Implantable Cardioverter-defibrillators (ICDs)NCT03832868
Syngery-Evaluating the Impact of Decision Aid
A study testing Pre-visit timing of receipt of the ICDs implantation decision aid and Post-visit timing of receipt of the ICDs implantation decision aid in people with Implantable Cardioverter-defibrillators (ICDs), run by Emory University at 3 sites in United States.
Trial summary
The aim of this study is to determine whether it is better to give patients an implantable cardioverter-defibrillators (ICDs) decision aid before they have their first consultation with an implanting cardiac electrophysiologist or after the consult. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Implantable Cardioverter-defibrillators (ICDs)
- What is being tested?
- Pre-visit timing of receipt of the ICDs implantation decision aid and Post-visit timing of receipt of the ICDs implantation decision aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Feb 2019to 6 Sep 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old and older
- evaluated for primary prevention implantable cardioverter-defibrillators (ICDs)
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Emory St. Joseph's Hospital
Atlanta, Georgia, 30322
Emory University Hospital Midtown
Atlanta, Georgia, 30322
Emory University Hospital
Atlanta, Georgia, 30322
About this study
Official title: Evaluating the Impact of Decision Aid Timing on Mandatory Shared Decision Making for Defibrillator Implantation
The aim of this study is to determine whether it is better to give patients an implantable cardioverter-defibrillators (ICDs) decision aid before they have their first consultation with an implanting cardiac electrophysiologist or after the consult.
Read the detailed description
There are many unanswered questions about how shared decision making should be executed and how decision aids should be employed. The aim of this study is to determine whether it is better to give patients an implantable cardioverter-defibrillators (ICDs) decision aid before they have their first consultation with an implanting cardiac electrophysiologist or after the consult.
- Being tested
- Pre-visit timing of receipt of the ICDs implantation decision aid, Post-visit timing of receipt of the ICDs implantation decision aid
- Keywords
- Decision aid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-visit timing of receipt of the ICDs implantation decision aidBehavioural
The intervention is the timing of receipt of the decision aid. The decision aid is designed to facilitate informing patients and helping to reach a decision.The implantable cardioverter-defibrillators (ICDs) implantation decision aid presents treatment options, risks, and benefits in lay terms.It is currently utilized in all of the Emory cardiac electrophysiology clinics as part of usual clinical care.
Post-visit timing of receipt of the ICDs implantation decision aidBehavioural
The intervention is the timing of receipt of the decision aid. The decision aid is designed to facilitate informing patients and helping to reach a decision.The implantable cardioverter-defibrillators (ICDs) implantation decision aid presents treatment options, risks, and benefits in lay terms.It is currently utilized in all of the Emory cardiac electrophysiology clinics as part of usual clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Pre-visit decision aid | Experimental | Patients receiving the decision aid pre-visit will be given a paper copy of the decision aid in the waiting room and will have a minimum of 15 minutes to review it - either in the waiting room or in the exam room while waiting for the electrophysiologist. Receives: Behavioral: Pre-visit timing of receipt of the ICDs implantation decision aid |
| Post-visit decision aid | Experimental | Patients receiving the decision aid after the encounter will meet with the electrophysiologist first and receive the aid afterward. Receives: Behavioral: Post-visit timing of receipt of the ICDs implantation decision aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional ICDs knowledge score among pre-visit arm participants compare to post-visit arm participants
Patients will receive a survey including 11 questions to gauge decisional knowledge about ICDs. The survey is expected to take no more than 10-15 minutes to complete, which should allow adequate time for completion in the pre-procedure area without interrupting clinical workflow.
Measured: Date of ICD implantation (up to 60 days from the date of receiving the decision aid)
Secondary outcomes (2)
Decision Conflict Scale score among pre-visit arm participants compare to post-visit arm participants
Patients will receive a survey including 12 questions to measure decisional conflict. The surveys are expected to take no more than 10-15 minutes to complete, which should allow adequate time for completion in the pre-procedure area without interrupting clinical workflow.
Measured: Date of ICD implantation (up to 60 days from the date of receiving the decision aid)
Values-choice ICDs concordance score among pre-visit arm participants compare to post-visit arm participants
Patients will receive a survey including 12 questions to measure values-choice concordance. The surveys are expected to take no more than 10-15 minutes to complete, which should allow adequate time for completion in the pre-procedure area without interrupting clinical workflow.
Measured: Date of ICD implantation (up to 60 days from the date of receiving the decision aid)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start20 Feb 2019
- Primary completion6 Sep 2019
- Study completion6 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implantable Cardioverter-defibrillators (ICDs)Studies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinic sites will be block-randomized to eliminate contamination induced by individual-level randomization for a system-level intervention. Each site will rotate on a monthly basis whether the decision aid is administered pre- or post-office visit, and this will be applied to all ICD patients. Each site will have a minimum of 2 months exposure to each "arm." No blinding will occur.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faisal Merchant MD, Emory University
- Investigators
- Faisal Merchant, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03832868
- Sponsor's protocol ID
- IRB00107168
- Status last verified
- Sep 2019
- First submitted
- 4 Feb 2019
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data is being collected in REDCAP and is deidentified. The study team will have the tool to match subjects if needed. The team has no current plans to share data, but can if necessary (including the data dictionaries). All data can be shared after being deidentified.The study team can share the protocol, statistical plan, ICF, and survey tool. The decision tool is already available. Data will be available immediately following publication and for 3 years after. Those requesting access to data should contact the principal investigator (Dr. Faisal Merchant). Requests will be evaluated based on need and data usage agreement.
