Empowering patients across the maternal-newborn care continuum: A cluster randomized controlled trial testing a digital health platform in Kenya

Background: Accelerating improvements in maternal and newborn healthcare is a major public health priority in Kenya. While utilization of formal healthcare has increased, many pregnant and postpartum women do not receive the recommended number of maternal care visits. Even when they do, visits are often short with many providers not offering important elements of evaluation and counseling, leaving gaps in women's knowledge and preparedness. Digital health tools have been proposed as a complement to care that is provided by maternity care facilities, with the potential to empower patients to receive the right care at the right place and time. However, there is limited evidence of the impact of digital health tools at scale on patients' knowledge, preparedness, and the content of care they receive. We evaluated a digital health platform (PROMPTS) composed of informational messages, appointment reminders, and a two-way clinical helpdesk that has been implemented at scale in Kenya on six domains across the pregnancy-postpartum care continuum. Methods and Findings: We conducted an unmasked, 1:1 parallel arm cluster randomized controlled trial in 40 health facilities (clusters) across eight counties in Kenya. 6,139 pregnant individuals were consented at baseline and followed through pregnancy and postpartum. Individuals recruited from treatment facilities were invited to enroll in the PROMPTS platform, with roughly 85% reporting take-up. Our outcomes were derived from phone surveys conducted with participants at 36-42 weeks of gestation and 7-8 weeks post-childbirth. Among eligible participants, 3,399/3,678 women completed antenatal follow-up, and 5,509/6,128 women completed postpartum follow-up, with response rates of 92% and 90%, respectively. Outcomes were organized into six domains: knowledge, preparedness, routine care seeking, danger sign care seeking, newborn care, and postpartum care content. We generated standardized summary indices to account for multiple hypothesis testing but also analyzed individual index components. Intention-to-treat analyses were conducted for all outcomes at the individual level, with standard errors clustered by facility. Participants recruited from treatment facilities had a 0.08 standard deviation (SD) (95% CI: 0.03, 0.12) higher knowledge index, a 0.08 SD (95% CI: 0.02, 0.13) higher preparedness index, a 0.10 SD (95% CI: 0.05, 0.16) higher routine care seeking index, a 0.09 SD (95% CI: 0.07, 0.12) higher newborn care index, and a 0.06 SD (95% CI: 0.01, 0.12) higher postpartum care content index than those recruited from control facilities. No significant effect on the danger sign care seeking index was found (95% CI: -0.01, 0.08). A limitation of our study was that outcomes were self-reported, and the study was not powered to detect effects on health outcomes. Conclusions: Digital health tools indicate promise in filling gaps in pregnant and postpartum women's health care, amidst systems that fail to deliver a minimally adequate standard of care. Through providing patients with critical information and empowering them to seek recommended care, such tools can ensure that individuals are prepared for a safe childbirth and receive access to comprehensive, high quality postpartum care. Future work is needed to ascertain the impact of at-scale digital platforms like PROMPTS on health outcomes. Trial Registration: ClinicalTrials.gov ID: [NCT05110521][1]; AEA RCT Registry ID: R-0008449 ### Competing Interest Statement Sharon Akinyi, Cynthia Kahumbura, Sarah Little, Sathy Rajasekharan, and Anneka Wickramanayake are all employed by Jacaranda Health. Otherwise, all authors declare no financial relationships with any organizations that might have an interest in the submitted work in the previous three years and no other relationships or activities that could appear to have influenced the submitted work. ### Clinical Trial NCT05110521, AEARCTR-0008449 ### Funding Statement This publication was made possible by the generous support of the American people through the United States Agency for International Development (USAID) under a fixed award (FAIN 7200AA20FA00025). The contents of this document are the sole responsibility of the authors, and do not necessarily reflect the views of USAID or the United States Government. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The IRB of the Harvard T.H. Chan School of Public Health gave ethical approval for this work. The Ethics and Scientific Review Committee of AMREF Health Africa in Kenya gave ethical approval for this work. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors for up to five years following the end of the study period, after which they will be destroyed. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT05110521&atom=%2Fmedrxiv%2Fearly%2F2024%2F06%2F04%2F2024.06.03.24308340.atom