- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04737733
Effects of a Dementia-friendly Program
Effects of a Dementia-friendly Program on Detection and Management of Patients With Cognitive Impairment and Delirium in Acute-care Hospital Units: a Non-equivalent Control Group Design
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Lørenskog, Norway, 1478
- University Hospital, Akershus
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: The dementia friendly hospital program
The dementia-friendly hospital program comprised three parts; 1) Educational program for health practitioners to increase the staff's knowledge and awareness of patients with cognitive impairment and/or delirium; 2) Screening, for early identification of cognitive impairment and delirium, using the Four Assessment Test (4AT); 3) Delirium risk factor modification and management for patients defined with potential cognitive impairment and risk of delirium, implying that risk factor modifications should be implemented in the patient's care plan.
For patients with suspected delirium, the program promoted an additional delirium management plan.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Detection of patients with cognitive impairment
Time Frame: During the stay at the participating wards, assessed from the electronical medical record within 6 months after discharge
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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.
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During the stay at the participating wards, assessed from the electronical medical record within 6 months after discharge
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Management of patients with cognitive impairment and delirium
Time Frame: During the stay at the participating wards, assessed from the electronical medical record within 6 months after discharge
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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.
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During the stay at the participating wards, assessed from the electronical medical record within 6 months after discharge
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Screening within 24 hours
Time Frame: Within 24 hours after admission to the ward
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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.
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Within 24 hours after admission to the ward
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Use of antipsychotics, hypnotics and sedatives
Time Frame: During the stay at the participating wards, assessed from the electronical medical record within 6 months after discharge
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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.
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During the stay at the participating wards, assessed from the electronical medical record within 6 months after discharge
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Use of medications not recommended for the patient group
Time Frame: During the stay at the participating wards, assessed from the electronical medical record within 6 months after discharge
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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.
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During the stay at the participating wards, assessed from the electronical medical record within 6 months after discharge
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Departure to rehabilitation or nursing home
Time Frame: Assessed from the electronical medical record, within 6 month after discharge
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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.
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Assessed from the electronical medical record, within 6 month after discharge
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Length of hospital stay
Time Frame: Assessed from the electronical medical record, within 6 month after discharge
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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.
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Assessed from the electronical medical record, within 6 month after discharge
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Delirium
Time Frame: Assessed from the electronical medical record, within 6 month after discharge
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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.
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Assessed from the electronical medical record, within 6 month after discharge
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30-day readmission to the hospital
Time Frame: Readmissions to the hospital were assessed from the electronical medical record 30 days after discharge.
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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.
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Readmissions to the hospital were assessed from the electronical medical record 30 days after discharge.
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30-day mortality
Time Frame: Mortality were assessed from the electronical medical record 30 days after discharge.
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Proportion of mortality in the patient group within 30 days after discharge from the hospital.
Differences between the control group and the intervention group.
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Mortality were assessed from the electronical medical record 30 days after discharge.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nina M Weldingh, Master, University Hospital, Akershus
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018/666(REK)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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