Evaluating the equity impact and cost-effectiveness of digital adherence technologies with differentiated care to support tuberculosis treatment adherence in Ethiopia: protocol and analysis plan for the health economics component of a cluster randomised trial

Foster, Nicola; Tadesse, Amare Worku; McQuaid, Christopher Finn; Goscé, Lara; Abdurhman, Tofik; Assefa, Demelash; Bedru, Ahmed; Houben, Rein M. G. J.; Kalmthout, Kristian van; Letta, Taye; Mohammed, Zemedu; Rest, Job van; Umeta, Demekech G.; Weldemichael, Gedion T.; Yazew, Hiwot; Jerene, Degu; Quaife, Matthew; Fielding, Katherine

doi:10.1186/s13063-023-07289-x

Cited by 4 publications

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“…In this study, we focused the cost analysis on the staff time required to implement the DATs. The full opportunity costs of the implementation of DATs including the technology costs, medication, diagnostics used for monitoring, and subsequent treatment episodes will be assessed in a separate cost-utility analysis [8]. Some of the limitations of our study include that it was based on healthcare workers self-completing a time-and-motion survey retrospectively, at the end of each patient seen or at the end of the week for above-service tasks.…”

Section: Discussionmentioning

confidence: 99%

“…Healthcare workers use the data platform or mobile phone app to evaluate treatment adherence and update support provided including phone calls or home visits to the patient. Further details of the trial and associated health economics work is available from the protocol [7] and health economics analysis plan [8]. To compare human resource time spent and support costs between study arms, we conducted a time-and-motion study as part of the ASCENT-Ethiopia trial between October 2021 and June 2022 in a sample of 15 health facilities (five in each arm) participating in the trial.…”

Section: Methodsmentioning

confidence: 99%

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Effect of implementing digital adherence technologies on the use of health care providers’ time and the human resource cost of tuberculosis treatment adherence support in Ethiopia

Belachew,

Sahile,

Gadissa

et al. 2024

Preprint

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Background. The management of human resources for health is a key priority for resource constrained health systems. Digital adherence technologies (DATs) for treatment support offer an opportunity to reorganise existing healthcare worker workload. Historically, tuberculosis treatment services involved directly observed treatment with frequent patient visits to the clinic for treatment adherence support. More recently, digital technologies have offered an option for the digital monitoring of treatment adherence and remote support. The aim of this study was to determine how health care workers use their time following the implementation of digital adherence support, and the human resource cost of tuberculosis treatment adherence support. Methods. As part of the ASCENT three-arm cluster randomised trial of DATs for tuberculosis treatment support, we conducted time-and-motion studies in 15 of 78 ASCENT-trial health facilities for six-weeks. Healthcare workers recorded time spent on direct patient care and in-person adherence monitoring for 10 patients, as well as time spent on above-service activities. Total time use was calculated by multiplying time spent per visit by number of patient visits at the facility for six weeks and adding above-service time. In a facility-level analysis, we used negative binomial regression models to investigate associations between total time use and facility-level factors. Findings. HCWs spent 4% (126/2892) of time in minutes on in-person adherence monitoring in the Labels, compared to 7% (206/3126) in the Pillbox and 13% (587/4673) in the standard-of-care study arms. More time was spent on above-service activities in the standard-of-care (2360 minutes [SD:1951]) compared to the DAT arms (Pillbox: 2057min [SD:1570]; Labels: 2261min [SD:1360]). After adjusting for facility workload and number of people lost-to-follow-up, we did not find sufficient evidence of a difference in the human resource costs between the study arms (Labels IRR (95%CI): 0.71 (0.33; 1.52); Pillbox (95% CI) 0.71 (0.33; 1.52)). Conclusion. We found a small, although not statistically significant reduction, in human resource costs in the facilities where DATs were implemented. We observed changes in how healthcare workers spent their time, including a shift towards fewer health facility visits but more time spent on in-person adherence support. Further work is ongoing to assess the implications for the cost-effectiveness of the interventions.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Effect of implementing digital adherence technologies on the use of health care providers’ time and the human resource cost of tuberculosis treatment adherence support in Ethiopia

