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Background: Improving maternal and newborn health remains one of the most critical public health challenges, particularly in low- and lower-middle-income countries. To overcome this challenge, interventions to improve the continuum of care based on real-world settings need to be provided. The Ghana Ensure Mothers and Babies Regular Access to Care (EMBRACE) Implementation Research Team conducted a unique intervention program involving over 21 000 women to improve the continuum of care, thereby demonstrating an intervention program’s effectiveness in a real-world setting. This study evaluates the implementation process of the EMBRACE intervention program based on the RE-AIM framework. Methods: A cluster-randomized controlled trial was conducted in 32 sub-district-based clusters in Ghana. Interventions comprised of four components, and to evaluate the implementation process, we conducted baseline and endline questionnaire surveys for women who gave birth and lived in the study site. The key informant interviews of health workers and intervention monitoring were conducted at the health facilities in the intervention area. The data were analyzed using 34 components of the RE-AIM framework and classified under five general criteria (Reach, Effectiveness, Adoption, Implementation, and Maintenance). Results: In total, 1480 and 1490 women participated in the baseline and endline questionnaire survey, respectively. In the intervention area, 83.8% of women participated (reach). The completion rate of the continuum of care increased from 7.5% to 47.1%. Newborns who had danger signs immediately after birth decreased after the intervention (relative risk = 0.82, 95% confidence interval = 0.68-0.99) (effectiveness). In the intervention area, 94% of all health facilities participated. Mothers willing to use their continuum of care cards in future pregnancies reached 87% (adoption). Supervision and manual use resolved the logistical and human resource challenges identified initially (implementation). The government included the continuum of care measures in their routine program and developed a new Maternal and Child Health Record Book, which was successfully disseminated nationwide (maintenance). Conclusions: Following the RE-AIM framework evaluation, the EMBRACE intervention program was considered effective and as having great potential for scaling across in real-world settings, especially where the continuum of care needs to be improved. Trial registration: ISRCTN 90618993.
The study design of the EMBRACE intervention was a cluster-randomized controlled trial based on an effectiveness-implementation hybrid design [18,19]. The intervention was conducted in Ghana for one year, from October 2014 to September 2015. In total, over 21 000 women participated in the EMBRACE intervention program with their newborns. In this study, we evaluated the effectiveness of the EMBRACE intervention program based on the interview results of randomly selected women and health workers as well as based on the intervention monitoring reports. Quantitative and qualitative data were collected using different approaches to evaluate the implementation process. The EMBRACE study details are in the protocol registered under the International Standard Randomized Controlled Trial Number (ISRCTN: 90618993) and in a published study protocol [20]. No significant amendment has been made in the methods since the trial commencement. The Ghana EMBRACE intervention program was conducted at the Health and Demographic Surveillance System (HDSS) sites in Dodowa, Kintampo, and Navrongo (Figure 1). These three sites represent the country’s three ecological zones: coastal Savannah, forest belt, and northern Savannah. At each site, people’s basic medical histories have been continuously surveyed under the supervision of the Ghana Health Service. Study sites of Ghana EMBRACE Implementation Research. Dodowa is in a rural, but rapidly urbanizing district with a total area of 1529 km [21]. The location of the households is spread over a larger field. Kintampo is located in the center of Ghana with a surface area of 7162 km [22]. Access to health facilities is challenging, and the home birth rate is higher here than in the other two sites. Navrongo lies in northern Ghana with an area of 1675 km [23]. Community-based health planning (CHPS), and the service program and community health officers (CHO) in Ghana were first established in Navrango. In total, 32 sub-districts of the study site were randomly allocated to be intervention or control areas in a 1:1 ratio (Figure 2). In the intervention areas, 66 health facilities were included (three hospitals, eight private facilities, six health centers, and 49 CHPS zones/compounds); in the control area, 63 facilities were surveyed (one hospital, three private clinics, 10 health centers, and 49 CHPS zones/compounds). To conceal each area’s allocation, a data analyst, who was not a primary member of the study team, randomized the clusters using computer-generated random numbers. Due to the nature of the cluster-randomized controlled trial and intervention design, participants’ enrollment and intervention assignment were not concealed. Participants in the implementation evaluation analysis. The Ghana EMBRACE implementation research aimed to increase the CoC completion rate of mothers and newborns. The team developed an intervention program with three aims: reducing the coverage gap in PNC<48 hours postpartum, accelerating the understanding of the CoC among health care providers, and encouraging community members to support mothers in obtaining maternal and newborn care from skilled health workers. Following Ghana’s national guidelines on maternal and child health, the CoC components in the Ghana EMBRACE intervention program were defined as four ANC visits; delivery attended by a skilled birth attendant; and PNC at 48 hours, 7 days, and 6 weeks postpartum. The program included four important components with unique codes for the various interventions [20]: 1) use of the CoC card (A-1), 2) CoC reorienting for health workers (A-2), 3) 24-hour retention of women and newborns at a health facility after delivery (B-1), and 4) PNC by home visits (B-2). The CoC card (A-1) was a one-page pictorial educational and record card used by the health care providers to explain the value of CoC and encourage women to continuously receive care (Appendix S1 in the Online Supplementary Document). It was attached to the existing Maternal Health Record Book for easy reference. When a woman received services between 16 weeks of pregnancy and 6 weeks postpartum, her health worker placed a star sticker on her card to indicate her compliance with the CoC. A gold star indicated an on-time uptake, an orange star