Condition category
Not Applicable
Date applied
14/01/2010
Date assigned
17/02/2010
Last edited
17/02/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Elizabeth Rosted

ORCID ID

Contact details

University Hospital of Amager
Italiensvej 1
Copenhagen
2300
Denmark
elizabeth.rosted@amh.regionh.dk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Nursing intervention for older patients who are discharged home from Emergency Department: A randomised controlled trial

Acronym

Study hypothesis

The overall aim of the study is to investigate a model for structured nursing assessment and intervention for geriatric patients in the Emergency Department and the following months. The objectives are:
1. To examine the effect of identification of geriatric patients (>70 years) at risk of functional decline and readmission.
2. To examine the effect of nursing assessment and intervention given before discharge from Emergency Department and one and six months after.

Ethics approval

1. The Ethical Board of The Capital Region of Denmark approved on the 12th of December 2007 (ref: H-D-2007-0110)
2. The Danish Data Protection Agency approved on the 6th of November 2008 (ref: 2008-41-2768)

Study design

Randomised controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

No patient information available in web-format.

Condition

Geriatric patients; functional decline

Intervention

Geriatric patients admitted to the Emergency Department are detected using ISAR 1 screening tool. After randomisation and at discharge and one and six months after the geriatric intervention nurse does the experimental intervention that consists of a brief, standardised geriatric nursing assessment using a ten point checklist of physical, mental, medical, and social problems. The focus is on unresolved problems, new or pre-existing, that required medical intervention, new or different home care or other services, or comprehensive geriatric assessment. After this a discharge plan/plan is worked out with relevant referrals to the outpatient clinic, community care, primary physician or arrangements with next-of-kin.
Patients in the control group received the usual Emergency Department services and consultations. They are not referred to the intervention nurse.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Readmission to Emergency Department within one and six months, data collected from the Hospitals administrative database.
2. Admission to nursing home within one and six months, data collected from the Hospitals administrative database.
3. Death within one or six months, data collected from the Hospital administrative database.

Secondary outcome measures

1. Physical functional status at baseline, one, and six months, measured by
1.1. Chairstand test, total number of rise from a chair in 30 seconds (Jones CJ, Rikli RE, Beam WC, 1999)
1.2.Handgrip-strength using a Jamar dynamometer (Bohannon RW, Schaubert KL 2005)
1.3. Avlund’s Mobility-Tiredness Scale that counts activities managed without fatigue (Avlund K, Kreiner S, Schultz-Larsen K 1996).
2. Cognitive functional status at baseline, one, and six months, measured by mini-mental status examination that consists of 11 questions, maximum score (best performance)=30 (Folstein MF, Folstein SE, McHugh PR 1975).
3. Mental functional status at baseline, one, and six months, measured by Geriatric Depression Scale (0-1=not depressed,2- 5=risk of depression)(Bull 1988)
4. Health related quality of life at baseline, one, and six months, measured by 12-itim short-form Health Survey (SF 12) (Ware J Jr, Kosinski M, Keller SD 1996).
5. Amount of patient’s unresolved problems, data collected from intervention nurse records.
6. Amount of help at home from the community, data collected from the community health center utilisation database.

Overall trial start date

16/02/2009

Overall trial end date

01/08/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients 70 years and older scoring more than 2 points (out of 6) when screened with Identification of Seniors at Risk 1 (ISAR 1) screening tool (McCusker 1998)
2. Discharged home from Medical Emergency Department and residents of Amager, Copenhagen
3. Able to decide on informed consent
4. Able to communicate in Danish

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

300 patients

Participant exclusion criteria

1. Patients admitted to Medical Emergency Department from nursing home
2. Patients already included who are readmitted
3. Spouses to already included patients
4. Patients who do not wish to participate

Recruitment start date

16/02/2009

Recruitment end date

01/08/2011

Locations

Countries of recruitment

Denmark

Trial participating centre

University Hospital of Amager
Copenhagen
2300
Denmark

Sponsor information

Organisation

University Hospital of Amager (Denmark)

Sponsor details

Italiensvej 1
Copenhagen
2300
Denmark
amager.hospital@amh.regionh.dk

Sponsor type

Hospital/treatment centre

Website

http://www.amagerhospital.dk/

Funders

Funder type

Hospital/treatment centre

Funder name

Amager Hospital (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Danish Nurses’ Organization (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Lundbeck Foundation (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Tryg Foundation (Denmark) (ref: J.nr. 1072-09)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

University of Southern Denmark, Institute of Clinical Research (Denmark) - Research Unit of Nursing

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes