Abstract
Background High levels of maternal and newborn mortality and morbidity remain a daunting reality in many low-income countries. Several interventions delivered during antenatal care have been shown to improve maternal and newborn outcomes, but stockouts of medical supplies at point of care can prevent implementation of these services. We aimed to evaluate whether a supply chain strategy based on the provision of kits could improve quality of care. Methods We did a pragmatic, stepped-wedge, cluster-randomised controlled trial at ten antenatal care clinics in Mozambique. Clinics were eligible if they were not already implementing the proposed antenatal care package; they served at least 200 new pregnant women per year; they had Maternal and Child Health (MCH) nurses; and they were willing to participate. All women attending antenatal care visits at the participating clinics were included in the trial. Participating clinics were randomly assigned to shift from control to intervention on prespecified start dates. The intervention involved four components (kits with medical supplies, a cupboard to store these supplies, a tracking sheet to monitor stocks, and a one-day training session). The primary outcomes were the proportion of women screened for anaemia and proteinuria, and the proportion of women who received mebendazole in the first antenatal care visit. The intervention was delivered under routine care conditions, and analyses were done according to the intention-to-treat principle. This trial is registered with the Pan African Clinical Trial Registry, number PACTR201306000550192. Findings Between March, 2014, and January, 2016, 218 277 antenatal care visits were registered, with 68 598 first and 149 679 follow-up visits. We found significant improvements in all three primary outcomes. In first visits, 5519 (14·6%) of 37 826 women were screened for anaemia in the control period, compared with 30 057 (97·7%) of 30 772 in the intervention period (adjusted odds ratio 832·40; 99% CI 666·81–1039·11; p<0·0001); 3739 (9·9%) of 37 826 women were screened for proteinuria in the control period, compared with 29 874 (97·1%) of 30 772 in the intervention period (1875·18; 1447·56–2429·11; p<0·0001); and 17 926 (51·4%) of 34 842 received mebendazole in the control period, compared with 24 960 (88·2%) of 28 294 in the intervention period (1·88; 1·70–2·09; p<0·0001). The effect was immediate and sustained over time, with negligible heterogeneity between sites. Interpretation A supply chain strategy that resolves stockouts at point of care can result in a vast improvement in quality during antenatal care visits, when compared with the routine national process for procurement and distribution of supplies. Funding Government of Flanders and the UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction.
| Original language | English (US) |
|---|---|
| Pages (from-to) | e57-e65 |
| Journal | The Lancet Global Health |
| Volume | 6 |
| Issue number | 1 |
| DOIs | |
| State | Published - Jan 2018 |
| Externally published | Yes |
ASJC Scopus subject areas
- Medicine(all)
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In: The Lancet Global Health, Vol. 6, No. 1, 01.2018, p. e57-e65.
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TY - JOUR
T1 - Provision of medical supply kits to improve quality of antenatal care in Mozambique
T2 - a stepped-wedge cluster randomised trial
AU - for the
AU - WHO Antenatal Care Trial in Mozambique Research Group
AU - WHO Antenatal Care Trial in Mozambique Research Group
AU - Betrán, Ana Pilar
AU - Bergel, Eduardo
AU - Griffin, Sally
AU - Melo, Armando
AU - Nguyen, My Huong
AU - Carbonell, Alicia
AU - Mondlane, Santos
AU - Merialdi, Mario
AU - Temmerman, Marleen
AU - Gülmezoglu, A. Metin
AU - Aleman, Alicia
AU - Althabe, Fernando
AU - Biza, Adriano
AU - Crahay, Beatrice
AU - Chavane, Leonardo
AU - Colomar, Mercedes
AU - Delvaux, Therese
AU - Dique Ali, Ussumane
AU - Fersurela, Lucio
AU - Geelhoed, Diederike
AU - Jille-Taas, Ingeborg
AU - Malapende, Celsa Regina
AU - Langa, Célio
AU - Osman, Nafissa Bique
AU - Requejo, Jennifer
AU - Timbe, Geraldo
N1 - Funding Information: The results of this stepped-wedge cluster-randomised controlled trial show that implementation of a supply chain strategy based on the provision of pre-packed supply kits at the point of care can generate major and long lasting improvements in practice delivery and thus in quality of antenatal care. Importantly, through integration of all essential antenatal care practices, the kits created the necessary conditions for a woman-centred approach, resulting in improvements in antenatal care across practices (all >80% coverage for the whole intervention period). Furthermore, when looking at the effect of the intervention in each clinic and over time, we found a uniform effect across clinics, which was immediate and sustained throughout the entire intervention period. Our simple intervention addressed several limitations of the health system in Mozambique. Packaging of all required supplies and timely delivery of these kits at the clinics addressed weaknesses in the procurement and supply systems. 11 With the kits, screening for proteinuria and haemoglobin switched from laboratory testing to rapid testing, which enabled nurses to screen, diagnose, and treat women in a single antenatal care session, thus optimising the scarce contact between these women and the health-care system and ensuring that these women access the full range of recommended interventions. The shortage of human resources for antenatal care results in overburdened and frustrated nurses who are unable to deliver all recommended practices. 