Impact of Clinical Pharmacist Mediated Discharge Counseling and SMS Reminders Service on Medication Adherence in Chronic Disorders

Aims: This study aimed to assess the effect of discharge counseling with SMS reminders on medication adherence in chronic disorders. Study Design: Prospective randomized open-label trial Place and Duration of Study: The study was conducted at the dispensing department of a secondary care referral charity hospital located in a small village. The study was conducted for a period of six months from October 2018 to April 2019. Methodology: Upon consent, a total of 364 patients were enrolled in this study and randomized into two groups viz., intervention group (n=182) and control group (n=182) respectively, with and without discharge counseling and SMS reminder on medication usage by the clinical pharmacist. The level of medication adherence was measured using a pill count and visual analog scale (VAS) methods at two follow-up visits includes baseline and final follow-up visit (gap of two months). A two-sample Wilcoxon rank‐sum (Mann–Whitney) was used to compare the statistical mean difference of medication adherence levels between two groups at each follow‐up visit. Original Research Article Reddy and Reddy; JPRI, 33(59B): 446-453, 2021; Article no.JPRI.79766 447 Results: The mean age of intervention and control groups were 57.1±8.55 and 58.5±8.53; most of the subjects were >60 years of age and were typically suffering from hypertension (30.2%) and diabetes (34.8%). Initially, at baseline, the values of medication adherence level (pill-count method) were closer in both intervention (82.4±7.3) and control group (81.35±6.4), whereas at follow up visits, the levels of the intervention group (93.2±6.0, 95.6±2.25) were significantly increased (p<0.0001) as compared to the control group (81.2±8.5, 80.6±8.1). Conclusion: Thus, the statistical significance infers that the clinical pharmacist-mediated discharge counseling with SMS reminders would increase medication adherence levels in chronic disorders.


CSC
: Care

INTRODUCTION
According to World Health Organization (WHO), 'Medication adherence" is defined as the degree to which the person's behavior resembles the agreed recommendations from a health care provider [1]. Generically, adherence involves integrating the physician's medical advice and the patient's lifestyle, values, and preferences for care to achieve a better patient's health [2,3]. Focus on chronic disorders; many factors contributed to the increased morbidity and mortality. Among them, poor medication adherence is one of the critical factors that is associated not only with mortality, but also it causes re-hospitalization and economic burden [4]. There are reports on various documented causes responsible for medication nonadherence, especially the most common is forgetfulness [5]. Subsequently, several techniques have been introduced to solve this problem including, improvements to pillboxes and bottles, including manual and electronic reminder systems. But most of these techniques are costly and limit their use [6].
Today mobile phone usage was drastically raised, irrespective of region or country, urban area or rural area, literacy or illiteracy [7]. Evidence suggests that SMS reminders can serve as a simple and cost-effective option in improving medication adherence [8]. Nevertheless, the reported studies were conducted in a specific group of the population. Thus, those studies lack related evidence in connection to patients with chronic disorders in rural settings of south India [9].
Evidence suggests that the clinical pharmacist plays a critical role in providing counseling services to improve outcomes in chronic disorder patients [10]. Therefore, the present study is designed to evaluate the clinical pharmacist mediated discharge counseling with SMS reminders as a tool for improving desired medication adherence among patients with chronic disorders, especially in rural areas of south India.

Study Design and Settings
This prospective, trial was conducted in a dispensing pharmacy department of the secondary care referral hospital, located in rural settings of India. The pharmacy department is a service arm of the hospital, which delivers pharmaceutical services to the outpatient department, inpatient department, Intensive Care Unit (ICU), neonatal ICU, pediatric ICU, and Care & Supportive Centre (CSC) of the hospital. This study was carried out for a period of six months, from October 2018 to April 2019. Due permission was sought from the medical director and chief pharmacist of the hospital and approved with Institutional Review Board with a registration number of RIPER/IRB/2018/050.

Study Criteria
Patients aged 18 years or more, irrespective of gender, suffering from chronic disorders, suitable for discharge from the hospital, and use of any model mobile phone (personal) access to SMS services were included in the study. Patients who are not interested in receiving text message reminders about medication intake daily and unable to read Telugu/English text were excluded from this study.

