A Pilot Trial of Patient Decision Aids for Implantable Cardioverter-Defibrillators (ICDs)

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Systolic Heart Failure; Sudden Cardiac Death

Treatments: Behavioral: ICD Decision Aid Toolkit

Study type: Interventional

Funder types: Other

Identifiers

NCT02026102

121483 (Other Grant/Funding Number)

13-3152

Details and patient eligibility

About

The purpose of this study is to test the acceptability and feasibility of a "toolkit" of patient decision aids (PtDAs) for heart failure patients who are considering an ICD implant.

Full description

Specific Aim 1: Examine acceptability and feasibility of a toolkit of patient decision aids (PtDAs) for patients with heart failure referred for primary prevention implantable cardioverter-defibrillators using a randomized control trial design across three diverse health care systems (Kaiser Colorado, The University of Colorado, and The Denver Veterans Hospital).

1. Measure the acceptability of the decision aids
2. Explore feasibility by measuring patient participation rates and adherence to the study protocol across all three sites.
3. Conduct a preliminary assessment of outcomes by measuring changes in decision quality (knowledge and value concordance), quality of life, depressive symptoms, health status, and spiritual well-being.

Specific Aim 2: Determine the relative value of the various tools in the toolkit through in-depth interviews from study participants and providers at each intervention site

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• systolic heart failure (defined as an ejection fraction less than 35%)
• have been referred for a primary prevention ICD
• Note: Patients referred for an ICD with cardiac resynchronization therapy are NOT excluded.

Exclusion criteria

• Already have an ICD
• Non-English speaking (as the tools we have developed are only available in English currently)
• Other ICD indications (e.g. secondary prevention, hypertrophic obstructive cardiomyopathy)
• Cognitive Impairment defined only as people with an inability to consent

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Usual Care

No Intervention group

Description:

Patients will receive no additional ICD specific information other than what is offered by the clinic consistent with usual care. The control group will be asked where they went for information in the follow-up interviews.

ICD Decision Aid Toolkit

Experimental group

Description:

In the intervention arm, research assistants will provide the patients with the toolkit of decision aids. At that time, participants will have the option of using all of the decision aids or just some of the decision aids. Participants who do not have access to the internet, will be offered a DVD (digital video disc) version of the video and they will be asked if they would like to arrange a visit where they can review the website with the research assistant.

Treatment:

Behavioral: ICD Decision Aid Toolkit