Automatic Feedback Indicator to Enhance the Hospital Discharge Communication Between Acute Care and Primary Care. (FIAQLS)

Automatic Feedback Indicator to Enhance the Hospital Discharge Communication Between Acute Care and Primary Care: a Randomized Controlled Cluster Trial

This study, titled "Automated Indicator Feedback for Improving the Quality of Discharge Letters: A Cluster-Randomized Controlled Trial" (FIAQ-LS), aims to evaluate whether continuous real-time feedback to hospital teams can improve the quality of discharge letters. Discharge letters are critical for ensuring continuity of care and reducing adverse events by providing detailed information about a patient's hospital stay to both the patient and their primary care physician.

The study will be conducted at Grenoble Alpes University Hospital and involve 40 hospital services across three campuses. The trial design includes two parallel arms: an intervention group receiving monthly performance feedback through automated dashboards and a control group with no additional intervention. Services are randomized into these groups using a stratified cluster approach.

The primary objective is to assess whether this intervention increases the proportion of discharge letters validated on the day of discharge compared to usual care. Secondary objectives include evaluating patient satisfaction, rates of unplanned 30-day readmissions, and completeness of discharge letter content.

The study will include data from approximately 132,000 patient stays over two phases: a pre-implementation observational period (12 months) and an intervention phase (12 months). All data will be collected and analyzed anonymously, with findings expected to inform the broader implementation of quality improvement strategies in French hospitals.

Study Overview

• Status: Not yet recruiting
• Conditions: Communication; Patient Safety; Electronic Health Records; Hospital Discharge Communication Processes; Continuity of Care; Quality Indicators, Health Care
• Intervention / Treatment: Other: Monthly Performance Feedback with Dashboards (Automated Audit and Feedback)

Detailed Description

Detailed Description Effective communication at hospital discharge is vital for continuity of care and patient safety. Discharge letters summarize the hospital stay, outlining diagnoses, treatments, and follow-up care. Despite national guidelines mandating that discharge letters be validated and provided to patients on the day of discharge, compliance remains suboptimal in France, with average performance scores well below targets.

This study seeks to address this gap through an automated feedback mechanism. Using the hospital's electronic health record (EHR) system, the study will generate monthly dashboards for each participating service in the intervention group. These dashboards will provide a real-time view of performance metrics, including the proportion of discharge letters validated on the day of discharge and the completeness of required content fields.

The trial employs a cluster-randomized controlled design with 40 hospital services as the unit of randomization. Services are stratified by activity type (medicine, surgery/obstetrics) and baseline performance. The study is divided into two phases:

Pre-implementation Phase (January 2024 - January 2025): A 12-month observational period to collect baseline data and stratify services for randomization.

Implementation Phase (February 2025 - February 2026): Intervention services receive monthly performance feedback, while control services continue with standard care practices.

The primary endpoint is the proportion of hospital stays where discharge letters are validated on the day of discharge. Secondary outcomes include:

Patient satisfaction, measured through the national "e-Satis" survey. Rates of unplanned readmissions within 30 days of discharge. Completeness of discharge letters, evaluated across mandated content fields (e.g., patient identification, discharge summary, follow-up plan).

This study will enroll all eligible patient stays within the 40 participating services, excluding stays of less than 24 hours or cases where the patient died during hospitalization. The anticipated sample size is 132,000 stays.

Data collection will rely on routine administrative data from the EHR system, anonymized at the patient level. Statistical analyses will adopt a "difference-in-differences" approach, comparing changes in outcomes between the intervention and control groups over time. A mixed-effects logistic regression model will account for intra-cluster correlations.

The results of this study aim to demonstrate the effectiveness of automated feedback in driving quality improvements in hospital discharge processes. If successful, the approach could be scaled across other hospitals in France, contributing to better continuity of care and patient outcomes.

• Study Type: Interventional
• Enrollment (Estimated): 132000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bastien Boussat, MD PhD; Phone Number: 334476767575; Email: bboussat@chu-grenoble.fr

Study Locations

• France
  • Grenoble, France, 38000
    • Centre hospitalier de Grenoble Alpes
    • Contact: Cyrielle Vicier, PhD; Phone Number: +33476767900; Email: cvicier@chu-grenoble.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients hospitalized for at least 24 hours in participating services.
• Patients discharged alive directly from participating services.

Exclusion Criteria:

