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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02318680
Other study ID # SJ-329
Secondary ID
Status Completed
Phase N/A
First received December 11, 2014
Last updated January 9, 2015
Start date January 2013
Est. completion date January 2015

Study information

Verified date January 2015
Source Roskilde County Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: Region Zealand
Study type Interventional

Clinical Trial Summary

The study aims to assess whether a follow home visit after discharge of frail elderly patients from Nykøbing Falster Hospital reduces the risk of readmission within 180 days.

Staff from the hospital ward identifies patients fulfilling the inclusion criteria and refers the patients to two project nurses at the hospital (follow home team). One of the project nurses gets the informed consent from the patient, or in case of a patient who is not able to give informed consent, from the family and general practitioner. The patient is then randomized to intervention (follow home visit after discharge) or control.

In the intervention group, the hospital project nurse and the patient meets with the municipal nurse in the patient's home on the same day the patient is being discharged from the hospital. During this visit the discharge from the hospital and the actual functioning of the patient in his own surroundings is reviewed, using a structured assessment.


Description:

The study consists of two parts: First, the project nurse reviews the patients hospitalization and discharge together with the nurse from the ward. Next, the patient is discharged from the hospital and is driven by the project nurse from the hospital to the patient's home where they meet the nurse from the municipality. Together with the patient the two nurses review:

- Cognitive skills

- Medicine

- Nutrition

- Mobility

- Level of functioning

- Future appointments in the health care sector

All patients in the project - both patients in the intervention group and patients in the control group - will receive treatment and care equivalent to normal applicable quality standards with discharge from the hospital.

It is expected that the study will demonstrate a reduction of hospital readmissions within 180 days in the intervention group with 14 % (with a power of 90% and a significance level of 5%). There will be a need for 200 patients in both the control and intervention group, ie 400 patients in total.


Recruitment information / eligibility

Status Completed
Enrollment 545
Est. completion date January 2015
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 65 Years and older
Eligibility Inclusion Criteria:

- Discharge from the Medical Department, Geriatric Department B, Emergency Department, Surgical Department or Department of Orthopedic Surgery at Nykøbing Falster Hospital.

Address in Guldborgsund, Lolland or Vordingborg municipalities.

Minimum 3 out of the following 9 criteria must be met:

- The patient's behavior raises suspicion of cognitive disorders, including dementia, which affects how the patient masters his daily life.

- The patient has an abuse of medication, drugs and / or alcohol, which affects how the patient masters his daily life.

- The patient has a psychiatric disorder that affects how the patient masters his daily life.

- The patient has a strained - or no - social network.

- The patient has a significantly lower level of functioning compared to prior to admission.

- The patient uses 6 or more different types of drugs at the time of discharge.

- The patient has, within the preceding 6 months, had at least one acute hospital contact beyond the current.

- The patient has a fall-history where the cause is not yet determined.

- There are suspicion of housing conditions that hamper the patient in his daily activities.

Exclusion Criteria:

- Patients who do not want to participate or cannot give informed consent. Discharge between 4 pm and 8 am Monday-Friday and discharge on weekends. Patients with planned readmission. Former participant in the study. Patients who needs terminal care.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Other:
Review of follow home visits after discharge from Nykøbing Falster Hospital
The intervention is follow home visits which is randomized and is an intervention that is assigned by the investigator.

Locations

Country Name City State
Denmark Region Zealand, Nykøbing Falster Hospital Nykøbing Falster

Sponsors (6)

Lead Sponsor Collaborator
Roskilde County Hospital Guldborgsund Municipality, Lolland Municipality, Nykøbing Falster County Hospital, Region Zealand, Vordingborg Municipality

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary The proportion of patients who are readmitted 180 days No
Secondary Total use of municipal services (nursing, practical help, personal care) 180 days No
Secondary The number of contacts with general practitioner 180 days No
Secondary Time to readmission 180 days No
Secondary Total number of readmissions 180 days No
Secondary Total number of days of readmission 180 days No
Secondary Death 180 days No
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