Feasibility Testing of Decision Support for Patients Who Are Candidates for an Implantable Defibrillator

NCT ID: NCT01876173

Last Updated: 2016-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2014-12-31

Brief Summary

Sudden cardiac death (SCD) due to a ventricular arrhythmia is a serious cause of cardiovascular death in Canada. The implantable cardioverter defibrillator (ICD) offers high-risk patients a treatment option to reduce the incidence of SCD by delivering an internal shock to restore a normal rhythm, if needed. Definitive evidence has established the effectiveness of the ICD for reducing mortality when used as prophylaxis for SCD (a primary prevention indication). Approximately 3,700 new candidates accrue annually. Practice guidelines define the criteria to determine patient ICD candidacy for primary prevention. However, in addition to SCD risk, ICD candidates may have chronic diseases such as diabetes, renal insufficiency, hypertension, and atrial fibrillation. Thus, balancing the benefits and risks of an ICD can become complex, particularly when competing mortality risks are present. Research has recognized human costs associated with device complications and shocks affecting psychological, health related quality of life (HRQL), and morbidity outcomes. The complexities surrounding the long-term benefits/risks, complications, replacements, and shocks, warrant decision support to prepare patients to make decisions. In Canada, there is no clear framework to support patients' decision-making in the context of ICD treatment options. Decision support, using a decision aid, could moderate treatment related uncertainty and prepare patients to make active, informed, quality decisions.

Objectives: 1) develop a decision aid for ICD candidates to support quality decision-making (informed, deliberate, values-based choices), 2) to evaluate the decision aid, and 3) to determine the feasibility of conducting a trial.

Conditions

Cardiovascular Disease; Sudden Cardiac Death

Study Design

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

Study Groups

Patient Decision Aid for an ICD (primary prevention, non-CRT)

The intervention group will receive the PtDA, which provides a lay summary that outlines the facts, risks, benefits (including probabilities), specific to the option of an implantable defibrillator or the option of medical management to prepare them for consultation with the physician. Values are assessed to reveal which features of each option are important to patients.

Group Type: EXPERIMENTAL

Patient Decision Aid for an ICD (primary prevention, non-CRT)

Intervention Type: BEHAVIORAL

The intervention group will receive the PtDA, which provides a lay summary that outlines the facts, risks, benefits (including probabilities), specific to the option of an implantable defibrillator or the option of medical management to prepare them for consultation with the physician. Values are assessed to reveal which features of each option are important to patients.

Usual care

The control group will not receive the patient decision aid prior to consultation with the physician.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Patient Decision Aid for an ICD (primary prevention, non-CRT)

The intervention group will receive the PtDA, which provides a lay summary that outlines the facts, risks, benefits (including probabilities), specific to the option of an implantable defibrillator or the option of medical management to prepare them for consultation with the physician. Values are assessed to reveal which features of each option are important to patients.

Intervention Type: BEHAVIORAL

Other Intervention Names

PtDA

Eligibility Criteria

Inclusion Criteria

• Referred for consideration of an ICD(non-CRT)for a primary prevention indication
• English speaking
• able to provide informed consent

Exclusion Criteria

• unable to understand the decision aid due to a language barrier or visual impairment
• referred for secondary prevention indication

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

Sponsors

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Sandra Carroll

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sandra L Carroll, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

Hamilton Health Sciences

Hamilton, Ontario, Canada

Countries

Canada

References

Carroll SL, Stacey D, McGillion M, Healey JS, Foster G, Hutchings S, Arthur HM, Browne G, Thabane L. Evaluating the feasibility of conducting a trial using a patient decision aid in implantable cardioverter defibrillator candidates: a randomized controlled feasibility trial. Pilot Feasibility Stud. 2017 Nov 21;3:49. doi: 10.1186/s40814-017-0189-9. eCollection 2017.

Reference Type: DERIVED

PMID: 29201388 (View on PubMed)

Carroll SL, McGillion M, Stacey D, Healey JS, Browne G, Arthur HM, Thabane L. Development and feasibility testing of decision support for patients who are candidates for a prophylactic implantable defibrillator: a study protocol for a pilot randomized controlled trial. Trials. 2013 Oct 22;14:346. doi: 10.1186/1745-6215-14-346.

Reference Type: DERIVED

PMID: 24148851 (View on PubMed)

Related Links

http://decisionaid.ohri.ca/index.html

Related Info

Other Identifiers

119449 Grant number

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

12-214

Identifier Type: -

Identifier Source: org_study_id