Sample Size
The sample size was calculated by epi-info, by considering 80% power, 5% margin of error, 95% confidence level, 5% of un-exposed with the outcome, and 15% of exposed with the outcome. After accounting 10% dropout rate, 182 patients were needed in each group.

Study Procedure
A total of 980 patients were approached to participate in the study, in those 364 patients who met study criteria were enrolled and randomized into intervention (n=182) and control (n=182) groups by simple randomization technique. In intervention group 10 and in the control group, eight participants were failed for follow-up visits. A total of 172 in intervention and 174 in the control group were subjected for data analysis.
Patient demographic and clinical profiles including age, gender, educational status, socioeconomic status, current diagnosis, co-morbidities, duration of disease, different categories of drugs used, and a total number of drugs used are collected from all study participants using a suitable predefined and validated data collection form.

Intervention group
In the intervention group, the clinical pharmacist provided discharge counseling about the dose, frequency, duration, and use of each drug recommended in the prescription. The clinical pharmacist advised about medication intake in relation to meals (before or after) and foods that need to be avoided. After discharge, an SMS reminder about medication intake was sent just before 30 minutes of due dosage time. The SMS were sent every day from the start date to the end date of the study period. The study team bared all costs for sending SMS reminders. All subjects in the intervention group were advised for two followup visits with a gap of two months for each visit.

Control group
In the control group, there were no any sending of SMS reminders regarding medication intake and discharge counseling by the clinical pharmacist. After enrollment, all subjects in control group were advised for two follow-up visits with a gap of two months for each visit. The subjects in the control group receive routine advice from the clinicians in their regular follow-up visits.

Medication adherence measurement
Baseline medication adherence for the previous 1 month was measured using a pill count and Visual Analog Scale (VAS) methods in both intervention and control groups. In the pill-count method, the number of pills consumed was calculated by the number of remaining pills with the patient, the percentage of medication adherence was calculated as the number of pills consumed in relation to the number of pills prescribed. In the VAS method, patients were asked to mark their medication adherence rate on the scale for the past 1 month. The scale comprises of grading from zero to 10. In this, zero indicates no adherence, and 10 indicates 100% adherence to the medications [11].
Two follow-up visits were conducted after baseline visit with a gap of two months for each visit. In follow-up visits, again medication adherence levels were measured using pill count and VAS method and compared between two groups to assess the effect of mobile phone text message reminder on medication adherence in chronic disorders compared to without sending SMS.

Data Analysis
Graph Pad Prism version 6.04 software (La Jolla, California, USA), was used to analyze the collected data from the participants. Descriptive statistics such as mean, standard deviation, frequency, and proportion were used to represent the patients' baseline demographic, clinical and medication adherence profile. Z-test was used to match the mobile phone use profile between test and control groups. A two-sample Wilcoxon rank-sum (Mann-Whitney) was used to compare the mean difference of medication adherence (measured by pill count and VAS method) levels between two groups at each follow-up visit. P< 0.05 was considered statistically significant.

