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Capturing Readmission Internationally to Prevent Readmission by Safer@Home Group (CURIOS@)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02621723
Recruitment Status : Unknown
Verified December 2015 by Prabath W.B. Nanayakkara, Amsterdam UMC, location VUmc.
Recruitment status was:  Not yet recruiting
First Posted : December 3, 2015
Last Update Posted : December 3, 2015
Sponsor:
Information provided by (Responsible Party):
Prabath W.B. Nanayakkara, Amsterdam UMC, location VUmc

Study Description
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Brief Summary:

CURIOS@ is a prospective multi-centre cross-sectional study to investigate readmissions in participating units. The data collected is derived from two clinical episodes: the episode containing the re-admission and the previous admission (index admission).

The main aims are:

Outcomes:

  • Risk factors to predict preventable readmissions in non-surgical patients
  • Percentage of subjectively non-preventable and preventable readmissions from patient, carer, their nurses and their physician's point of view
  • Comparison for risk factors on readmissions throughout Europe
  • Increasing awareness and knowledge for health-care workers on readmissions and its preventability

Condition or disease
Hospital Readmission

Detailed Description:

Data will be derived directly from patients, from the clinical notes of the previous admission and records of discharge communication. Also information from treating physicians, nurses and immediate caregivers will be collected. The data set will contain no directly identifiable variables (data will be registered by using a research code for each patient).

Data collection will include: Hospital-related data, patient-related data, health-related data, time-related data, and physician related data. Also patient feedback is requested.

After obtaining written informed consent, the researcher will ask the patient 7 questions about the (preventability of their) readmission. Also the patient will be asked if one of the direct carers can be approached with 2 questions. The carer will most often be a sibling, a good friend or someone from the neighborhood. We will approach the carer in person or by telephone, and only after explicit permission from the patient. Lastly, we will ask a doctor and nurse (responsible for the patient in the first 24 hours of his readmission) similar questions.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Capturing Readmission Internationally to Prevent Readmission by Safer@Home
Study Start Date : January 2016
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2018
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Percentage of readmissions deemed preventable by patients, their informal carers, nurses and physicians [ Time Frame: 1 year ]
    Of all the readmissions in the study, we will look at the readmissions which are deemed potentially preventable (YES or NO) by all partners of care chain. In the end this will give us a percentage of readmissions judged as potentially preventable by all partners of care chain.


Secondary Outcome Measures :
  1. Causes of preventable readmissions [ Time Frame: 1 year ]

    We will ask all partners in the care chain about the causes of the readmissions. These will be categorised:

    Disease-related: Natural progress disease, out of control/influence physician or patient - for example: metastasis cancer.

    Patient-related: Related to control/influence patient, out of control/influence professionals - for example: a patient who refused extra home care after the index admission.

    Human/caregiver-related: Related to the control/influence professionals - for example: poor medication handover after index inclusion.

    Organisational: Readmission related to organisational problems - for example: no beds available, transfer from other hospital etc.

    Technical: Readmission related to technical defects of materials or equipment - for example: IV-drip home infusion antibiotics broken.


  2. Risk factors for preventable readmissions [ Time Frame: 1 year ]

    For every readmission, we will ask researchers to fill out a dataset with potential risk factors. These are:

    1. General data regarding readmission: i.e. length of stay, time between index admission and readmission.
    2. Patient-related factors: i.e. age, sex, marital status, living situation etc.
    3. Health-related: ie. comorbiditity, frailty score, polypharmacy etc.
    4. Time-related: i.e. Total admissions in previous year
    5. Physician related: i.e. was a discharge letter send?


