Protocol for a type 1 hybrid effectiveness implementation trial to evaluate whether a technology-based collaborative care model is non-inferior to remote blood pressure monitoring on persistent hypertension and preventive care attendance among postpartum people with hypertension.

BACKGROUND

Because persistent hypertensive disorders of pregnancy (HDP) are major sources of short- and long-term maternal morbidity, national guidelines recommend blood pressure (BP) measurement 3-10 days after childbirth and preventive care visits within one year of delivery. Programs in which patients self-measure BP (SMBP) at home improve BP ascertainment but have unclear effects on preventive care receipt or maternal morbidity. We aim to examine a novel SMBP program's effect on HDP-related morbidity and to develop a toolkit to support wide dissemination of our program.

METHODS

In this type 1 hybrid effectiveness implementation trial, 1536 postpartum patients with HDP will be randomized 1:1 to a routine SMBP program or a novel SMBP program, RI-SPHERES. In routine care, participants enter SMBP into the electronic medical record for provider response. In RI-SPHERES, a 4G Long Term Evolution (LTE)-enabled BP cuff automatically sends all SMBP to an artificial-intelligence-based platform, which provides participants with text-message feedback and notifies providers of abnormal SMBP. A multidisciplinary collaborative care group meets weekly to review RI-SPHERES's participant registry. The primary outcome of this non-inferiority trial is stage II hypertension (≥140/90 mmHg) at six weeks postpartum, with a non-inferiority margin of 6 %. The main secondary outcome is preventive care receipt (non-urgent well visit appointment from six weeks to one year postpartum). Mixed methods research will identify facilitators and barriers to RI-SPHERES that will promote its widespread implementation.

ETHICS AND DISSEMINATION: Women & Infants Hospital of Rhode Island's IRB approved this study.

CLINICAL TRIALS REGISTRATION: NCT06842875.