PHARM-MD; An Open-Label, Randomized Controlled Phase II Study to Evaluate the Efficacy of a Pharmacist Managed Diabetes Clinic in High-Risk Diabetes Patients
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Sponsor: Corewell Health East

Study protocol with statistical analysis plan 
 
Official Title: Pharm-MD; an Open-Label, Randomized Controlled Phase II Study to Evaluate the Efficacy 
of a Pharmacist Managed Diabetes Clinic in High-Risk Diabetes patients (Pharma MD) 
NCT Number: 03377127  
 
Document Date: February 20, 2020 

Protocol Information 
Study number 2017‐494 
NCT 03377127  
 
 
 
Title: Pharm‐MD; an Open‐Label, Randomized Controlled Phase II Study to Evaluate the Efficacy of a 
Pharmacist Managed Diabetes Clinic in High‐Risk Diabetes patients (Pharma MD) 
 
 
Version 1.14, (2/20/2020)  
 
 
Beaumont Health System – Department of Internal Medicine  
Principal Investigator: Halalau, Alexandra I, MD  
 
Additional Investigators:    
Bushman, Jordan S   
El Masri, Dana   
Gierer, Jacqueline L, DO   
Kaur, Madhupreet   
Keeney, Scott, DO    
Shelden, Daniel Thomas, D.O.   
Sonmez Ince, Melda   
Uddin, Ahsan   
 
Bradley, Kathleen M,   CRC I / CRA  
 Schumacher, Nicole M,   CRC I / CRA  
 Tessmar, Coleen M,   Research Nurse Clinician  
Kopper, Gloria, RN, MSA, Clinical Research Nurse Manager  
 Lewis, Bobbie L, RN, BSN, CCRC, Clinical Research Nurse Manager  
 
 
 
 

Study Information 
 
Phase of study:  N/A   
Sponsor: Beaumont Health 
Funding: Herb and Betty Fisher Seed Grant 
 
Locations of Study: 
Beaumont Hospital‐ Royal Oak 
3601 W. 13 Mile Rd., Royal Oak, MI 48073 
 
Beaumont Internal Medicine Center‐Southfield 
29355 Northwestern Hwy #210, Southfield, MI 48034 
 
Norton, Klein, Hug, Sabin & Maddens, MD, PC 
3290 West Big Beaver Road, Suite 420, Troy, MI 48084 
 
Beaumont Internal Medicine 
1949 12 Mile Road, Berkley, MI 48072 
 
 
 
 
IRB review: 
Expedited review by the Beaumont IRB was conducted under the following categories: 
• 
Study does not involve greater than minimal risk 
• 
Information on living individuals is included, and data collection will be via prospective collection 
of data from chart review or research activities, as well as prospective questionnaire or survey 
• 
Category 4: Study involves collection of data through non‐invasive procedures routinely 
employed in clinical practice, excluding procedures involving x‐rays of microwaves 
• 
Category 5: Study involves materials (data, documents, records, or specimens) which have been 
collected or will be collected solely for non‐research purposes 
• 
Use of an information sheet for informed consent with a waiver of consent documentation 
 
Study Overview/Inclusion/Exclusion Criteria 
 
Background and Significance: 
Type 2 diabetes mellitus (DM) is a chronic medical condition resulting in the inability to properly 
respond to insulin, a hormone responsible for the body’s use of sugar. This leads to abnormally elevated 
sugar levels in the bloodstream. Diabetes can affect any of the body’s organs, with long term effects 
including an increase in the risk of heart attack, stroke, kidney disease, eye disease, and nerve disease. 
According to the Centers for Disease Control (CDC), DM affected 29.1 million Americans in 2014, with 
approximately 8 million additional undiagnosed cases in 2012. DM was the 7th leading cause of death in 
2013 in the US. Additionally, diabetes imposes a large disease burden on society, with an estimated total 
cost of $245 billion in 2012.  
 
The main goal of diabetes treatment is to lower the blood sugar. A standard blood test called the 
hemoglobin A1c (HbA1c) is a numerical value (a percentage) that is a reflection of blood sugar control 
over the prior 2‐3 months. The higher the number, the worse the blood sugar control. Therefore, 

reduction of the HbA1c is the primary target for measuring disease control. Previous studies have 
demonstrated that for each 1% reduction in the HbA1c, there was a corresponding 14% reduction the in 
risk of heart attack, 12% reduction in the risk of stroke, and a 37% reduction of other problems such as 
nerve, kidney, and eye damage. The Royal Oak Beaumont Hospital resident clinic cares for 908 diabetic 
patients, of which 214 are considered “high risk” because their hemoglobin A1c is greater than or equal 
to 9%, which represents poor control of the disease.  
 