Belachew,

Sahile,

Gadissa

et al. 2024

Preprint

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“…We conducted a trial-based distributional cost-effectiveness analysis using participant-level data, following a pre-specified health economics analysis plan [14]. Costs and outcomes were assessed from a societal perspective.…”

Section: Methodsmentioning

confidence: 99%

“…Participants were followed up for 12 months until August 2023. Patient events were collected at enrolment, from treatment registers and at the 12month follow-up [14]. Household socio-economic position (SEP) as a relative measure of poverty was estimated by calculating an asset index through principal component analysis of 27 multidimensional poverty indicators collected using a survey at enrolment (table S2).…”

Section: Assessment Of Household Socio-economic Position Cost and Out...mentioning

confidence: 99%

Equity, cost and disability adjusted life years of tuberculosis treatment supported by digital adherence technologies and differentiated care in Ethiopia: a trial-based distributional cost-effectiveness analysis

Foster,

Tadesse,

Belachew

et al. 2024

Preprint

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SummaryBackgroundEvidence of the cost-effectiveness of digital adherence technologies (DATs) for supporting tuberculosis treatment has been inconclusive and primarily omitted patient-incurred costs. We aimed to assess the societal costs, equity impact and cost-effectiveness of DATs and differentiated care compared to routine care in Ethiopia.MethodsWe conducted a distributional cost-effectiveness analysis using data from the cluster randomised trial that evaluated the implementation of labels and pillbox followed by differentiated care to support tuberculosis treatment adherence in 78 health facilities in Ethiopia. We estimated the costs, cost per disability-adjusted life year (DALYs) averted and equity impact of the implementation of the DATs interventions. Costs and DALYs were estimated at a participant level based on patient events collected during the trial and the trial endpoints for intention-to-treat population. Uncertainty in cost-effectiveness estimates were assessed by plotting cost-effectiveness acceptability frontiers. The trial is registered with Pan African Clinical Trial Registry (PACTR) PACTR202008776694999, registered on 11 August 2020 athttps://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=12241and has been completed.FindingsThe mean total societal treatment cost per trial participant was US$507 (95%CI: 458; 555) in the SOC, US$196 (95%CI: 190; 218) in the labels and US$206 (95%CI: 167; 213) in the pillbox study arms. We estimated that there was a 49-56% probability that the implementation of the DAT interventions, would improve the cost-effectiveness of tuberculosis treatment at a cost-effectiveness threshold of US$100. There was no difference in DALYs between socio-economic position groups (p=0.920), however, patient costs were less concentrated among those relatively poor in the intervention arms – labels (illness concentration index [ICI]=0.03 (95%CI: 0.01; 0.05)) and pillbox (ICI=0.01 (95%CI:-0.01; 0.02)); compared to the SOC (ICI=-0.05 (95%CI: -0.07; -0.02). Between group comparison (p<0.001).InterpretationDAT interventions were cost-saving and reduced the inequitable distribution of patient costs compared to the SOC. This highlights the potential value of interventions that reduce health service visits in improving the equitable distribution of health services.FundingUnitaid (Grant Agreement Number: 2019-33-ASCENT).Research in contextEvidence before this studyIn November 2022, we searched PubMed and MedRxiv for English-language studies published between January 2000 and current, using the terms “tuberculosis” AND “cost” AND (“Digital Adherence Technologies” OR “DATS” OR “99DOTS” OR “Pillbox”). This search was repeated as part of a systematic review in April 2023 followed by an update in May 2024. Twenty-nine relevant studies have been identified, estimating the costs of DATS, though many did not assess the full economic costs of implementation. Only two studies included an assessment of patient-incurred costs, and none considering the equity distribution of costs or outcomes using an asset-based index.Added value of this studyThe ASCENT study provides robust evidence using a comprehensive economic evaluation framework, that DATs decreased the cost of tuberculosis treatment in Ethiopia for a cohort of adults with pulmonary tuberculosis. There was a 49-56% probability of DATs improving the cost-effectiveness of tuberculosis treatment and there was no significant difference in disability adjusted life years (DALYs) between study arms. The implementation of DATs did not change the distribution of costs or DALYs between people with tuberculosis (PWTB) of different household socio-economic position, however it did reduce the magnitude of patient costs among PWTB in the lower socio-economic position (SEP) quintile.Implications of all the available evidenceWhile there is limited evidence of the effectiveness of Digital Adherence Technologies (DATs), this study is the first to show what impact the DATs may have on the costs of treatment, by reducing the number of healthcare visits leading to cost savings. There is further evidence that DATs may reduce the burden of patient costs on those who are least wealthy. We recommend that future investments in DATs for tuberculosis treatment support consider how healthcare providers integrate DATs for tuberculosis treatment support in the health facility workflow and how this translates to cost savings.

