HospitalizationPhase 3NCT01422811

Unnecessary, Avoidable Lengths of Stay: a Strategy for Clinician Empowerment and Effectiveness Evaluation

A Phase 3 study testing Multicomponent strategy to reduce avoidable length of stay in people with Hospitalization and Length of Stay, run by Azienda Ospedaliero-Universitaria di Parma at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

1. Background: In recent years an increasing trend in excessive lengths of stay has been recorded at the Parma University Hospital, compared with regional mean values. Excessive lengths of stay have been demonstrated to constitute not just an economic problem, but also a clinical and public health issue. Read more about this study

Who is it for?: Any age
Conditions the study is for: Hospitalization, Length of Stay
What is being tested?: Multicomponent strategy to reduce avoidable length of stay
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3,862 participants
Where: 1 siteItaly
Study dates: Feb 2008to Feb 2010
Phase: Phase 3
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

patients present on the participating wards during one of 12 randomly selected index days (one for each month of data collection)

Who cannot join

patients admitted or discharged on the index days
patients with length of stay (interview date - admission date) > 90 days

Trial locations and contacts

1 site in 1 country.

Italy1 site

Azienda Ospedaliero-Universitaria di Parma
Parma, 43126

Other trials in Italy

About this study

Background: In recent years an increasing trend in excessive lengths of stay has been recorded at the Parma University Hospital, compared with regional mean values. Excessive lengths of stay have been demonstrated to constitute not just an economic problem, but also a clinical and public health issue. Since the measures taken at our institution so far have not proven effective, the investigators carried out a literature review, which mostly detected observational studies, restricted to the assessment of the impact of a single intervention.
Objectives: This project intends to evaluate the effectiveness of a multifaceted strategy aiming to empower clinicians on the issues associated with excessively long and avoidable hospital stays, and enable them to identify corrective measures (according to the principles of clinical governance).
Study design: cluster-randomized, parallel group, open-label, community trial
Methods: trained personnel will periodically record causes for excessive lengths of stay in all participating wards using an ad hoc data collection sheet. In the wards randomized to the experimental group, interventions aimed to clinician empowerment - provision of reminders and periodical audits - will be implemented.
Expected results: A reduction in the experimental vs. the control arm unnecessary lengths of stay is expected, although the introduced measures will also presumably lead to improvement in the wards where they are not implemented.

Conditions: Hospitalization, Length of Stay
Being tested: Multicomponent strategy to reduce avoidable length of stay, No intervention
Keywords: Public health, Policy, Training

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Multicomponent strategy to reduce avoidable length of stayBehavioural
The strategy comprises two integrated components:
1. Distribution of two monthly reports, one consisting in the list of patients who, through data collection performed, are classified to be present on the ward although their clinical status is considered compatible with discharge; the other featuring individual length of stay profiles for each physician operating in the intervention arm (information taken from administrative data), allowing comparisons with the rest of the medical staff;
2. Audits performed by professionals of each ward of the intervention arm designed to discuss cases judged to be compatible with discharge. The organization of this work are left to the wards, without any interference from the project team.
No interventionOther
No interventions (reporting, auditing) are planned; nevertheless control ward physicians know study aims and are informed about their patient's data collection.

Study groups in NCT01422811
Study group	Role	What they receive
Intervention	Experimental	Not described Receives: Behavioral: Multicomponent strategy to reduce avoidable length of stay
Control	Other	No Intervention Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of patient-days compatible with discharge
Measured: 12 month period [02/2008 - 02/2009] +1 follow up month [02/2010]

Secondary outcomes (1)

Overall length of stay (in days)
Overall length of stay = discharge date - admission date
Measured: 12 month period [02/2008 - 02/2009]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2008Feb 2010

First posted24 Aug 2011 (estimated)
Study startFeb 2008
Primary completionFeb 2009
Study completionFeb 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for HospitalizationStudies 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 3
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 3,862 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01422811
Sponsor's protocol ID: aopr-rct-los
Status last verified: Jul 2018
First submitted: 23 Aug 2011
Last updated: 3 Jul 2018
Results posted: No
Data monitoring committee: No

