A Pilot Trial of Patient Decision Aids for Implantable Cardioverter-Defibrillators (ICDs)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 6
- 主要终点
- Measure the acceptability and feasibility of the decision aids
研究概览
简要总结
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.
详细描述
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).
- Measure the acceptability of the decision aids
- Explore feasibility by measuring patient participation rates and adherence to the study protocol across all three sites.
- 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
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.
干预措施: ICD Decision Aid Toolkit (Behavioral)
结局指标
主要结局
Measure the acceptability and feasibility of the decision aids
时间窗: 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.
次要结局
- Determine relative value of the four decision aids(3 months after baseline interview)
- Measure the acceptability and feasibility of the decision aids(3 months after baseline interview)