Abstract
Background
Though self-care is a critical component of diabetes management, it is unknown whether pharmacist-run medication review service (MRS) can be an additional intervention to enhance self-care in diabetic patients.
Objectives
Hence, this study aims to determine the effectiveness of MRS in addition to existing care protocol in improving self-care in diabetic patients.
Methods
This randomised controlled study was conducted in five polyclinics from December 2014 to October 2016. Participants were 40 to 80 years of age and had been diagnosed with type 2 diabetes. These participants were prescribed with five or more chronic medications, of which at least one was an antidiabetic medication, by the primary healthcare centres’ doctors. The participants were randomly recruited into the intervention or control arm. A self-developed questionnaire which incorporated the validated Diabetes Self-Management Questionnaire (DSMQ) was administered face-to-face by the study team to the participants prior to and after MRS. MRS was not administered to participants in the control group.
Results
A total of 221 participants completed the follow up. There were 105 participants in the control arm and 116 in the intervention arm. The DSMQ Sum Scale score of the control group improved by 0.16 ± 1.11 (p = 0.136) while the intervention group improved by 0.40 ± 0.99 (p = 0.000). Participants in the intervention group reported a better improvement in their self-care of diabetes, specifically in glucose management (p = 0.003), dietary control (p = 0.096) and physical activity (p = 0.003).
Conclusions
Pharmacist-run MRS can be included in addition to existing care to improve self-care in patients with diabetes.
Introduction
Despite concerted efforts and much money spent on preventing type 2 diabetes such as promoting active lifestyles and educating the public on healthier food choices, 1 the prevalence of diabetes and deaths associated with it worldwide is increasing over the years and is projected to keep rising.2,3 The management of diabetes to prevent both acute and chronic complications associated with the metabolic condition is a long and often costly process.4–6 This translates to a huge economic burden to the society.7,8 In US alone, the total estimated cost of diagnosed diabetes in 2017 is $327 billion, including $237 billion in direct medical costs and $90 billion in reduced productivity. 7 The amount spent by each patient with diabetes is approximately 2.3 times more than those without the disease. 7
Diabetes is one of the top 3 chronic medical conditions managed at Singapore’s public primary healthcare institutions, also known as polyclinics. 9 Diabetes alone accounted for 10.3% of the total polyclinics attendance which was about 6.19 million in 2021. 9 The prevalence of diabetes in Singapore amongst adults aged 18 to 69 years have increased from 8.3% in 2010 to 8.6% in 2017. 10 As with the rest of the world, Singapore currently faces a greying population, which has a higher incidence of chronic diseases such as diabetes. 11 The disease burden caused by diabetes will thus increase astronomically 8 if no effective interventions are put in place.
Pharmacists in primary care settings run medication review service (MRS), managing patients with a wide spectrum of medical conditions. As diabetes is one of the top three medical conditions referred to these pharmacists, MRS provides a valuable platform to resolve medication-related issues faced by patients with diabetes and educate these patients on medications, medical conditions, management and complications associated with the disease. In addition, through MRS services, pharmacists help to review these patients’ medications and optimise them, identifying any medication-related issues and providing appropriate solutions to resolve them, with the intention to improve their diabetic control. Despite these efforts, the effectiveness of MRS on diabetes self-care, which is a critical component of diabetes management advocated by both American Diabetes Association (ADA) and the Association of Diabetes Care and Education Specialists (ADCES) and is incorporated as part of U.S. national standards for Diabetes Self-Management Education and Support (DSMES), 12 has not been assessed locally. Hence, this study aims to determine whether MRS can be an effective tool in the management of diabetes by testing the following hypothesis, and thereby providing an additional intervention to enhance diabetes care.
Hypothesis: “MRS is effective in improving patients’ participation in self-care of diabetes”.
Methods
Study design
This randomised controlled study was conducted in five SingHealth Polyclinics, which are primary healthcare centres in Singapore, from December 2014 to October 2016. These five polyclinics are mainly located in the eastern, north-eastern and southern regions of the island-state.
