Diabetes has become a serious global health problem due to its high prevalence and associated disability and mortality (GBD, 2016 Disease and Injury Incidence and Prevalence Collaborators, 2017). Rapid economic development in the last 2 decades has led to changes in the lifestyles of the Chinese population, developing sedentary behaviors, physical inactivity and energy-dense eating habits, which have resulted in a rapidly increasing diabetes population (Pan et al., 2021; Pang et al., 2021). According to the International Diabetes Federation (IDF), the prevalence of diabetes in China is growing rapidly, ranking first in the world, at about 11.9% of the adult population (Saeedi et al., 2019). Estimates show that 116.4 million adults in China have diabetes, more than 90% of which are type 2 diabetes (T2DM), accounting for 24% of the global diabetic population (International Diabetes Federation, 2021).

Diabetes is a long-term chronic disease, and the patient’s daily behavior and self-management ability are key factors affecting the control of diabetes (Yoon et al., 2022). The management of T2DM is complex, requiring multiple interventions to optimize glucose control, reduce risk factors, and prevent complications, which is physician-dominated in China (Conlin et al., 2017; Professional Practice Committee, 2018). So far, diabetes management in China is not yet well implemented, especially in rural areas. The two main reasons for poor management are the lower density of physicians and the lower socioeconomic status and education background of patients, which are particularly common in primary healthcare (Anand et al., 2008; Wang et al., 2014; Liu et al., 2016; Jin et al., 2017). According to a national cross-sectional study in 2018, the rates of awareness, treatment and glucose control of diabetes in urban areas in China were only 40.0%, 36.2%, and 54.1%, respectively. The situation is more serious in rural areas, where rates were 32.6%, 28.8%, and 44.1% respectively (Wang et al., 2021a). There are rigorous challenges in terms of diabetes management, especially in primary medical care.

The physician-pharmacist collaborative clinics were first introduced in the United States, aiming to optimize medical treatment and reduce medical expenses (Hammad et al., 2011; Wei et al., 2022). The mode of physician-pharmacist collaboration was based on Medication Therapy Management (MTM), a service provided by pharmacists to ensure optimum therapeutic outcomes for individualization by reducing the risk of adverse events, improving patient medication compliance and quality of care (Oladapo and Rascati, 2012; Miller et al., 2016; Brandt and Cooke, 2017; Song et al., 2022). Based on comprehensive research evidence, the involvement of pharmacists in diabetes management significantly improve treatment cost-effectiveness and lower clinical parameters of glycosylated hemoglobin (HbA1c) and low-density lipoprotein (LDL) (Kiel and McCord, 2005; Farland et al., 2013).

In tertiary hospitals in China, physician-pharmacist collaborative mode has been well-established. Pharmacists conduct investigations to collect patient information, including laboratory parameters, medical and family history (Zhang et al., 2022). Pharmacists also assess medical risks and monitor adverse drug reactions to help physicians determine the therapeutic scheme. Finally, pharmacists provide medication counseling and disease education to patients (Wang et al., 2021b). However, traditional mode still dominates in primary healthcare, where physicians often make diagnoses, determine treatment plans and provide medication guidance independently, leading to several problems. As reported in previous studies, physicians were overwhelmed by the large number of patient visits, resulting in the limited time for disease education and medication instruction, and low patient satisfaction (Wen et al., 2016; Manzoor et al., 2019; Li et al., 2021).

Despite the physician-pharmacist collaborative clinics have attracted widespread attention in Chinese tertiary hospitals, no study has been carried out in Chinese primary healthcare. Therefore, we conducted a mixed-methods study to evaluate the effects and influencing factors of implementing physician-pharmacist collaborative clinics to manage T2DM in primary healthcare.

The mixed-methods study using an explanatory design, consists of three key components: a multi-center randomized controlled trial (RCT); and qualitative interviews with participants; and integration of quantitative and qualitative data (Figure 1). This study was reported following the Good Reporting of a Mixed Methods Study (GRAMMS) checklist and Consolidated Standards of Reporting Trials (CONSORT).

