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

NCT ID: NCT02668900

Last Updated: 2018-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2018-10-31

Brief 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.

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:

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

Conditions

Death, Sudden, Cardiac; Death, Sudden; Cardiovascular Diseases

Keywords

Feasibility trial; Cardiovascular disease; Decision Support; Patient Decision Aid; implantable cardioverter defibrillator; implantable cardioverter defibrillator replacement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Decision Support

Intervention Type: BEHAVIORAL

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).

Usual care

The control group will not receive the decision support intervention prior to consultation with the physician.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Heart Institute Research Corporation

OTHER

Sponsor Role: lead

Responsible Party

David Birnie

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dawn Stacey, RN, PhD

Role: STUDY_DIRECTOR

University of Ottawa; Ottawa Hospital Research Institute

Locations

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 32453274 (View on PubMed)

Other Identifiers

UOHI-06

Identifier Type: -

Identifier Source: org_study_id