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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04737733
Other study ID # 2018/666(REK)
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 22, 2018
Est. completion date June 16, 2020

Study information

Verified date January 2021
Source University Hospital, Akershus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Frail older persons with cognitive impairment are at special risk of experiencing delirium during acute hospitalisation. The purpose of this study was to investigate whether a dementia-friendly hospital program contributes to improved detection and management of patients with cognitive impairment and delirium.


Description:

Study design This study, has a non-equivalent control group design and a historical control Group. The Control group received usual care and the experimental group received usual care plus the dementia-friendly program. One Group received care after implementing the dementia-friendly hospital program. The study is performed at two medical wards at a large acute-care hospital in Norway. A medical pulmonary ward and a cardiac ward participated. Data Collection: Demographic data included age, gender, place of residence (home, adapted housing, institution), and family/relative network, and were obtained upon admission to the study. Medical data included cause of admission, active medical diagnoses, medications and medical treatment, and were obtained both at admission and from their electronic medical records after discharge. Cognitive Impairment and delirium were assessed with two different screening tools: the Four Assessment Test (4AT) and the Confusion Assessment Method (CAM). For all patients with a positive 4AT (≥1) or identified cognitive impairment during their hospital stays, a thorough review of the patient's journal was conducted upon discharge to record if, in case of yes, which type of preventive or treatment measures according to the dementia-friendly program, the patients had received during their stays.


Recruitment information / eligibility

Status Completed
Enrollment 423
Est. completion date June 16, 2020
Est. primary completion date March 30, 2020
Accepts healthy volunteers No
Gender All
Age group 75 Years and older
Eligibility Inclusion Criteria: - Patients =75 years - acute admission to the cardiac or pulmonary wards. - Patient who has given informed written consent, or proxy consent from relatives for patients who lacked cognitive capacity. Exclusion Criteria: - Readmitted patients enrolled in a previous hospital stay. - Patients who do not have sufficient verbal function or hearing to communicate - Patients in a coma or too ill to participate - Patients who are isolated - Patients who do not wish to participate or relatives who do not want the patient to participate, in the cases where the patient lacked cognitive capacity to consent.

Study Design


Intervention

Other:
The dementia friendly program
Implementation of a systematic screening and risk modification and management plan, to identify and enhance the management of patients with cognitive impairment and risk of delirium.

Locations

Country Name City State
Norway University hospital, Akershus Lørenskog

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Detection of patients with cognitive impairment Proportion of patients identified with cognitive impairment during the hospital stay, documented in the electronic Medical record. Difference between the control group and the intervention group. Patients were assessed with The Four Assessment Test at admission and during the stay at the participating wards. Furthermore, documentation of cognitive impairment in the electronic medical journal during the stay were assessed after discharge. During the stay at the participating wards, assessed from the electronical medical record within 6 months after discharge
Primary Management of patients with cognitive impairment and delirium Proportion of patients identified with cognitive impairment, delirium or at risk of delirium who has documented interventions to prevent and/or treat delirium, according to the implemented dementia-friendly program.Differences between the control group and the intervention group. During the stay at the participating wards, assessed from the electronical medical record within 6 months after discharge
Secondary Screening within 24 hours Proportion of patients screened with The Four Assessment Test within 24 after hours after admission to the ward. Differences between the control group and the intervention group. Within 24 hours after admission to the ward
Secondary Use of antipsychotics, hypnotics and sedatives Proportion of patients with cognitive impairment given doses of antipsychotics, hypnotics and sedatives during the stay at the participating wards. Differences between the control group and the intervention group. Given doses of antipsychotics, hypnotics and sedatives during the stay at the participating wards registered in the electronic medical journal, were assessed after discharge. During the stay at the participating wards, assessed from the electronical medical record within 6 months after discharge
Secondary Use of medications not recommended for the patient group Proportion of patients with cognitive impairment who uses medications which are not recommended for the patient group. Differences between the control group and the intervention group. During the stay at the participating wards, assessed from the electronical medical record within 6 months after discharge
Secondary Departure to rehabilitation or nursing home Proportion of patients with departure to rehabilitation or nursing home. Departure to care level were assessed from the electronic medical journal after discharge.Differences between the control group and the intervention group. Assessed from the electronical medical record, within 6 month after discharge
Secondary Length of hospital stay Mean number of days at the hospital stay.Length of hospital stay were collected from the electronic medical journal after discharge.Differences between the control group and the intervention group. Assessed from the electronical medical record, within 6 month after discharge
Secondary Delirium Proportion of patients diagnosed with delirium. Delirium diagnosis documented during the stay at the participating wards were collected from the electronical medical record after discharge. Differences between the control group and the intervention group. Assessed from the electronical medical record, within 6 month after discharge
Secondary 30-day readmission to the hospital Proportion of patients who are readmitted to the hospital within 30 days after discharge from the hospital. Differences between the control group and the intervention group. Readmissions to the hospital were assessed from the electronical medical record 30 days after discharge.
Secondary 30-day mortality Proportion of mortality in the patient group within 30 days after discharge from the hospital. Differences between the control group and the intervention group. Mortality were assessed from the electronical medical record 30 days after discharge.
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