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

NCT02668900 | Completed

• 1 other identifier: UOHI-06
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (7)

• Knowledge

  1 month; intervention and usual care groups

• Decisional conflict

  1 month, 6 months, 12 months post; intervention and usual care groups

• Values about ICD replacement

  1 month; intervention and usual care groups

• Preferred option

  Baseline visit, 1 month, 6 months, 12 months; intervention and usual care groups

• Perceptions of involvement in decision-making

  6 months, 12 months; intervention and usual care groups

Other Outcomes (2)

• Actual choice

  6 months, 12 months; intervention and usual care groups

• Survival

  6 months, 12 months; intervention and usual care groups

Study Arms (2)

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).

Behavioral: Decision Support

Usual care

NO INTERVENTION

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

Interventions

Decision Support 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).

Decision support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Related Publications (1)

• 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.

  PMID: 32453274 DERIVED

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dawn Stacey, RN, PhD

  University of Ottawa; Ottawa Hospital Research Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 15, 2016
• First Posted: January 29, 2016
• Study Start: April 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: October 1, 2018
• Last Updated: December 24, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)