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Effects of a Dementia-friendly Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04737733
Recruitment Status : Completed
First Posted : February 4, 2021
Last Update Posted : February 4, 2021
Sponsor:
Information provided by (Responsible Party):
Nina Mickelson Weldingh, University Hospital, Akershus

Study Description
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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.

Condition or disease Intervention/treatment Phase
Delirium Cognitive Impairment Dementia Other: The dementia friendly program Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 423 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: A non-equivalent control group design with a historical control group
Masking: None (Open Label)
Primary Purpose: Health Services Research
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
Actual Study Start Date : November 22, 2018
Actual Primary Completion Date : March 30, 2020
Actual Study Completion Date : June 16, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium Dementia

Arms and Interventions
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Arm Intervention/treatment
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    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.

  2. 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 ]
    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 :
  1. Screening within 24 hours [ Time Frame: Within 24 hours after admission to the ward ]
    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.

  2. 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 ]
    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.

  3. 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 ]
    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.

  4. Departure to rehabilitation or nursing home [ Time Frame: Assessed from the electronical medical record, within 6 month after discharge ]
    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.

  5. Length of hospital stay [ Time Frame: Assessed from the electronical medical record, within 6 month after discharge ]
    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.

  6. Delirium [ Time Frame: Assessed from the electronical medical record, within 6 month after discharge ]
    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.

  7. 30-day readmission to the hospital [ Time Frame: Readmissions to the hospital were assessed from the electronical medical record 30 days after discharge. ]
    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.

  8. 30-day mortality [ Time Frame: Mortality were assessed from the electronical medical record 30 days after discharge. ]
    Proportion of mortality in the patient group within 30 days after discharge from the hospital. Differences between the control group and the intervention group.


Eligibility Criteria
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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04737733


Locations
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Norway
University hospital, Akershus
Lørenskog, Norway, 1478
Sponsors and Collaborators
University Hospital, Akershus
Investigators
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Principal Investigator: Nina M Weldingh, Master University Hospital, Akershus
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Nina Mickelson Weldingh, Prinsipal Investigator, University Hospital, Akershus
ClinicalTrials.gov Identifier: NCT04737733    
Other Study ID Numbers: 2018/666(REK)
First Posted: February 4, 2021    Key Record Dates
Last Update Posted: February 4, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dementia
Delirium
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations