Decision Support for Adults Facing Implantable Cardioverter-Defibrillator Pulse Generator Replacement

Cardiovascular Diseases Clinical Trial

Official title:

Evaluation of Decision Support for Adults Facing Implantable Cardioverter-Defibrillator Pulse Generator Replacement: A Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02668900
• Other study ID #: UOHI-06
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: October 2018

Study information

• Verified date: December 2018
• Source: Ottawa Heart Institute Research Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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:

1. Conduct a pilot randomized controlled trial (RCT) to determine the feasibility of conducting a larger trial.

2. To determine the effect of the decision support intervention for adults faced with ICD replacement on attributes of decision quality and decision-making processes

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Death
• Death, Sudden
• Death, Sudden, Cardiac

Intervention

Behavioral:
• Decision Support
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).

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Actual choice	The number of participants who choose to accept ICD replacement, decline ICD replacement, or defer their decision to later.	6 months, 12 months; intervention and usual care groups
Other	Survival	The number of participants who are alive or dead at 6 months. If participant is dead, include cause of death.	6 months, 12 months; intervention and usual care groups
Primary	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.	Baseline to 6 months
Primary	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.	Baseline to 6 months
Primary	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.	Baseline to 6 months
Secondary	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.	1 month; intervention and usual care groups
Secondary	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.	1 month, 6 months, 12 months post; intervention and usual care groups
Secondary	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.	1 month; intervention and usual care groups
Secondary	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.	Baseline visit, 1 month, 6 months, 12 months; intervention and usual care groups
Secondary	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	6 months, 12 months; intervention and usual care groups
Secondary	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.	Baseline visit intervention and usual care groups
Secondary	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.	1 month; intervention group only