Study participants
The target participants of this study were patients who visited the five polyclinics’ in-house pharmacies to refill their prescriptions. These participants were 40 to 80 years of age and had been diagnosed with type 2 diabetes. They had been prescribed with five or more chronic medications, of which at least one was an antidiabetic medication, by the polyclinics’ doctors. The participants’ HbA1c readings were above 7.0% and they would be followed up at the polyclinic within the next 2 to 6 months. Participants who could not understand or converse in the most commonly used languages locally, namely English, Mandarin, Chinese dialects or Malay were excluded.
The participants were randomised into the control and intervention arms. A randomisation table was set up using a random number generator to allocate the participants into either the control or intervention arm. In the control group, the participants would receive care as per existing protocols. In the intervention group, the participants would receive care as per existing protocols plus MRS.
Using an assumed effect size of 50%, it was estimated that at least 64 participants in each of the intervention and control groups were required to test whether MRS was effective in improving the diabetic participants’ HbA1c at 5% significance level with 80% statistical power.
Study instrument
Participants’ characteristics.
DSMQ was selected for use in this study over the commonly used 11-item research tool Summary of Diabetes Self-care Activities Measure (SDSCA). DSMQ’s self-management behaviours have been found to have strong negative association with levels of glycaemic control as reflected by HbA1c and is significantly better in this regards when compared with SDSCA (an equivalent scale also designed to assess diabetes self-management). 14 This helps one to better understand the causes of hyperglycaemia in patients by evaluating their self-management behaviours. 14
The DSMQ, designed and validated by Schall S and team, is a 16-item questionnaire.
13
It consists of 7 positively and 9 negatively worded statements on diabetic self-care. The questionnaire consists of 4 subscales of ratings (see below) and assesses the following aspects of diabetic self-care, with an overall rating which is also known as the Sum Scale (SS) score of self-care. The Sum Scale is a global measure of the quality of diabetes self-care and it comprises all 16 items in the DSMQ (15 items of which are distributed into 4 subscales and there is one additional solitary item). A Sum Scale score of 6 or below indicates suboptimal self-care. • Glucose Management (GM) subscale: Self-monitoring of blood glucose and medication intake • Dietary Control (DC) subscale: Diabetes-related diet • Health-Care Use (HU) subscale: Appointment adherence • Physical Activity (PA) subscale: Physical activity
Each question in the DSMQ is scored using the 4-point Likert scale and a score is associated with each of the option. For statements in DSMQ where the participant indicates that the treatment or management option is not part of the medical care, the item would not be scored. For statements that are negatively-worded, the scores would be in reverse such that higher values would indicate more effective self-care.
Each subscale score is then calculated by summing up the scores associated with the relevant statements in the questionnaire in accordance to the DSMQ scoring guide and computed using the following formula.
Subscale Score = (Actual Sum of Item Scores/Maximum Possible Item Scores) × 10
The Sum Scale is computed as follows:
Sum Scale Score = [(Sum of all 4 Subscale Scores + Score for the additional solitary item)/Maximum Possible Item Scores] × 10
Statistical methods
Descriptive analyses were used to describe demographic characteristics of the study participants. Student paired t-test was used to determine whether pharmacist-run MRS was an effective intervention tool to improve participants’ participation in self-care of diabetes. All the statistical analyses were performed using SPSS Statistics for Windows, Version 25.0. Armonk, NY: IBM Corp. p-values of less than 0.05 were considered statistically significant.
Results
Participants’ characteristics
A total of 221 participants completed the follow up. There were 105 participants enrolled in the control arm and 116 enrolled in the intervention arm (Figure 1). The number of male and female participants involved in the study were 101 (45.7%) and 120 (54.3%) respectively. The median age of the participants was 64.0 ± 8.8 years. (Table 1). Please refer to other details in Table 1. Flow chart of the inclusion process.
Impact of pharmacist-run MRS on diabetic self-care
Impact of Pharmacist-run MRS on Diabetes Self-care using the DSMQ Sum Scale Score.
Physical activity subscale
The study found that the intervention group reported a bigger improvement in the physical activity subscale at 0.67 ± 2.36 (p = .003) while the control group reported an improvement of 0.31 ± 2.40 (p = .194). (Table 2).