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients readmitted for at least one night for a medical specialism after any type of admission at any ward in the previous 30 days, with an overnight stay. This could be from any ward, for any procedure (elective/non-elective)
Criteria

Inclusion criteria:

  • Adult patients aged 18 or above admitted to hospital as unscheduled medical admission for a minimum of a single night following a previous admission within 30 days
  • Index admission can be for any procedure (elective/non-elective)
  • Index admission at any hospital ward (except psychiatry, pediatrics or gynaecology) for a minimum of a single night during the previous 30 days
  • Readmission should be to a medical ward (Medical ward: Cardiology, geriatrics, gastroenterology, hematology, internal medicine, nephrology, neurology, oncology, pulmonary medicine, rheumatology.)
  • If a patient is readmitted more than once within the study period, only the first readmission will be included
  • The port of entry is through an Emergency Department, Acute Medical Unit or any other clinical ward (i.e. department of internal medicine).
  • Patients should all be capable of understanding the study and give written informed consent. They should all be mentally competent.

Exclusion criteria:

  • Patients readmitted electively for procedures, surgery or chemotherapy
  • Patients readmitted for a non-medical specialism (surgery, urology, ent etc..)
  • Patients admitted or readmitted who are pregnant
  • Patients admitted or readmitted aged under 18
  • Patients index or readmission for pediatrics, psychiatry, gynaecology
  • Patients who stayed less than one night during index and readmission
  • Patients who have been admitted to another institution in their index admission (To facilitate timely case identification and ready access to treating physicians, we will only review same-hospital readmissions)
  • A second readmission for the same patient within the study period
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02621723


Contacts
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Contact: Prabath Nanayakkara, MD, PhD, FRCP 031204444444 ext 6791 p.nanayakkara@vumc.nl
Contact: Louise van Galen, MD 031613767381 ext 6185

Locations
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Denmark
Hospital of South West Jutland
Esbjerg, Denmark, 5270 Odense N
Contact: Mikkel Brabrand, MD,PhD       mikkel@brabrand.net   
Principal Investigator: Mikkel Brabrand, MD,PhD         
Netherlands
VU University Medical Centre
Amsterdam, Noord-Holland, Netherlands, 1081 HV
Contact: Prabath W Nanayakkara, MD,PhD,FRCP    0031204444444 ext 6179    p.nanayakkara@vumc.nl   
Contact: Louise S van Galen, MD    0031613767381 ext 6185    lo.vangalen@vumc.nl   
Principal Investigator: Prabath Nanayakkara, MD,PhD,FRCP         
Academic Medical Centre (AMC)
Amsterdam, Netherlands, 1105AZ
Contact: Frits Holleman, MD, PhD       f.holleman@amc.uva.nl   
Principal Investigator: Frits Holleman         
Albert Schweitzer
Dordrecht, Netherlands, 3300 AK
Contact: Wilma Jansen       w.jansen@asz.nl   
Contact: Ralph So, MD       r.so@asz.nl   
Principal Investigator: Ralph So, MD         
Westfriesgasthuis
Hoorn, Netherlands, 1624 NP
VieCuri Hospital
Venlo, Netherlands, 5912 BL
Contact: Dennis Barten, MD       dbarten@viecuri.nl   
Contact: Loes Hooff, MD       loesvhooff@hotmail.com   
Principal Investigator: Dennis Barten, MD         
Sub-Investigator: Loes van Hooff, MD         
United Kingdom
Ysbyty Gwynedd Hospital
Bangor, United Kingdom, LL57 2PW
Contact: Chris P Subbe, MD,PhD,FRCP       csubbe@hotmail.com   
Principal Investigator: Chris Subbe, MD,PhD,FRCP         
University Hospital of South Manchester
Manchester, United Kingdom, M13 9WL
Contact: Tim Cooksley, MD,MRCP       cooks199@hotmail.com   
Principal Investigator: Tim Cooksley, MD,MRCP         
Sponsors and Collaborators
Amsterdam UMC, location VUmc
More Information
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Additional Information:

Publications:

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Responsible Party: Prabath W.B. Nanayakkara, PhD, MD, FRCP, Amsterdam UMC, location VUmc
ClinicalTrials.gov Identifier: NCT02621723    
Other Study ID Numbers: VUMedicalcenter
First Posted: December 3, 2015    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: December 2015
Keywords provided by Prabath W.B. Nanayakkara, Amsterdam UMC, location VUmc:
Preventability