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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02295319
Other study ID # Discharge AAU
Secondary ID
Status Completed
Phase N/A
First received November 12, 2014
Last updated December 1, 2015
Start date November 2014
Est. completion date November 2015

Study information

Verified date November 2014
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: The Danish National Committee on Biomedical Research Ethics
Study type Interventional

Clinical Trial Summary

The present non-blinded randomized controlled trial (RCT) investigates the effect of a comprehensive discharge model in adult medical patients discharged directly home from an Acute Admission Unit (AAU). In addition, eligible patients should have, at least, one hospital admission 12 months prior to index hospitalization and be discharged for further follow-up by general practitioner, home care nursing or in an out-patient clinic. The model consists of 3 main steps during the short term stay in the AAU. First, patients are screened for pre-hospital conditions that might have contributed to the index hospitalization i.e. functional ability, ongoing treatment including drug treatment, need for additional assistance to maintain daily living, relatives, and use of e.g. hearing aid, glasses, walker. Second, at point of discharge there will be a thorough assessment of the discharge plan focusing on the patients' comprehension of the discharge plan as well as accept of the suggested treatment and follow-up. Third, within 2 days after discharge the patient will receive a discharge letter by email or postal mail written in plain language and repeating the information provided in the discharge summary to the general practitioner. Subsequently, the patient will receive a telephone follow-up from the research nurse addressing the content in the discharge letter and possible unresolved issues related to the index hospitalization. Patients in the control group receives the usual discharge practice in the AAU which does not include a discharge letter to the patient and telephone follow-up after discharge.

The primary endpoint is number of readmissions within 72 hours and 30 days after discharge. Secondary endpoints are healthcare service utilization within 30 days after discharge this includes number of contacts to general practitioner, out-of-hours physicians, emergency departments and if possible visits by home care nurses. Additionally, Quality-of-Life measured 30 days after discharge by the questionnaire EQ5D and Patient Experience of the discharge process is measured 7 days after discharge by a Danish national patient experience survey - serves as secondary endpoints.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date November 2015
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- medicine diagnosis

- discharged directly to home

- 1 admission during the last 12 months

- having a planned follow-up after discharge (general practitioner, home care nurse, out-patient clinic)

- read and understand Danish

Exclusion Criteria:

- demented, living outside the council of Aarhus, included in a rival study

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Individual discharge
See previous description in "Arms"

Locations

Country Name City State
Denmark Aarhus University Hospital Aarhus

Sponsors (1)

Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Readmissions 30 days No
Secondary Healthcare Service Utilization 30 days No
Secondary Quality of Life (EQ5D) 30 days No
Secondary Patients experience of the discharge process 7 days No
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