|Year : 2018 | Volume
| Issue : 4 | Page : 801-808
|Impact of pharmaceutical care on clinical outcomes among hemodialysis patients: A multicenter randomized controlled study
Uday Venkat Mateti1, Anantha Naik Nagappa2, Ravindra Prabhu Attur3, Shankar Prasad Nagaraju3, Dharshan Rangaswamy3
1 Department of Pharmacy Management, Manipal College of Pharmaceutical Sciences, MAHE, Manipal; Department of Pharmacy Practice, Nitte Gulabi Shetty Memorial Institute of Pharmaceutical Sciences, Nitte (Deemed to be University), Mangaluru, India
2 Department of Pharmacy Management, Manipal College of Pharmaceutical Sciences, MAHE, Manipal, India
3 Department of Nephrology, Kasturba Medical College, Kasturba Hospital, MAHE, Manipal, India
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|Date of Submission||02-Jul-2017|
|Date of Decision||15-Aug-2017|
|Date of Acceptance||17-Aug-2017|
|Date of Web Publication||28-Aug-2018|
| Abstract|| |
The aim of this study is to assess the impact of pharmaceutical care on medication adherence, hemoglobin (Hb) levels, blood pressure (BP), and interdialytic weight gain (IDW) among hemodialysis (HD) patients. An open-label randomized controlled study has been conducted at three different hospitals of HD centers. The patients have been randomized into two groups [usual care group (UCG) and pharmaceutical care group (PCG)] by block design. The assessment has been carried out at baseline, 6th, and 12th months. At the end of the study, a total number of 153 patients have been followed. Out of 153 patients, 83 (UCG: n = 41; PCG: n = 42), 18 (UCG: n = 09; PCG: n = 09), and 52 (UCG: n = 25; PCG: n = 27) patients have been followed from academic, government, and corporate hospitals, respectively. The PCG had significantly reduced its IDW and BP levels in comparison to UCG at different time intervals with a statistical significance of P <0.05. The Hb levels and medication adherence rate scores of HD patients had significantly increased in PCG compared to UCG at different time intervals. The “World Health Organization-International Pharmaceutical Federation pharmaceutical care” plan model delivered by the registered pharmacist regarding the knowledge about the disease, medications, life style changes, nutritional information, personal interview, and medication review had a positive impact on the on medication adherence, Hb levels, BP, and IDW.
|How to cite this article:|
Mateti UV, Nagappa AN, Attur RP, Nagaraju SP, Rangaswamy D. Impact of pharmaceutical care on clinical outcomes among hemodialysis patients: A multicenter randomized controlled study. Saudi J Kidney Dis Transpl 2018;29:801-8
|How to cite this URL:|
Mateti UV, Nagappa AN, Attur RP, Nagaraju SP, Rangaswamy D. Impact of pharmaceutical care on clinical outcomes among hemodialysis patients: A multicenter randomized controlled study. Saudi J Kidney Dis Transpl [serial online] 2018 [cited 2019 Nov 15];29:801-8. Available from: http://www.sjkdt.org/text.asp?2018/29/4/801/239639
| Introduction|| |
In India, the concept of pharmaceutical care is not well developed as compared to developed countries such as USA, Canada, New Zealand, and Australia. In India, pharmacists were limited to dispensing and selling of drugs. In the year 2006, the World Health Organization (WHO) and the International Pharmaceutical Federation (FIP) have been developed guidelines on “the process of delivering pharmaceutical care in a general practice environ-ment.”, Most of the publications have revealed that there is a lack of knowledge, attitude, and practice (KAP) regarding the drugs, disease, and lifestyle changes among chronic kidney disease (CKD) patients on hemodialysis (HD) ., The poor adherence is a common problem where patient's myths and beliefs play an important role in shaping the KAP. The comprehension and the practice should go hand in hand to achieve good clinical outcomes in HD patients. In the field of healthcare, gaps in the knowledge are rampant and have their impact on patient's KAP, which are usually unnoticed irrespective of their socioeconomic status. There is an utmost need for all the patients to get information in the area of drugs, disease, lifestyle and nutritional changes. Kidney failure shoves the patients into a stiff condition wherein massive adjustments for serum potassium, calcium, sodium, phosphate, albumin, and hemoglobin (Hb) levels turn out to be serious. Although HD supplements some of the renal functions it cannot be a substitute for the kidney itself. HD is a cumbersome and perilous process requiring the patients and attendants to be on highly attentive. The even slight disparity in lifestyle, diet, and ignorance about the disease can lead to relentless outcomes leading to admissions to intensive care unit or death. The pharmaceutical care provision has been benefited in HD patients in the field of quality of life, clinical, economic out-comes., The aim of the study is to assess the impact of pharmaceutical care on medication adherence, Hb levels, blood pressure (BP), and interdialytic weight gain (IDW) among HD patients.
| Methods|| |
Study design, patients, site, and criteria
An open-label randomized controlled study registered under the clinical trial registry of India (Ref. no. CTRI/2014/004900) was carried out for 15 months between March 2014 and May 2015 at three diverse HD centers of academic, government, and corporate hospitals. The ethical approval (IEC/165/2013) was obtained from the ethics committee before the beginning of the study.
