Death, Sudden, CardiacNCT02668900
Decision Support for Adults Facing Implantable Cardioverter-Defibrillator Pulse Generator Replacement
A study testing Decision Support in people with Death, Sudden, Cardiac and Death, Sudden, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial summary
The implantable-cardioverter defibrillator (ICD) is a small medical device used to treat dangerously fast and potentially life-threatening heart rates. For patients at risk, the ICD can detect an abnormal rhythm and provide life-saving therapy by delivering a shock. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Death, Sudden, Cardiac, Death, Sudden, Cardiovascular Diseases
- What is being tested?
- Decision Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2016to Oct 2018
- 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
- ICD battery nearing depletion or at elective replacement indicator
- Able to speak and read in English
- Able to provide informed consent; or if incapable of providing informed consent, can be obtained by the patient's appointed substitute decision-maker or power of attorney for personal care.
Who cannot join
- Participants and/or substitute decision maker unable to understand the patient decision aid or decision coaching session due to language barrier or visual impairment
- Participants with cardiac resynchronization therapy (CRT) or participants eligible for an upgrade to CRT.
- Participants with conduction system disease who are pacemaker dependent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Decision Support for Adults Facing Implantable Cardioverter-Defibrillator Pulse Generator Replacement: A Feasibility Study
The implantable-cardioverter defibrillator (ICD) is a small medical device used to treat dangerously fast and potentially life-threatening heart rates. For patients at risk, the ICD can detect an abnormal rhythm and provide life-saving therapy by delivering a shock. ICD therapy has risks and benefits that should be weighed from each patient's perspective. An ICD battery needs to be surgically replaced 4 to 7 years to ensure ongoing function. At present, the majority of these batteries are automatically changed without eliciting patients' preferences. There is a need for a better way to engage with patients. Patients want to be involved in their healthcare decisions, yet more than half of patients with an ICD do not know that ICD replacement is optional. To ensure that patients are receiving treatment that they value and want, members of the interprofessional team should ensure that treatment decisions align with patients' expectations, values and preferences. This rests on the principle of shared decision making in which members of the healthcare team and patients deliberate together to arrive at a decision which best reflects the preferences and values of the patient. To facilitate the achievement of this goal, a patient decision aid (PDA) can be used. As a result, the investigators developed PDA for ICD replacement. The purpose of this feasibility trial is to collect preliminary data to test the feasibility of conducting a larger trial, and to evaluate the PDA for its acceptability and ease of use. Eligible and consented participants facing ICD replacement will be randomized to receive the decision aid or to usual care. The investigators will assess if this decision aid can improve participants' knowledge on ICD therapy and the replacement surgery, increase patients' perceived involvement in the decision, and determine whether their actual choice reflects their personal values.
Read the detailed description
Sudden cardiac death (SCD) due to a ventricular arrhythmia is a serious cause of cardiovascular death in Canada. The implantable cardioverter defibrillator (ICD) can reduce the incidence of SCD in high-risk patients by delivering an internal shock to restore a normal rhythm. The life expectancy of an ICD generator is estimated between four and seven years, and must be surgically replaced to ensure ongoing function. Implantable cardioverter-defibrillator (ICD) replacement is becoming increasingly common constituting nearly 40% of all ICD procedures. For the most part, ICDs are automatically replaced. With every ICD replacement, the net benefit of continued ICD therapy should be assessed individually in view of the procedural risks, inappropriate shocks, psychological risks, changes in health status, and the potential for harm and suffering at end-of-life. Some studies have shown that the mortality benefit of an ICD attenuates with advancing age and comorbidities.
There are many legitimate reasons for declining ICD generator replacement. The chronic nature of a cardiac condition and/or the diagnosis of a life-limiting disease since initial implantation may compel a patient to reconsider their health care goals from supporting quantity of life, to prioritizing one of quality. This is an important distinction as the ICD can prolong the dying process by delivering shock(s) which can result in pain and discomfort for the patient, and helplessness for witnesses. Other patients have reported psychological distress, while others report only truly understanding the effects of living with an ICD after receiving one, possibly leading to changes in treatment preference when they are faced with the decision to replace. Also, the replacement procedure includes a substantially greater risk for infection and reoperation as compared to the initial implantation.
These complexities warrant decision support to prepare patients to make decisions. Yet, no means exists to support patients' decision-making in the context of ICD replacement. A decision support intervention (including a patient decision aid with decision coaching) was developed using a user-centered design with various stakeholders and potential end-users, which could moderate treatment related uncertainty and prepare patients to make high quality decisions that are informed and based on their personal preferences and values.
Objectives:
- Conduct a pilot randomized controlled trial (RCT) to determine the feasibility of conducting a larger trial.