12,16 The trial kits streamlined the antenatal care processes, achieving increased efficiency without increasing the size of the workforce. Vertical approaches to health care, focusing on a single health condition, have been criticised because they can force busy health-care providers to deflect attention from other critical activities, which could result in deterioration of the overall quality of care. 16–18 Baseline data from this trial are consistent with this view. Vertical, well-resourced HIV programmes are deeply established in Mozambique; we saw that screening and treatment for HIV were two practices with very high baseline coverage, at 90% or more, and therefore little room for improvement as reflected in the non-significant increase, whereas screening for high blood pressure, proteinuria, and anaemia was much less common ( table 2 ). The public health and practical implications of this finding are important, particularly in a setting where haemorrhage and hypertensive disorders of pregnancy are leading direct causes of maternal mortality. 19 The supply of pre-packed kits—targeted at women, health-care providers, or facilities—has been proposed as a simple, low-cost intervention with the potential to address challenges routinely encountered in low-resource settings that prevent patients from receiving appropriate care. 20–23 However, in maternal health, almost all evidence on supply kits derives from observational studies and has focused mainly on clean childbirth and reducing the incidence of infection and its complications, particularly in settings where women give birth at home. 20,21 To our knowledge, this is the first trial assessing supply kits targeted at health facilities as an intervention to improve coverage of routine evidence-based practices for maternal care. 24 In this trial, the combination of a robust design, large sample size, and large effect size provides a strong level of evidence to support the effectiveness of the intervention, since bias or random error are unlikely to explain these findings. Other strengths of the study include the stepped-wedge design, which allowed delivery of the intervention in all clusters, avoiding some of the logistic and political challenges typically faced by researchers. 25 We randomised the order in which facilities received the intervention and adjusted for potential secular trends. We also validated the source data by doing surveys with women leaving antenatal care and doing an audit. Contamination was deemed unlikely because it would imply the improbable transfer of kits between clinics, which were dispersed across the country. Additionally, the kits' stocks were monitored. This was a pragmatic trial designed from the ground up to inform policy makers. The close partnership between the Ministry of Health and WHO, and the ownership and full engagement of the Ministry of Health, catalysed this implementation research, embedded in a real-world setting and driven by the needs and priorities of the country. Consequently, a relevant and practical intervention was designed on the basis of the formative research. The study population included all women attending antenatal care visits, with no exclusion criteria. The intervention was implemented by the available nurses under routine care conditions and regardless of any event occurring in the clinics during the trial period. We used the government antenatal care registration logbook as our source of data and thus the trial did not place additional burden on the health-care providers. To our knowledge, this is the first trial to evaluate an intervention with these characteristics. For all parties involved in the study, scaling up and sustainability were important considerations. Subsequent to the trial, the study partners, including the Ministry of Health, have been engaged in an assessment of the cost-effectiveness and implementation options for scaling up the use of antenatal care supply kits in Mozambique. This information will inform how antenatal care supply kits could be incorporated into the supply chain in Mozambique, including whether the use of other (private) supply solutions would be feasible and cost-effective. Our study has some limitations. The stepped-wedge design can be vulnerable to secular trends if outcomes are already improving. However, the large sample size and large number of steps in this trial allowed us to estimate and adjust for time trends. 15 The effect might also be explained by differences in reporting during the intervention period. To avoid this problem, we isolated the data collection procedures from those relating to implementation of the interventions as much as was feasible and implemented strict data management procedures that included several data audits. Although rapid tests for HIV and syphilis were being used in antenatal care before the intervention, the kits introduced two additional rapid tests for proteinuria and anaemia—the conditions for which the most substantial increase in screening was observed. The availability of rapid tests for these conditions is likely to have an effect independently of the provision of kits. 26 Unfortunately, however, in evaluations of complex interventions delivered as a package, disentangling the individual effect of each component is not possible. We could not report on all the initially prespecified secondary outcomes because of limitations in the data collection instrument from the Ministry of Health. Iron and folic acid supplementation and tetanus toxoid administration had to be excluded because the information to compute these outcomes was not recorded in the logbook. Lastly, we did not collect data on final maternal and newborn outcomes, so the overall effect of the antenatal care practices on mortality or morbidity cannot be assessed. However, we only included evidence-based practices for which the benefits have already been clearly established. The health-system and resource challenges underpinning the design of our intervention are undoubtedly not unique to the facilities participating in this trial or to Mozambique. 