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

NCT01876173 | Completed

• 2 other identifiers: 12-214119449 Grant number
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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

Keywords

Sudden cardiac death; implantable cardioverter defibrillator; decision aid

Outcome Measures

Primary Outcomes (1)

• Primary Outcomes(composite): i) decision aid development, and ii) decision aid evaluation.

  Development of the decision aid will be guided by the Ottawa Decision Support Framework (ODSF). Evaluation will include the Decision Aid Acceptability questionnaire comprised of 10 items including comprehensibility, balance of presentation of information, and overall suitability.

  Phase 1-2 (1- year)

Secondary Outcomes (7)

• Pilot RCT (feasibility)

  Pre-Post consultation - participants will be followed until consultation is completed and at 3 months post consultation (average of 16 weeks)

• Decision quality measures

  Pre consultation (baseline visit)

• Decisional Conflict Scale (DCS)

  Pre and post consultation- (intervention and usual care group, baseline visit + 1 week post consult)

• Sure Test

  Pre-consultation - baseline visit

• The Center for Epidemiologic Studies Depression Scale (CES-D)

  Pre consultation - baseline visit (intervention and usual care)

Other Outcomes (2)

• Vital status

  3 months post baseline visit

• Implant status

  Phase 3, three months post baseline visit

Study Arms (2)

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

EXPERIMENTAL

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.

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

Usual care

NO INTERVENTION

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

Interventions

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

Also known as: PtDA

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

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

Hamilton Health Sciences

Hamilton, Ontario, L8P 2X2, Canada

Location

Related Publications (2)

• 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.

  PMID: 29201388 DERIVED

• 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.

  PMID: 24148851 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Cardiovascular Diseases; Death, Sudden, Cardiac

Interventions

Primary Prevention

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Public Health Practice; Public Health; Environment and Public Health

Study Officials

• Sandra L Carroll, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 30, 2013
• First Posted: June 12, 2013
• Study Start: June 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 17, 2016

Record last verified: 2016-03

Locations

CA (1)