This study integrated findings from the quantitative and qualitative data, providing a conducive perspective through which to evaluate the effects of physician-pharmacist collaborative clinics. In the 12-month RCT among patients with diabetes, we found that patients in collaborative clinics improved medication compliance and QoL more effectively and rapidly than usual care. As a result, the number of outpatient visits for patients in collaborative clinics increased while the emergency visits significantly decreased. The four thematic domains from qualitative study showed that pharmaceutical service, team-base care, psychological support and acceptability of care were the core of physician-pharmacist collaborative clinics, providing better healthcare for diabetic patients in primary healthcare. These findings demonstrate that the physician-pharmacist collaborative clinics effectively achieve better patient outcomes by improving medication compliance and QoL.

The integration of quantitative data and qualitative data showed partial agreement in the difference of QoL and dissonance in diabetes knowledge score between groups. It is worth noting that the TTO score at baseline both in the intervention group (0.977 ± 0.0380) and the control group (0.968 ± 0.0743) are better than the average of 2017 Chinese Heilongjiang population TTO score (0.959) (Huang et al., 2017). A mainly reason for this may be that most of patients included the trail had no complications that affect daily life. Due to the long process of the emergence of diabetic complications, the main impact of diabetes on early stage patients was reflected in the VAS score.

However, we noticed that both groups showed improvements in the medication compliance and VAS scores, despite the collaborative clinics being more effective and rapid. It means that the routine treatment in primary healthcare also has a positive effect on patients, but takes longer and carries a greater risk of complications. We also found that diabetes knowledge score showed great improvement in both two groups over the 12 months, indicating no additional benefit from the collaborative clinics. In fact, a survey on the awareness rate of diabetes knowledge in Chinese counties reported that diabetes-related knowledge of patients with T2DM was mainly acquired through media such as television or the Internet, accounting for 85.58%, followed by books or newspapers, accounting for 32.84% (Shao et al., 2022). This suggests that the traditional education mode seems to be ineffective in primary healthcare, and that the education mode in collaborative clinics needs to be combined with common and fast-spreading media.

We compared the sociodemographic characteristics of the patients to illustrate comparability between the two groups. There was a difference in gender between the two groups at baseline. As a matter of fact, the dramatic increase in T2DM and related complications is accompanied by evidence of clinical gender differences, in which both biological and psychosocial factors contribute to gender differences in diabetes risk and outcome (Kautzky-Willer et al., 2016). Overall, psychosocial stress appears to affect women more than men. However, previous studies have showed that gender differences have no influence on medication compliance and diabetes knowledge score, but educational background had a greater influence (Zhao et al., 2004). Therefore, gender differences between the two groups at baseline did not affect the results of this study.

Effectiveness of physician-pharmacist collaborative clinics for T2DM management has been proved by many clinical studies. By providing comprehensive medication education and patient management, pharmacists helped patients reduce HbA1c, LDL cholesterol, total cholesterol and blood pressure, further reducing emergency events compared to usual care (Shane-McWhorter and Oderda, 2005; Aguiar et al., 2018; Matzke et al., 2018). Moreover, pharmacists’ qualifications and service contribute to better healthcare and a favorable return on investment of $1.1–2.8 million dollars for patients (Lehn et al., 2019). Pharmaceutical care, pharmacist counselling and diabetes management provided by pharmacists have been proved to improve patient outcomes (Shao et al., 2017; Lum et al., 2019; Besemah et al., 2021).

A burning question over diabetes healthcare in primary healthcare of China is to maintain stable glucose control, delay diabetic complications and reduce emergency events, which require an effective and feasible healthcare mode. The diabetes population in primary healthcare, especially in rural China, has been increasing dramatically due to multiple reasons, including the growth of the economy, the aged tendency of the population, and the changed lifestyle (Huang et al., 2022). Diabetes management, as the most important part of treatment, includes physician’s management and patient self-management. However, both two aspects are insufficient in primary healthcare. Firstly, the number of physicians in China ranks forefront in the world with 2.27 per 1000, slightly less than the United State with 2.61 per 1000 in 2019 (World Health Organization, 2022). However, there is a serious maldistribution of physician density, which in urban areas was more than twice that in rural areas (Anand et al., 2008). Moreover, each physician per 1,000 population added to primary healthcare centers was associated with 67% more outpatient visits (Anand et al., 2008). However, certified physicians tend to serve in provincial urban centers rather than in rural areas due to multiple reasons, including low income, limitations in their qualification and career development (Hu et al., 2017; Wang et al., 2021c). Therefore, it’s necessary to ensure and improve the quality and quantity of health professionals in primary healthcare, especially in rural areas. Secondly, the lower socioeconomic status and educational background of rural patients limit their diabetes self-management (Wallace et al., 2010; Le et al., 2016). Studies show that patients with a higher level of education had a greater probability of regularly self-monitoring blood glucose, medication compliance, and taking measures to control diabetes (Hill et al., 2013).

