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  • 1. SHORT-TERM OUTCOMES FOR AN EMPLOYER SPONSORED PHARMACIST-PROVIDED MULTI CENTER DIABETES MANAGEMENT PROGRAM Sharrel L. Pinto, B.S Pharm, Ph.D, Assistant Professor and Director 1 , Jinender Kumar, B. Pharm, PGDBM, Research Assistant 2 1,2 The Pharmaceutical Care and Outcomes Research Laboratory, Department of Pharmacy Health Care Administration, College of Pharmacy, University of Toledo, Ohio, USA Introduction Objective Methods Results Discussion and Study Implications References Results Cont….. Clinical, Social and Process Measures Humanistic Outcomes Economic Outcomes Table 2: Quality of life (Using SF – 36 v.2) Table 3: Disease-Specific Knowledge Surveys Table 4: Patient Satisfaction and Self-Reported Patient Adherence Conclusion Table1 : Changes in Clinical, Social, And Process Measures Table 5: Economic Outcomes PDB53 Goal Methods Cont….. Medication Therapy Management (MTM) programs are an innovative approach to optimize patient health outcomes for ongoing disease states through integrative care. 1 In last few years, there is a strong emphasis for employer sponsored MTM programs to develop across the country. These programs encourage employees to take advantage of MTM programs at the cost of their employer.   Previous work in this area has demonstrated a positive impact of pharmacists’ interventions but has lacked the foundation of a conceptually coherent framework to track outcomes. 2-4 This study has utilized a theoretical framework to examine effects of pharmacists’ interventions on patient health outcomes using economic, clinical, and humanistic outcomes (ECHO) model. To measure the impact of a pharmacist-provided MTMP on the economic, clinical, and humanistic outcomes for the City of Toledo employees and their dependents for a period of six months
    • Humanistic Outcome Measures: Quality of life ( QoL measured using SF-36v2), patient satisfaction, patient adherence (Morisky scale), and disease-specific knowledge (diabetes mellitus (DM), hypertension (HTM) and hyperlipidemia (HL))
    • Patient quality of life and disease specific knowledge was assessed at baseline visit and 6 months. Patient satisfaction and Patient Adherence using Morisky Scale was evaluated at the baseline visit and 3 months. Patients completed these surveys at the sites.
    • Knowledge Surveys: Three (one each for DM, HTM, HL) newly developed surveys containing 10 items each. Items correspond with education provided. E.g.: What are common problems associated with type 2 diabetes? What is normal fasting blood glucose level?
    • Patient Satisfaction Survey: Developed based on 3 previously validated and reliable surveys. 5- 7 Total of 34 items measuring 3 domains (experience with the pharmacist (18 items), experience with the pharmacy (12 items), and experience with pharmacy staff (4 items)).
    • Economic Outcome Measures: Costs and number of physician office visits, ER visits, hospitalizations, and length of stay per hospitalization. These economic outcomes were measured for one year prior to baseline visit, and every 6 months thereafter and is provided by the employer’s third party payer.
    • Data Analysis: Friedman test was used to compare variables at multiple time points. Wilcoxon-Signed rank test was used to compare variables at two time points . A priori level of 0.05 was used for the data analysis.
    • A subgroup analysis was also conducted for patient’s who had high A1c ≥ 7 at baseline. The subgroup analysis was also conducted for diabetes patient’s who were hypertensive (B.P ≥ 140/90) at baseline.
    • This study found that the study participants had improved economic, clinical, and humanistic outcomes at the end of 6 months.
    • Patients with higher baseline A1cs benefitted most from the program. About a third saw A1c decreases by more than 1%.. Furthermore, glycemic control was maintained in most patients who were at goal at baseline. Patients who had hypertension also saw a decrease in blood pressure reaching goal. These results are consistent with the results of similar pharmacist managed MTM programs for diabetes. 2,3,8, 9
    • Improved glycemic control is associated with positive economic outcomes such as reduced rate of hospital admissions for selected short term complications and reduced medical costs. 9 This study found that patients had fewer diabetes related ER visits and hospitalizations since enrolling in the program. Consequently, the average costs per ER visit and hospitalization also decreased. T otal costs decreased by 62.69%.