In 2016, the Association of American Medical Colleges estimated that the shortage of physicians in the 
United States would be between 61,700 and 94,700 by 2025. As a means of addressing this shortage, 
the role of “physician extenders” such as nurse practitioners and physician assistants has increased. 
Their role in the treatment of diabetes is well established, but our data from a previous study as well as 
data from our review of the literature suggests that pharmacists are an underutilized resource. In an 
effort to improve the quality of care delivered to our patients, a Pharmacist Managed Diabetes Clinic 
(PMDC) was created. The uniqueness of our PMDC, which differentiates it from those in prior studies, is 
the focus of educational visits on patient‐identified goals and barriers to attaining better diabetes 
management.  
 
The impact of our PMDC on the quality of care for high risk diabetes patients was evaluated in a study 
looking back at the electronic health record from our clinic. The results at three and six months revealed 
a significant decrease in the HbA1c in the patients who go to the PMDC versus the patients who did not. 
The data from this study is very impressive, but there are limitations to studies that look back in time 
versus forward in time. Therefore, we aim to conduct a randomized controlled trial (RCT) in which 
patients would be randomly assigned to attend the PMDC or to continue with regular physician visits. 
Our hypothesis is that the PMDC, which is focused on patient‐identified diabetes management gaps and 
goals, would result in a higher quality of care at a lower price. A RCT would provide further clarity on the 
impact on patient outcomes and important evidence with regard to how we can deliver the best care for 
this high‐risk population.   
 
Outcomes: 
The primary outcome for this study is the hemoglobin A1c (HbA1c), measured at baseline, at 6 months 
and at 12 months after randomization. 
 
Secondary outcomes for this study are related to the impact of the PMDC on all diabetes core measures, 
patient quality of life, and harms and cost effectiveness related to the intervention.  Secondary 
outcomes for this study include the following: 
 
• 
Percentage of patients achieving a hemoglobin A1c measurement of less than 8.0% at the end of 
the trial period. 
• 
Achievement of annual lipid panel testing. 
• 
Compliance with statin therapy per the 2013 American College of Cardiology / American Heart 
Association guidelines. 
• 
Blood pressure goal of less than 140/90 at the end of the trial period. 
• 
Compliance with recommended diabetic screening: annual retinopathy examination via dilated 
retinal examination, annual nephropathy evaluation with urine microalbumin testing, and 
annual neuropathy evaluation with lower extremity monofilament testing. 
• 
Compliance with recommended vaccinations including annual influenza vaccination and 
pneumococcal vaccination. 

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hemoglobin A1c greater than 9% and overdue for their primary care physician follow up diabetes visit, 
identified through the diabetes registry, will be called to schedule an appointment with their primary 
care physician (PCP) and will be approached at the time of the clinic visit.      
 
The patients will also be identified from the daily schedule through electronic reports from the EPIC 
electronic medical record. Daily reports will be run for the next day to identify the patients with diabetes 
and hemoglobin A1c greater or equal to 9, that have an appointment with our clinic. Manual chart 
review will be performed to confirm the eligibility criteria based on hemoglobin A1c higher than 9.  
 
Recruitment letters will be mailed to all the patients found eligible to be enrolled in the study based on 
their hemoglobin A1c level and being overdue (over 3 months) for their primary care visit. The patients 
will be directed to call the research assistant and they will be helped to schedule a PCP appointment if 
they are overdue. We considered overdue appointment for patients with hemoglobin A1c greater or 
equal than 9 if they haven’t seen their PCP in over 3 months. If the patients had a recent PCP 
appointment and therefore are not overdue, but are interested to be enrolled in the study, the research 
assistant will help them schedule their next PCP visit and will advise them that they will be enrolled at 
that visit. The research assistant will keep record of these patients and their follow up PCP appointment 
date and time. 
 
A brochure with information about the PHARMA MD study is to be displayed in exam rooms, pharmacist 
offices where they meet with patients and waiting rooms of the Royal Oak Medical Office Building 
outpatient clinics for patients that might be interested in joining the study.   
 
Consent procedure: 
Research assistant will provide an Information sheet to the patients and enroll them. Full consent will 
not be needed as this study does not involve more than minimal risk. Sandra Baker CRA II, Kathleen 
Bradley CRA II, Coleen Tessmar (senior research nurse clinician) and Janna Fett (PharmD) will provide the 
information sheet to the patients and will get an information sheet receipt. 
 