Actually, with the development of clinical pharmacy, pharmacists have gradually completed the transition from pharmacy to clinical practice. They made a lot of attempts in the process, including pharmacotherapy clinics (Shahrami et al., 2022), MTM service (Johnson et al., 2018), and patient centered pharmacist care (Paneerselvam et al., 2022). Those pharmacists with rich pharmacotherapy knowledge reserves, as irreplaceable partners of physicians, ensure rational drug use, improve patient medication compliance, and ultimately ameliorate patient outcomes (Marr et al., 2018). Under the brunt of Corona Virus Disease 2019 (COVID-19), pharmacists motivated by medical professionalism were reassigned to new tasks, such as disseminating educational materials, intensive care and remote clinical service (Hao et al., 2021). Undoubtedly, pharmacists play a more important role in healthcare during the special time.

Due to the COVID-19 pandemic, medical resources have been reallocated, resulting in reduced outpatient clinics, which inevitably affected chronic disease management. Recently, research focused on diabetes management has shifted from outpatient clinics to online remote management. However, trials with larger populations tend to be negative, especially among patients broadly recruited from primary healthcare (Jia et al., 2021). One obvious reason is that eHealth platforms seem not user-friendly for patients, particularly for elderly users who are the major group of diabetics (Gao et al., 2017). Moreover, remote training may spend longer time for patients, resulting in poor patient adherence (Heselmans et al., 2020). Conversely, pharmacists in collaborative clinics play an important role in diabetes education, management, follow-up visits and remote introduction if necessary during the COVID-19 pandemic.

However, the main barriers to implement physician-pharmacist collaborative clinics are the lack of clinical experience and understaffing of pharmacists. In fact, the education background and knowledge structure of pharmacists in primary healthcare are far from the current clinical needs, resulting in their poor capability in guiding clinical practice, especially for the highly educated population (Hu et al., 2014). Overall, it’s more important to carry out professional training for pharmacists in primary healthcare, including knowledge in disease, communication skills and comprehensive management capabilities (Huang et al., 2021). Due to the long payback period, many primary healthcare centers do not attach importance to the development of pharmacy departments. Fortunately, pharmacists participate in clinical practices gradually, which is conducive to the development of pharmacy and the transformation of pharmacists in primary healthcare. In our enrolled intervention healthcare centers, Taoyuan People’s Hospital was the first to officially launch physician-pharmacist collaborative clinics for T2DM management.

This study has several limitations. First, unobserved confounding bias cannot be ruled out in this study. Second, the sample size was calculated based on primary outcomes, that may restrict the representative of this study. All primary healthcare centers are from Hunan Province, which may not reflect the situation in other regions of China. Third, this study could not be blinded, and Hawthorne effect could appear.

This study is the first mixed study to explore the effects and influencing factors of implementation of physician-pharmacist collaborative clinics in primary healthcare in China. Implementation of physician-pharmacist collaborative clinics had effectively strengthened patient management, especially the management of patient medication compliance and QoL. Through the pharmaceutical service, team-based care, psychological support and acceptability of care, physician-pharmacist collaborative clinics improved patient medication compliance and QoL more effectively and rapidly than usual care, which had been highly commended by patients. Our findings suggest that the insufficient clinical knowledge and severe understaffing of pharmacists should be considered in primary healthcare. In the future, professional training of primary pharmacist should become the focus of pharmacy practice to enhance patient-centered care in primary healthcare. Our findings provide evidence of the effectiveness of physician-pharmacist collaborative clinics and lay a solid foundation for further development and implementation of collaborative clinics in primary healthcare.