Impact of Deferred Clinic Visits on Patients With Cardiovascular Comorbidities: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 458
- 试验地点
- 1
- 主要终点
- uncontrolled CVRF
研究概览
简要总结
This is a prospective cohort study examining the effects of prolonged clinic visit on patient's cardiovascular (CV) risk factors control and whether it will increase the risk of adverse clinical events. This study leveraged the clinic visit deferment arrangement implemented during the COVID-19 pandemic to examine the difference in CV risk factors between patients who deferred and a control group who attended their clinic visit as scheduled.
详细描述
Introduction Hypertension, diabetes and dyslipidaemia are key cardiovascular risk factors (CVRF) that contribute to adverse cardiovascular events and increase the risk of premature deaths from cardiovascular causes(1-3). Effective management of these risk factors is crucial in reducing the incidence of adverse vascular events such as stroke or myocardial infarction. Currently recommendations suggest follow-up intervals of 3 to 12 months for stable patients, but these recommendations are mostly arbitrary (1, 3-5). The association between more frequent follow-ups and improved cardiovascular risk factor control remains unclear, with conflicting data on its effectiveness (6-10). Notably, no prospective studies have examined the feasibility and safety of extended follow-up intervals beyond 6 months in patients with these CV risk factors. The COVID-19 pandemic introduced a unique challenge, as concerns about person-to-person transmission led many patients to voluntarily defer their scheduled clinic visits. This study aims to prospectively assess the impact of extended follow-up intervals on disease management and risk factors control in patients with CVRF.
Method This single-centre, prospective cohort study compared CVRF control between patients who deferred their physical clinic visit and those who attended as scheduled. The study protocol was approved by the Jointed Chinese University of Hong Kong and North Territory East Cluster Clinical Research Ethic Committee. All patients provided written informed consent data collection. This study followed The Strengthening the Reporting of Observational studies in Epidemiology (STROBE) guidelines for cohort studies reporting.
Setting This study was conducted at the Medical Specialist Outpatient Clinics of the Prince of Wales Hospital, a tertiary regional teaching hospital in Hong Kong, from April 2020 to January 2022. This timeframe was selected to coincide with the implementation of the Drug Refilling Clinic Scheme during the COVID-19 pandemic, which allowed patients to voluntarily defer their scheduled clinic visits while receiving medications from their last prescription for their chronic conditions via postal delivery. Data was collected from clinical notes and the electronic health records.
Participants Patients were recruited if they have at least one of three CVRF: diabetes, hypertension, or dyslipidaemia. Patient newly diagnosed with these conditions were excluded. Additionally, unstable patients defined as those with a history of hospitalization or emergency department visit within the preceding three months, those with complex medical problems indicated by a Charlson Comorbidity Index (CCI)(11) of equal or greater than five, or those whose primary medical issues were unrelated to cardiovascular disease - were excluded. Patients who defaulted their subsequent follow-up appointments with no recorded clinic visit by the end of the study period were also excluded. The study flow is summarized in figure 1.
Patients who deferred their appointment were categorized into the 'deferred' group, while those who attended their appointment as scheduled were placed in the 'control' group. Patients in the deferred group received a prescription refill by post along with a new appointment date. They were instructed to seek medical attention if they experienced any health concerns between follow-up intervals. Routine Blood test including lipid profile, HbA1c and other standard assessments, were conducted at the time of their next clinic visit. Additionally, they were instructed to monitor and record their blood pressure and glucose level at home with these records reviewed during the new follow-up appointments. Patients in the control group followed the standard local practice of clinic visits at intervals of 3 to 6 months. These patients were randomly selected from the list of clinic attendees and screened for eligibility at a 2:1 ratio to the 'deferred' group. A 2:1 ratio was used as more patients attended their scheduled visits than deferring. Similar blood test was performed during each clinic visit, as in the deferred group.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who attend outpatient clinics at the Prince of Wales Hospital
- •Patients who are followed up at the clinics for at least 1 CV risk factors, namely diabetes, hypertension, dyslipidaemia, or history of vascular events including cerebrovascular accidence, ischemic heart disease or peripheral vascular disease.
排除标准
- •New referrals to the outpatient clinics
- •Unstable patients such as patients with recent hospitalization within 3 months to the interviewing date
- •Patients with complex medical problems indicated by Charlson Comorbidity Index of equal or more than 5
- •Patients whose active medical problems are not cardiovascular related
- •Patient who are taking vitamin K antagonist
- •Patients who defaulted their follow-up appointment with no new appointment on record.
结局指标
主要结局
uncontrolled CVRF
时间窗: through study completion, an average of 1 year
uncontrolled CVRF, defined as the presence of any of the following: uncontrolled DM with HbA1c \>7%, uncontrolled hypertension with office systolic blood pressure (SBP)\>130mmHg and/or diastolic blood pressure (DBP) \>80mmHg, or uncontrolled dyslipidaemia defined as low-density-lipoprotein (LDL) \>1.8mmol/L.
次要结局
- unscheduled emergency service visit or hospitalization(through study completion, an average 2 years)
- major adverse cardiovascular events (MACE)(through study completion, an average 2 years)
- blood pressure(through study completion, an average 2 years)
- patient satisfaction(baseline, 1 year)
- all-cause death(through study completion, an average 2 years)
- HbA1c(through study completion, an average 2 years)
- low density lipoprotein(through study completion, an average 2 years)
研究者
GuangMing Tan
assistant professor
Chinese University of Hong Kong
