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Effects of a Dementia-friendly Program

Primary Purpose

Delirium, Cognitive Impairment, Dementia

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
The dementia friendly program
Sponsored by
University Hospital, Akershus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Delirium

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University hospital, Akershus

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

The dementia friendly hospital program

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
January 26, 2021
Last Updated
January 29, 2021
Sponsor
University Hospital, Akershus
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1. Study Identification

Unique Protocol Identification Number
NCT04737733
Brief Title
Effects of a Dementia-friendly Program
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
November 22, 2018 (Actual)
Primary Completion Date
March 30, 2020 (Actual)
Study Completion Date
June 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Akershus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium, Cognitive Impairment, Dementia

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A non-equivalent control group design with a historical control group
Masking
None (Open Label)
Allocation
N/A
Enrollment
423 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The dementia friendly hospital program
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
The dementia friendly program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Detection of patients with cognitive impairment
Description
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.
Time Frame
During the stay at the participating wards, assessed from the electronical medical record within 6 months after discharge
Title
Management of patients with cognitive impairment and delirium
Description
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.
Time Frame
During the stay at the participating wards, assessed from the electronical medical record within 6 months after discharge
Secondary Outcome Measure Information:
Title
Screening within 24 hours
Description
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.
Time Frame
Within 24 hours after admission to the ward
Title
Use of antipsychotics, hypnotics and sedatives
Description
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.
Time Frame
During the stay at the participating wards, assessed from the electronical medical record within 6 months after discharge
Title
Use of medications not recommended for the patient group
Description
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.
Time Frame
During the stay at the participating wards, assessed from the electronical medical record within 6 months after discharge
Title
Departure to rehabilitation or nursing home
Description
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.
Time Frame
Assessed from the electronical medical record, within 6 month after discharge
Title
Length of hospital stay
Description
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.
Time Frame
Assessed from the electronical medical record, within 6 month after discharge
Title
Delirium
Description
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.
Time Frame
Assessed from the electronical medical record, within 6 month after discharge
Title
30-day readmission to the hospital
Description
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.
Time Frame
Readmissions to the hospital were assessed from the electronical medical record 30 days after discharge.
Title
30-day mortality
Description
Proportion of mortality in the patient group within 30 days after discharge from the hospital. Differences between the control group and the intervention group.
Time Frame
Mortality were assessed from the electronical medical record 30 days after discharge.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nina M Weldingh, Master
Organizational Affiliation
University Hospital, Akershus
Official's Role
Principal Investigator
Facility Information:
Facility Name
University hospital, Akershus
City
Lørenskog
ZIP/Postal Code
1478
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
35361136
Citation
Weldingh NM, Mellingsaeter MR, Hegna BW, Benth JS, Einvik G, Juliebo V, Thommessen B, Kirkevold M. Impact of a dementia-friendly program on detection and management of patients with cognitive impairment and delirium in acute-care hospital units: a controlled clinical trial design. BMC Geriatr. 2022 Mar 31;22(1):266. doi: 10.1186/s12877-022-02949-0.
Results Reference
derived

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Effects of a Dementia-friendly Program

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