An economic evaluation of a primary care-based technology-enabled intervention for stroke secondary prevention and management in rural China: a study protocol

This is pathetic to the nth degree. Economic analysis does ABSOLUTELY NOTHING TO GET SURVIVORS RECOVERED!  Just maybe you want to analyze the recovery of stroke patients in rural China.

An economic evaluation of a primary care-based technology-enabled intervention for stroke secondary prevention and management in rural China: a study protocol

Enying Gong^1†, Bolu Yang^2†, Xingxing Chen^2,3, Yuhan Li², Zixiao Li⁴, Janet Prvu Bettger⁵, Brian Oldenburg^6,7, Dejin Dong⁸, Lei Si^9,10* and Lijing L. Yan^2,3,11*

• ¹School of Population Medicine and Public Health, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
• ²Global Health Research Center, Duke Kunshan University, Kunshan, China
• ³School of Public Health, Wuhan University, Wuhan, China
• ⁴Beijing Tiantan Hospital, Capital Medical University, Beijing, China
• ⁵College of Public Health, Temple University, Philadelphia, PA, United States
• ⁶Academic and Research Collaborative in Health, La Trobe University, Melbourne, VIC, Australia
• ⁷NHMRC CRE in Digital Technology to Transform Chronic Disease Outcomes, Baker Heart and Diabetes Institute, Melbourne, VIC, Australia
• ⁸Xingtai Center for Disease Control and Prevention, Xingtai, Hebei, China
• ⁹School of Health Sciences, Western Sydney University, Campbelltown, NSW, Australia
• ¹⁰Translational Health Research Institute, Western Sydney University, Penrith, NSW, Australia
• ¹¹Ningbo Eye Hospital, Wenzhou Medical University, Ningbo, China

Introduction: Secondary prevention of stroke is a leading challenge globally and only a few strategies have been tested to be effective in supporting stroke survivors. The system-integrated and technology-enabled model of care (SINEMA) intervention, a primary care-based and technology-enabled model of care, has been proven effective in strengthening the secondary prevention of stroke in rural China. The aim of this protocol is to outline the methods for the cost-effectiveness evaluation of the SINEMA intervention to better understand its potential economic benefits.

Methods: The economic evaluation will be a nested study based on the SINEMA trial; a cluster-randomized controlled trial implemented in 50 villages in rural China. The effectiveness of the intervention will be estimated using quality-adjusted life years for the cost-utility analysis and reduction in systolic blood pressure for the cost-effectiveness analysis. Health resource and service use and program costs will be identified, measured, and valued at the individual level based on medication use, hospital visits, and inpatients' records. The economic evaluation will be conducted from the perspective of the healthcare system.

Conclusion: The economic evaluation will be used to establish the value of the SINEMA intervention in the Chinese rural setting, which has great potential to be adapted and implemented in other resource-limited settings.

Introduction

Stroke is one of the rising public health challenges worldwide. In 2019, there were ~12 million incident cases of stroke, of which 32.8% were in China (1). Although the stroke incidence rate is increasing, the stroke mortality rate has been decreasing over the past few decades, resulting in a huge number of stroke survivors globally (2). As these stroke survivors need continuous health management and risk control, the spending on post-stroke care causes an economic burden (3). The financial burden of stroke in rural areas is extremely severe (4, 5). As in many undeveloped areas, primary care lacks the capacity to provide guideline-based essential care to stroke patients, and community-based management for secondary prevention of stroke is far from adequate (6). Therefore, it is necessary to emphasize the prevention of recurrent strokes in the rural setting.

The system-integrated and technology-enabled model of care (SINEMA) study was designed to empower both stroke survivors and primary healthcare providers for secondary stroke prevention by training and incorporating both provider-facing and patient-facing mHealth technologies. The effectiveness of the SINEMA model has been evaluated and proven through a two-arm cluster-randomized controlled trial conducted in 50 rural villages of Hebei province in northern China (7). During the 1-year intervention, a statistically significant greater reduction in systolic blood pressure (SBP) was observed in the intervention arm compared with the control arm. Improvement in a few secondary outcomes including a 35–55% relative reduction in stroke recurrence, hospitalization, disability, and death has also been reported, which indicates the great potential benefits of the SINEMA intervention on secondary stroke prevention (8).

Despite indicating the effectiveness of the intervention, cost-effectiveness is another important factor to be considered. Previous economic evaluation studies of mHealth-based stroke prevention were reported to be cost effective. For example, the TEXT-ME trial conducted in Australia, a text message-based intervention for patients with cardiovascular diseases, reported that the intervention could gain 1,143 more QALYs and save a direct medical cost of Aus$10.56 million over a lifetime horizon for a hypothetical cohort of 50,000 patients with cardiovascular diseases in Australia (9). However, previous economic evaluations were mainly conducted in developed countries, and the cost-effectiveness of an integrated mobile health intervention on secondary stroke prevention in a resource-constrained setting like rural China remains unclear. Therefore, the economic evaluation of the SINEMA intervention is necessary. This protocol describes the methods for the economic evaluation of the SINEMA program based in a rural Chinese setting.

Aim and objectives

This protocol describes the methods for the economic evaluation of the SINEMA program, which is nested in the SINEMA trial (8). This study aims to provide an economic evaluation of the SINEMA program to identify, measure, and value key resource and outcome impacts from the SINEMA intervention model compared with usual care for stroke secondary prevention in rural China. A within-trial economic evaluation will be conducted to calculate the within-trial incremental cost-effectiveness ratio to determine the value of the SINEMA intervention model.

