had been informed about the DAUM program during their ED visit / number of patients to whom the DAUM program was proposed by the TSP] x 100, calculated each month
One year
Indicator Maintenance I1 - Percentage of patients notified to the TSP by ED physicians within three days of their ED visit
Time Frame: One year
[number of patients notified to the TSP by ED physicians within three days of their ED visit / number of patients notified to the TSP by ED physicians] x 100, calculated each month
One year
Indicator Maintenance I2 - Percentage of patients whose GP was contacted within 48 hours of the notification by an ED physician
Time Frame: One year
[number of patients whose GP was contacted within 48 hours of the notification by an ED physician / number of eligible patients] x 100, calculated each month
One year
Indicator Maintenance I3 - Percentage of patients contacted by the TSP team within seven days of the notification by an ED physician
Time Frame: One year
[number of patients contacted by the TSP team within seven days of the notification by an ED physician / number of patients to whom the DAUM program was proposed] x 100, calculated each month
One year
Indicator Maintenance I4 - Percentage of patients for whom a PHCP was validated within a month of the first contact between the TSP team and the patient
Time Frame: One year
[number of patients for whom a PHCP was validated within a month of the first contact (between the TSP team and the patient) / number of patients who had a PHCP] x 100, calculated each month
One year
Indicator Maintenance I5 - Percentage of patients who benefited from the first actions of the PHCP within two weeks of the PHCP validation
Time Frame: One year
[number of patients who benefited from the first actions of the PHCP within two weeks of the PHCP validation / number of patients who had a PHCP validated] x 100, calculated each month
One year
Indicator Maintenance I6 - Percentage of patients with a 3- to 6-month assessment
Time Frame: One year
[number of patients with a 3-to 6-month assessment / number of patients who had a PHCP validated] x 100, calculated each month
One year
Indicator Maintenance I7 - Percentage of patients with a 1-year assessment
Time Frame: One year
[number of patients with a 1-year assessment / number of patients not dead or lost to follow-up during the year] x 100, calculated each month
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Central Hospital, Nancy, France

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
agence régionale de santé Grand Est
Dispositif d'appui à la coordination de Meurthe-et-Moselle

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 7, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022_PI_095

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

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Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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