Publications

Carey MR, Sheth H, Braithwaite RS. A prospective study of reasons for prolonged hospitalizations on a general medicine teaching service. J Gen Intern Med. 2005 Feb;20(2):108-15. doi: 10.1111/j.1525-1497.2005.40269.x.
PubMed 15836542
Lagoe RJ, Westert GP, Kendrick K, Morreale G, Mnich S. Managing hospital length of stay reduction: a multihospital approach. Health Care Manage Rev. 2005 Apr-Jun;30(2):82-92. doi: 10.1097/00004010-200504000-00002.
PubMed 15923910
Moro ML. Health care-associated infections. Surg Infect (Larchmt). 2006;7 Suppl 2:S21-3. doi: 10.1089/sur.2006.7.s2-21.
PubMed 16895497
Selker HP, Beshansky JR, Pauker SG, Kassirer JP. The epidemiology of delays in a teaching hospital. The development and use of a tool that detects unnecessary hospital days. Med Care. 1989 Feb;27(2):112-29. doi: 10.1097/00005650-198902000-00003.
PubMed 2918764
Setrakian JC, Flegel KM, Hutchinson TA, Charest S, Cote L, Edwardes MD, Corbett IB. A physician-centred intervention to shorten hospital stay: a pilot study. CMAJ. 1999 Jun 15;160(12):1735-7.
PubMed 10410639
Shojania KG, Wald H, Gross R. Understanding medical error and improving patient safety in the inpatient setting. Med Clin North Am. 2002 Jul;86(4):847-67. doi: 10.1016/s0025-7125(02)00016-0.
PubMed 12365343
Meschi T, Fiaccadori E, Cocconi S, Adorni G, Ridolo E, Stefani N, Schianchi T, Novarini A, Spagnoli G, Caminiti C, Pini M, Borghi L. [Analysis of the problem of "difficult hospital discharges" in the University Hospital of Parma]. Ann Ital Med Int. 2004 Apr-Jun;19(2):109-17. Italian.
PubMed 15317271
Caminiti C, Meschi T, Braglia L, Diodati F, Iezzi E, Marcomini B, Nouvenne A, Palermo E, Prati B, Schianchi T, Borghi L. Reducing unnecessary hospital days to improve quality of care through physician accountability: a cluster randomised trial. BMC Health Serv Res. 2013 Jan 10;13:14. doi: 10.1186/1472-6963-13-14.
PubMed 23305251

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Unnecessary, Avoidable Lengths of Stay: a Strategy for Clinician Empowerment and Effectiveness Evaluation
ClinicalTrials.gov ID: NCT01422811
Acronym / sponsor ID: aopr-rct-los
Conditions: Hospitalization, Length of Stay
Keywords: Public health, Policy, Training
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 3,862 participants (actual)
Lead sponsor: Azienda Ospedaliero-Universitaria di ParmaUniversity, hospital or other
Collaborators: Regione Emilia-Romagna
Study start: Feb 2008
Primary completion: Feb 2009 (actual)
Study completion: Feb 2010 (actual)
First posted: 24 Aug 2011 (estimated)
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.

Background: In recent years an increasing trend in excessive lengths of stay has been recorded at the Parma University Hospital, compared with regional mean values. Excessive lengths of stay have been demonstrated to constitute not just an economic problem, but also a clinical and public health issue. Since the measures taken at our institution so far have not proven effective, the investigators carried out a literature review, which mostly detected observational studies, restricted to the assessment of the impact of a single intervention.
Objectives: This project intends to evaluate the effectiveness of a multifaceted strategy aiming to empower clinicians on the issues associated with excessively long and avoidable hospital stays, and enable them to identify corrective measures (according to the principles of clinical governance).
Study design: cluster-randomized, parallel group, open-label, community trial
Methods: trained personnel will periodically record causes for excessive lengths of stay in all participating wards using an ad hoc data collection sheet. In the wards randomized to the experimental group, interventions aimed to clinician empowerment - provision of reminders and periodical audits - will be implemented.
Expected results: A reduction in the experimental vs. the control arm unnecessary lengths of stay is expected, although the introduced measures will also presumably lead to improvement in the wards where they are not implemented.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Intervention	Experimental	Behavioral: Multicomponent strategy to reduce avoidable length of stay
Control	Other	Other: No interventionNo Intervention