- To determine the effect of the decision support intervention for adults faced with ICD replacement on attributes of decision quality and decision-making processes
- Being tested
- Decision Support
- Keywords
- Feasibility trial, Cardiovascular disease, Decision Support, Patient Decision Aid, implantable cardioverter defibrillator, implantable cardioverter defibrillator replacement
- Medical subject headings
- Death, Sudden, Cardiac, Death, Sudden, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision SupportBehavioural
The decision support intervention includes a patient decision and a decision coaching session. The patient decision aid includes a summary about the ICD's function, and the risks and benefits (including probabilities) associated with the option of replacing or not replacing the ICD. The decision coaching session will be led by a trained, non-directive decision coach who will provide support that aims to develop patients' skills in thinking about the options, assess their values associated with each option, and prepare them to discuss the decision in a consultation with their physician. The final decision, whether to replace or not replace the ICD, will be made with their treating physician (e.g., cardiologist, electrophysiologist).
| Study group | Role | What they receive |
|---|---|---|
| Decision support | Experimental | The decision support intervention includes a patient decision and a decision coaching session. The patient decision aid includes a summary about the ICD's function, and the risks and benefits (including probabilities) associated with the option of replacing or not replacing the ICD. The decision coaching session will be led by a trained, non-directive decision coach who will provide support that aims to develop patients' skills in thinking about the options, assess their values associated with each option, and prepare them to discuss the decision in a consultation with their physician. The final decision, whether to replace or not replace the ICD, will be made with their treating physician (e.g., cardiologist, electrophysiologist). Receives: Behavioral: Decision Support |
| Usual care | No intervention | The control group will not receive the decision support intervention prior to consultation with the physician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pilot RCT (feasibility measure): Participant referral/recruitment rate.
In this feasibility RCT, the feasibility regarding key processes to the success of a larger trial will be assessed. The investigators will descriptively collect the proportion of participant referral versus recruitment rate.
Measured: Baseline to 6 months
Pilot RCT (feasibility measure): Completion of decision support intervention
In this feasibility RCT, the feasibility regarding key processes to the success of a larger trial will be assessed. The investigators will descriptively collect the rate of participants who complete the decision support intervention.
Measured: Baseline to 6 months
PIlot RCT (feasibility measure)
In this feasibility RCT, the feasibility regarding key processes to the success of a larger trial will be assessed. The investigators will descriptively collect the proportion of missing data from the questionnaires.
Measured: Baseline to 6 months
Secondary outcomes (7)
Knowledge
The investigators developed a knowledge test based on the content of the patient decision aid. It was endorsed for validity by the patient decision aid (PtDA) development team using a standardized template in the form of true or false questions. There are six questions meant to assess a patient's understanding of their heart condition, treatment options, and risks and benefits of each option. Correct answers will be summed to determine an overall score.
Measured: 1 month; intervention and usual care groups
Decisional conflict
The Decisional Conflict Scale measures a person's perception of the difficulty in making a decision, the extent to which they feel uncertain about treatment options, are knowledgeable about the risks and benefits of options, clear about personal values, and supported in decision making. The scale has good test-retest reliability (Cronbach's alpha coefficients > 0.78) and predictive validity.
Measured: 1 month, 6 months, 12 months post; intervention and usual care groups
Values about ICD replacement
The investigators developed a values clarification exercise based on the characteristics of the ICD replacement decision. It was endorsed for validity by the patient decision aid (PtDA) development team using a standardized template in the form of likert-type questions. There are four statements meant to help participants consider the risks and benefits of replacing or not replacing the ICD battery than matter most to them. There are no right or wrong answers.
Measured: 1 month; intervention and usual care groups
Preferred option
Preferred option will be measured by asking patients whether they prefer to have their ICD's pulse generator replaced, not replaced, or whether they are unsure using the 15-point Choice Predisposition Scale that demonstrates a patient's inclination toward a given option. This scale has a test-retest coefficient >0.90.
Measured: Baseline visit, 1 month, 6 months, 12 months; intervention and usual care groups
Perceptions of involvement in decision-making
This will be measured using a modified version of Strull, Lo, \& Charles's (1984) role in decision-making survey. Five statements rest along the continuum of how decisions can be made between patients and providers. Participants must select the statement that best represents their perceived involvement in the final decision
Measured: 6 months, 12 months; intervention and usual care groups
The Medical Outcomes Trust Short Form (SF-36v2)
The SF-36 is a reliable and valid generic health related quality of life scale (HRQL) comprised of 36 items. Associations between HRQL and decision choice will be made.
