Atrial FibrillationeCDSSNCT06014268
Electronic Clinical Decision Support System (eCDSS) for Prevention of Atrial Fibrillation-related Stroke
An observational study of Atrial Fibrillation and Stroke, run by South London and Maudsley NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Stroke
- What is being tested?
- electronic clinical decision support system
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Mar 2023to 31 Mar 2024
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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.
Who cannot join
- Staff on recruited wards who are not of a clinical or healthcare professional background
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
South London and Maudsley Nhs Foundation Trust
London, BR3 3BX
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Atrial Fibrillation, Stroke
- Being tested
- electronic clinical decision support system
- Keywords
- electronic clinical decision support system
- Medical subject headings
- Atrial Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electronic clinical decision support systemOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: before and 3 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start21 Mar 2023
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South London and Maudsley NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06014268
- Sponsor's protocol ID
- IRAS 319691
- Acronym
- eCDSS
- Status last verified
- Aug 2023
- First submitted
- 23 Aug 2023
- Last updated
- 28 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of an Electronic Clinical Decision Support System (eCDSS) for Prevention of Atrial Fibrillation-related Stroke in a Mental Healthcare Setting: a Feasibility Study
- ClinicalTrials.gov ID
- NCT06014268
- Acronym / sponsor ID
- eCDSS / IRAS 319691
- Conditions
- Atrial Fibrillation, Stroke
- Keywords
- electronic clinical decision support system
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- South London and Maudsley NHS Foundation TrustUniversity, hospital or other
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 28 Aug 2023 (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.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Staff on recruited wards who are not of a clinical or healthcare professional background
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 |
|---|---|---|
| electronic clinical decision support systemeCDSS 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. | Other | – |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Stroke, run by South London and Maudsley NHS Foundation Trust at 1 site in United Kingdom.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 28 Aug 2023. 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 United Kingdom. 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?
Results are not available in the source record.
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?
feasibility and acceptability of the eCDSS (time frame: before and 3 months post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2023.