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Decision Aid Timing on Mandatory Shared Decision Making for Defibrillator Implantation
- ClinicalTrials.gov ID
- NCT03832868
- Acronym / sponsor ID
- IRB00107168
- Keywords
- Decision aid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 20 Feb 2019 (actual)
- Primary completion
- 6 Sep 2019 (actual)
- Study completion
- 6 Sep 2019 (actual)
- First posted
- 6 Feb 2019 (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.
The aim of this study is to determine whether it is better to give patients an implantable cardioverter-defibrillators (ICDs) decision aid before they have their first consultation with an implanting cardiac electrophysiologist or after the consult.
Detailed description
There are many unanswered questions about how shared decision making should be executed and how decision aids should be employed. The aim of this study is to determine whether it is better to give patients an implantable cardioverter-defibrillators (ICDs) decision aid before they have their first consultation with an implanting cardiac electrophysiologist or after the consult.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Clinic sites will be block-randomized to eliminate contamination induced by individual-level randomization for a system-level intervention. Each site will rotate on a monthly basis whether the decision aid is administered pre- or post-office visit, and this will be applied to all ICD patients. Each site will have a minimum of 2 months exposure to each "arm." No blinding will occur.
| Arm | Type | Receives |
|---|---|---|
| Pre-visit decision aid | Experimental | Behavioral: Pre-visit timing of receipt of the ICDs implantation decision aidPatients receiving the decision aid pre-visit will be given a paper copy of the decision aid in the waiting room and will have a minimum of 15 minutes to review it - either in the waiting room or in the exam room while waiting for the electrophysiologist. |
| Post-visit decision aid | Experimental | Behavioral: Post-visit timing of receipt of the ICDs implantation decision aidPatients receiving the decision aid after the encounter will meet with the electrophysiologist first and receive the aid afterward. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years old and older
- evaluated for primary prevention implantable cardioverter-defibrillators (ICDs)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Pre-visit timing of receipt of the ICDs implantation decision aidThe intervention is the timing of receipt of the decision aid. The decision aid is designed to facilitate informing patients and helping to reach a decision.The implantable cardioverter-defibrillators (ICDs) implantation decision aid presents treatment options, risks, and benefits in lay terms.It is currently utilized in all of the Emory cardiac electrophysiology clinics as part of usual clinical care. | Behavioural | Pre-visit decision aid |
| Post-visit timing of receipt of the ICDs implantation decision aidThe intervention is the timing of receipt of the decision aid. The decision aid is designed to facilitate informing patients and helping to reach a decision.The implantable cardioverter-defibrillators (ICDs) implantation decision aid presents treatment options, risks, and benefits in lay terms.It is currently utilized in all of the Emory cardiac electrophysiology clinics as part of usual clinical care. | Behavioural | Post-visit decision aid |
Primary outcome
Decisional ICDs knowledge score among pre-visit arm participants compare to post-visit arm participants
Time frame: Date of ICD implantation (up to 60 days from the date of receiving the decision aid)
Patients will receive a survey including 11 questions to gauge decisional knowledge about ICDs. The survey is expected to take no more than 10-15 minutes to complete, which should allow adequate time for completion in the pre-procedure area without interrupting clinical workflow.
2 secondary outcomes
Decision Conflict Scale score among pre-visit arm participants compare to post-visit arm participants
Time frame: Date of ICD implantation (up to 60 days from the date of receiving the decision aid)
Values-choice ICDs concordance score among pre-visit arm participants compare to post-visit arm participants
Time frame: Date of ICD implantation (up to 60 days from the date of receiving the decision aid)
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 12 Sep 2019.
- Individual participant dataSharing planned: Yes. Data is being collected in REDCAP and is deidentified. The study team will have the tool to match subjects if needed. The team has no current plans to share data, but can if necessary (including the data dictionaries). All data can be shared after being deidentified.The study team can share the protocol, statistical plan, ICF, and survey tool. The decision tool is already available. Data will be available immediately following publication and for 3 years after. Those requesting access to data should contact the principal investigator (Dr. Faisal Merchant). Requests will be evaluated based on need and data usage agreement.
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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.
Faisal Merchant, MD principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-visit timing of receipt of the ICDs implantation decision aid and Post-visit timing of receipt of the ICDs implantation decision aid in people with Implantable Cardioverter-defibrillators (ICDs), run by Emory University at 3 sites in United States.
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 2 inclusion and 0 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 12 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Decisional ICDs knowledge score among pre-visit arm participants compare to post-visit arm participants (time frame: Date of ICD implantation (up to 60 days from the date of receiving the decision aid)). 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 12 Sep 2019.