    • From an employer perspective, there were significant cost savings resulting from participation in a pharmacist-conducted MTM program. This study adds to the existing literature demonstrating pharmacist-led EAPs lead to positive outcomes thereby increasing external validity for studies such as the Ashville Project, Diabetes Ten City Challenge etc. 1,3 Based on the results from this study, employers might be encouraged to invest in similar program for patients with other chronic conditions.
    • During 2008, there was a 30% increase in the number of patients visiting their physician’s office. Pharmacists in this program strongly encouraged patients to see their podiatrist, ophthalmologist and dentist. Patients who have annual exams are less likely to incur long term costs associated with micro and macrovascular complications.
    • Patient satisfaction with pharmacists, pharmacy and staff improved significantly by 3 months. Patient satisfaction has been associated with improved quality of life, adherence to medication therapy, level of pharmaceutical care received, and patients’ perception of the pharmacist's ability to help them. 10-12 Patients reported high levels of satisfaction with the pharmacist when the pharmacist involved them in decisions about using their medications, explained what their medications were used for, and improved their knowledge and skills on lifestyle changes.
    • No significant changes were observed in QoL. Previous studies have also shown lack of improvement in QoL using SF-36 despite improved clinical outcomes. 13,14 However, in our study, PCS mean score (48.72) was higher than the US norm of 39.30. 15 Role physical and social functioning scores improved. Items on the role physical domain measure constraints/inability to perform at work as a result of the disease. It was interesting to note that patients performed better at work after participating in the program. These findings mimic those of a similar program for patients with hypertension at the end of 6 months. 16
    • Patients’ knowledge about their diabetes improved post counseling. Additionally, patients seemed to retain this gain in knowledge at their 6 month visit. This was a result of the pharmacist’s efforts to educate patients about their disease state. Better awareness is linked with improved adherence and improved outcomes. 13 Patients in this study reported better adherence at the end of 3 months. For diabetes, a high level of medication adherence has been associated with lower disease-related medical costs. 14
    1. Bennett M, Bertram C, Chater R, et al. Medication Therapy Management in Community Pharmacy Practice: Core Elements of an MTM Service Version 1.0. April 25, 2005. 2. Cranor C.W., Bunting B.A., Christensen D.B. The Asheville Project:Long-Term Clinical and Economic Outcomes of a Community Pharmacy Diabetes Care Program. J Am Pharm Assoc.2003;43:173-84. 3. Fera T, Bluml B.M. et a., The Diabetes Ten City Challenge: Interim clinicaland humanistic outcomes of a multisite community pharmacy diabetes care program. J Am Pharm Assoc.2008;48:181-190. 4. Garrett D.G, Bluml B.M, Patient Self-Management Program for Diabetes : First-Year Clinical, Humanistic, and Economic Outcomes. J Am Pharm Assoc.2005;45:130-137 5. Larson, LN, Rovers, JP, MacKeigan, LD. Patient satisfaction with pharmaceutical care: update of a validated instrument. J Am Pharm Assoc. 2002; 42(1): 44-50. 6. Doucette, WR, McDonough, RP. Beyond the 4Ps: using relationship marketing to build value and demand for pharmacy services. J Am Pharm Assoc. 2002; 42: 183-93. 7. Hooker, RS, Potts, R, Ray, W. Patient satisfaction: comparing physician assistants, nurse practitioners, and physicians. The Permanente Journal. 1997; 1(1): 38-42. 8. Ragucci K.R., Fermo J.D. et al. Effectiveness of pharmacist-adminstered diabetes mellitus education and management services. Pharmacotherapy. 2005;25(12):1809-1816. 9. Wagner e, Sandhu N, Newton K et al. Effect of improved glycemic control on health care cost ad utilization. JAMA.2001;285:182-9. 10. Kimmel PL, Patel SS. Quality of life in patients with chronic kidney disease: focus on end-stage renal disease treated with hemodialysis. Semin Nephrol. 2006; 26(1):68-79. 11. Bultman DC, Svarstad BL. Effects of pharmacist monitoring on patient satisfaction with antidepressant medication therapy. J Am Pharm Assoc. 2002; 42(1):36-43. 12. Ried LD, Wang F, Young H, Awiphan R. Patients' satisfaction and their perception of the pharmacist. J Am Pharm Assoc. 1999; 39(6):835-842. 