Promoting the adoption of local governmental policy on the reimbursement of chronic disease medicines (PAPMed): study protocol of a field-based cluster randomized trial in rural Nantong, China

• Published in: Current controlled trials in cardiovascular medicine Vol. 23; no. 1; p. 785
• Main Authors: He, Zhengting, Cao, Xin, Zhao, Duan, Tang, Zemin, Zhao, Jiayu, Beasley, Mariel, Renne, Angela, Liu, Lei, Zhu, Shengjie, Gao, Yuexia, Yan, Lijing L
• Format: Journal Article
• Language: English
• Published: London BioMed Central Ltd 15.09.2022; BioMed Central; BMC
• Subjects: Behavior science; Blood pressure; China; Chronic diseases; Chronic illnesses; Clinical trials; Cluster randomized trial; Costs; Diabetes; Drug prices; Drug therapy; Drugs; Economic aspects; Health care policy; Health education; Health facilities; Health policy; Hospitals; Hypertension; Infectious diseases; Intervention; Local government; Management; Medical care, Cost of; Medication reimbursement policy; Methods; Non-communicable disease; Patient compliance; Physicians; Public health; Purchasing; Registration; Reimbursement; Rural areas; Rural health; Study Protocol; Urban areas; China
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-022-06710-1

Abstract Background Among rural Chinese patients with non-communicable diseases (NCDs), low socioeconomic status increases the risk of developing NCDs and associated financial burdens in paying for medicines and treatments. Despite the chronic disease medicine reimbursement policy of the local government in Nantong City, China, various barriers prevent patients from registering for and benefitting from the policy. This study aims to develop a behavior science-based intervention program for promoting the adoption of the policy and to evaluate the effectiveness of the program compared with usual practices. Methods Barriers and opportunities affecting stakeholders in adopting the policy were identified through contextual research and summarized through behavior mapping. The intervention is designed to target these barriers and opportunities through behavior science theories and will be evaluated through a 6-month cluster randomized controlled trial in Tongzhou District, Nantong, China. A total of 30 villages from two townships are randomized in a 1:1 ratio to either the intervention or the control arm (usual practices). Village doctors in the intervention arm (1) receive systematic training on policy details, registration procedures, and intervention protocol, (2) promote the policy and encourage registration, (3) follow up with patients in the first, third, and sixth months after the intervention, and (4) receive financial incentives based on performance. The primary outcome is policy registration rate and the secondary outcomes include the number of patients registering for the policy, medical costs saved, frequency of village doctor visits, and health measures such as blood pressure and glucose levels. Discussion This study is one of very few that aims to promote adoption of NCDs outpatient medication reimbursement policies, and the first study to evaluate the impact of these policies on patients’ financial and physical wellbeing in China. The simple, feasible, and scalable intervention is designed based on the theories of behavior science and is applicable to similar low-income regions nationwide where outpatient medical costs remain a financial burden for patients. Trial registration ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT04731194?term=PAPMed&draw=2&rank=1, registered on 29 January 2021; Chinese Clinical Trial Registry http://www.chictr.org.cn/showproj.aspx?proj=65987, registered on 14 January 14 2021.