- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03436940
Comparison Between Two Strategies of Discharge Planning for the Reduction of Short Term Hospital Readmissions (PROMENADE)
Comparison Between Two Strategies of Discharge Planning for the Reduction of Short Term Hospital Readmissions: A Cluster Randomized Cross-over Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to improve discharge planning effectiveness by comparing two strategies [on-Demand Discharge Planning (DDP) vs. Routine Discharge Planning (RDP)], in terms of reduction of hospital readmissions for inpatients classified at intermediate risk of complex discharge using the simplified Blaylock Risk Assessment Screening Score (BRASS).
Five Internal Medicine Unit and four Units of Neurology will be randomized to the two different strategies of discharge planning (RDP or DDP), based on two different alternating sequences of four periods (each period comprising three months). The randomization will be stratified by type of unit.
Patients at risk of complex discharge, according to the simplified BRASS score, are assigned to the Hospital Unit of Continuity of Care (NOCC) team, using the hospital telematics system. Afterwards, the NOCC team proposes an appropriate discharge planning, considering clinical and social needs.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Torino, Italy, 10100
- AOU Città della Salute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults patients (age ≥ 18 years);
- Residents in Piedmont, Italy;
- Patients admitted to General Internal Medicine or Neurology Units of Molinette Hospital (Turin)
- Patients with a score in the simplified BRASS between 4 and 6 at admission
No specific exclusion criteria were applied.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: On Demand Discharge Planning (DDP)
Patients with an intermediate score, according to the simplified Blaylock Risk Assessment Screening Score, are addressed to the NOCC team only in case of a specific request by the unit of hospitalization.
|
Patients with an intermediate score, according to the simplified Blaylock Risk Assessment Screening Score, are addressed to the NOCC team (hospital Continuity of care team) only in case of a specific request by the unit of hospitalization.
|
|
Experimental: Routine Discharge Planning (RDP)
All patients with an intermediate threshold value of the simplified Blaylock Risk Assessment Screening Score are submitted to discharge planning by the NOCC team (Hospital Unit of Continuity of Care)
|
All patients with an intermediate threshold value of the simplified Blaylock Risk Assessment Screening Score are submitted to discharge planning by the NOCC team (Hospital Unit of Continuity of Care)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Unexpected hospital readmission within 90 days from discharge
Time Frame: 90 days
|
Proportion of hospital admissions in the standard admission regime within 90 days from the date of discharge.
The endpoint will be calculated only for patients discharged alive.
Readmissions for any cause under ordinary admissions will be considered as event.
The Day Hospital re-admissions will not be considered for the endpoint calculation.
|
90 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of Long Length of Stay (LLOS)
Time Frame: 150 days
|
Proportion of admissions with long duration of hospitalization (LLOS - Long Length of Stay).
The endpoint will be calculated for all hospitalized patients.
An admission will be considered as LLOS if its duration will be higher than the 90th specific percentile for Diagnostic Related Group (DRG ) detected at the regional level in Piedmont in 2016.
|
150 days
|
|
Death within 90 days from discharge
Time Frame: 90 days
|
Proportion of deaths within 90 days of discharge date.
The endpoint will be calculated only for patients discharged alive.
Death for any cause will be considered as event.
|
90 days
|
|
Proportion of patients reported to the NOCC team during the DDP-experimental phase
Time Frame: 150 days
|
Incidence of activations of the NOCC in the periods of adoption of the DDP strategy (only for admissions treated with DDP strategy)
|
150 days
|
|
Healthcare costs until 90 days from the discharge
Time Frame: 90 days
|
Health care costs charged to the National Health Service (NHS) between the date of admission and 90 days from the date of discharge or death of the patient.
|
90 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Daniela Corsi, MD, Azienda Ospedaliera Città della Salute e della Scienza di Torino
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CS2/378/2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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