was for a delayed uptake, and no star denoted missed care. Trained District Health Management Team (DHMT) members provided an orientation to facilitate the understanding of the CoC (A-2) among health workers at the start of the intervention period. To increase the coverage of 48-hour PNC, mothers and newborns were retained at the health facility for 24 hours after delivery (B-1) and then provided PNC. The CHO, whose core mandate is to undertake home visits, visited mothers who delivered at home to provide PNC within 48 hours postpartum (B-2). The program provided minimum materials such as a manual sphygmomanometer, stethoscopes, thermometers, and penlights for health checkups to all health facilities. In addition, the program provided beds to facilities to enable the provision of postpartum rest for the mothers and newborns under intervention B-1, and motorcycles to enable home visits to ensure completion of intervention B-2. The interventions were administered to women and their newborns through primary and secondary health facilities between 16 weeks of pregnancy and 6 weeks postpartum. The B-1 intervention was implemented only in Dodowa and Navrongo because fewer midwives were available in Kintampo. In the control area, no intervention was conducted, and standard maternal and newborn health care was provided as routine care at health facilities. This study targeted the implementation outcomes, assessed in terms of five criteria (reach, effectiveness, adoption, implementation, and maintenance) of the RE-AIM framework [12,15-17]. Details of each definition are presented in the analysis section. To evaluate the EMBRACE intervention, women recruited through random sampling were surveyed from the study site before (baseline survey) and after (endline survey) the intervention period. Participants in both baseline and endline surveys were women aged 15-49 years. The inclusion criterion was having given birth between 1 September 2012 and 30 June 2014 for the baseline survey, and between 1 October 2014 and 30 September 2015 for the endline survey. Exclusion criteria were declining to be interviewed or moving out of the target HDSS areas. The sample size for the surveys was set as 1500 (intervention: 750, control: 750) for each survey sample size, and the intra-class correlation coefficient (0.02675) was calculated based on the data collected from our formative study in the previous year at the same sites. A two-step cluster random sampling method was used. Geographical units were created in proportion to the cluster’s population size, and 50 geographical units were selected from each of the three HDSS sites. From within each geographical unit, 10 eligible women were randomly selected. The details of this process were presented in the study protocol [20]. The key informant interviews were also conducted with 18 health workers chosen through convenience sampling in the intervention arm. The intervention monitoring data were collected monthly from all 66 health facilities in the intervention area. A baseline and an endline survey were conducted in August 2014 and November 2015, respectively. The interviews were conducted by trained interviewers who visited the selected women’s homes. Using a structured questionnaire, women were asked about their sociodemographic characteristics, use of maternal and child health care services, complications experienced during pregnancy and till six weeks postpartum. Prior to the baseline and endline surveys, research assistants were trained at each HDSS site. Data were cross-checked with the maternal health record book, which each woman usually possessed. Key informant interviews were conducted with the health workers between November 2014 and November 2015 using an interview guide. The topics included changes in service quality, women’s responses to services, and the interviewees’ evaluation of the implementation fidelity and sustainability after the intervention. A member of the study team interviewed each health worker at the health facility for 30-45 minutes. The interviewer made notes or audio-recorded the interview. The monitoring team collected intervention monitoring data at all health facilities of the intervention area for each month of the 12-month intervention period. The monitoring team was created at each HDSS site, comprising the persons in charge of supervision in the DHMT, Sub-District Health Management Team (SDHMT), and HDSS research members. Every month, the team visited all the health facilities located in the intervention areas for routine supervision to support the health service providers in implementing intervention programs in accordance with the study protocol. They also interviewed health workers and noted all the issues raised, good practices, requests, and mothers’ comments on the interventions; further, they noted the number of ANC or PNC check-up received during the monthly monitoring on a monitoring sheet. In total, 34 components of the RE-AIM framework were reported [15,24] and classified under five general criteria of RE-AIM according to the operational definitions as listed in Table 1. RE-AIM criteria, definitions, and measurements EMBRACE – Ensure Mothers and Babies Regular Access to Care, ANC – antenatal care, PNC – postnatal care, CoC – continuum of care *Definitions of RE-AIM five criteria: Glasgow et al., 1999 [15]. Survey data were analyzed descriptively to compare the distribution of women’s characteristics and program coverage. Bivariate analyses were performed to compare differences between intervention and control areas using the t test and the χ2 test. Relative risks of maternal/newborn complications and stillbirth/neonatal deaths were assessed for the intervention area relative to the control area. Statistical significance was set at P < 0.05. These data were analyzed using an intention-to-treat analysis, with SPSS version 25 (IBM Co., Armonk, NY, USA). Coding was performed for the scripts of the audio-recorded data from key informant interviews, interview notes, and intervention monitoring reports. The codes were then analyzed using content analysis according to the categories of the related RE-AIM elements. Ethical approval was obtained from the Ethics Review Committee of the Ghana Health Service (reference: GHS-ERC: 13/03/14); the institutional review boards of Dodowa HRC (reference: FGS-DHRC: 280214), Kintampo HRC (reference: 2014-11), and Navrongo HRC (reference NHRCIRB137) in Ghana; and the Research Ethics Committee of the Graduate School of Medicine of the University of Tokyo in Japan (reference serial number: 10513). In addition, we collected informed consent from all the study participants before including them in the study. All study procedures were performed in accordance with the principles included in the Declaration of Helsinki.
