Evaluation of Decision Support for Adults Facing Implantable Cardioverter-Defibrillator Pulse Generator Replacement: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Pilot RCT (feasibility measure): Participant referral/recruitment rate.
研究概览
简要总结
The implantable-cardioverter defibrillator (ICD) is a small medical device used to treat dangerously fast and potentially life-threatening heart rates. For patients at risk, the ICD can detect an abnormal rhythm and provide life-saving therapy by delivering a shock. ICD therapy has risks and benefits that should be weighed from each patient's perspective. An ICD battery needs to be surgically replaced 4 to 7 years to ensure ongoing function. At present, the majority of these batteries are automatically changed without eliciting patients' preferences. There is a need for a better way to engage with patients. Patients want to be involved in their healthcare decisions, yet more than half of patients with an ICD do not know that ICD replacement is optional. To ensure that patients are receiving treatment that they value and want, members of the interprofessional team should ensure that treatment decisions align with patients' expectations, values and preferences. This rests on the principle of shared decision making in which members of the healthcare team and patients deliberate together to arrive at a decision which best reflects the preferences and values of the patient. To facilitate the achievement of this goal, a patient decision aid (PDA) can be used. As a result, the investigators developed PDA for ICD replacement. The purpose of this feasibility trial is to collect preliminary data to test the feasibility of conducting a larger trial, and to evaluate the PDA for its acceptability and ease of use. Eligible and consented participants facing ICD replacement will be randomized to receive the decision aid or to usual care. The investigators will assess if this decision aid can improve participants' knowledge on ICD therapy and the replacement surgery, increase patients' perceived involvement in the decision, and determine whether their actual choice reflects their personal values.
详细描述
Sudden cardiac death (SCD) due to a ventricular arrhythmia is a serious cause of cardiovascular death in Canada. The implantable cardioverter defibrillator (ICD) can reduce the incidence of SCD in high-risk patients by delivering an internal shock to restore a normal rhythm. The life expectancy of an ICD generator is estimated between four and seven years, and must be surgically replaced to ensure ongoing function. Implantable cardioverter-defibrillator (ICD) replacement is becoming increasingly common constituting nearly 40% of all ICD procedures. For the most part, ICDs are automatically replaced. With every ICD replacement, the net benefit of continued ICD therapy should be assessed individually in view of the procedural risks, inappropriate shocks, psychological risks, changes in health status, and the potential for harm and suffering at end-of-life. Some studies have shown that the mortality benefit of an ICD attenuates with advancing age and comorbidities.
There are many legitimate reasons for declining ICD generator replacement. The chronic nature of a cardiac condition and/or the diagnosis of a life-limiting disease since initial implantation may compel a patient to reconsider their health care goals from supporting quantity of life, to prioritizing one of quality. This is an important distinction as the ICD can prolong the dying process by delivering shock(s) which can result in pain and discomfort for the patient, and helplessness for witnesses. Other patients have reported psychological distress, while others report only truly understanding the effects of living with an ICD after receiving one, possibly leading to changes in treatment preference when they are faced with the decision to replace. Also, the replacement procedure includes a substantially greater risk for infection and reoperation as compared to the initial implantation.
These complexities warrant decision support to prepare patients to make decisions. Yet, no means exists to support patients' decision-making in the context of ICD replacement. A decision support intervention (including a patient decision aid with decision coaching) was developed using a user-centered design with various stakeholders and potential end-users, which could moderate treatment related uncertainty and prepare patients to make high quality decisions that are informed and based on their personal preferences and values.
Objectives:
- Conduct a pilot randomized controlled trial (RCT) to determine the feasibility of conducting a larger trial.
- To determine the effect of the decision support intervention for adults faced with ICD replacement on attributes of decision quality and decision-making processes
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
- Single (Outcomes Assessor)
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
- •ICD battery nearing depletion or at elective replacement indicator
- •Able to speak and read in English
- •Able to provide informed consent; or if incapable of providing informed consent, can be obtained by the patient's appointed substitute decision-maker or power of attorney for personal care.
排除标准
- •Participants and/or substitute decision maker unable to understand the patient decision aid or decision coaching session due to language barrier or visual impairment
- •Participants with cardiac resynchronization therapy (CRT) or participants eligible for an upgrade to CRT.
- •Participants with conduction system disease who are pacemaker dependent
结局指标
主要结局
Pilot RCT (feasibility measure): Participant referral/recruitment rate.
时间窗: Baseline to 6 months
In this feasibility RCT, the feasibility regarding key processes to the success of a larger trial will be assessed. The investigators will descriptively collect the proportion of participant referral versus recruitment rate.
PIlot RCT (feasibility measure)
时间窗: Baseline to 6 months
In this feasibility RCT, the feasibility regarding key processes to the success of a larger trial will be assessed. The investigators will descriptively collect the proportion of missing data from the questionnaires.
Pilot RCT (feasibility measure): Completion of decision support intervention
时间窗: Baseline to 6 months
In this feasibility RCT, the feasibility regarding key processes to the success of a larger trial will be assessed. The investigators will descriptively collect the rate of participants who complete the decision support intervention.
次要结局
- Decisional conflict(1 month, 6 months, 12 months post; intervention and usual care groups)
- Values about ICD replacement(1 month; intervention and usual care groups)
- Knowledge(1 month; intervention and usual care groups)
- The Medical Outcomes Trust Short Form (SF-36v2)(Baseline visit intervention and usual care groups)
- Preferred option(Baseline visit, 1 month, 6 months, 12 months; intervention and usual care groups)
- Acceptability and Usability of Decision Support(1 month; intervention group only)
- Perceptions of involvement in decision-making(6 months, 12 months; intervention and usual care groups)
研究者
David Birnie
MD
Ottawa Heart Institute Research Corporation