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

Not Applicable

Completed

• Conditions: Sudden Cardiac Death; Systolic Heart Failure

• Registration Number: NCT02026102
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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.

Detailed 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

Study Timeline

• Study First Submitted: 2013-12-12
• Study First Submitted QC: 2013-12-30
• Study First Posted: 2014-01-01
• Study Start: 2014-09
• Primary Completion: 2016-08
• Study Completion: 2016-11
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-29
• Last Update Posted: 2019-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Measure the acceptability and feasibility of the decision aids	pre-ICD discussion - baseline	Acceptability-measure decision aid acceptability using modified version of decision aid acceptability developed by Barry et al.; Feasibility-explore participation rates and adherence to study protocol; weekly team meetings to discuss recruitment strategies Knowledge: 21 item knowledge measure developed in-house Decision Conflict: validated 15-item decision conflict measure developed by O'Connor et al.; Decision Regret: validated 5-item decision regret scale Decision choice: ultimate choice patient made about getting an ICD Decision participation: Prior to intervention, we measure patients' preferred role in decision making using the control preferences scale. After the decision, we measure the participants' actual role in decision making.; Anxiety and Depression: Hospital Anxiety and Depression Scale (HADS). Chart Review Outcome: For those that had not yet had a procedure, we will review the charts at the end of study to determine if they received an ICD or not.

Secondary Outcome Measures

Name	Time	Method
Determine relative value of the four decision aids	3 months after baseline interview	Determine the relative value of the various tools in the toolkit through in-depth interviews from study participants and providers at each intervention site.; We will ask participants the following questions: * Have you made a decision about getting or not getting the ICD?; * What information did you use to make your decision?; * How are you feeling about your decision?; * What else would have been helpful in making your decision?; * (Intervention only) Did you use any of the decision aids you were given?; * If yes, please tell us how you used them? Did the decision aids make you feel better or worse about your decision? Did you like one of them better than the others? Is there any aspect that wasn't helpful?; * If no, please tell us why not? What would have been helpful?; * Do you have any advice on the best way to deliver these decision aids to future patients?
Measure the acceptability and feasibility of the decision aids	3 months after baseline interview	Acceptability-measure decision aid acceptability using modified version of decision aid acceptability developed by Barry et al.; Feasibility-explore participation rates and adherence to study protocol; weekly team meetings to discuss recruitment strategies Knowledge: 21 item knowledge measure developed in-house Decision Conflict: validated 15-item decision conflict measure developed by O'Connor et al.; Decision Regret: validated 5-item decision regret scale Decision choice: ultimate choice patient made about getting an ICD Decision participation: Prior to intervention, we measure patients' preferred role in decision making using the control preferences scale. After the decision, we measure the participants' actual role in decision making.; Anxiety and Depression: Hospital Anxiety and Depression Scale (HADS). Chart Review Outcome: For those that had not yet had a procedure, we will review the charts at the end of study to determine if they received an ICD or not.

Trial Locations

Locations (3)

University of Colorado Hospital (UCH); 🇺🇸 Aurora, Colorado, United States

Kaiser Permanente of Colorado; 🇺🇸 Denver, Colorado, United States

Denver VA Medical Center; 🇺🇸 Denver, Colorado, United States