NCT02295319

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

November 12, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 20, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

December 3, 2015

Status Verified

November 1, 2014

Enrollment Period

1 year

First QC Date

November 12, 2014

Last Update Submit

December 1, 2015

Conditions

Keywords

DischargeAcute Admission UnitRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • Readmissions

    30 days

Secondary Outcomes (3)

  • Healthcare Service Utilization

    30 days

  • Quality of Life (EQ5D)

    30 days

  • Patients experience of the discharge process

    7 days

Study Arms (2)

Individual discharge

EXPERIMENTAL

Discharge based on the patients individual needs and conditions. The discharge focus on information, communication, follow-up plans and collaboration, as well as the patients understanding and accept of the discharge plan. In addition, it includes a telephone interview 2 days after discharge to home.

Other: Individual discharge

Control

NO INTERVENTION

Usual discharge procedures

Interventions

See previous description in "Arms"

Individual discharge

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • medicine diagnosis
  • discharged directly to home
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2014

First Posted

November 20, 2014

Study Start

November 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

December 3, 2015

Record last verified: 2014-11

Locations