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Background Limited data exist on health outcomes during pregnancy and childbirth in low- and middleincome countries. This is a pilot of an innovative data collection tool using mobile technology to collect patient-reported outcome measures (PROMs) selected from the International Consortium of Health Outcomes Measurement (ICHOM) Pregnancy and Childbirth Standard Set in Nairobi, Kenya. Methods Pregnant women in the third trimester were recruited at three primary care facilities in Nairobi and followed prospectively throughout delivery and until six weeks postpartum. PROMs were collected via mobile surveys at three antenatal and two postnatal time points. Outcomes included incontinence, dyspareunia, mental health, breastfeeding and satisfaction with care. Hospitals reported morbidity and mortality. Descriptive statistics on maternal and child outcomes, survey completion and follow-up rates were calculated. Results In six months, 204 women were recruited: 50% of women returned for a second ante-natal care visit, 50% delivered at referral hospitals and 51% completed the postnatal visit. The completion rates for the five PROM surveys were highest at the first antenatal care visit (92%) and lowest in the postnatal care visit (38%). Data on depression, dyspareunia, fecal and urinary incontinence were successfully collected during the antenatal and postnatal period. At six weeks postpartum, 86% of women breastfeed exclusively. Most women that completed the survey were very satisfied with antenatal care (66%), delivery care (51%), and post-natal care (60%). Conclusion We have demonstrated that it is feasible to use mobile technology to follow women throughout pregnancy, track their attendance to pre-natal and post-natal care visits and obtain data on PROM. This study demonstrates the potential of mobile technology to collect PROM in a low-resource setting. The data provide insight into the quality of maternal care services provided and will be used to identify and address gaps in access and provision of high quality care to pregnant women.
This is a pilot study on the feasibility of implementation of the ICHOM Pregnancy and Childbirth (PCB) Standard Set in a prospective cohort of mothers in Nairobi, Kenya using mHealth technology. Focus groups were conducted to adapt the ICHOM PCB Standard Set to the local setting. A mobile wallet M-TIBA and a mobile platform mSurvey were adapted and integrated to collect administrative and PROM data. Administrative and PROM data were collected prospectively. The ICHOM PCB Standard Set collects data from women during pregnancy, delivery, and up to six weeks postpartum, contains hospital-reported data, seven domains within patient-reported outcomes, and a set of case-mix factors[23]. A committee of medical experts and stakeholders reviewed the indicators for implementation based on level of importance, social and cultural acceptability. In the first-round medical research experts from Kenya, Ghana and the Netherlands conducted a feasibility assessment and a preliminary selection of outcome indicators to pilot; considerations included literacy, language spoken, and constraints of using a mobile platform. The selected indicators were presented and finalized in the second round at a workshop in Nairobi to key stakeholders from the private and public Kenyan healthcare sector. When required, licensing was requested for the selected PROM tools (ICIQ-SF, Wexner, PROMIS SFFAC102 and PHQ-2). The timeline for data collection was modified from the original ICHOM timeline which recommends the first survey to be administered during the first trimester, since this is a proof of concept pilot we adapted the timeline to recruit women in the third trimester (Fig 1). The top timeline is recommended by the ICHOM Pregnancy and Childbirth Standard Set and spans from the third month of pregnancy until 6 months postpartum. The revised timeline adapted to the Kenyan context and used in the pilot starts at the 28th week of pregnancy and ends 6 weeks postpartum. The new timeline was adopted in line with the existing patient pathway for maternal health management in Nairobi. The green diamonds represent data collection points that coincide with clinic visits. The M-TIBA mobile wallet was developed by PharmAccess Group in partnership with Safaricom and CarePay as a virtual wallet for healthcare expenses. It contains funds that can only be used for healthcare by selected providers across Kenya. The connected health care providers are all enrolled in the SafeCare program which comprises healthcare standards accredited by the International Society for Quality in Health Care (ISQua) for healthcare providers in LMICs. The M-TIBA platform collects real-time medical and financial data on health care transactions and allows for measurement of administrative outcome indicators. mSurvey is a Nairobi-based start-up that collects consumer data from communities that are difficult to reach; given this capability, it was utilized to collect PROM from women in Nairobi settlements through the mobile phone platform. M-TIBA allowed participants to access healthcare financing thus reducing the financing barriers to care. For this pilot project, M-TIBA and mSurvey were connected through an application-programming interface to link PROMs to administrative data and financial data while ensuring privacy and confidentiality of patients. At each facility, the M-TIBA account is opened upon patient registration, and upon completion of the visit, the closing of the M-TIBA account triggers the delivery of the mSurvey to patients, therefore linking clinical and administrative data from M-TIBA with the ICHOM Set on the mSurvey. Participants had 5 days to complete