Implementing Individualized Patient Reported Outcome Measures in Routine Care of Patients With Coronary Artery Disease: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- ePROM usage metrics
研究概览
简要总结
Investigators recently developed the APPROACH electronic patient reported outcome (ePROM) Survey and Clinician Report tools to collect individual results from online quality of life and health status surveys for patients with coronary heart disease, and report them back to their treating clinicians. This pilot interventional study uses a pre-post design to assess whether implementing the ePROM system into routine care is feasible and acceptable to patients and physicians, and to inform feasibility for a larger clinical trial. Specifically, the investigators aim to evaluate use of the ePROM Patient Survey and Clinician Report among eligible outpatients with known or suspected coronary artery disease and their cardiologists. Additionally, the investigators aim to determine if the use of the APPROACH ePROMs Clinician Report in routine medical encounters is acceptable (based on administrative burden, ease of use, and time required) to patients and clinicians, and supports effective communication for management of symptoms of coronary artery disease.
详细描述
Background
Electronic capture and reporting of patient reported outcome measures has the potential to improve patient-physician communication and the delivery of cardiac care for patients with chronic health conditions, including coronary artery disease.[1, 2] Input from both patients and clinicians was used to develop an ePROMs Patient Survey and a Clinician Report that summarizes and contextualizes the responses for patients with coronary artery disease. The investigators plan to perform a staged implementation of both aspects for patients attending cardiac catheterization labs in Alberta and evaluate the impact of this intervention on patient outcomes and use of health services in a randomized clinical trial. However, before proceeding with this large-scale trial, the investigators need to ensure that the intervention can be delivered effectively and assess its impact on the processes of care. This pilot study is designed to assess the perceived utility of the APPROACH ePROM Clinician Report in routine clinical care and to inform feasibility for a larger clinical trial.
Methods
Design: Prospective, pre-post intervention clinical study.
Setting: Outpatient cardiology practices in Alberta.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient Inclusion Criteria:
- •age at least 40 years.
- •either (i) known coronary artery disease (defined as a history of myocardial infarction, percutaneous or surgical coronary revascularization, or documentation of obstructive coronary artery disease on previous invasive or CT angiography) or (ii) suspected coronary artery disease (defined as stable angina or anginal equivalent symptoms) as the reason for referral to a cardiologist.
- •Able to communicate in English or be willing to have an English-speaking family member or friend assist with survey completion.
- •Access to the internet, valid email address, and a web-enabled device, for survey completion.
- •Upcoming outpatient visit with a study cardiologist in the next 14-28 day
排除标准
- •- N/A, all inclusion criteria must be met to participate
- •Physician Inclusion Criteria: We will recruit 4 cardiologists to participate, 2 each from Alberta Health Services Edmonton and Calgary zones, including both academic and community practice settings. To be eligible, cardiologists will need to have an active outpatient practice including moderate to high volumes of patients being assessed and managed for coronary artery disease, and to be willing to commit to participating in all aspects of the study
研究组 & 干预措施
Control Group
Patients in this group will attend their cardiology appointment as normal. No intervention present.
Intervention Group
Patients in this group will complete the ePROM patient survey in advance of their care visit.
干预措施: ePROM Survey (Other)
结局指标
主要结局
ePROM usage metrics
时间窗: Usage metrics will be collected during the intervention period (~4 months)
data extract for the ePROM Patient Survey will be prepared, summarizing the proportion of patients who completed the survey, as well as scale-level and item-level missingness among completers. Quantitative data for each component subscale (SAQ-7, EQ5D-5L and VAS, MOS SSS, PHQ2/PHQ9, CAS) will be summarized. Our target is a ≥70% survey response rate, with ≥ 90% item-level completion rate among respondents.
Acceptability and utility of the ePROM Patient Survey and Clinician Report to patients
时间窗: Patients will complete a post-visit survey following each visit during both the control and intervention period (~8 months).
Participating patients will be sent an electronic survey within 48 hours after their scheduled clinic visit, with a reminder phone call 4-7 days later to those who have not yet completed it.
Acceptability of the Clinician Report to clinicians
时间窗: Post-visit surveys will be completed following every patient visit during the intervention period (~4 months), the exit interview will occur at the end of the intervention period.
Participating cardiologists will be asked to complete an evaluation of their experience using the ePROM Clinician Report. This will be collected using a brief electronic survey administered after each study visit in the intervention period. This post-visit survey will be complemented by a single exit interview with participating physicians at study's end. The exit interview will assess the following using a semi-structured interview format with qualitative analysis.
次要结局
未报告次要终点