• Patients hospitalized for less than 24 hours.
• Patients who died during hospitalization.
• Stays in services not meeting inclusion criteria (e.g., psychiatry, long-term care, emergency services with rare direct discharges, or critical care units).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Hospital services in this group will receive monthly performance feedback through automated dashboards, provided electronically to the entire service team, including all physicians, nurse managers, and secretarial staff. These dashboards will display data on the proportion of discharge letters validated on the day of discharge and the completeness of required content fields. The intervention also includes support from a designated quality improvement officer, who will assist teams in implementing organizational changes as needed to improve performance.	Other: Monthly Performance Feedback with Dashboards (Automated Audit and Feedback); Hospital services in the intervention group will receive monthly automated dashboards that provide detailed performance metrics. These include: The proportion of patients with a discharge letter generated on the day of discharge, The proportion of discharge letters validated on the day of discharge, Median delays for generating discharge letters, Median delays for validating discharge letters. The dashboards are shared with all physicians, nurse managers, and secretarial staff in each service. A designated quality improvement officer is available to assist teams in interpreting the data and implementing organizational changes based on the feedback. The intervention uses real-time data extraction from the hospital's electronic health record system to generate these insights.
No Intervention: Control Group with Usual Care; Hospital services in this group will continue with usual care practices and may access routine support from institutional departments, such as quality management and IT services, upon request. However, no automated feedback on discharge letter performance will be provided or proposed. This setup ensures the control group reflects the typical resources and support available in standard practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Discharge Letters Generated on the Day of Discharge	The proportion of hospital stays where discharge letters are generated electronically on the same day as the patient's discharge. This measure evaluates the timeliness of generating discharge communication, a critical factor for continuity of care and patient engagement. Data will be extracted from the hospital's electronic health record system (EHR) and aggregated at the service level for analysis.	Measured monthly over the study period (January 2024 to February 2026), comparing a 12-month pre-implementation period to a 12-month intervention period.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Discharge Letters Validated on the Day of Discharge	The proportion of hospital stays where discharge letters are validated electronically on the day of discharge. This measure assesses the quality and timeliness of the validation process, ensuring that discharge letters are ready for patient handover and communication with primary care providers. Data will be extracted from the hospital's electronic health record system and analyzed at the service level.	Measured monthly over the study period (January 2024 to February 2026), comparing a 12-month pre-implementation period to a 12-month intervention period.
Median Time to Generate Discharge Letters	The median time (in hours) from the patient's discharge to the generation of the discharge letter. This measure evaluates process efficiency and timeliness, critical for improving discharge workflows and patient communication. Data will be extracted from the hospital's electronic health record system.	Measured monthly over the study period (January 2024 to February 2026), comparing a 12-month pre-implementation period to a 12-month intervention period.
Median Time to Validate Discharge Letters	The median time (in hours) from the generation of a discharge letter to its validation. This outcome assesses the efficiency of the validation process, a key step in finalizing discharge communication for patients and primary care providers.	Measured monthly over the study period (January 2024 to February 2026), comparing a 12-month pre-implementation period to a 12-month intervention period.
Time from Patient Discharge to Electronic Submission of Discharge Letter to Primary Care Physicians	The median time (in days) from the patient's discharge to the electronic transmission of the discharge letter to the external primary care physician (e.g., general practitioner). This outcome assesses the timeliness of communication between hospital services and external care providers, a key factor in ensuring continuity of care after hospitalization.	Measured monthly during the study period (January 2024 to February 2026), comparing the 12-month pre-implementation period to the 12-month intervention period.
Patient Satisfaction with Discharge Process (e-Satis Survey)	Scores from the national e-Satis survey evaluating patient satisfaction with their hospital discharge process. Aggregate scores and specific sub-scores for "organization of discharge" and "interaction with physicians" will be compared between intervention and control groups.	Collected monthly during the 12-month intervention period (February 2025 to February 2026).
Rate of Unplanned 30-Day Readmissions	The proportion of hospital stays followed by unplanned readmissions within 30 days of discharge, measured via emergency admissions. This measure evaluates the impact of improved discharge communication on post-hospitalization outcomes.	Measured monthly over the study period (January 2024 to February 2026), comparing a 12-month pre-implementation period to a 12-month intervention period.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completeness of Required Fields in Discharge Letters	The proportion of discharge letters that include all mandatory fields as per national guidelines. These fields include patient identification, hospital stay dates, discharge summary, follow-up plan, and other regulatory elements. Completeness is critical to ensuring comprehensive communication for continuity of care.	Measured monthly during the 12-month intervention period (February 2025 to February 2026), comparing intervention and control groups.
Documentation of Organizational Changes in Intervention Services	Tracking and analysis of organizational adjustments reported by services in the intervention group in response to performance feedback. These changes will be documented through service logs and interviews, providing qualitative insights into the mechanisms driving performance improvement.	Ongoing during the 12-month intervention period (February 2025 to February 2026).

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: Bastien Boussat, MD PhD, Grenoble Alps University, Faculty of Medicine.

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: January 13, 2025
• First Submitted That Met QC Criteria: February 13, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 13, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Quality Improvement; Patient Satisfaction; Cluster Randomized Trial; Healthcare Outcomes; Quality Indicators; Electronic Health Records (EHR); Discharge Summary; Patient Handover; Real-Time Feedback
• Other Study ID Numbers: PREPS-20-0195

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The study plans to share de-identified individual participant data (IPD) with other researchers upon request, after the publication of primary results. The shared data will include:

Anonymized patient-level data for all outcomes (e.g., discharge letter generation and validation times, patient satisfaction scores, readmission rates).

Aggregated service-level performance data. Access to IPD will be granted under a data-sharing agreement to ensure proper use and compliance with ethical guidelines. Requests for data must be submitted to the corresponding investigator and approved by the study's oversight committee.

• IPD Sharing Time Frame: IPD and supporting information will be made available starting 6 months after publication of the primary study results and will remain accessible for 5 years.
• IPD Sharing Access Criteria: Access to the IPD and supporting documentation will be granted to researchers upon request. Requests must include a detailed research proposal outlining the intended use of the data, which will be reviewed by the study's oversight committee. Approved researchers will sign a data-sharing agreement to ensure compliance with ethical and data protection standards. Access will be provided via a secure platform managed by the CHU Grenoble Alpes.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No