Clinical trial NCT02668900: Decision Support for Adults Facing Implantable Cardioverter-Defibrillator Pulse Generator Replacement
Official title: Evaluation of Decision Support for Adults Facing Implantable Cardioverter-Defibrillator Pulse Generator Replacement: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
First posted: 2016-01-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

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

Primary outcomes:
measure: Pilot RCT (feasibility measure): Participant referral/recruitment rate.
timeFrame: Baseline to 6 months
measure: Pilot RCT (feasibility measure): Completion of decision support intervention
timeFrame: Baseline to 6 months
measure: PIlot RCT (feasibility measure)
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Knowledge
timeFrame: 1 month; intervention and usual care groups
measure: Decisional conflict
timeFrame: 1 month, 6 months, 12 months post; intervention and usual care groups
measure: Values about ICD replacement
timeFrame: 1 month; intervention and usual care groups
measure: Preferred option
timeFrame: Baseline visit, 1 month, 6 months, 12 months; intervention and usual care groups
measure: Perceptions of involvement in decision-making
timeFrame: 6 months, 12 months; intervention and usual care groups
measure: The Medical Outcomes Trust Short Form (SF-36v2)
timeFrame: Baseline visit intervention and usual care groups
measure: Acceptability and Usability of Decision Support
timeFrame: 1 month; intervention group only
Other outcomes:
measure: Actual choice
timeFrame: 6 months, 12 months; intervention and usual care groups
measure: Survival
timeFrame: 6 months, 12 months; intervention and usual care groups
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: University of Ottawa; Ottawa Hospital Research Institute
name: Dawn Stacey, RN, PhD
role: STUDY_DIRECTOR
References:
citation: 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.