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Process evaluation of pragmatic cluster randomized trials of digital adherence technologies for tuberculosis treatment support: a mixed methods study in five countries

Madden,

Tadesse,

Leung

et al. 2024

Preprint

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BackgroundDigital adherence technologies (DATs) could improve the person-centredness of TB treatment. Acceptability of DATs is high, though evidence of their effectiveness is varied. Our objective was to understand the fidelity of DAT interventions within five cluster-randomized trials.MethodsTwo DATs (smart pill box, medication labels) were assessed, with real-time adherence data made available to healthcare providers (HCPs) on a digital platform in Ethiopia, the Philippines, South Africa, Tanzania, and Ukraine. The process evaluation framework assessed four components: inputs, processes, outputs, and outcomes. Fidelity of the most important intervention components was evaluated by quantitative indicators, with analysis conducted by country and DAT type. Content analysis of qualitative sub-studies supplemented some indicators.ResultsEngagement with DATs was high among persons with TB (PwTB). Pillbox users showed high levels of sustained engagement, with digitally recorded doses ranging from 82% to 91%. Sole ownership of a mobile phone was highest in South Africa (90%) and lowest in the Philippines (63%). Differences were also observed in the frequency of logins by HCPs to the adherence platform and the type of device used. In the Philippines and Ukraine, >50% of logins were from mobile phones. In Ethiopia, Tanzania, and Ukraine there was at least one login to the platform on 71% of weekdays per facility, compared with the Philippines and South Africa at 42% and 52%, respectively. A feeling of connection between PwTB and their HCP was reported by over 95% of participants surveyed in Ethiopia and Tanzania, this was 84% in South Africa and 76% Philippines, a finding underpinned by qualitative data.ConclusionWe observed varying levels of intervention fidelity between countries. Timeliness and intensity of utilization of real-time data, and taking required actions are impacted by staff and health system capacity. Acceptance of DATs is high; therefore, future work should focus on identifying optimal intervention strategies.

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Evaluating the equity impact and cost-effectiveness of digital adherence technologies with differentiated care to support tuberculosis treatment adherence in Ethiopia: protocol and analysis plan for the health economics component of a cluster randomised trial

Cited by 4 publications

References 49 publications

Effect of implementing digital adherence technologies on the use of health care providers’ time and the human resource cost of tuberculosis treatment adherence support in Ethiopia

Effect of implementing digital adherence technologies on the use of health care providers’ time and the human resource cost of tuberculosis treatment adherence support in Ethiopia

Equity, cost and disability adjusted life years of tuberculosis treatment supported by digital adherence technologies and differentiated care in Ethiopia: a trial-based distributional cost-effectiveness analysis

Process evaluation of pragmatic cluster randomized trials of digital adherence technologies for tuberculosis treatment support: a mixed methods study in five countries

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