The study criteria for selecting the patients, recruitment and follow-up during the study [Figure 1], [Figure 2], [Figure 3], sample size, randomization, sampling and pharmaceutical care and usual care groups (UCGS) and data collection of the patients, detailed information have been provided in our previously published study in Saudi Journal of Kidney Diseases and Transplantation (SJKDT).
The tailored care plan has been designed and provided to the PCG patients on periodic basis (monthly) based on the situation of the patient by the “WHO-FIP Pharmaceutical care model.” The PC accentuates the motivation and patient education regarding the knowledge about the drugs, disease, lifestyle modifications (restriction of fluid, daily salt intake limit, thirst management, foodstuffs-containing potassium, phosphate, protein, and sodium), nutritional information, personal interview, and medication review. The PC group has also provided with a validated pictogram-based information leaflets and advice on medication administration, laboratory monitoring and adherence to HD and medication related issues.
The assessment of outcomes includes Hb levels, IDW, BP, and medication adherence have been carried out at baseline, 6th and 12th months by follow-up in both the groups for a total period of 12 months.
Hemoglobin levels, interdialytic weight gain and blood pressure assessment
The Hb levels have been monitored at baseline, 6th and 12th months for each patient. The IDW has been calculated by using below-mentioned formula.,
IDW = (Pre HD weight –Post HD weight)
For each time point, the average eight preceding readings of IDW, systolic BP and diastolic BP have been recorded at baseline, 6th and 12th months for each patient.
Medication adherence assessment
Medication adherence has been assessed by using validated medication adherence self-reported scale (Morisky Medication Adherence - 8 Item Scale) at baseline, 6th and 12th months for each patient.
| Statistical Analysis|| |
Data were analyzed on the basis of per protocol method. Repeated measures analysis has been carried out for the analysis of change in the Hb levels, BP, IDW, and medication adherence scores in the two groups. The survival time (days) for the UCG and PCG has been analyzed using Kaplan-Meier estimates. The P <0.05 have been considered as statistically significant.
| Results|| |
A total number of 200 patients were recruited during the study. At the end of the study, a total number of 153 patients have been followed. Out of 153 patients, 83(UCG: n = 41; PCG: n = 42), 18 (UCG: n = 09; PCG: n = 09) and 52 (UCG: n = 25; PCG: n = 27) patients have been followed from academic, government and corporate hospitals respectively. There were 47 dropouts in total, out of which 25 were in UCG and 22 in PCG. The detailed baseline characteristics of HD patients are summarized in the [Table 1] of our previously published study in SJKDT.
|Table 1: Baseline clinical outcomes of HD patients from academic/government/corporate hospitals.|
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The baseline outcomes such as IDW, Hb levels, BP and medication adherence rate scores have not been significantly differing in the UCG vs. PCG in all the three HD centers. The detailed baseline outcomes of the HD patients are presented in [Table 1].
The PCG had significantly reduced its IDW and BP levels in comparison to UCG at different time intervals with a statistical significance of P <0.05 when analyzed by repeated measures of ANOVA. The Hb levels and medication adherence rate scores of HD patients had significantly increased in PCG compared to UCG at different time intervals when analyzed by repeated measures of ANOVA. There was a significant increase in Hb levels noticed in PCG compared to UCG with a statistically significance of P <0.05 in academic hospital and government hospital data of HD patients. There was a statistically significant improvement in medication adherence rate scores seen in PCG compared to UCG in academic hospital and government hospital data of HD patients. However, a significant increase has been noticed in the medication adherence rate scores, but the overall medication adherence rate of the patients was moderate. The significant rise in Hb levels has not been observed in the two groups (UCG and PCG) of corporate hospital as the patients' had already achieved the optimal Hb levels at 10 g/dL.
