Know Your Pressures NYC

Columbia University

Status: Begins enrollment in 4 months

Conditions: Hypertension; Elevated Blood Pressure; Glaucoma; Glaucoma, Suspect

Treatments: Other: Virtual Automated Navigator Intervention with Health Education; Other: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT05992415

ACYY0034

Details and patient eligibility

About

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.

Full description

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.

1. The primary Implementation outcome measure for Aim 2 is adherence to in-office appointments for those referred for follow-up.
2. 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.

Hypothesis: Participants referred and randomized to the Virtual Automated Navigator Intervention with Health Education Arm will show higher rates of adherence to in-office appointments over 1 year compared to those receiving Usual Care, who will only receive the initial appointment.

Aim 3: Using RE-AIM, assess Reach, Adoption, Implementation, Maintenance and Sustainability at 1-4 years using a mixed-methods study for those screened and referred.

Hypothesis: Assessing implementation outcomes about Reach (% eligible who are screened); Adoption (% screened who require follow-up); and Maintenance (% returning in 1-year) will inform future interventions.

Enrollment: 7,085 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Individuals age 40 and older.
• Living independently in an affordable housing development.
• Have a cell phone that can receive and send text messages (SMS).

Exclusion criteria

• Self-reported terminal illness with life expectancy less than 1 year.
• Inability to provide informed consent due to dementia or other reasons.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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7,085 participants in 2 patient groups

Arm 1: Virtual Automated Navigator Intervention with Health Education

Active Comparator group

Description:

Consented participants referred for follow-up to in-office appointments from the 10 NYCHA developments randomized to the Virtual Automated Navigator Intervention with Health Education Arm will receive text messaging support with all aspects of follow-up appointments at either Columbia University Irving Medical Center or Harlem Hospital, specifically appointment scheduling and education about hypertension and/or glaucoma/suspect over a 1 year period.

Treatment:

Other: Virtual Automated Navigator Intervention with Health Education

Arm 2: Usual Care

Active Comparator group

Description:

Consented participants referred for follow-up to in-office appointments from the 4 NYCHA developments randomized to the Usual Care Arm will only be scheduled for their initial appointments at either Columbia University Irving Medical Center or Harlem Hospital. They will not receive enhanced support. Scheduling this initial appointment will allow tracking of adherence. Arm 2 represents a realistic choice available for participants following screening over a 1 year period.

Treatment:

Other: Usual Care