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

无干预：Usual Care

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.

实验性的：ICD Decision Aid Toolkit

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.

行为的：ICD Decision Aid Toolkit

Research assistants will provide patients with a toolkit of decision aids. Participants will have the option of using all of the decision aids or just some of the decision aids.

Measure the acceptability and feasibility of the decision aids

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.

Determine relative value of the four decision aids

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

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.

Measure the acceptability and feasibility of the decision aids

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.