13. Lau, C., Qureshi, A., & Scott, S. (2004). Association between glycaemic control and quality of life in diabetes mellitus. Journal of Postgraduate Medicine, 50(3), 189-93; discussion 194. 14. Hill-Briggs, F., Gary, T., Baptiste-Roberts, K.,  & Brancati, F. (2005). Thirty-six-item short-form outcomes following a randomized controlled trial in type 2 diabetes.  Diabetes Care ,  28 (2), 443-4. 15. Mayer B. Davidson, MD SF-36 and Diabetes Outcome Measures Diabetes Care 28:1536-1537, 2005 16. Mann DM, Ponieman D, Leventhal H, Halm EA. Predictors of adherence to diabetes medications: the role of disease and medication beliefs J Behav Med. 2009 Jan 30. Epub ahead of print. 17. Viviam E.M., Improving Blood Pressure Control in a Pharmacists-Managed Hypertension Clinic. Pharmacotherapy.2002;22(12):1553-1540 . Available Data: 92 Patients Available data: Baseline - 98 Patients 3 Months – 73 Patients 6 Months – 50 Patients The six month evaluation of the pharmacist-provided MTM program for diabetes has shown to be successful in improving clinical, humanistic, and economic outcomes of City of Toledo employees and their dependents. # - Friedman Test for Paired Data (significance at α = 0.05) * - Wilcoxon Signed Rank Test for Paired Data (Baseline to 3 months) (significance at α = 0.05) The mean norm based score for US general population with diabetes are 41.10 ± 11.16 for Physical component Summary and 47.75 ± 11.49 for Mental Component Summary. A higher score at follow up visit indicates improved quality of life. Each domain have separate minimum and maximum scores. The details about the meaning of each domain scores can be found in the User Manual for SF-36 v2 Survey by Quality Metrics. Knowledge tests are scored on a scale of 1-10 (1 – Low Knowledge, 10 – High Knowledge) Patient satisfaction and patient adherence are scored on a scale of 1-5. The higher the score, the more improved was the satisfaction or adherence. Funding: This study was funded by a seed grant from The National Business Coalition on Health Acknowledgements: City of Toledo, FrontPath Health Coalition, Toledo Area Network of Independent Pharmacies To measure the short term outcomes of an employer sponsored pharmacists- provided MTM program in a community pharmacy setting
    • Study Design: Prospective, pre-post longitudinal study design
    • Inclusion and Exclusion Criteria: The main inclusion criteria were as follows:
    • The study participants primary provider for medical insurance and prescription coverage must be the City of Toledo (includes employees and dependents).
    • At the time of enrollment, participants must be taking medications or have a new prescription for the treatment of Type 2 diabetes.
    • Over 18 years of age, speak English and have transportation to one of the practicing sites.
    • Participants not meeting the above stated inclusion criteria were excluded from the study.
    • MTM Program Setting: The MTM program was provided by the pharmacists from a Toledo Area Coalition of Independent pharmacies (known as PharmacistCare TM ) . . PharmacistCare TM consists of five independent community pharmacies from Northwest Ohio region: The Pharmacy Counter Pharmacy (three locations), Glenbyrne Pharmacy, Kahler Pharmacy, Erie Drugs, and Ryan Pharmacy.
    • MTM Program Framework: Enrolled patients were required to visit the pharmacy on three occasions during the six months period. The initial visit (baseline) was with the pharmacy technician for completing the consent forms and collecting enrollment information. This was followed by two counseling sessions with the pharmacist. Each visit was scheduled based on a program algorithm developed using national guidelines (ADA, JNC-VII, and NCEP) and published literature. The main outcomes collected at each visit were:
    • Clinical Outcome Measures: A1c, systolic and diastolic blood pressure, and body mass index (BMI)
    • Social Outcome Measures: Number of caffeine beverages consumed per day, alcohol beverages consumed per week, number of packs of cigarettes smoked per day and number of exercise hours per week
    • Process Outcome Measures: Podiatrist visits, eye exams, dentist visits, sick days, ER visits, self monitored blood glucose levels (SMBG), hypoglycemic episodes, and flu shots
    • These clinical, social, and process measures were measured at the baseline visit and every 3 months thereafter. Data was collected by the pharmacist or the pharmacy staff at each visit.
    Presented at the ISPOR 14th Annual International Meeting, Orlando, Florida, May 16-20, 2009