Study population and study setting
This study is part of a bigger study looking into the effectiveness of a complex community intervention (the Jom Mama intervention) aimed at enhancing women’s health through behaviour change prior to conception. A randomised controlled trial to test its efficacy was carried out in the district of Seremban, in Negeri Sembilan, Malaysia, from December 2015 to December 2017. The trial was registered at the National Medical Research Registry (NMRR), protocol number: NMRR-14-904-21963 on 21 September 2015, and at Clinical.Trials.gov, Identifier: NCT02617693 on 30 November 2015. Ethical approval to conduct the study was obtained from the Ministry of Health Malaysia. Details of the intervention and study is published elsewhere (Skau et al., 2016).
The study population consisted of newly married or engaged women living in Negeri Sembilan, aged between 20 to 39 years, nulliparous, not pregnant at the time of signing the informed consent, own a smartphone, with either an Android operating system version 4.1 and above or iOS operating system 7.0 and above with internet access. Women that are undergoing treatment for type 1 or 2 diabetes mellitus and not residing in the district of Seremban was excluded from the study.
The women were randomly assigned to either intervention or control group. At the end of the study, 305 participants completed the intervention, 145 from intervention and 160 from control group. Both groups received care as usual with the intervention group receiving additional Jom Mama Intervention. The Jom Mama intervention consists of two components; interactions with a community health promoter (CHP) which is made up of three face-to-face meetings, three phone calls, and communication through Whatsapp group chat; and an E-health platform which consists of a mobile application (for the participants) and a web-based interface which can be accessed by the CHP (total of six contact points). Aim of the intervention was to provide support and help participants improve their lifestyle (i.e. physical activity, diet, etc.). Intervention follow-up period is eight months from randomisation/baseline. The CHPs received 40 hours of training prior to the intervention. Monitoring and support mechanism for the CHPs consisted of regular peer support sessions, refresher training sessions and other lifestyle related training such as nutritional course and physical activity course.
The purpose of this paper is to provide an estimate of the resources needed and the cost to provide the intervention at the health clinics. For this purpose, we assumed that 1) the intervention is assumed to have matured and is running at a ‘steady state’; 2) implementation of the intervention utilises existing facilities and equipment, except for new equipment that were required specifically for this initiative and for monitoring of the clients’ progress, such as tablets, computers, stadiometer and weighing scale; and 3) that the conduct of the intervention or contact points does not take up additional time, i.e. was done within the usual working hours.
We describe costs associated with becoming familiar with and managing the intervention (including start-up costs for training CHPs in intervention implementation) and costs associated with providing the six contact points to approximately 145 clients. Costs associated with conducting a research protocol are not reported here as we assume that the health clinics provides the intervention as part of their normal operating activities and not as part of a research study.
Cost data collection and cost data analysis
The cost analysis was performed from a provider’s perspective, i.e. the Ministry of Health Malaysia calculated in Malaysian ringgit (RM) and therefore excluded client and societal costs (and savings) (Drummond, Sculpher, Claxton, Stoddart, & Torrance, 2015). Only the costs of training and providing the intervention is reported in this paper. Costs of planning the intervention, and other one-off costs of developing the resources used in the intervention (e.g. development of the e-health platform and other educational materials) were not included, as these are “sunk” costs that would not be incurred if it were to be replicated to other health clinics. Research costs associated with the trial, such as investigator time, data collection and data entry costs were also excluded from the cost analysis.
Only costs that accumulate within the trial period were included as the cost analysis was performed alongside the main trial. Other costs that was taken into consideration included the cost of monitoring equipment such as information technology (IT) equipment (computers and tablets), stadiometer, weighing scales and measuring tape, were included in the marginal costs, as, if the intervention were to be repeated, these equipment would be required for monitoring of the participants.
Costs were identified and valued as all intervention-related direct costs such as contact with primary and secondary healthcare provider. Implementation costs, including training and education of the CHPs and all relevant healthcare personnel, and the ongoing contact between the clients and the providers were included. The costs were categorised into fixed and variable costs. Fixed costs were defined as cost inputs that does not vary with the quantity of output in the short term and vary with time rather than quantity. They include furniture and equipment costs. Variable costs were defined as costs that vary with the level of output and included supplies, consumables and salaries. No discounting was applied to the costs in the second year as the intervention was carried out over the two years, and the cost data was collected accordingly as it was accrued. Cost data was sourced from project documents and accounting records. Using a top-down approach, the costs were calculated using an Excel costing tool developed by the research team.
A sensitivity analysis was performed to determine how the differences in the cost items affects the total cost under different set of assumptions. The baseline costs were compared to the variations in the parameters.