An interventional study of Decision Support in Death, Sudden, Cardiac, Death, Sudden and Cardiovascular Diseases, sponsored by Ottawa Heart Institute Research Corporation. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Ottawa Heart Institute Research Corporation · Not applicable, Interventional, and Health services research
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.
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:
363 studies on the registry are indexed under Death, Sudden, Cardiac; 84 are open to participants now.
This study's enrollment of 30 is below the median of 126 across 135 interventional studies indexed under Death, Sudden, Cardiac.
Browse Death, Sudden, Cardiac studies →Ottawa Heart Institute Research Corporation is the lead sponsor of 182 studies on the registry; 42 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Behavioral: Decision Support
The control group will not receive the decision support intervention prior to consultation with the physician.
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).
Pilot RCT (Feasibility Measure): Participant Referral/Recruitment Rate.
Time frame: Baseline to 12 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.
Time frame: Baseline to 6 months
Percentage of Participants With Missing Questionnaires
The percentage of participants with missing questionnaire data is reported.
Time frame: Baseline to 6 months
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. Reported scores are the mean percentage of correctly answered questions from the knowledge based test.
Time frame: Measured at 2-4 week Follow Up
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. The scores for each item range from 0-4. The scores for all items are summed, then divided by 16 and multiplied by 25. Total scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict). Scores lower than 25 are associated with decision implementation and scores higher than 37.5 are associated with delayed decisions.
Time frame: 1 month, 6 months, 12 months follow-up
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. Score scale 1-15 with lower scores indicating a preference to not replacing the ICD, and high scores toward replacing.
Time frame: Assessed at 2-4 weeks
Perceptions of Involvement in Decision-making at 6Months
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. Results are cumulative across timepoints.
Time frame: at 6 month follow up
Perceptions of Involvement in Decision-making at 12Months
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. Results are cumulative across timepoints.
Time frame: at 12 month follow up
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. Score ranges from 0 to 100. Higher scores indicate better perception of health.
Time frame: Baseline visit intervention and usual care groups
Acceptability and Usability of Patient Decision Aid
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). Results are reported as the number of participants selecting the highest acceptability for each category with the most positive answer in parenthesis in the row title.
Time frame: 1 month; intervention group only
Participant Satisfaction With Decision Coaching
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. Results are reported as number of participants that rated the highest satisfaction for each question, with the most positive response in parentheses in the row name.
Time frame: 1 month; intervention group only
Actual Choice at 6months
The number of participants who chose to accept ICD replacement, or decline ICD replacement. Only participants that were required to make a final decision and procedure dates occurred at the 6 month timeline.
Time frame: 6 month followup; intervention and usual care groups
Actual Choice at 12months
The number of participants who chose to accept ICD replacement or decline ICD replacement. Results include only those participants required to make a final decision, with procedure dates up to the 12month follow-up. Note that the results at 12months include those at 6months as cumulative data.
Time frame: 12 month followup; intervention and usual care groups
Survival
The number of participants who are alive or dead at 6 months and 12months.
Time frame: 6 months, 12 months; intervention and usual care groups14
| Milestone | Decision Support | Usual Care |
|---|---|---|
| Started | 14 | 15 |
| Completed | 14 | 15 |
| Not completed | 0 | 0 |
| Milestone | Decision Support | Usual Care |
|---|---|---|
| Started | 14 | 15 |
| Completed | 13 | 15 |
| Not completed | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Milestone | Decision Support | Usual Care |
|---|---|---|
| Started | 13 | 15 |
| Completed | 12 | 14 |
| Not completed | 1 | 1 |
| Withdrew: Death | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Participants | Total Population |
|---|---|
| Assessed for eligibility | 129 |
| Eligible | 48 |
| Randomized | 30 |
| Received treatment | 29 |
| Completed 2-4 week follow up | 29 |
| Completed 6month follow up | 28 |
| Completed 12month follow up | 26 |
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.
| Participants | Decision Support | Usual Care |
|---|---|---|
| Pilot RCT (Feasibility Measure): Completion of Decision Support Intervention | 14 | — |
The percentage of participants with missing questionnaire data is reported.
| Participants | Decision Support | Usual Care |
|---|---|---|
| Percentage of Participants With Missing Questionnaires | 2 | 1 |
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. Reported scores are the mean percentage of correctly answered questions from the knowledge based test.
| Percent | Decision Support | Usual Care |
|---|---|---|
| Knowledge | 77.4 ± 16.8 | 51.1 ± 24.0 |
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. The scores for each item range from 0-4. The scores for all items are summed, then divided by 16 and multiplied by 25. Total scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict). Scores lower than 25 are associated with decision implementation and scores higher than 37.5 are associated with delayed decisions.
| Score on a scale | Decision Support | Usual Care |
|---|---|---|
| Total Score - 2 to 4 Week follow up | 8.0 ± 13.8 | 14.3 ± 18.4 |
| Total Score - 6 months | 16.2 ± 13.5 | 14.6 ± 16.1 |
| Total Score - 12 months | 14.1 ± 17.1 | 11.4 ± 13.7 |
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. Score scale 1-15 with lower scores indicating a preference to not replacing the ICD, and high scores toward replacing.
