- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01422811
Unnecessary, Avoidable Lengths of Stay: a Strategy for Clinician Empowerment and Effectiveness Evaluation
July 2, 2018 updated by: Caterina Caminiti, Azienda Ospedaliero-Universitaria di Parma
- 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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
3862
Phase
- Phase 3
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
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-
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Parma, Italy, 43126
- Azienda Ospedaliero-Universitaria di Parma
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-
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
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients present on the participating wards during one of 12 randomly selected index days (one for each month of data collection)
Exclusion Criteria:
- patients admitted or discharged on the index days
- patients with length of stay (interview date - admission date) > 90 days
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: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intervention
|
The strategy comprises two integrated components:
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Other: Control
No Intervention
|
No interventions (reporting, auditing) are planned; nevertheless control ward physicians know study aims and are informed about their patient's data collection.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percentage of patient-days compatible with discharge
Time Frame: 12 month period [02/2008 - 02/2009] +1 follow up month [02/2010]
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12 month period [02/2008 - 02/2009] +1 follow up month [02/2010]
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall length of stay (in days)
Time Frame: 12 month period [02/2008 - 02/2009]
|
Overall length of stay = discharge date - admission date
|
12 month period [02/2008 - 02/2009]
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Caterina Caminiti, Azienda Ospedaliero-Universitaria di Parma
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
- Moro ML. Health care-associated infections. Surg Infect (Larchmt). 2006;7 Suppl 2:S21-3. doi: 10.1089/sur.2006.7.s2-21.
- 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. Erratum In: Med Care 1989 Aug;27(8):841.
- 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.
- 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.
- 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.
- 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.
Helpful Links
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
February 1, 2008
Primary Completion (Actual)
February 1, 2009
Study Completion (Actual)
February 1, 2010
Study Registration Dates
First Submitted
August 23, 2011
First Submitted That Met QC Criteria
August 23, 2011
First Posted (Estimate)
August 24, 2011
Study Record Updates
Last Update Posted (Actual)
July 3, 2018
Last Update Submitted That Met QC Criteria
July 2, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- aopr-rct-los
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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