RESULTS AND DISCUSSION
A total of 364 patients were enrolled and randomized into the intervention group (n=182) to receive counseling and SMS reminders by the clinical pharmacist, and the control group (n=182) no SMS reminders and counseling about medications by the clinical pharmacist. The mean age of intervention and control groups is 57.1 ± 8.55 and 58.5 ± 8.53; most subjects were > 60 years of age. All patients were equally distributed in intervention and control groups in relation to gender, educational status, marital status, diagnosis, category of drugs used, number of drugs and baseline medication adherence levels with a P -value of > 0.05 as shown in Table 1. The mobile phone use profile of the study participants in intervention and control was similar except that the control group reported more messages received from relatives (P = 0.006) and bank notification (P = 0.009). The intervention group showed more messages from cricket alerts (P = 0.02) as shown in Table 2.
At baseline, medication adherence levels measured by pill count method were nearly similar in both intervention (82.4 ± 7.3) and control group (81.35 ± 6.4), whereas these levels were increased in the intervention group (93.2 ± 6.0, 95.6 ± 2.25) compared to control group (81.2 ± 8.5, 80.6 ± 8.1) in both first and second follow up visits. Medication adherence measured by the VAS method also shown a rise in adherence level in the intervention group compared to the control group in follow-up visits, as depicted in Table 3. The mean difference of medication adherence levels (measured by pill count method) was higher in the intervention group (10.8 ± 6.1, 13.2 ± 7.1) during baseline to first follow-up and baseline to second follow-up visits, compared to the control group (0.09 ± 5.7, 0.76 ± 10.2) with a P = 0.00001 in both visits. In the VAS method also the mean difference of medication adherence levels in the intervention group (7.1 ± 6.3, 11.9 ± 6.6) was higher from baseline to first follow-up and baseline to second follow-up compared to the control group (0.82 ± 5.77, 0.4 ±5.89) with a P = 0.00001, as represented in Table 4.
One of the innovative processes in improving medication adherence is technology-based health care delivery, including mobile health, Ehealth, and telehealth. These techniques will offer ease delivery of health care according to patients' needs and improve the Economical, Clinical, and Humanistic outcomes (ECHO). Evidence shows that SMS reminder has a more significant impact over improvement in medication adherence [12,13]. These text messages have distinct benefits in terms of reducing interferences into the patient's life and their relative easiness and low cost compared to voice communication [14]. However, there is a lack of evidence on how messages can help in the management of chronic diseases in resource-limited settings of south India. This study provides evidence on the effect of discharge counseling and SMS reminders by the clinical pharmacist on medication adherence in chronic disorders.
In the current study, most of the patients are above 60 years (201; 55.2%) of age, and the majority of them were suffering from hypertension (110; 30.2%) and diabetes (127; 34.8%). A similar type of findings like advanced age (46.9%) and diagnosed with hypertension (27.6%) and diabetes (20.2) were also observed in the study conducted by Haung et al. [15]. At baseline, medication adherence levels, which are measured by pill count and VAS method in the intervention (82.4 ± 7.3, 78.8 ± 5.2) and control (81.35 ± 6.4, 79.1 ± 4.9) group are nearly similar with a P-value of 0.076 and 0.267. Medication adherence measured by the VAS method was slightly lower compared to the pill-count method. These findings are contrast with the findings of Anti-Retroviral Therapy (ART) adherence study conducted by Amico KR et al. [16]. The ART trial shows that 87% of optimal adherence in VAS method. There is no gold standard method to assess accurate medication adherence levels; every method has its own acceptable error in the measurement of medication adherence. The current study used both pill-count and VAS methods to assess medication adherence, which will increase the reliability of the results.  [18]. Even, counseling and SMS reminders had shown a rise in medication adherence levels in chronic disorders, there is still a gap in the achievement of 100% adherence towards medications. This can be achieved by using a combination of various tools, including patient information leaflet, collaborative health support (Pharmacist, clinician, and nurse-led interventions), use of reminders (beepers, pagers, smartphone apps, and automated telephone calls), one dose packaging, and regular clinic visits [19].

Strengths and Limitations
This study provides insights for improving medication adherence levels in chronic disorders by adapting an SMS reminder system in medication management policies. The study was conducted for a shorter duration, so a time and effect relationship was not established. After the withdrawal of the intervention, whether the study population constantly maintained the medication adherence levels is unknown. Pill count and VAS methods will not give accurate value about medication adherence levels. Still, there is a need to develop novel techniques to measure and improve medication adherence, which will further improve the outcomes of the diseases.

CONCLUSION
The study concludes that clinical pharmacistmediated discharge counseling with SMS reminders had shown increased medication adherence levels in chronic disorders. This technique is very simple, effective, and has low interference with patients' lives in improving adherence towards prescribed medications. A combination of medication adherence measurement and improvement tools should be used to prevent variations and make accuracy in the study findings. Clinical measures of outcomes are needed to know them a better identity of SMS reminders in the management of chronic disorders.

CONSENT
Patients were clearly explained about the purpose of the study and enrolled after getting oral and written informed consent.

ETHICAL CONSIDERATIONS
The study was conducted after getting approval from the Institutional Review Board (IRB) with a number of RIPER/IRB/2018/050 in accordance with Good Clinical Practice (GCP) guidelines.