Patient DischargePROMENADENCT03436940
Comparison Between Two Strategies of Discharge Planning for the Reduction of Short Term Hospital Readmissions
A study testing On Demand Discharge Planning (DDP) and Routine Discharge Planning (RDP) in people with Patient Discharge, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Discharge
- What is being tested?
- On Demand Discharge Planning (DDP) and Routine Discharge Planning (RDP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 802 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2018to 13 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Patient Discharge
- Being tested
- On Demand Discharge Planning (DDP), Routine Discharge Planning (RDP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
On Demand Discharge Planning (DDP)Other
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.
Routine Discharge Planning (RDP)Other
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)
| Study group | Role | What they receive |
|---|---|---|
| On Demand Discharge Planning (DDP) | Active comparator | 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. Receives: Other: On Demand Discharge Planning (DDP) |
| Routine Discharge Planning (RDP) | Experimental | 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) Receives: Other: Routine Discharge Planning (RDP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unexpected hospital readmission within 90 days from discharge
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.
Measured: 90 days
Secondary outcomes (4)
Proportion of Long Length of Stay (LLOS)
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.
Measured: 150 days
Death within 90 days from discharge
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.
Measured: 90 days
Proportion of patients reported to the NOCC team during the DDP-experimental phase
Incidence of activations of the NOCC in the periods of adoption of the DDP strategy (only for admissions treated with DDP strategy)
Measured: 150 days
Healthcare costs until 90 days from the discharge
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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start1 Jun 2018
- Primary completion12 Oct 2019
- Study completion13 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient DischargeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- cluster randomized cross-over trial
- Masking
- None (open label)
- Enrolment
- 802 participants (actual)
Sponsor and investigators
- Lead sponsor
- A.O.U. Città della Salute e della Scienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniela Corsi, A.O.U. Città della Salute e della Scienza
- Investigators
- Daniela Corsi, MD, Principal investigator, A.O.U. Città della Salute e della Scienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03436940
- Sponsor's protocol ID
- CS2/378/2017
- Acronym
- PROMENADE
- Status last verified
- Mar 2022
- First submitted
- 13 Feb 2018
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Evangelista A, Camussi E, Corezzi M, Gilardetti M, Fonte G, Scarmozzino A, La Valle G, Angelone L, Olivero E, Ciccone G, Corsi D. Routine vs. On-Demand Discharge Planning Strategy in Intermediate-Risk Patients for Complex Discharge: a Cluster-Randomized, Multiple Crossover Trial. J Gen Intern Med. 2023 Sep;38(12):2749-2754. doi: 10.1007/s11606-023-08186-4. Epub 2023 May 11.
PubMed 37170018
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Two Strategies of Discharge Planning for the Reduction of Short Term Hospital Readmissions: A Cluster Randomized Cross-over Trial
- ClinicalTrials.gov ID
- NCT03436940
- Acronym / sponsor ID
- PROMENADE / CS2/378/2017
- Conditions
- Patient Discharge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 802 participants (actual)
- Lead sponsor
- A.O.U. Città della Salute e della ScienzaUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 12 Oct 2019 (actual)
- Study completion
- 13 Oct 2019 (actual)
- First posted
- 19 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- cluster randomized cross-over trial
| Arm | Type | Receives |
|---|---|---|
| On Demand Discharge Planning (DDP) | Active comparator | 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 only in case of a specific request by the unit of hospitalization. |
| Routine Discharge Planning (RDP) | Experimental | 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | On Demand Discharge Planning (DDP) |
| 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) |
Primary outcome
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.
4 secondary outcomes
Proportion of Long Length of Stay (LLOS)
Time frame: 150 days
Death within 90 days from discharge
Time frame: 90 days
Proportion of patients reported to the NOCC team during the DDP-experimental phase
Time frame: 150 days
Healthcare costs until 90 days from the discharge
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Derived from this study: PubMed 37170018Evangelista A, Camussi E, Corezzi M, Gilardetti M, Fonte G, Scarmozzino A, La Valle G, Angelone L, Olivero E, Ciccone G, Corsi D. Routine vs. On-Demand Discharge Planning Strategy in Intermediate-Risk Patients for Complex Discharge: a Cluster-Randomized, Multiple Crossover Trial. J Gen Intern Med. 2023 Sep;38(12):2749-2754. doi: 10.1007/s11606-023-08186-4. Epub 2023 May 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniela Corsi, MD principal investigator
A.O.U. Città della Salute e della Scienza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing On Demand Discharge Planning (DDP) and Routine Discharge Planning (RDP) in people with Patient Discharge, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unexpected hospital readmission within 90 days from discharge (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03436940, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.