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

NCT02668900 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-12-24

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • Ottawa Heart Institute Research Corporation

    lead OTHER

Principal Investigators

  • Dawn Stacey, RN, PhD · University of Ottawa; Ottawa Hospital Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2018-04-30
Completion
2018-10-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02668900 on ClinicalTrials.gov