Comparison Between Two Strategies of Discharge Planning for the Reduction of Short Term Hospital Readmissions (PROMENADE)

March 15, 2022 updated by: Daniela Corsi, Azienda Ospedaliera Città della Salute e della Scienza di Torino

Comparison Between Two Strategies of Discharge Planning for the Reduction of Short Term Hospital Readmissions: A Cluster Randomized Cross-over Trial

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).

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.

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

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.
802

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

  • Italy
      • Torino, Italy, 10100
        • AOU Città della Salute

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

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: Other
  • Allocation: Randomized
  • Interventional Model: Crossover 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.
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.
Other: 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 (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)
Other: 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)

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
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

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
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

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.
Azienda Ospedaliera Città della Salute e della Scienza di Torino

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Daniela Corsi, MD, Azienda Ospedaliera Città della Salute e della Scienza di Torino

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.
June 1, 2018

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 12, 2019

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 13, 2019

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).
February 13, 2018

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.
February 16, 2018

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.
February 19, 2018

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.
March 29, 2022

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.
March 15, 2022

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.
March 1, 2022

More Information

Terms related to this study

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.
  • CS2/378/2017

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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