NCT02094040

Brief Summary

The purpose of this study is to determine whether discharge follow-up visit by primary physician and community-based nurse affects the risk of early re-hospitalisation among high risk older people discharged from a medical ward.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
531

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2012

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 21, 2014

Completed
Last Updated

March 21, 2014

Status Verified

March 1, 2014

Enrollment Period

1.8 years

First QC Date

March 12, 2014

Last Update Submit

March 19, 2014

Conditions

Keywords

frailtyreadmissiontransitiondischargeprimary care

Outcome Measures

Primary Outcomes (1)

  • Re-admission

    The primary outcome is re-hospitalisation rate within 30 days from discharge. Data is obtained from the official register of danish patients (Landspatientregistret).

    Within 30 days from discharge

Secondary Outcomes (1)

  • Long-term hospitalization rate

    Within 180 days from discharge

Other Outcomes (3)

  • Long-term death rate

    Within 180 days from discharge

  • Long-term use of primary health care services

    Within 180 days from discharge

  • Long-term use of secondary health care services

    Within 180 days from discharge

Study Arms (2)

Follow-up visit

EXPERIMENTAL

Receive municipality-based follow-up visit including primary physician.

Behavioral: Receive municipality-based follow-up visit

Usual care

NO INTERVENTION

Does not receive follow-up visit

Interventions

Systematic electronic referral from hospital to municipality of high risk people at discharge from a medical ward. Contact from municipality service to primary physician and citizen, to arrange first home visit within 7 days with focus on: medication, rehabilitation plan and health care appointments, functional level and need for further health care initiatives. The visit is concluded by planning of further visits (up till tree) and division of responsibilities between primary physician and the municipality service.

Also known as: Intervention group
Follow-up visit

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patient geography (The participant live in; Holbæk Kommune, Odsherred Kommune or Kalundborg Kommune.)
  • Discharged from medical ward Holbæk Sygehus.
  • Frailty (Rated by following criterion: dementia or a minimum of two of the following conditions; two or more hospitalisations within 12 month prior to follow up, los of physical function, treatment of two or more concurrent medical and/or surgical conditions, psychiatric disease, multi-pharmacy of more than 6 prescription medication, suspicious of congenital disturbances, substance abuse problem, disadvantaged social network, need for increasing home care following index hospitalization.)

You may not qualify if:

  • Not discharged to home (If the patient are not discharged to home.)
  • No written consent (If the patient does not wish to participate / written consent are not signed.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medicinsk Afdeling, Holbæk Sygehus

Holbæk, 4300, Denmark

Location

Related Publications (1)

  • Thygesen LC, Fokdal S, Gjorup T, Taylor RS, Zwisler AD; Prevention of Early Readmission Research Group. Can municipality-based post-discharge follow-up visits including a general practitioner reduce early readmission among the fragile elderly (65+ years old)? A randomized controlled trial. Scand J Prim Health Care. 2015 Jun;33(2):65-73. doi: 10.3109/02813432.2015.1041831. Epub 2015 Jun 10.

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Thomas Gjørup

    Medicinsk Afdeling, Holbæk Sygehus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2014

First Posted

March 21, 2014

Study Start

February 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

March 21, 2014

Record last verified: 2014-03

Locations