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

patients present on the participating wards during one of 12 randomly selected index days (one for each month of data collection)

Key exclusion criteria (2 listed)

patients admitted or discharged on the index days
patients with length of stay (interview date - admission date) > 90 days

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
Multicomponent strategy to reduce avoidable length of stayThe strategy comprises two integrated components: 1. Distribution of two monthly reports, one consisting in the list of patients who, through data collection performed, are classified to be present on the ward although their clinical status is considered compatible with discharge; the other featuring individual length of stay profiles for each physician operating in the intervention arm (information taken from administrative data), allowing comparisons with the rest of the medical staff; 2. Audits performed by professionals of each ward of the intervention arm designed to discuss cases judged to be compatible with discharge. The organization of this work are left to the wards, without any interference from the project team.	Behavioural	Intervention
No interventionNo interventions (reporting, auditing) are planned; nevertheless control ward physicians know study aims and are informed about their patient's data collection.	Other	Control

Primary outcome

Percentage of patient-days compatible with discharge
Time frame: 12 month period [02/2008 - 02/2009] +1 follow up month [02/2010]

1 secondary outcome

Overall length of stay (in days)
Time frame: 12 month period [02/2008 - 02/2009]

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 3 Jul 2018.
Background: PubMed 15836542Carey MR, Sheth H, Braithwaite RS. A prospective study of reasons for prolonged hospitalizations on a general medicine teaching service. J Gen Intern Med. 2005 Feb;20(2):108-15. doi: 10.1111/j.1525-1497.2005.40269.x.
Background: PubMed 15923910Lagoe RJ, Westert GP, Kendrick K, Morreale G, Mnich S. Managing hospital length of stay reduction: a multihospital approach. Health Care Manage Rev. 2005 Apr-Jun;30(2):82-92. doi: 10.1097/00004010-200504000-00002.
Background: PubMed 16895497Moro ML. Health care-associated infections. Surg Infect (Larchmt). 2006;7 Suppl 2:S21-3. doi: 10.1089/sur.2006.7.s2-21.
Background: PubMed 2918764Selker HP, Beshansky JR, Pauker SG, Kassirer JP. The epidemiology of delays in a teaching hospital. The development and use of a tool that detects unnecessary hospital days. Med Care. 1989 Feb;27(2):112-29. doi: 10.1097/00005650-198902000-00003.
Background: PubMed 10410639Setrakian JC, Flegel KM, Hutchinson TA, Charest S, Cote L, Edwardes MD, Corbett IB. A physician-centred intervention to shorten hospital stay: a pilot study. CMAJ. 1999 Jun 15;160(12):1735-7.
Background: PubMed 12365343Shojania KG, Wald H, Gross R. Understanding medical error and improving patient safety in the inpatient setting. Med Clin North Am. 2002 Jul;86(4):847-67. doi: 10.1016/s0025-7125(02)00016-0.
Background: PubMed 15317271Meschi T, Fiaccadori E, Cocconi S, Adorni G, Ridolo E, Stefani N, Schianchi T, Novarini A, Spagnoli G, Caminiti C, Pini M, Borghi L. [Analysis of the problem of "difficult hospital discharges" in the University Hospital of Parma]. Ann Ital Med Int. 2004 Apr-Jun;19(2):109-17. Italian.
Derived from this study: PubMed 23305251Caminiti C, Meschi T, Braglia L, Diodati F, Iezzi E, Marcomini B, Nouvenne A, Palermo E, Prati B, Schianchi T, Borghi L. Reducing unnecessary hospital days to improve quality of care through physician accountability: a cluster randomised trial. BMC Health Serv Res. 2013 Jan 10;13:14. doi: 10.1186/1472-6963-13-14.
Study sponsor's website \[ita\]Link provided by the sponsor.

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A Retrospective Observational Study of Epidemiology and Outcomes in Transthyretin Amyloid Cardiomyopathy in Germany
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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.

Caterina Caminiti principal investigator

Azienda Ospedaliero-Universitaria di Parma

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 2 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 3 Jul 2018. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Percentage of patient-days compatible with discharge (time frame: 12 month period [02/2008 - 02/2009] +1 follow up month [02/2010]). 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 NCT01422811, which also lists 8 linked publications.

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 3 Jul 2018.