Article Text
Abstract
Introduction Many families in low-income and middle-income countries have high out-of-pocket expenditures (OOPE) for healthcare, and some face impoverishment. We aimed to assess the effect of Kangaroo Mother Care initiated in community setting (ciKMC) on financial risk protection estimated by healthcare OOPE, catastrophic healthcare expenditure (CHE) and impoverishment due to healthcare seeking for low birthweight infants, using a randomised controlled trial design.
Methods We included 4475 low birthweight infants randomised to a ciKMC (2491 infants) and a control (1984 infants) arm, in a large trial conducted between 2017 and 2018 in Haryana, India. We used generalised linear models of the Gaussian family with an identity link to estimate the mean difference in healthcare OOPE, and Cox regression to estimate the HRs for CHE and impoverishment, between the trial arms.
Results Overall, in the 8-week observation period, the mean healthcare OOPE per infant was lower (US$20.0) in the ciKMC arm compared with the control arm (US$25.6) that is, difference of −US$5.5, 95% CI −US$11.4 to US$0.3, p=0.06). Among infants who sought care it was US$8.5 (95% CI −US$17.0 to −US$0.03, p=0.03) lower in the ciKMC arm compared with the control arm. The HR for impoverishment due to healthcare seeking was 0.56 (95% CI 0.36 to 0.89, p=0.01) and it was 0.91 (95% CI 0.74 to 1.12, p=0.37) for CHE.
Conclusion ciKMC can substantially reduce the cost of care seeking and the risk of impoverishment for households. Our findings show that supporting mothers to provide KMC to low birthweight infants at home, in addition to reducing early infant mortality, may provide financial risk protection.
Trial registration number CTRI/2017/10/010114
- Child health
- Health economics
- Health policy
Data availability statement
Data are available on reasonable request. The dataset pertaining to the results reported in the manuscript will be made available to others only for health and medical research, subject to constraints of the consent under which the data were collected. Deidentified individual participant data will be made available along with the data dictionary, study protocol and informed consent form. Data will be available beginning 12 months and ending 5 years after publication of this article. Requests for data should be made to TSC (tarun.choudhary@sas.org.in). The requester should provide a methodologically sound secondary research proposal, approved by an independent review committee. The requester must be able to show their ability to carry out the proposed use of the requested dataset through their peer review publications and declare conflicts of interest in relation to the requested dataset and their funding sources. The authors reserve the right to refuse sharing of data in the face of potential adversarial conflicts of interest. A Data Sharing Agreement that meets the data sharing requirements of the Society for Applied Studies (New Delhi, India) and Centre for International Health, University of Bergen (Norway) will be signed with the data requester. Data must only be used for the purpose described in the secondary research proposal as further stipulated in the Data Sharing Agreement. Data will be transferred only to requesters named in the original proposal and as specified in the relevant data sharing agreement.
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Data availability statement
Data are available on reasonable request. The dataset pertaining to the results reported in the manuscript will be made available to others only for health and medical research, subject to constraints of the consent under which the data were collected. Deidentified individual participant data will be made available along with the data dictionary, study protocol and informed consent form. Data will be available beginning 12 months and ending 5 years after publication of this article. Requests for data should be made to TSC (tarun.choudhary@sas.org.in). The requester should provide a methodologically sound secondary research proposal, approved by an independent review committee. The requester must be able to show their ability to carry out the proposed use of the requested dataset through their peer review publications and declare conflicts of interest in relation to the requested dataset and their funding sources. The authors reserve the right to refuse sharing of data in the face of potential adversarial conflicts of interest. A Data Sharing Agreement that meets the data sharing requirements of the Society for Applied Studies (New Delhi, India) and Centre for International Health, University of Bergen (Norway) will be signed with the data requester. Data must only be used for the purpose described in the secondary research proposal as further stipulated in the Data Sharing Agreement. Data will be transferred only to requesters named in the original proposal and as specified in the relevant data sharing agreement.
Supplementary materials
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Footnotes
Handling editor Valery Ridde
Twitter @tarunschoudhary, @DoctorHaaland, @KA_Johansson
Contributors All authors contributed substantially to the conception or design of the study or to the data acquisition, analysis or interpretation. TSC, SM and ST were responsible for the day-to-day implementation of the study, data management and analysis. TSC, OH, HS and KAJ performed the statistical analysis. TSC, OFN, OH, KAJ, HS and SM drafted the manuscript. NB, RB, JM, MKB and HS provided technical support, monitoring, and coordination for the trial. All authors critically revised the manuscript for important intellectual content. TSC is the guarantor and corresponding author. He attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted. The manuscript was reviewed and has final approval from all authors.
Funding A grant for the study was received from the Norwegian Research Council through its Centres of Excellence scheme and the University of Bergen to the Centre of Intervention Science in Maternal and Child Health (project No. 223269) and Equifinance (project no. 316354).
Disclaimer The funder of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. The corresponding author had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Competing interests None declared.
Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.
Provenance and peer review Not commissioned; externally peer reviewed.
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