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 measure
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. Avlunds 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 patients 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 (if study stopped)
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
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
Basic results (scientific)
Publication list