The percentage of participants who would tend to skip planned physical activity increased by 1.9% (an increment from 46.7% to 48.6%) in the control group while the intervention group decreased by 6.9% (a reduction from 48.3% to 41.4%).
Impact of pharmacist-run MRS on diabetes self-care on each DSMQ subscales.
Glucose management subscale
The study found that the intervention group reported a bigger improvement in the glucose management subscale at 0.38 ± 1.35 (p = .003) while the control group reported an improvement of 0.23 ± 1.59 (p = .146).
There were more participants in the intervention group who would check their blood sugar levels with care and attention, and record their blood sugar levels regularly compared to the control group. The percentage of participants in the intervention group who would check their blood sugar levels with care and attention increased by 5.8% (an increment from 39.4% to 45.2%) while that in the control group decreased by 0.7% (a reduction from 33.4% to 32.7%). There was an increase from 45.2% to 46.7% (an increment of 1.5%) of participants in the intervention group who would record their blood sugar levels regularly versus a decrease from 38.6% to 33.6% (a reduction of 5%) in the control group.
The percentage of participants in the control arm who took their diabetes medications as prescribed increased by 1.0% (an increment from 97.1% to 98.1%), while that in the intervention arm increased by 1.7% (an increment from 96.6% to 98.3%). Both groups of participants improved in terms of not forgetting or skipping their diabetes medications. The percentage of participants in the control group who tended to forget to take or skip their diabetes medications decreased by 8.6% (a reduction from 34.3% to 25.7%) while that in the intervention group decreased by a higher percentage of 10.2% (a reduction from 38.7% to 28.5%). (Table 3).
Dietary control subscale
The intervention group reported a bigger improvement in the dietary control subscale with an improvement of 0.26 ± 1.66 (p = .096) than that for the control group (0.15 ± 1.85, p = .406).
Both groups’ scores deteriorated in terms of avoiding sweets or carbohydrate-rich food. The percentage of participants who would occasionally eat a lot of sweets or food rich in carbohydrates increased by 1.9% (an increment from 83.8% to 85.7%) in the control group while the intervention group reported an increase of 0.8% (an increment from 77.6% to 78.4%).
For following dietary recommendations, the percentage of participants in the control arm who strictly followed the dietary recommendations given by their doctor or diabetes specialist remained unchanged at 87.6%, while that in the intervention arm increased by 3.5% (an increment from 86.2% to 89.7%). (Table 3).
Health-care use subscale
The intervention arm had a smaller improvement in the health-care use subscale at 0.49 ± 1.83 (p = .005) while the control group reported an improvement of 0.50 ± 1.48 (p = .001).
The percentage of participants in the control arm who would keep to all their doctors’ appointments recommended for their diabetes treatment remained unchanged at 98.1%, while that in the intervention arm improved by 1.7% (an increment from 97.4%% to 99.1%).
There were fewer participants who would avoid diabetes-related doctor’s appointment in both control and intervention groups, with the former reporting a reduction of 13.2% (a decrease from 17.1% to 3.9%) while the latter reported 9.6% reduction (a decrease from 18.2% to 8.6%). (Table 3).
Discussions
This study found that patients who had received MRS in addition to care as per existing protocol reported better self-care than those who only received care as per existing protocol (without MRS). Patients who received MRS also reported higher scores for all DSMQ subscales, except the health-care use subscale.
The value of a pharmacist goes beyond supplying medications to patients and providing them with advice on their medications.15–19 The pharmacist-run MRS was introduced to help patients optimise the benefits they can derive from their medications in achieving their therapeutic goals for management of their disease conditions, and to address patients’ medication-related issues and needs.
Feedback from patients has revealed that a significant number of them have medication-related issues.20,21 This finding is corroborated by our study, which found that close to 5% of the study population did not take their diabetic medications and almost 1 in 3 patients tended to skip, or forget to take their diabetic medications. If focus on medication adherence is narrowed to include only adherence to diabetic medications, the findings in our study are also fairly consistent with the 75.0% adherence rate to oral hypoglycaemic agents reported by WHO in 2003. 22
Evaluating patients’ adherence during MRS, educating them on their medications and medical conditions, as well as addressing the concerns that the patients have with their medications will encourage and empower patients to take on a more active role in the management of their diabetic condition, in partnership with their healthcare professionals. 23 The study results provide support for this observation, with the percentage of patients who took their diabetic medications as prescribed increased from 96.6% to 98.3% through MRS and the percentage of patients who tended to forget to take or skip their diabetic medications decreased from 38.7% to 28.5% after MRS.
