DeliriumNCT04737733
Effects of a Dementia-friendly Program
A study testing The dementia friendly program in people with Delirium and Cognitive Impairment, run by University Hospital, Akershus at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Delirium, Cognitive Impairment, Dementia
- What is being tested?
- The dementia friendly program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 423 participants
- Where
- 1 siteNorway
- Study dates
- 22 Nov 2018to 16 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Delirium, Cognitive Impairment, Dementia
- Being tested
- The dementia friendly program
- Medical subject headings
- Delirium, Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The dementia friendly programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: The dementia friendly program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: Within 24 hours after admission to the ward
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.
Measured: 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
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.
Measured: During the stay at the participating wards, assessed from the electronical medical record within 6 months after discharge
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.
Measured: Assessed from the electronical medical record, within 6 month after discharge
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.
Measured: Assessed from the electronical medical record, within 6 month after discharge
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.
Measured: Assessed from the electronical medical record, within 6 month after discharge
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.
Measured: Readmissions to the hospital were assessed from the electronical medical record 30 days after discharge.
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.
Measured: Mortality were assessed from the electronical medical record 30 days after discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start22 Nov 2018
- Primary completion30 Mar 2020
- Study completion16 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A non-equivalent control group design with a historical control group
- Masking
- None (open label)
- Enrolment
- 423 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nina Mickelson Weldingh, University Hospital, Akershus
- Investigators
- Nina M Weldingh, Master, Principal investigator, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04737733
- Sponsor's protocol ID
- 2018/666(REK)
- Status last verified
- Jan 2021
- First submitted
- 26 Jan 2021
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35361136
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04737733
- Acronym / sponsor ID
- 2018/666(REK)
- Conditions
- Delirium, Cognitive Impairment, Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 423 participants (actual)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Study start
- 22 Nov 2018 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 16 Jun 2020 (actual)
- First posted
- 4 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A non-equivalent control group design with a historical control group
| Arm | Type | Receives |
|---|---|---|
| The dementia friendly hospital program | Other | Other: The dementia friendly programThe 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. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The dementia friendly programImplementation 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. | Other | The dementia friendly hospital program |
Primary outcome
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.
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.
8 secondary outcomes
Screening within 24 hours
Time frame: Within 24 hours after admission to the ward
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
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
Departure to rehabilitation or nursing home
Time frame: Assessed from the electronical medical record, within 6 month after discharge
Length of hospital stay
Time frame: Assessed from the electronical medical record, within 6 month after discharge
Delirium
Time frame: Assessed from the electronical medical record, within 6 month after discharge
30-day readmission to the hospital
Time frame: Readmissions to the hospital were assessed from the electronical medical record 30 days after discharge.
30-day mortality
Time frame: Mortality were assessed from the electronical medical record 30 days after discharge.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Derived from this study: PubMed 35361136Weldingh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nina M Weldingh, Master principal investigator
University Hospital, Akershus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The dementia friendly program in people with Delirium and Cognitive Impairment, run by University Hospital, Akershus at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04737733, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.