Methods: 
Allocation (patient group assignment): Subjects will be allocated to the PMDC or the standard of care in 
a 1 to 1  fashion, meaning the groups will have equal numbers of patients.  The randomization scheme 
and the study  envelopes with each protocol, based on the randomization scheme, will be prepared by a 
biostatistician that will not  be involved in the study. The envelopes with each assigned protocol will be 
closed and opaque and will be given to the research assistant.  The opaque envelopes that will contain 
the group allocation will be kept in a locked boxed in the clinic and the research assistant will be the 
only person with access to the box. The envelopes will be opaque in order to maintain the concealment 
of the allocation, which minimizes study bias. Once the eligible patients present to their PCP visit, the 
research assistant will consent the patients and enroll them into the study and provide the next 
available envelope with the assigned group protocol (intervention or control group).  The research 
assistant will be under the supervision of a medically trained principal investigator.  
 
As this is an open‐label study, the patients and the physicians will be aware of group allocation.  
However, individuals who collect and analyze the data, the biostatistician, and individuals who assess 
the outcomes of the study will be unaware of which group the patients are in.  Only the research 
assistant will be aware of the real allocation after the patients are assigned to a group randomly.  The 
research assistant will enter the enrolled patients in a spreadsheet within a secured, shareable online 
database and assign each patient a number (0 or 1) based on the group assignment.  The group number 

assigned will not be revealed to any study personnel until the final statistical analysis will be completed.  
 
The majority of the data will be collected at the baseline (beginning) of the study and at 6 and 12 
months after starting  the intervention. Hemoglobin A1c will be collected at 6 months (+/‐ 3 months ) 
and at 12 months (+/‐ 3 months) to be able to capture any value done in between the 6‐12 months 
mark. This will include the hemoglobin A1c value and “goal of < 8%”, lipid panel, blood pressure  
management (goal of < 140/90 mmHg), compliance with recommended DM screening (checking the 
eyes, kidneys,  and nerves for diabetic‐related damage), immunizations (influenza and pneumonia 
vaccines), quality of life (Diabetes 39, description below), number of emergency center visits for high or 
low blood sugar, overall numbers of  hospital and clinic visits, and the ‘no‐show’ rate (the rate at which 
the patients do not attend scheduled appointments).   
 
Personnel will include investigators, a research assistant, and a research nurse manager. They will be 
trained in the  standardized measurement of blood pressure and administering immunizations as well as 
eliciting information and  collecting questionnaires from patients in a uniform manner.  To assess patient 
quality of life at the start and conclusion of the study period, the Diabetes‐39 questionnaire will be 
utilized.  This questionnaire is appropriate for use in a diverse diabetic patient population and is an 
excellent query of a broad conceptualization of diabetes specific quality of life [Watkins].  There are 5 
domains assessed in the questionnaire: energy and mobility, diabetes control, anxiety and worry, 
social/peer burden, and sexual functioning.  The questionnaire is comprised of 39 total questions and is 
scored via a visual analogue scale, with higher scores reflecting a poorer quality of life [Boyer].  The 
diabetes‐39 questionnaire has good reliability (Cronbach’s alpha ranging from 0.81 to 0.93) and internal 
and external validity [Garratt].   
 
All the pharmacy visits from the patients in the intervention group will be analyzed and data will be 
pulled accordingly to the data collection sheet. There will be no patient contact or communication. 
 
Dr. Halalau has entered the study into the CinicalTrails.gov website and will update as needed.       
 
 
Inclusion Criteria: 
 
The target population will be comprised of high risk diabetes mellitus type 2 patients (hemoglobin A1c 
equal to or greater than 9%) that are not currently enrolled in PMDC. In order for the patient to be 
eligible for enrollment, they will have to be established with a primary care resident internal medicine or 
medicine‐pediatrics resident. The patient will have to carry a diagnosis of diabetes mellitus type 2. The 
patient’s will be screened based on the diabetic registry in the electronic medical record. If the patient is 
diagnosed with diabetes mellitus type 2, has a hemoglobin A1c equal to or greater than 9%, and is under 
the care of a primary care resident they will be eligible for enrollment. 
 
 
Exclusion criteria: 
 
Patients will be excluded if they have been seen by the PMDC within the past 3 months. This time period 
was chosen to mitigate the risk for the potential confounder of a PMDC visit directly affecting the 
hemoglobin A1c. By selecting this time period, we aim to maintain a larger pool of patients to select 
from than we would otherwise if we completely excluded patients who had previously been seen in the 
PMDC.  

 
Patients will be excluded if they are under 18 years of age. Patients will also be excluded if they are 
documented as having type 1 diabetes. 
 
Patients older than 75 years of age will be excluded because their hemoglobin A1c goal might be 
different than the general population given all the concurent comorbidities. 
  
