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

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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.

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