The impact of MRS is not only limited to enhancing patients’ adherence to their prescribed medication regimen. This study also found that MRS increased the percentage of patients who kept to their doctors’ appointments for diabetes review from 97.4% to 99.1%. The patients were also less likely to skip planned physical activity. The percentage of patients in this study who would tend to skip planned physical activity decreased from 48.3% to 41.4%. Patients who have undergone MRS tend to check their blood sugar level more frequently and record their blood sugar levels regularly with care and attention. The percentage of patients who would check their blood sugar regularly increased from 45.2% to 46.7% after MRS. Further, the percentage of patients who would check their blood sugar levels with care and attention also increased from 39.4% to 45.2% after MRS. Patients are also more likely to strictly follow the dietary recommendations given by their doctors or diabetes specialists to control their diabetes after MRS. As observed in this study, the percentage of patients in the intervention arm who adhered to dietary recommendations by doctors/diabetes specialists increased from 86.2% to 89.7% after MRS. These observations in our study resonate with the findings of the study conducted by Helen Jones and team. 24
Strengths and limitations
Over the years, healthcare systems in the world have evolved from one that is physician-driven to one that is patient-centric. 25 For patients to benefit most from this new healthcare model, a supportive healthcare ecosystem must be put in place to engage patients in self-care in partnership with their healthcare professionals. 26 Empowering patients for self-care in partnership with their healthcare professionals presents an opportunity for healthcare systems to achieve optimal healthcare outcomes with limited resources. 27 Our study has shown the promise of MRS in contributing to patients’ empowerment for self-care for diabetes management, particularly in the area of optimising pharmacotherapeutic outcomes.
The English version of the DSMQ questionnaire was internally validated by the study team members as DSMQ has not been validated in Singapore population. Participants who were not English-literate were administered the questionnaire face-to-face in a language that they were conversant in. It would be ideal if the questionnaire had been translated into other languages and the translated questionnaires had been validated as well. Another limitation of this study was that the point measurement of the effectiveness of MRS on diabetes self-care was conducted over an average period of about 3 months. Researchers could, in future, look into the sustainability of the effectiveness of the pharmacist-run MRS on diabetes self-care over a longer time frame and to identify factors that may affect patients’ self-care of diabetes. Future studies could also measure the impact of diabetes self-care arising from MRS on glycaemic control and disease complications which will be able to shed light on the potential impact of MRS on the clinical outcomes of the diabetic population.
Conclusions
This study has found that receiving pharmacist-run MRS, in addition to care as per usual protocol, helped patients to achieve better diabetes self-care. Hence, our study has shown the promise of MRS in improving patient self-care, and by extension, in improving care of patients with diabetes.
Footnotes
Acknowledgements
We acknowledge Dr Andreas Schmitt and his team for granting us the use of the validated Diabetes Self-Management Questionnaire (DSMQ). We would also like to thank Mrs Lo Fei Ling for granting her approval for the team to proceed with this study, and all the participants involved in the study.
Author contributions
STS- Conception, methodology, project administration, acquisition of data, drafted and revised manuscript, and final approval. DTS, MTS, CJY and OWL - acquisition of data, revised manuscript and final approval. CLJ- Conception, methodology, supervision, drafted and revised manuscript, and final approval. BGQ - Conception, methodology, project administration, data curation, data analysis, drafted and revised manuscript, and final approval. GBK, KSY and TWP- Supervision, drafted and revised manuscript, and final approval.
Declaration of conflicting interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.
Ethical approval
SingHealth Centralised Institutional Review Board’s approval (IRB number: 2014/2059) was sought prior to the commencement of the study.
Informed consent
Written informed consent was obtained from all subjects before the study. Participants’ informed consent was obtained prior to their participation in the study.
