NCT06014268

Brief Summary

Cardiovascular diseases are the leading cause of premature mortality in people with serious mental illness (such as schizophrenia, bipolar disorder, schizoaffective disorder) and dementia. Atrial fibrillation (AF) is the most prevalent cardiac arrhythmia and is associated with fivefold increased risk of stroke also contributing to heart failure and death. Electronic clinical decision support systems (eCDSS) are computer based programs that analyse data within electronic health records (EHRs) and provide prompts to assist health care providers in implementing evidencebased clinical guidelines. Adoption of an eCDSS to address the risk of stroke in people with AF and co-morbid mental illness presents a unique opportunity for research but requires evidence of acceptability and feasibility. This study aims to establish the feasibility and acceptability of an eCDSS (Cogstack@Maudsley) for AF-related stroke prevention in Mental Health of Older Adults inpatient wards. First, we will conduct surveys and interviews with clinicians on inpatient wards to scope experiences of managing atrial fibrillation in secondary mental healthcare settings and attitudes towards use of digital technologies to aid in clinical decision making. A feasibility study will then be run to evaluate the acceptability and feasibility of implementing eCDSS on inpatient wards. Finally, participating clinicians will be invited to take part in a survey and interview which will explore their experiences and attitudes towards using the eCDSS.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 21, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

August 28, 2023

Status Verified

August 1, 2023

Enrollment Period

1 year

First QC Date

August 23, 2023

Last Update Submit

August 23, 2023

Conditions

Keywords

electronic clinical decision support system

Outcome Measures

Primary Outcomes (1)

  • feasibility and acceptability of the eCDSS

    Acceptability - Extent to which eCDSS is perceived by clinician users to be appropriate and acceptable in prompting evidence-based atrial fibrillation management, and an effective system for improving atrial fibrillation care (measured by qualitative methods - pre- and post- survey and semi-structured interviews). Feasibility - Ability to recruit wards and clinicians to the study (measured by retention and participation of clinicians on recruited wards through to end of study)

    before and 3 months post intervention

Interventions

eCDSS will alert clinicians if patients with documented atrial fibrillation are admitted to the hospital under their care. The eCDSS will consist of prompts appearing on patients' electronic health records asking clinicians to clinically assess the risk of stroke (using CHAD2AD2-VASc tool) and the risk of bleeding (using the ORBIT tool) and record the scores on ePJS. Recommendations include reviewing the stroke and bleeding scores in specific cases, referral to an anticoagulation clinic to reduce AF related stroke risk (a referral template and emails/ telephone of the OAC clinics will be provided) and managing modifiable bleeding risk factors.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

healthcare providers including junior Drs, consultants, and pharmacists on wards participating in the study (AL1 Ward at Maudsley, Chelsham House at Bethlem, Hayworth Ward at Ladywell)

You may qualify if:

  • Wards will be entered in the study if their respective ward manager agrees to participate. Clinical staff on participating wards will be eligible to take part in the study.

You may not qualify if:

  • Staff on recruited wards who are not of a clinical or healthcare professional background

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South London and Maudsley Nhs Foundation Trust

London, BR3 3BX, United Kingdom

Location

MeSH Terms

Conditions

Atrial FibrillationStroke

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2023

First Posted

August 28, 2023

Study Start

March 21, 2023

Primary Completion

March 31, 2024

Study Completion

March 31, 2024

Last Updated

August 28, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations