Know Your Pressures NYC
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 7,085
- 试验地点
- 2
- 主要终点
- Adherence to the Initial In-Office Appointment for those Referred to Ophthalmology and/or Primary Care (Implementation Outcome)
研究概览
简要总结
Dr. Lisa A. Hark (PI and Study Chair) and an interdisciplinary team have designed "Know Your Pressures NYC" to conduct blood pressure (BP)/glaucoma screenings in adults age 40+ to identify undiagnosed and/or uncontrolled hypertension and/or glaucoma/suspect. For the purpose of this study, individuals will be identified as glaucoma suspects if they have elevated intraocular pressure (IOP) or have features of glaucoma optic neuropathy, as assessed by optical coherence tomography (OCT) and fundus/optic nerve photographs, as interpreted by the masked Reading Center.
详细描述
Led by Dr. Lisa A. Hark, with support from an interdisciplinary team with experience in ophthalmology, preventive cardiology, primary care, nursing, biostatistics, implementation science, mixed-methods epidemiology, and informatics, Know Your Pressures NYC is an innovative, type 2 hybrid effectiveness-implementation 2:1 cluster-randomized clinical trial (RCT) design enrolling individuals living in 14 NYCHA developments, home to 19,098 residents in Upper Manhattan. All participants referred for in-office follow-up exams will be scheduled for an initial appointment, followed by an RCT for those referred. Specific aims are guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) Framework.
Aim 1: Conduct combined blood pressure (BP) and glaucoma screenings, and subsequent referrals, among adults age 40+ living in NYC affordable housing developments over 4 years.
Estimation: We will estimate, within a 4% margin of error, the detection rates of undiagnosed and/or uncontrolled HTN and/or glaucoma/suspect by assessing BP, IOP, visual acuity, and optic nerve imaging (OCT and fundus photography).
Aim 2: Evaluate the effectiveness of a Virtual Automated Navigator Intervention with Health Education on appointment adherence in participants referred for follow-up in-office exams after BP/glaucoma screenings compared to Usual Care.
- The primary Implementation outcome measure for Aim 2 is adherence to in-office appointments for those referred for follow-up.
- The primary clinical effectiveness outcome measure for Aim 2 is detection of undiagnosed and/or uncontrolled HTN and/or glaucoma/suspect confirmed by in-office appointment(s) and will be measured by rates of newly diagnosed and/or uncontrolled cases of HTN and/or glaucoma/suspect in the office over 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The Ophthalmology Reading Center outcome assessors and investigators will interpret fundus/optic nerve photographs and OCT imaging and will be masked to participants' demographic and clinical information.
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
- •Individuals age 40 and older.
- •Living independently in an affordable housing development.
- •Have a cell phone that can receive and send text messages (SMS).
排除标准
- •Self-reported terminal illness with life expectancy less than 1 year.
- •Inability to provide informed consent due to dementia or other reasons.
结局指标
主要结局
Adherence to the Initial In-Office Appointment for those Referred to Ophthalmology and/or Primary Care (Implementation Outcome)
时间窗: 1 year
The primary implementation outcome measure for Aim 1 is ADHERENCE TO INITIAL IN-OFFICE APPOINTMENT FOR THOSE REFERRED for follow-up and will be measured by attendance at the initial in-office appointment. The initial in-office appointment will be scheduled by the study team at the conclusion of the BP/glaucoma screening. A comparison will be made between participants living in the 10 developments randomized to the Virtual Automated Intervention Arm compared to 4 developments randomized to Usual Care Arm.
Detection of undiagnosed and/or uncontrolled hypertension and/or glaucoma/suspect for those Referred to follow-up confirmed by in-office eye exam (Clinical Effectiveness Outcome)
时间窗: 1 year
The primary clinical effectiveness outcome measure for Aim 2 is detection of undiagnosed and/or uncontrolled HTN and/or glaucoma/suspect confirmed by in-office exams and will calculate the proportion of referred participants who attend and are newly diagnosed and/or treated for uncontrolled HTN and/or glaucoma/suspect in the office over 1 year. Uncontrolled BP is defined as \>130/80 mmHg and uncontrolled glaucoma/suspect is defined as IOP \>24 including an abnormal optic nerve photograph or OCT image. We will compare the proportion of participants by arm with newly diagnosed and/or uncontrolled HTN and/or glaucoma/suspect in the office over 1 year. Participants who request their own eye doctor will be encouraged to make an appointment as soon as possible. These individuals will be excluded from the Outcome analysis for Aim 2.
次要结局
- Follow-up Adherence to Recommended In-office Exams at 1-3 Years (Secondary Implementation Outcome)(1-3 years)
- Return Attendance at Blood Pressure/Glaucoma Screenings at 1-3 Years (Secondary Implementation Outcome)(1-3 years)
研究者
Lisa Hark, PhD, MBA
Professor of Ophthalmic Sciences
Columbia University