the questionnaire before receiving an automated reminder. Once the mSurvey was developed, a focus group consisting of 12 women who met inclusion criteria was conducted to test its use as a tool for PROM data collection. Focus group participants received 10 outcome questions via text on their mobile phones in order to test the mobile platform. They were each given 20 minutes to respond to the survey. After which, participants were asked about their experience utilizing the mobile platform. Participants provided feedback that fell into five main themes including: (1) English was a barrier for some participants, (2) for most this was their first experience with mobile surveys, (3) concerns for desirability bias, (4) willingness to participate especially if responses were integrated into clinical care and (5) positive feedback on potential for benefiting from survey with added education and awareness around pregnancy and childbirth. As a result, the need for initial support using the mobile application was identified and patient liaison officers (PLO) were recruited for the enrollment process. PLOs also followed up women who did not present to clinic to reduce bias from loss to follow up. Participating facilities that provide ANC, PNC and/or delivery services were chosen based on their previous enrollment as M-TIBA facilities and participants of PharmAccess’ SafeCare quality improvement program. In total, four pilot facilities were selected; two outreach clinics from Gertrude’s Children’s Hospital (Githogoro and Mathare clinics), and two referral hospitals, Jacaranda Maternity and Nazareth Hospital. The clinics provide approximately 2,000 ANC visits and 1,400 PNC visits per year respectively, they are privately run and are located in informal settlements. Nazareth is a faith-based tertiary hospital with approximately 8,000 deliveries per year and Jacaranda is a specialized private maternity hospital with approximately 5,700 deliveries per year. All facilities are situated in an urban setting and serve low-resource patients in Nairobi. Each pilot facility signed a memorandum of understanding and a site visit was done to conduct process mapping of patient flow and identify optimal timing for PROM and administrative data collection. At Gertrude’s outreach clinics, patients receive ANC throughout pregnancy and are referred to Jacaranda or Nazareth hospital for the last ANC appointment and delivery. The clinicians and administrative staff of the pilot facilities were trained on data collection, each of the outcome measurements, and VBHC. Additional training on mental health was provided as it was identified as a knowledge gap by staff. Throughout the pilot project, ICHOM supported the facilities through site visits, tele-conferences, and a structured framework designed to support each facility in engaging patients and in data collection and evaluation. The goal was to recruit 200 pregnant women during the third trimester anticipating, based on the experience of local clinicians, that approximately half of the women would be lost to follow up Since the goal of this project was to demonstrate feasibility of a protocol to collect patient-reported outcomes via novel methodology in a low-resource setting, no sample size was calculated. Inclusion criteria for participants were 1) presenting at the participating clinics for an ANC visit in their third trimester of pregnancy, 2) having access to a mobile phone and personal M-TIBA account, and 3) having comprehension of written English. Exclusion criteria were not owning a mobile phone, gestational age less than 28 weeks or greater than 35 weeks, limited English literacy or having already received prenatal care. Patient enrollment commenced in July 2017 and continued until January 2018. Patients enrolled did not receive any compensation but were given cellphone credit to complete the surveys. Pregnant women were enrolled by PLO at the Gertrudes clinic and written informed consent was obtained. Through the study, the PLO followed up on incomplete responses, missing surveys, or missed visits with a text message. PLOs received standardized training and followed standard protocols (S1 File). Case mix and PROM questions were included in the surveys that were triggered through M-TIBA and sent through the mSurvey platform (Fig 2). Manual data collected by PLOs on women who discontinued their clinical care at participating facilities were captured. Data were collected and stored by PharmAccess. Data from the different databases were linked through unique identifiers ensuring anonymity of the data. Feedback surveys were sent to patients who missed clinic visits or who did not deliver at facilities. Aggregate data were shared with clinicians at the pilot facilities. Of the administratively collected indicators, domains included survival, neonatal morbidity and treatment variables (Fig 3, S2 File). Patient reported indicators spanned the domains of patient reported health status, mental health, breast feeding, satisfaction with care, obstetrical and medical history and case mix variables (Fig 3, S3, S4 and S5 Files). ICHOM PCB Standard Set domains, indicators and case-mix domains selected for pilot in Nairobi, Kenya. “Yes” indicates selection of the ICHOM indicator for pilot in Kenya. Following the validation of a subset of data from 15 women, descriptive statistics were generated using SAS software, Version 9.4 (Copyright 2013, SAS Institute Inc., Cary, NC, USA). Sociodemographic characteristics were compared across women using ANOVA and Chi-Square tests, as appropriate. This pilot was approved by the Gertrude’s Children’s Hospital Ethics Review Board. Data management and analysis was approved by the Harvard Medical School Institutional Review Board.
