NCT04737733

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
423

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 22, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 4, 2021

Completed
Last Updated

February 4, 2021

Status Verified

January 1, 2021

Enrollment Period

1.4 years

First QC Date

January 26, 2021

Last Update Submit

January 29, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (8)

  • Screening within 24 hours

    Within 24 hours after admission to the ward

  • Use of antipsychotics, hypnotics and sedatives

    During the stay at the participating wards, assessed from the electronical medical record within 6 months after discharge

  • Use of medications not recommended for the patient group

    During the stay at the participating wards, assessed from the electronical medical record within 6 months after discharge

  • Departure to rehabilitation or nursing home

    Assessed from the electronical medical record, within 6 month after discharge

  • Length of hospital stay

    Assessed from the electronical medical record, within 6 month after discharge

  • +3 more secondary outcomes

Study Arms (1)

The dementia friendly hospital program

OTHER

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.

Other: The dementia friendly program

Interventions

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.

The dementia friendly hospital program

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital, Akershus

Lørenskog, 1478, Norway

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

DeliriumCognitive DysfunctionDementia

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersCognition DisordersBrain DiseasesCentral Nervous System Diseases

Study Officials

  • Nina M Weldingh, Master

    University Hospital, Akershus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: A non-equivalent control group design with a historical control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinsipal Investigator

Study Record Dates

First Submitted

January 26, 2021

First Posted

February 4, 2021

Study Start

November 22, 2018

Primary Completion

March 30, 2020

Study Completion

June 16, 2020

Last Updated

February 4, 2021

Record last verified: 2021-01

Locations