A 3-arm randomized pilot trial aimed at comparing the effectiveness of different approaches to recruiting patients to participate in a 6-month remote monitoring program for the management of hypertension (HTN).
The investigators will utilize the Way to Health (WTH) platform to develop and evaluate a new remote monitoring enrollment model that is integrated with routine clinical care at Penn Family Care (PFC), an academic family medicine practice in West Philadelphia. Among patients with poorly controlled HTN the investigators will: 1. Compare the effect of sending eligible patients a blood pressure cuff with the mailed invitation letter and opt-out framing versus the more conventional method of phone calls following mailed letters. 2. Evaluate the feasibility and effectiveness of a remote monitoring program with individualized stepped escalation for hypertension management.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
425
Patients in the opt-in recruitment arm will receive a letter describing the program and inviting them to participate in the remote monitoring program. Along with the letter they will receive an informational brochure and a copy of the informed consent form. Patients in this arm will then receive a recruitment phone call explaining the program and consenting the participant verbally. If the participant consents to participate in the remote monitoring program, to receive text messaging, and to connection to care, the research coordinator will mail a blood pressure cuff and begin the remote monitoring program for the patient 6 days later.
Patients assigned to opt-out recruitment will receive a blood pressure cuff with instructions in the mail along with a letter describing the program and opt-out framing regarding their participation, as well as a brochure and a copy of the informed consent form. Patients in this arm will receive a recruitment phone call similar to recruitment arm A, explaining the program and consenting the participant verbally. If the participant consents to participate in the remote monitoring program, to receive text messaging, and to connection to care, the research coordinator will begin the remote monitoring program for the patient immediately.
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Proportion Participating by Recruitment Method
The proportion of patients participating in each study arm out of the number randomized to that study arm.
Time frame: 6 months, from date of consent to end of remote monitoring program
Proportion Engaged by Recruitment Method
The proportion of patients recruited by each method who are actively engaged with the program
Time frame: 6 months, from date of consent to end of remote monitoring period
Proportion with Controlled Blood Pressure by Monitoring vs. Usual Care
The proportion with controlled blood pressure by remote monitoring and the proportion with controlled blood pressure by clinic visits (usual care).
Time frame: 6 months, from date of consent to end of remote monitoring program
Blood Pressure Trajectory by Recruitment Method
The systolic and diastolic blood pressure trajectory by recruitment arm.
Time frame: 6 months, from date of consent to end of remote monitoring program
Proportion of BP Measurements Submitted by Recruitment Method
The proportion of requested BP measurements submitted by each patient by recruitment arm
Time frame: 6 months, from date of consent to end of remote monitoring program
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