11,12 This study provides crucial information to policy makers in countries with similar supply chain deficiencies but its relevance goes well beyond this obvious target. We believe that this simple intervention could be easily adapted beyond low-resource settings and beyond the area of maternal health. The simplicity and the nature of the intervention make it likely to be acceptable and adaptable across many countries and settings. However, context-specific kits need to be designed. What to include, where to produce and store the kits, and how to distribute these kits to facilities will vary across countries and settings and requires careful analysis to avoid the very same challenges that these kits aim to address. In conclusion, although the evidence-based practices for improving maternal and newborn health are well known, approaches to effectively and sustainably scale up these interventions are urgently needed, particularly in low-resource settings. The results of this study show that a simple intervention focused on the provision, at point of care, of supplies for evidence-based practices packaged in kits resulted in a vast improvement in quality of antenatal care when compared with the routine national system for procurement and distribution of supplies. The pragmatic nature of this trial, embedded in routine care conditions, makes these findings particularly valuable for policy makers in low-resource settings. Contributors APB, EB, MM, and MT conceived and designed the study. APB, EB, AC, MM, MHN, and MT developed the protocol. APB, EB, SG, AM, MHN, AC, and SM participated in the implementation of the study and data acquisition. APB and EB designed the data analysis. EB did the data analysis. APB, EB, SG, AM, AC, and SM interpreted the results. APB, EB, and SG drafted the manuscript. AM, MHN, AC, SM, MM, MT, and AMG provided substantial comments to the writing of the manuscript. All authors read and approved the final manuscript. WHO Antenatal Care Trial in Mozambique Research Group In addition to the listed authors: Alicia Aleman, Montevideo Clinical and Epidemiological Research Unit, Montevideo, Uruguay; Fernando Althabe, Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina; Adriano Biza, International Center for Reproductive Health, Maputo, Mozambique; Beatrice Crahay, International Center for Reproductive Health, Maputo, Mozambique; Leonardo Chavane, Mozambique Ministry of Health, Maputo, Mozambique; Mercedes Colomar, Montevideo Clinical and Epidemiological Research Unit, Montevideo, Uruguay; Therese Delvaux, Institute of Tropical Medicine, Antwerp, Belgium; Ussumane Dique Ali, Consultório de Estatística e Serviço de Soluções, Maputo, Mozambique; Lucio Fersurella, Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland; Diederike Geelhoed, International Center for Reproductive Health, Maputo, Mozambique; Ingeborg Jille-Taas, International Center for Reproductive Health, Maputo, Mozambique; Celsa Regina Malapende, Central de Medicamentos e Artigos Médicos, Maputo, Mozambique; Célio Langa, Consultório de Estatística e Serviço de Soluções, Maputo, Mozambique; Nafissa Bique Osman, Department of Obstetrics and Gynecology, Faculdade de Medicina, Eduardo Mondlane University, Hospital Central, Maputo, Mozambique; Jennifer Requejo-Harris: Institute for International Programs, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA; and Geraldo Timbe, Consultório de Estatística e Serviço de Soluções, Maputo, Mozambique. Declaration of interests MM reports personal fees from BD, a medical device company, outside of the submitted work. SG reports grants from WHO during the conduct of the study. SM reports grants and payment for services from the International Center for Reproductive Health in Mozambique, during the conduct of the study. All other authors declare no competing interests. Acknowledgments We thank the participating health facilities and their staff: Health Center Primeiro de Maio in Maputo city, Health Center Matola II in Maputo Province; Health Center annexed to Rural Hospital of Chowké in Gaza Province; Health Center of Chibuto in Gaza Province; Health Center annexed to Dondo District Hospital in Sofala Province; Health Center annexed to Songo Rural Hospital in Tete Province; Health Center N° 2 in Tete City; Health Center 25 de Setembro in Nampula city; Health Center of Anchilo in Nampula Province; and Health Center annexed to Montepuez Rural Hospital in Cabo Delgado Province. We also thank the research assistants of the study; representatives from the Mozambique Ministry of Health; the Provincial Health Departments of Cabo Delgado, Nampula, Tete, Sofala, Gaza, Maputo, and Maputo City; members of the Study Steering Committee; and staff from the International Centre for Reproductive Health in Mozambique. Publisher Copyright: © 2018 World Health Organization
PY - 2018/1
Y1 - 2018/1