The changes in the outcomes of IDW, Hb levels, BP, and medication adherence rate scores at different time intervals are given in the tables of the academic hospital, government hospital and corporate hospital data respectively [Table 2], [Table 3], [Table 4]. The mean survival time (days) for UCG and PCG has been noted as 311.94 and 322.08 days, respectively, with the log-rank (Mantel-Cox) P value 0.583. The survival time is comparatively high in PCG but not statistically differ from UCG in all the centers. The mean survival days by KaplanMeier analysis of HD for UC and PC groups are presented in [Table 5].
|Table 2: Clinical outcomes data for UC and PC groups of academic hospital HD patients.|
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|Table 3: Clinical outcomes data for UC and PC groups of government hospital HD patients.|
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|Table 4: Clinical outcomes data for UC and PC groups of corporate hospital HD patients.|
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|Table 5: Kaplan-Meier survival analysis of HD patients from academic/government/corporate hospitals.|
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| Discussion|| |
The pharmaceutical care is a comprehensive patient education system serving in the areas of drug, disease, nutritional, and lifestyle information with an objective to empower the patient with self-management of his or her condition. The clinical outcomes are considered as important in deciding the therapy by care providers. The clinical outcomes are measurable and quantitative. The clinical outcomes are heavily relied on deciding the outcomes previously due to advancement in tools.
Failure to the dietary habits compliance, fluid management, and drug therapy have an impact on morbidity and mortality in HD patients. The previously conducted studies have been reported that 50% of the HD patients are non-adherence to the fluid restriction.,, It has been reported in the survey of the literature that the increase in IDW in HD patients increases the BP by 3 mm Hg per kg of body weight. The PCG had significantly reduced its IDW and BP levels in comparison to UCG at different time intervals. The similar results have been found with the study conducted by Tsay, Barnett et al, Jafari et al, Casey et al, and Nozaki et al.,,,, This suggests that the tailored pharmaceutical care has a positive impact on fluid compliance and BP control in HD patients.
Noncompliance is a common problem in the HD patients, where demystifying the myths and beliefs plays an important role in shaping the KAP. In the present study, the significant increase in medication adherence rate scores has been seen in PCG compared to UCG. These findings were consistent with other interventional studies.,,,,, The psycho-educational intervention study conducted by Karamanidou et al, had to impact in improvement in adherence. The other two previously conducted educational interventional studies had significantly reduced the non-compliance rate in HD patients.,
It is also observed that the significant increase in Hb levels was seen in PCG compared to UCG with a statistical significance of P <0.05 in the academic hospital, government hospital and cumulative data of HD patients. This rise in Hb levels is due to the medication adherence and close monitoring of anemia. The significant rise in Hb levels has not been observed in the two (UCG and PCG) groups of the corporate hospital as the patients' had already achieved the optimal Hb levels 10 g/dL. The three landmark trials “CREATE, CHOIR, and TREAT” results state that the increasing of the target Hb levels in the range of 10–12 g/dL had no benefit.,, The “Kidney Disease: Improving Global Outcomes” disseminated guidelines for the use of erythropoietin stimulating agents (ESA) in patients with dialysis, advising them to know that the ESA can increase the risk for heart attack, heart failure, stroke, blood clots, and death when given to maintain higher Hb levels. The similar clinical pharmacist initiated an “anemia educational program' among the CKD had a positive effect on patients” “energy, daily activities, and general well-being.”
| Conclusion|| |
This is the premier study in India carried out in the multi-healthcare centers representing a spectrum of hospitals from the teaching, govt. and private sectors with an aim to assess the differences in response to the intervention of pharmaceutical care on clinical outcomes. The 'WHO-FIP pharmaceutical care” plan model delivered by the registered pharmacist regarding the knowledge about the disease, medications, lifestyle changes, nutritional information, personal interview, and medication review had a positive impact on medication adherence, Hb levels, BP and IDW. However, a significant increase has been noticed in the medication adherence rate scores, but the overall medication adherence rate of the patients was moderate.
| Acknowledgment|| |
We would like to thank all the patients who have actively participated in the present study. Our deepest thanks go to Dr. Manohar Bairy, Consultant Nephrologist, Tan Tock Seng Hospital, Singapore for his valuable suggestions and we also place on record our gratitude to the Hospitals of Hemodialysis Centers for permitting to conduct this study. Finally, we owe our special thanks to Manipal College of Pharmaceutical Sciences, Manipal University for providing us with the Research facilities.
Conflict of interest: None declared.
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Dr. Uday Venkat Mateti
Department of Pharmacy Practice, Nitte Gulabi Shetty Memorial Institute of Pharmaceutical Sciences, Nitte (Deemed to be University), Deralakatte, Mangaluru - 575 018, Karnataka
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]
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