Measured: Baseline visit intervention and usual care groups
Acceptability and Usability of Decision Support
Intervention group participants will be asked common acceptability and usability questions extensively used for evaluating PtDAs during development (Barry, Cherkin, Chang, Fowler, \& Skates, 1997; Kushniruk \& Patel, 2004; O'Connor \& Cranney, 2002). Patients' satisfaction with decision coaching will be measured using the Genetic Counseling Satisfaction Scale and perceptions of decision coach neutrality (Schwalm, Stacey, Pericak, \& Natarajan, 2012; Tercyak, Johnson, Roberts, \& Cruz, 2001). This scale has face validity and a reliability coefficient of alpha 0.80 to 0.90 in genetic counselling contexts with adults.
Measured: 1 month; intervention group only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2018
- Study completionOct 2018
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 Death, Sudden, CardiacStudies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Birnie, Ottawa Heart Institute Research Corporation
- Investigators
- Dawn Stacey, RN, PhD, Study director, University of Ottawa; Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02668900
- Sponsor's protocol ID
- UOHI-06
- Status last verified
- Dec 2018
- First submitted
- 15 Jan 2016
- Last updated
- 24 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lewis KB, Birnie D, Carroll SL, Brousseau-Whaley C, Clark L, Green M, Nair GM, Nery PB, Redpath C, Stacey D. Decision Support for Implantable Cardioverter-Defibrillator Replacement: A Pilot Feasibility Randomized Controlled Trial. J Cardiovasc Nurs. 2021 Mar-Apr 01;36(2):143-150. doi: 10.1097/JCN.0000000000000694.
PubMed 32453274
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Decision Support for Adults Facing Implantable Cardioverter-Defibrillator Pulse Generator Replacement: A Feasibility Study
- ClinicalTrials.gov ID
- NCT02668900
- Acronym / sponsor ID
- UOHI-06
- Keywords
- Feasibility trial, Cardiovascular disease, Decision Support, Patient Decision Aid, implantable cardioverter defibrillator, implantable cardioverter defibrillator replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Apr 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 29 Jan 2016 (estimated)
- 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 implantable-cardioverter defibrillator (ICD) is a small medical device used to treat dangerously fast and potentially life-threatening heart rates. For patients at risk, the ICD can detect an abnormal rhythm and provide life-saving therapy by delivering a shock. ICD therapy has risks and benefits that should be weighed from each patient's perspective. An ICD battery needs to be surgically replaced 4 to 7 years to ensure ongoing function. At present, the majority of these batteries are automatically changed without eliciting patients' preferences. There is a need for a better way to engage with patients. Patients want to be involved in their healthcare decisions, yet more than half of patients with an ICD do not know that ICD replacement is optional. To ensure that patients are receiving treatment that they value and want, members of the interprofessional team should ensure that treatment decisions align with patients' expectations, values and preferences. This rests on the principle of shared decision making in which members of the healthcare team and patients deliberate together to arrive at a decision which best reflects the preferences and values of the patient. To facilitate the achievement of this goal, a patient decision aid (PDA) can be used. As a result, the investigators developed PDA for ICD replacement. The purpose of this feasibility trial is to collect preliminary data to test the feasibility of conducting a larger trial, and to evaluate the PDA for its acceptability and ease of use. Eligible and consented participants facing ICD replacement will be randomized to receive the decision aid or to usual care. The investigators will assess if this decision aid can improve participants' knowledge on ICD therapy and the replacement surgery, increase patients' perceived involvement in the decision, and determine whether their actual choice reflects their personal values.
Detailed description
Sudden cardiac death (SCD) due to a ventricular arrhythmia is a serious cause of cardiovascular death in Canada. The implantable cardioverter defibrillator (ICD) can reduce the incidence of SCD in high-risk patients by delivering an internal shock to restore a normal rhythm. The life expectancy of an ICD generator is estimated between four and seven years, and must be surgically replaced to ensure ongoing function. Implantable cardioverter-defibrillator (ICD) replacement is becoming increasingly common constituting nearly 40% of all ICD procedures. For the most part, ICDs are automatically replaced. With every ICD replacement, the net benefit of continued ICD therapy should be assessed individually in view of the procedural risks, inappropriate shocks, psychological risks, changes in health status, and the potential for harm and suffering at end-of-life. Some studies have shown that the mortality benefit of an ICD attenuates with advancing age and comorbidities.
There are many legitimate reasons for declining ICD generator replacement. The chronic nature of a cardiac condition and/or the diagnosis of a life-limiting disease since initial implantation may compel a patient to reconsider their health care goals from supporting quantity of life, to prioritizing one of quality. This is an important distinction as the ICD can prolong the dying process by delivering shock(s) which can result in pain and discomfort for the patient, and helplessness for witnesses. Other patients have reported psychological distress, while others report only truly understanding the effects of living with an ICD after receiving one, possibly leading to changes in treatment preference when they are faced with the decision to replace. Also, the replacement procedure includes a substantially greater risk for infection and reoperation as compared to the initial implantation.