N2 - Background High levels of maternal and newborn mortality and morbidity remain a daunting reality in many low-income countries. Several interventions delivered during antenatal care have been shown to improve maternal and newborn outcomes, but stockouts of medical supplies at point of care can prevent implementation of these services. We aimed to evaluate whether a supply chain strategy based on the provision of kits could improve quality of care. Methods We did a pragmatic, stepped-wedge, cluster-randomised controlled trial at ten antenatal care clinics in Mozambique. Clinics were eligible if they were not already implementing the proposed antenatal care package; they served at least 200 new pregnant women per year; they had Maternal and Child Health (MCH) nurses; and they were willing to participate. All women attending antenatal care visits at the participating clinics were included in the trial. Participating clinics were randomly assigned to shift from control to intervention on prespecified start dates. The intervention involved four components (kits with medical supplies, a cupboard to store these supplies, a tracking sheet to monitor stocks, and a one-day training session). The primary outcomes were the proportion of women screened for anaemia and proteinuria, and the proportion of women who received mebendazole in the first antenatal care visit. The intervention was delivered under routine care conditions, and analyses were done according to the intention-to-treat principle. This trial is registered with the Pan African Clinical Trial Registry, number PACTR201306000550192. Findings Between March, 2014, and January, 2016, 218 277 antenatal care visits were registered, with 68 598 first and 149 679 follow-up visits. We found significant improvements in all three primary outcomes. In first visits, 5519 (14·6%) of 37 826 women were screened for anaemia in the control period, compared with 30 057 (97·7%) of 30 772 in the intervention period (adjusted odds ratio 832·40; 99% CI 666·81–1039·11; p<0·0001); 3739 (9·9%) of 37 826 women were screened for proteinuria in the control period, compared with 29 874 (97·1%) of 30 772 in the intervention period (1875·18; 1447·56–2429·11; p<0·0001); and 17 926 (51·4%) of 34 842 received mebendazole in the control period, compared with 24 960 (88·2%) of 28 294 in the intervention period (1·88; 1·70–2·09; p<0·0001). The effect was immediate and sustained over time, with negligible heterogeneity between sites. Interpretation A supply chain strategy that resolves stockouts at point of care can result in a vast improvement in quality during antenatal care visits, when compared with the routine national process for procurement and distribution of supplies. Funding Government of Flanders and the UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction.
AB - Background High levels of maternal and newborn mortality and morbidity remain a daunting reality in many low-income countries. Several interventions delivered during antenatal care have been shown to improve maternal and newborn outcomes, but stockouts of medical supplies at point of care can prevent implementation of these services. We aimed to evaluate whether a supply chain strategy based on the provision of kits could improve quality of care. Methods We did a pragmatic, stepped-wedge, cluster-randomised controlled trial at ten antenatal care clinics in Mozambique. Clinics were eligible if they were not already implementing the proposed antenatal care package; they served at least 200 new pregnant women per year; they had Maternal and Child Health (MCH) nurses; and they were willing to participate. All women attending antenatal care visits at the participating clinics were included in the trial. Participating clinics were randomly assigned to shift from control to intervention on prespecified start dates. The intervention involved four components (kits with medical supplies, a cupboard to store these supplies, a tracking sheet to monitor stocks, and a one-day training session). The primary outcomes were the proportion of women screened for anaemia and proteinuria, and the proportion of women who received mebendazole in the first antenatal care visit. The intervention was delivered under routine care conditions, and analyses were done according to the intention-to-treat principle. This trial is registered with the Pan African Clinical Trial Registry, number PACTR201306000550192. Findings Between March, 2014, and January, 2016, 218 277 antenatal care visits were registered, with 68 598 first and 149 679 follow-up visits. We found significant improvements in all three primary outcomes. In first visits, 5519 (14·6%) of 37 826 women were screened for anaemia in the control period, compared with 30 057 (97·7%) of 30 772 in the intervention period (adjusted odds ratio 832·40; 99% CI 666·81–1039·11; p<0·0001); 3739 (9·9%) of 37 826 women were screened for proteinuria in the control period, compared with 29 874 (97·1%) of 30 772 in the intervention period (1875·18; 1447·56–2429·11; p<0·0001); and 17 926 (51·4%) of 34 842 received mebendazole in the control period, compared with 24 960 (88·2%) of 28 294 in the intervention period (1·88; 1·70–2·09; p<0·0001). The effect was immediate and sustained over time, with negligible heterogeneity between sites. Interpretation A supply chain strategy that resolves stockouts at point of care can result in a vast improvement in quality during antenatal care visits, when compared with the routine national process for procurement and distribution of supplies. Funding Government of Flanders and the UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction.
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UR - http://www.scopus.com/inward/citedby.url?scp=85037611701&partnerID=8YFLogxK
U2 - 10.1016/S2214-109X(17)30421-7
DO - 10.1016/S2214-109X(17)30421-7
M3 - Article
C2 - 29241615
AN - SCOPUS:85037611701
SN - 2214-109X
VL - 6
SP - e57-e65
JO - The Lancet Global Health
JF - The Lancet Global Health
IS - 1
ER -