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

NCT06835153 | Not Yet Recruiting DMC

• 1 other identifier: PREPS-20-0195
• Study Type: interventional
• Target: 132,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Continuity of Care; Patient Safety; Hospital Discharge Communication Processes; Communication; Quality Indicators, Health Care; Electronic Health Records

Keywords

Discharge Summary; Patient Handover; Quality Improvement; Cluster Randomized Trial; Healthcare Outcomes; Patient Satisfaction; Quality Indicators; Real-Time Feedback; Electronic Health Records (EHR)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Proportion of Discharge Letters Validated on the Day of Discharge

  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

  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

  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

  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)

  Collected monthly during the 12-month intervention period (February 2025 to February 2026).

Other Outcomes (2)

• Completeness of Required Fields in Discharge Letters

  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

  Ongoing during the 12-month intervention period (February 2025 to February 2026).

Study Arms (2)

Intervention Group

EXPERIMENTAL

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)

Control Group with Usual Care

NO INTERVENTION

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.

Interventions

Monthly Performance Feedback with Dashboards (Automated Audit and Feedback) OTHER

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.

Intervention Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients hospitalized for less than 24 hours.
• Patients who died during hospitalization.

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

Centre hospitalier de Grenoble Alpes

Grenoble, 38000, France

Location

MeSH Terms

Conditions

Communication; Patient Satisfaction

Condition Hierarchy (Ancestors)

Behavior; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Bastien Boussat, MD PhD

  Grenoble Alps University, Faculty of Medicine.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bastien Boussat, MD PhD

CONTACT

334476767575; bboussat@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistician in charge of the data analyses will be blinded to the allocation of hospital services to the intervention or control group to prevent bias in the statistical evaluation of outcomes. This includes the primary outcome (proportion of discharge letters validated on the day of discharge) and secondary outcomes. Outcomes assessors and the statistician will work with anonymized datasets without group allocation information. However, participants (hospital services), care providers, and investigators managing the intervention are not masked due to the need to deliver feedback in real-time and monitor its implementation.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a cluster-randomized controlled trial with two parallel arms. The unit of randomization is the hospital service, with 40 services participating across three campuses of Grenoble Alpes University Hospital. Services are stratified by activity type (medicine vs. surgery/obstetrics) and baseline performance on the primary outcome. The intervention arm will receive monthly feedback via automated performance dashboards, highlighting the proportion of discharge letters validated on the day of discharge and the completeness of required content fields. The control arm will not receive any feedback but will continue routine care practices. Outcomes will be assessed over two phases: a 12-month pre-implementation observational phase and a 12-month intervention phase. The analysis uses a "difference-in-differences" approach to compare changes in outcomes between the two groups, accounting for intra-cluster correlations using mixed-effects logistic regression models.

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: February 19, 2025
• Study Start: March 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

FR (1)