These complexities warrant decision support to prepare patients to make decisions. Yet, no means exists to support patients' decision-making in the context of ICD replacement. A decision support intervention (including a patient decision aid with decision coaching) was developed using a user-centered design with various stakeholders and potential end-users, which could moderate treatment related uncertainty and prepare patients to make high quality decisions that are informed and based on their personal preferences and values.
Objectives:
- Conduct a pilot randomized controlled trial (RCT) to determine the feasibility of conducting a larger trial.
- To determine the effect of the decision support intervention for adults faced with ICD replacement on attributes of decision quality and decision-making processes
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decision support | Experimental | Behavioral: Decision SupportThe decision support intervention includes a patient decision and a decision coaching session. The patient decision aid includes a summary about the ICD's function, and the risks and benefits (including probabilities) associated with the option of replacing or not replacing the ICD. The decision coaching session will be led by a trained, non-directive decision coach who will provide support that aims to develop patients' skills in thinking about the options, assess their values associated with each option, and prepare them to discuss the decision in a consultation with their physician. The final decision, whether to replace or not replace the ICD, will be made with their treating physician (e.g., cardiologist, electrophysiologist). |
| Usual care | No intervention | –The control group will not receive the decision support intervention prior to consultation with the physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ICD battery nearing depletion or at elective replacement indicator
- Able to speak and read in English
- Able to provide informed consent; or if incapable of providing informed consent, can be obtained by the patient's appointed substitute decision-maker or power of attorney for personal care.
Key exclusion criteria (3 listed)
- Participants and/or substitute decision maker unable to understand the patient decision aid or decision coaching session due to language barrier or visual impairment
- Participants with cardiac resynchronization therapy (CRT) or participants eligible for an upgrade to CRT.
- Participants with conduction system disease who are pacemaker dependent
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 |
|---|---|---|
| Decision SupportThe decision support intervention includes a patient decision and a decision coaching session. The patient decision aid includes a summary about the ICD's function, and the risks and benefits (including probabilities) associated with the option of replacing or not replacing the ICD. The decision coaching session will be led by a trained, non-directive decision coach who will provide support that aims to develop patients' skills in thinking about the options, assess their values associated with each option, and prepare them to discuss the decision in a consultation with their physician. The final decision, whether to replace or not replace the ICD, will be made with their treating physician (e.g., cardiologist, electrophysiologist). | Behavioural | Decision support |
Primary outcome
Pilot RCT (feasibility measure): Participant referral/recruitment rate.
Time frame: Baseline to 6 months
In this feasibility RCT, the feasibility regarding key processes to the success of a larger trial will be assessed. The investigators will descriptively collect the proportion of participant referral versus recruitment rate.
Pilot RCT (feasibility measure): Completion of decision support intervention
Time frame: Baseline to 6 months
In this feasibility RCT, the feasibility regarding key processes to the success of a larger trial will be assessed. The investigators will descriptively collect the rate of participants who complete the decision support intervention.
PIlot RCT (feasibility measure)
Time frame: Baseline to 6 months
In this feasibility RCT, the feasibility regarding key processes to the success of a larger trial will be assessed. The investigators will descriptively collect the proportion of missing data from the questionnaires.
7 secondary outcomes
Knowledge
Time frame: 1 month; intervention and usual care groups
Decisional conflict
Time frame: 1 month, 6 months, 12 months post; intervention and usual care groups
Values about ICD replacement
Time frame: 1 month; intervention and usual care groups
Preferred option
Time frame: Baseline visit, 1 month, 6 months, 12 months; intervention and usual care groups
Perceptions of involvement in decision-making
Time frame: 6 months, 12 months; intervention and usual care groups
The Medical Outcomes Trust Short Form (SF-36v2)
Time frame: Baseline visit intervention and usual care groups
Acceptability and Usability of Decision Support
Time frame: 1 month; intervention group only
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 24 Dec 2018.
- Derived from this study: PubMed 32453274Lewis KB, Birnie D, Carroll SL, Brousseau-Whaley C, Clark L, Green M, Nair GM, Nery PB, Redpath C, Stacey D. Decision Support for Implantable Cardioverter-Defibrillator Replacement: A Pilot Feasibility Randomized Controlled Trial. J Cardiovasc Nurs. 2021 Mar-Apr 01;36(2):143-150. doi: 10.1097/JCN.0000000000000694.
- 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.
Dawn Stacey, RN, PhD study director
University of Ottawa; Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision Support in people with Death, Sudden, Cardiac and Death, Sudden, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
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 3 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 24 Dec 2018. 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 Canada. 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?
Pilot RCT (feasibility measure): Participant referral/recruitment rate. (time frame: Baseline to 6 months). The study lists 3 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 NCT02668900, 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 24 Dec 2018.