Utilizing a mixed-methods approach to assess implementation fidelity of a group antenatal care trial in Rwanda.

BACKGROUND: The Preterm Birth Initiative (PTBi)-Rwanda conducted a cluster randomized controlled trial to assess the impact of group antenatal care (group ANC) on preterm birth, using a group ANC approach adapted for the Rwanda setting, and implemented in 18 health centers. Previous research showed high overall fidelity of implementation, but lacked correlation with provider self-assessment and left unanswered questions. This study utilizes a mixed-methods approach to study the fidelity with which the health centers' implementation followed the model specified for group ANC. METHODS: Implementation fidelity was measured using two tools, repeated Model Fidelity Assessments (MFAs) and Activity Reports (ARs) completed by Master Trainers, who visited each health center between 7 and 13 times (9 on average) to provide monitoring and training over 18 months between 2017 and 2019. Each center's MFA item and overall scores were regressed (linear regression) on the time elapsed since the center's start of implementation. The Activity Report (AR) is an open-ended template to record comments on implementation. For the qualitative analysis, the ARs from the times of each center's highest and lowest MFA score were analyzed using thematic analysis. Coding was conducted via Dedoose, with two coders independently reviewing and coding transcripts, followed by joint consensus coding. RESULTS: A total of 160 MFA reports were included in the analysis. There was a significant positive association between elapsed time since a health center started implementation and greater implementation fidelity (as measured by MFA scores). In the qualitative AR analysis, Master Trainers identified key areas to improve fidelity of implementation, including: group ANC scheduling, preparing the room for group ANC sessions, provider capacity to co-facilitate group ANC, and facilitator knowledge and skills regarding group ANC content and process. These results reveal that monitoring visits are an important part of acquisition and fidelity of the "soft skills" required to effectively implement group ANC and provide an understanding of the elements that may have impacted fidelity as described by Master Trainers. CONCLUSIONS: For interventions like Group ANC, where "soft-skills" like group facilitation are important, we recommend continuous monitoring and mentoring throughout program implementation to strengthen these new skills, provide corrective feedback and guard against skills decay. We suggest the use of quantitative tools to provide direct measures of implementation fidelity over time and qualitative tools to gain a more complete understanding of what factors influence implementation fidelity. Identifying areas of implementation requiring additional support and mentoring may ensure effective translation of evidence-based interventions into real-world settings.

Assessing the impact of group antenatal care on gestational length in Rwanda: A cluster-randomized trial.

BACKGROUND: Research on group antenatal care in low- and middle-income contexts suggests high acceptability and preliminary implementation success. METHODS: We studied the effect of group antenatal care on gestational age at birth among women in Rwanda, hypothesizing that participation would increase mean gestational length. For this unblinded cluster randomized trial, 36 health centers were pair-matched and randomized; half continued individual antenatal care (control), half implemented group antenatal care (intervention). Women who initiated antenatal care between May 2017 and December 2018 were invited to participate, and included in analyses if they presented before 24 weeks gestation, attended at least two visits, and their birth outcome was obtained. We used a generalized estimating equations model for analysis. FINDINGS: In total, 4091 women in 18 control clusters and 4752 women in 18 intervention clusters were included in the analysis. On average, women attended three total antenatal care visits. Gestational length was equivalent in the intervention and control groups (39.3 weeks (SD 1.6) and 39.3 weeks (SD 1.5)). There were no significant differences between groups in secondary outcomes except that more women in control sites attended postnatal care visits (40.1% versus 29.7%, p = 0.003) and more women in intervention sites attended at least three total antenatal care visits (80.7% versus 71.7%, p = 0.003). No harms were observed. INTERPRETATION: Group antenatal care did not result in a difference in gestational length between groups. This may be due to the low intervention dose. We suggest studies of both the effectiveness and costs of higher doses of group antenatal care among women at higher risk of preterm birth. We observed threats to group care due to facility staff shortages; we recommend studies in which antenatal care providers are exclusively allocated to group antenatal care during visits. TRIAL REGISTRATION: ClinicalTrials.gov NCT03154177.

Model fidelity of group antenatal and postnatal care: a process analysis of the first implementation of this innovative service model by the Preterm Birth Initiative-Rwanda.

Background: For a large trial of the effect of group antenatal care on perinatal outcomes in Rwanda, a Technical Working Group customized the group care model for implementation in this context. This process analysis aimed to understand the degree of fidelity with which the group antenatal care model was implemented during the trial period. Methods: We used two discreet questionnaires to collect data from two groups about the fidelity with which the group antenatal care model was implemented during this trial period. Group care facilitators recorded descriptive data about each visit and self-assessed process fidelity with a series of yes/no checkboxes. Master Trainers assessed process fidelity with an 11-item tool using a 5-point scale of 0 (worst) to 4 (best). Results: We analyzed 2763 questionnaires completed by group care facilitators that documented discreet group visits among pregnant and postnatal women and 140 questionnaires completed by Master Trainers during supervision visits. Data recorded by both groups was available for 84 group care visits, and we compared these assessments by visit. Approximately 80% of all group visits were provided as intended, with respect to both objective measures (e.g. group size) and process fidelity. We did not find reliable correlations between conceptually-related items scored by Master Trainers and self-assessment data reported by group visit facilitators. Conclusions: We recommend both the continued participation of expert observers at new and existing group care sites and ongoing self-assessment by group care facilitators. Finally, we present two abbreviated assessment tools developed by a Rwanda-specific Technical Working Group that reviewed these research results.

