The Virtual Atrial Fibrillation Clinic: Improving Specialty Care Delivery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change from baseline Atrial Fibrillation Effect on Quality of Life (AFEQT)
研究概览
简要总结
The purpose of this third phase of a three-phase study is to pilot a virtual AF clinic (vAFC) compared to usual onsite care provided by a specialty AF clinic. Older adults with AF will be recruited and randomized into either the vAFC (videoconference appointments with specialists at the Vancouver AF clinic, supplemented with educational content on an AF website developed from phase one results) or the usual care group (onsite appointments with specialists at the Vancouver AF clinic). This pilot will generate evidence to determine the feasibility of scaling up the vAFC model to other sites.
详细描述
Background: Specialty atrial fibrillation (AF) clinics have been shown to reduce AF-related hospitalizations, emergency department readmissions, and overall healthcare costs, while at the same time improving health behaviours and quality of life for patients. An AF clinic delivered virtually may offer a viable approach to remove barriers to accessing specialty care, but currently, no virtual AF models exist. However, virtual clinics that use new and emerging digital and communications technologies have been used in managing patients with a variety of chronic diseases: inflammatory bowel disease, diabetes, kidney disease, ophthalmology problems, and for post-operative follow-up (e.g., orthopedic surgery). They have been found to facilitate rapid referral, improve communication with providers, improve clinical indicators, improve self-efficacy, and achieve knowledge comparable to usual care. Purpose: The primary purpose of phase 3 of the project is to implement and evaluate an alternative model of care, a Virtual AF Clinic (vAFC) to referred patients with AF living in communities outside the Greater Vancouver area.
Methodology:
Design: We will test two modes of AF care: 1) virtual AF care (intervention group) and 2) in person AF clinic care (control group). The intervention group will receive the vAFC. The vAFC will include up to four scheduled encounters with the NPs/cardiologist: an initial encounter following baseline work-up (e.g., Holter, echo) and at 4 to 6 weeks, 3 months, and 6 months. For the duration of the intervention, the vAFC group will also receive access to a website with specific AF educational content and resources. The control group will receive usual onsite AF care provided by the Vancouver AF clinic. Recruitment: A total of 60-80 patients with AF, 30-40 allocated to each group, will be recruited from the Vancouver AF clinic. This sample size is consistent with recommendations for pilot/feasibility studies. AF clinic staff will identify eligible patients, and will send them a "letter of initial contact" letter. Patients will contact or be contacted by the research team who will provide additional study details, answer questions, conduct screening for eligibility, and obtain consent. Data Collection: Intervention and control groups will complete the same repeated measures during the study period. Demographics will be obtained at baseline. The primary outcomes: AF
Knowledge and AF Quality of Life, and secondary outcomes:
Healthcare Utilization, and Perceived Stress, will be obtained at three time points: baseline (t1) (following consent, prior to randomization), 3 months (t2), and 6 months (t3).The secondary outcomes: Lifestyle Behaviors, Physical Activity, and Patient Satisfaction will be obtained at t1 and t3. Questionnaire data will be collected using the online survey program Qualtrics. Each participant will be assigned a unique identifier code and emailed a link to the survey and consent form once they have completed eligibility screening. Patient health history, stroke risk, bleeding risk, and medications will be extracted from the consult letter sent to the AF clinic during patient referral. Website usage will be measured for each participant using Google Analytics. Following the study, approximately eight participants from each study arm will be invited to participate in an hour-long interview. Data Analysis: The focus of the pilot will be on effect sizes, as a
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
- 65 Years 至 —(Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •65 years or older;
- •Patients with a diagnosis of atrial fibrillation confirmed through an ECG;
- •first time patient at the AF Vancouver clinic;
- •live outside Vancouver city;
- •have no problems with memory and recall;
- •will be English speaking or have a family member who can assist with reading, understanding and completing the consent and survey documents;
- •able to give own consent to participate in this study;
- •have access to a computer/tablet/laptop with reliable internet;
- •participate voluntarily and freely.
排除标准
- •if the participant seems like a poor candidate for virtual care based on the discretion of the AF clinic staff;
- •cognitive impairment;
- •uncompensated hearing impairment.
结局指标
主要结局
Change from baseline Atrial Fibrillation Effect on Quality of Life (AFEQT)
时间窗: baseline, 3 months and 6 months
Atrial Fibrillation Effect on QualiTy-of-Life Questionnaire (AFEQT), a 20 item, 7-point scale, with four domains: Symptoms, Daily Activities, Treatment Concerns, and Satisfaction.
Change from baseline Atrial Fibrillation Knowledge
时间窗: baseline, 3 months and 6 months
Multiple choice survey with three response options, asking questions about atrial fibrillation, including questions regarding symptoms, treatment, medications, risk factors, and lifestyle.
次要结局
- Healthcare Utilization(baseline, 3 months and 6 months)
- Nutrition(baseline and 6 months)
- Physical Activity(baseline and 6 months)
- Weight(baseline and 6 months)
- Website Usage(baseline to 6 months)
- Height(baseline and 6 months)
- Bleeding Risk(baseline and 6 months)
- Perceived Stress(baseline, 3 months and 6 months)
- Smoking behaviour(baseline and 6 months)
- Alcohol consumption(baseline and 6 months)
- Demographics and health history(baseline)
- Waist Circumference(baseline and 6 months)
- Stroke Risk(baseline and 6 months)
- Patient satisfaction(6 months)
研究者
Kathy Rush
Principal Investigator
University of British Columbia