| Scale Score | Decision Support | Usual Care |
|---|---|---|
| Preferred Option | 14.0 ± 1.8 | 13.1 ± 3.3 |
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. Results are cumulative across timepoints.
| Participants | Decision Support | Usual Care |
|---|---|---|
| Physician decided — at 6 Months | 0 | 3 |
| Physician decided with patient's opinion — at 6 Months | 2 | 1 |
| Physician and patient decided together — at 6 Months | 0 | 2 |
| Patient decided with physician's opinion — at 6 Months | 1 | 1 |
| Patient decided — at 6 Months | 2 | 1 |
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. Results are cumulative across timepoints.
| Participants | Decision Support | Usual Care |
|---|---|---|
| Physician decided | 0 | 3 |
| Physician decided with patient's opinion | 1 | 1 |
| Physician and patient decided together | 1 | 2 |
| Patient decided with physician's opinion | 3 | 2 |
| Patient decided | 3 | 3 |
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. Score ranges from 0 to 100. Higher scores indicate better perception of health.
| Score 0-100 | Decision Support | Usual Care |
|---|---|---|
| Physical Component Summary (PCS) | 44.5 ± 13.9 | 47.8 ± 11.7 |
| Mental Component Summary (MCS) | 53.6 ± 9.7 | 49.4 ± 10.9 |
The number of participants who chose to accept ICD replacement, or decline ICD replacement. Only participants that were required to make a final decision and procedure dates occurred at the 6 month timeline.
| Participants | Decision Support | Usual Care |
|---|---|---|
| Replaced ICD | 4 | 7 |
| Did not replace ICD | 1 | 1 |
The number of participants who chose to accept ICD replacement or decline ICD replacement. Results include only those participants required to make a final decision, with procedure dates up to the 12month follow-up. Note that the results at 12months include those at 6months as cumulative data.
| Participants | Decision Support | Usual Care |
|---|---|---|
| Replaced ICD | 8 | 10 |
| Did not replace ICD | 1 | 1 |
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). Results are reported as the number of participants selecting the highest acceptability for each category with the most positive answer in parenthesis in the row title.
| Participants | Intervention Arm |
|---|---|
| Amount of Information (about right) | 13 |
| Length of the Patient Decision Aid (about right) | 13 |
| Balanced presentation of options (completely balanced) | 13 |
| Font size and readable (yes) | 13 |
| Enough space to write notes (yes) | 13 |
| Language in the Patient Decision Aid makes sense (yes) | 14 |
| Patient Decision Aid fits into discussion with clinician (yes, as it is) | 10 |
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. Results are reported as number of participants that rated the highest satisfaction for each question, with the most positive response in parentheses in the row name.
| Participants | Intervention Arm |
|---|---|
| The decision coach seemed to understand the stresses I was facing (agree strongly) | 11 |
| Decision Coach helped me to identify what I needed to know and what would happen (agree strongly) | 9 |
| I felt better about my decision after meeting with the decision coach (agree strongly) | 7 |
| The decision coach was concerned with my well-being (agree strongly) | 11 |
| The decision coaching session was valuable to me (agree strongly) | 8 |
| Was the decision coaching helpful for you to come to a preferred option (very helpful) | 7 |
| Would you recommend decision coaching to others (definitely recommend) | 11 |
| Was the decision coaching about the right length of time ( agree strongly) | 9 |
| Did the coaching session prepare you for follow up in the device clinic (yes) | 11 |
The number of participants who are alive or dead at 6 months and 12months.
| Participants | Decision Support | Usual Care |
|---|---|---|
| Participants alive at 6Months | 14 | 15 |
| Participants alive at 12Months | 13 | 15 |
Collected over Enrollment to 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Decision Support | 1/14 (7.1%) | 1/14 (7.1%) | 0/14 (0%) |
| Usual Care | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Event | Decision Support | Usual Care |
|---|---|---|
| All Cause MortalityGeneral disorders | 1/14 | 0/15 |
| Age, Categorical(Participants) | Decision Support | Usual Care | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 7 | 7 | 14 |
| >=65 years | 7 | 8 | 15 |
| Age, Continuous(years) | Decision Support | Usual Care | Total |
|---|---|---|---|
| Mean | 63.8 ± 10.4 | 63.4 ± 16.2 | 63.7 ± 13.3 |
| Sex: Female, Male(Participants) | Decision Support | Usual Care | Total |
|---|---|---|---|
| Female | 1 | 2 | 3 |
| Male | 13 | 13 | 26 |
| Ethnicity (NIH/OMB)(Participants) | Decision Support | Usual Care | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 14 | 15 | 29 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Decision Support | Usual Care | Total |
|---|---|---|---|
| Canada | 14 | 15 | 29 |
| Previous ICD shock or Previous ICD Replacement(Participants) | Decision Support | Usual Care | Total |
|---|---|---|---|
| ICD Shocks : | 7 | 7 | 14 |
| ICD Replacement : | 3 | 5 | 8 |
| No previous ICD shock or ICD replacement | 4 | 3 | 7 |
| Device Acceptance Score(Score on a scale) | Decision Support | Usual Care | Total |
|---|---|---|---|
| Mean | 83.3 ± 20.1 | 78.4 ± 12.1 | 80.7 ± 16.9 |
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