Group antenatal care versus standard antenatal care and effect on mean gestational age at birth in Rwanda: protocol for a cluster randomized controlled trial.

Background: Group antenatal care has demonstrated promise as a service delivery model that may result in improved outcomes compared to standard antenatal care in socio-demographic populations at disparately high risk for poor perinatal outcomes. Intrigued by results from the United States showing lower preterm birth rates among high-risk women who participate in group antenatal care, partners working together as the Preterm Birth Initiative - Rwanda designed a trial to assess the impact of group antenatal care on gestational age at birth. Methods: This study is a pair-matched cluster randomized controlled trial with four arms. Pairs randomized to group or standard care were further matched with other pairs into quadruples, within which one pair was assigned to implement basic obstetric ultrasound at the health center and early pregnancy testing at the community. At facilities randomized to group care, this will follow the opt-out model of service delivery and individual visits will always be available for those who need or prefer them. The primary outcome of interest is mean gestational age at birth among women who presented for antenatal care before 24 completed weeks of pregnancy and attended more than one antenatal care visit. Secondary outcomes of interest include attendance at antenatal and postnatal care, preterm birth rates, satisfaction of mothers and providers, and feasibility. A convenience sample of women will be recruited to participate in a longitudinal survey in which they will report such indicators as self-reported health-related behaviors and depressive symptoms. Providers will be surveyed about satisfaction and stress. Discussion: This is the largest cluster randomized controlled trial of group antenatal and postnatal care ever conducted, and the first in a low- or middle-income country to examine the effect of this model on gestational age at birth. Trial registration: This study is registered on ClinicalTrials.gov as NCT03154177 May 16, 2017.

Nurses' and midwives' experiences of providing group antenatal and postnatal care at 18 health centers in Rwanda: A mixed methods study.

BACKGROUND: The East Africa Preterm Birth Initiative-Rwanda began a cluster randomized controlled trial of group antenatal care (ANC) and postnatal care (PNC) in Rwanda in 2017. That trial will report its primary outcome, gestational length at birth, after data collection concludes in 2019. This nested study includes providers of ANC and/or PNC at the 18 health centers randomized to provide the group model of ANC/PNC and the 18 health centers randomized to continue providing ANC/PNC in the traditional, individual visit model. The objective of this study is to understand the experiences of providers of group ANC/PNC and compare their job satisfaction and perceived stress with individual ANC/PNC providers. METHODS: We collected both quantitative and qualitative data from providers (nurses and midwives) who were recruited by health center directors to participate as group ANC and PNC facilitators at intervention sites and from a similar number of providers of standard ANC and PNC at control sites. Quantitative data was collected with questionnaires administered at baseline and approximately 9 months later (follow up). Qualitative data was collected in 3 focus groups of group ANC/PNC providers conducted one year after group care began. RESULTS: Eighty-six percent of nurses and midwives surveyed who implemented group ANC and PNC reported that they prefer group care to the traditional individual model of ANC and PNC. Perceived stress levels and job satisfaction results were similar between groups. Mixed focus group discussions among both nurses and midwives experienced in group ANC and PNC suggest that the group model of care has advantages for both service beneficiaries and providers. When providers described implementation challenges, their peers in the focus groups offered them suggestions to cope and improve service delivery. DISCUSSION: These results are consistent with studies of providers of group ANC and PNC in other LMIC contexts with respect to the perceived benefits of group care. This study adds new insights into the ways peer providers can help one another solve implementation problems. When given the opportunity to meet as a group, these study participants offered one another peer support and shared knowledge about best practices for successful implementation of group ANC/PNC. This trial is registered at clinicaltrials.gov as NCT03154177.

Postnatal care in Rwanda: facilitators and barriers to postnatal care attendance and recommendations to improve participation.

BACKGROUND: Sub-Saharan Africa has the highest rates of neonatal mortality in the world with an estimated 1.2 million deaths within the first 28 days of life. Postnatal care (PNC) can contribute to reductions in morbidity and mortality in mothers and newborns through vital support that identifies danger signs and establishes valuable practices and referral processes. METHODS: This qualitative data was collected as a part the East Africa Preterm Birth Initiative (PTBi-EA) to guide development of a group antenatal (ANC) and PNC model in Rwanda. Key-informant in-depth interviews (IDIs) and focus group discussions (FGDs) were conducted in four districts. Sixteen FGDs with 180 participants and 22 IDIs were completed at the time of thematic saturation. RESULTS: Four themes highlighted facilitators and barriers to PNC attendance and recommendations to improve participation: 1) There is little awareness in the community of what the PNC package is; PNC 4 in particular is not well understood; 2) PNC visits by community health workers (CHWs) are well accepted and valued; 3) Providers perceive PNC 4 as an added burden to an already high workload; 4) Community structures exist to better disseminate key messages about PNC, but have not yet been effectively utilized. CONCLUSIONS: This qualitative work provides evidence that the PNC package was not initially well understood. Regardless, PNC service delivery performed by CHWs in Rwanda is well accepted and appreciated by the population, providing assurance that the full package has potential to be well utilized and valued by the population.