Electronic Clinical Decision Support System (eCDSS) for Prevention of Atrial Fibrillation-related Stroke (eCDSS)

August 23, 2023 updated by: South London and Maudsley NHS Foundation Trust

Implementation of an Electronic Clinical Decision Support System (eCDSS) for Prevention of Atrial Fibrillation-related Stroke in a Mental Healthcare Setting: a Feasibility Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Cardiovascular diseases are the leading cause of premature mortality in people with serious mental illness (SMI) (such as schizophrenia, bipolar disorder, and 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.

According to the National Institute for Health and Care Excellence (NICE) guidelines, the management of AF requires a comprehensive assessment of risk factors for thromboembolic (using the CHAD2AD2-VASc tool) and bleeding events (using ORBIT or HAS-BLED tools), and long-term treatment with oral anticoagulants (OAC) when appropriate.

Although oral anticoagulation has been effective in reducing the risk of stroke in people with AF, underuse continues to be reported, especially in patients with co-morbid SMI and/or dementia.

The primary objective of this study is to establish the feasibility and acceptability of an eCDSS compromising a real-time computerised alerting and clinical decision support system for AF-related stroke prevention in secondary mental healthcare. We will conduct a process evaluation to assess the barriers, facilitators, and unintended consequences of implementing the system onto an inpatient mental health of older adult ward. Data gathered from this study will allow us to refine the system, address potential problems with future successful implementation, and inform larger trials.

This feasibility study will be conducted over a period of 3 months in Mental Health of Older Adults inpatient wards at South London and Maudsley NHS Foundation Trust.

Wards participating in the study will receive the electronic clinical decision support system (eCDSS) with clinicians being the end-users.

The key digital tool to be used for eCDSS in this study is CogStack which is an open source information retrieval and extraction system with the capability to offer near real-time natural language processing (NLP) of electronic health records. The eCDSS will alert clinicians if patients with documented atrial fibrillation are admitted to the hospital under their care. Alerts will be triggered by the presence of old or new diagnosis of atrial fibrillation (AF) on the electronic health records.

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 in clinical notes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, BR3 3BX
        • South London and Maudsley NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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)

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
feasibility and acceptability of the eCDSS
Time Frame: before and 3 months post intervention

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
South London and Maudsley NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 21, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRAS 319691

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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