Materials and methods

Study design

The economic evaluation is a nested study based on the SINEMA trial, a cluster-randomized controlled trial implemented in 50 villages in rural China. A detailed description of the SINEMA program and intervention design can be found in previous publications (7, 10–12). The economic evaluation will involve a within-trial cost-effectiveness analysis and cost-utility analysis with a 12-month time horizon equal to the follow-up period of the trial. We will calculate the incremental cost-effectiveness ratio in terms of the incremental cost per 1 mmHg change in systolic blood pressure, which is the primary outcome of the trial. In addition, we will also conduct a cost-utility analysis to calculate the incremental cost per quality-adjusted life year (QALY). The SINEMA intervention is deemed as cost-effective if the incremental cost per QALY is no greater than the cost-effective threshold. Following previous research (13), we will adopt the conventional approach by considering the benchmark as 1.5 times of gross domestic product per capita.

Participants and study settings

Study participants in the economic evaluation will be the same as those recruited in the SINEMA trial. Participants were eligible if they were adults (older than 18 years), had a history of stroke diagnosed at a county or higher level hospital, were in a clinically stable condition with at least basic communication ability, and were expected to be available for the 12-month follow-up. Individuals who were unable to get out of bed had severe life-threatening diseases or had an expected life span shorter than 6 months were excluded. All participants were recruited in 50 villages from five townships in a rural county in Hebei Province, China. The county is a provincial-level impoverished county lying on the “stroke belt,” with a stroke burden double the national average level (10). Participants were recruited between 23 June 2017 and 21 July 2017 and followed until 27 July 2018.

Intervention and control

The SINEMA intervention involved provider-side components and patient-facing components and was supported by a digital health system. In brief, village doctors, as primary healthcare providers, received training based on the train-the-trainer to train model. They were also equipped with the SINEMA app, they conducted monthly follow-up visits to patients. Additionally, financial incentives were also provided to encourage their ongoing commitment to deliver quality healthcare services. Stroke patients received monthly follow-up visits delivered by village doctors at the village clinics or their own homes if they had difficulty visiting the clinics. During each visit, they were provided with suggestions about medication use and physical activities. Participants who had access to their own or shared cell phones received one voice message, at no cost to them, for delivering health education information regarding medication adherence and physical activities.

For villages allocated to the control arm, village doctors continued their standard practices, which included practicing general clinical care and performing the “Basic Public Health Services” (BPHS). BPHS was announced when a new healthcare reform plan started in China in 2009, aiming at assisting community health organizations in delivering a set package of basic health services across the country (14). Patients in the control villages received the usual care. In the context of rural China, the usual care involved patients seeking care in village clinics, township healthcare centers, or county hospitals, as necessary. People with hypertension and diabetes may also receive quarterly follow-up visits by village doctors as covered by the Basic Public Health Services (10).

Identification, measurement, and valuation of effectiveness

The intervention effectiveness will be measured by comparing the systolic blood pressure reduction and the QALYs between the intervention and control arm over the 12-month follow-up period.

Measurement of systolic blood pressure as the primary outcome

Blood pressure (BP) was measured as the primary outcome in the SINEMA trial at baseline and 1-year later, following the sample measurement protocol and approach among all participants. Blood pressure was measured on the right upper arm with participants seated and after 5 min of rest, with an electronic BP monitor (Omron HEM-7052). Two measurements were taken, and the mean value was calculated. If the difference between the two systolic BP measures was larger than 10 mmHg, a third measurement was conducted, and the mean value of the last two readings was calculated.

Health state utility

Health state utility (HSU) estimations will be derived from self-reported health-related quality of life (HRQoL) which was measured using the Chinese version of the EQ-5D-5L, a broadly used generic multi-attribute health utility instrument (15) at baseline and 1-year follow-up. For assessing HRQoL, study data collectors who were staff from the Center of Disease Prevention and Control in the nearby county read out the questionnaire and items for participants and collected the data. After answering the questions for EQ-5D, participants were asked to point out the health score by fingers on a paper version of the EQ-Visual Analog Scale, and then, the data collectors entered the responded values into the online survey platform. An HSU was calculated for each respondent by using the Chinese version of population-based preference weights (16), which ranged from −0.391 to 1, with 1 representing the value of full health, 0 representing deaths, and −0.391 representing the worst state.

Stroke recurrence, hospitalization, disability, and all-cause mortality were measured by using questionnaires at one-year follow-up. Medical and deaths records were also extracted from four major hospitals in the region. These data provide information about the status and trajectory of stroke during the trial period.

Identification, measurement, and valuation of resource use and costs

The aim of the economic evaluation is to inform decision-makers about the costs and cost-effectiveness of introducing the SINEMA intervention to stroke patients in rural regions. As such, the economic evaluation will mainly be performed from the health sector perspective, reflecting the cost and values of the healthcare system.

The resources used to support the SINEMA program include as follows: (1) the cost used to support SINEMA program delivery and (2) the health resources used to support the healthcare service delivery to stroke patients. Table 1 describes the detailed measurement and valuation of costs. The research costs, including the investigator's time and data collection, were not included in the analysis. The costs of designing the SINEMA intervention and the digital health system and other “one-off” costs were excluded, but the operation and maintenance costs of the digital health system were included in the analysis.

TABLE 1