  
A Screening/Eligibility Checklist will be used to ensure only the intended populations are enrolled.  
 Other ‐ Describe tool or method to assure that participants meet inclusion/exclusion criteria  
   
 
Statistical Data Analysis:  
 
Sample size calculation:  
Assuming an allocation of 1:1 that will result in equal sample sizes and a mean difference of hemoglobin 
A1c of 1.0 between the two groups and SD of 1.5 for both groups, the sample size was calculated at 36 
per arm or a total of 72 with 80% power at a p<0.05 significance. Adding 20% for attrition, the final 
sample size was calculated at 86 patients. We considered a hemoglobin A1c difference of 1% as being 
clinically significant in long term reduction of stroke, myocardial infarction and microvascular 
complications. (2)  
 
Data analysis plan: 
Continuous variables will be reported as means or medians with standard deviation or range, based on 
the normality of the sample distribution. Categorical variables will be reported as percentages. 
Parametric or non‐parametric statistics will be used for inferential statistics. A p‐value of <0.05 is 
considered statistical significant. 
 
Data from the pharmacy visits will be qualitatively and quantitatively analysed by the Beaumont 
biostatistician with the help from the OU biostatistician for the qualitative part.  
 
Research Participant Enrollment and Participation 
  
Duration of participation for individual participant is 12 months.     
Target participant enrollment:   100 
Expected number of participants to be screened to meet enrollment goal: 1000   
 
Participant population by age and gender:  
Gender:  Male and  Female  
Age range: 18‐75  
   
Screening for potential study participants will include the use of medical records, computer databases 
and recruitment letters. 
Participants/specimens/charts will be recruited or identified via:   
• 
Direct person to person solicitation  
• 
Medical record / One Chart Review / Computer databases  
• 
Advertisement/ Notice / Flyer   
• 
Recruitment letters  

   
A recruitment letter will be mailed to the patients. 
 
A brochure with information about the PHARMA MD study will be displayed in exam rooms, pharmacist 
offices where they meet with patients and waiting rooms of the Royal Oak Medical Office Building 
outpatient clinic for patients that might be interested in joining the study.   
 
Vulnerable Participant Populations: 
Children (< 18 years of age) are excluded from study   
Patients younger than 18 years of age are likely having diabetes mellitus type 1 and these patients are 
excluded from the study population. 
  
Pregnant Women, Fetuses & Neonates may be incidentally included   
 
Economically or Educationally Disadvantaged individuals may be incidentally included   
Any incentives offered for study participation will be within the guidelines set forth by the HIC.   
   
Students/Trainees/Staff may be incidentally included   
Students, trainees or staff will not be recruited or consented by a supervisor or individual who may have 
influence over their decision to participate.   
 
Cognitively Impaired or Mentally Disabled individuals may be incidentally included   
   
Risks of Research:  
The main risk of this research is breach of confidentiality  
In order to protect the rights and welfare of the research participants, data will be stored on a secure 
SharePointe site, or in a secured/locked department office.   
 
 
Data Collection & Storage, Research Records, Confidentiality and Privacy: 
  
Research participants/specimens/documents will be identified in research documents by:  
• 
Name  
• 
Medical record number  
• 
Unique code/study ID  
 
Direct participant identifiers will not be shared outside of Beaumont study key personnel, The 
Institutional Review Board, Food and Drug Administration (FDA), Office for Human Research Protections 
(OHRP), Office of Civil Rights (OCR) and/or the study sponsor has the authority to access study data.      
  
Electronic data will be stored to minimize risk, preserve confidentiality of the research information 
collected and protect the privacy of participants on Beaumont SharePointe sites. 
 
Hard copy data (i.e. source document, consent form, checklists, data collection forms) will be stored to 
minimize risk, preserve confidentiality of the research information collected and protect the privacy of 
participants locked in the research assistant office area.  
 
Research records, for approved human participants’ protocols, in accordance with all federal and 

institutional requirements, including but not limited to the HIPPA Privacy Rule, the Food and Drug Act 
and Medicare policy will be stored in a secure, protected manner in an off‐site storage facility as 
designated by Beaumont Health System for a minimum of 11 years per HIPAA regulations  
  
Funding: 
Funding was received from the Herb and Betty Fisher Seed Grant 
 
Participant Reimbursement/compensation: 
Research participants will receive patient stipends of 
‐ 
$15 per visit X 9 visits for 43 patients in the intervention arm 
‐ 
$5,805; $15 per visit X 3 visits for 43 patients in the control arm 
Total dispersed: 
‐ 
$1,935. The patient stipends were calculated based on the sample size and 20% possible attrition.  
 
An individual  participant may receive up to $135 in stipends.  
The compensation will be dispensed after each visit that is designated to receive a stipend.  
 
Research Waiver of Authorization:  
This study meets the HIPAA Requirements to Review Patient Data without Patient Consent      
‐ 
The identifiers will be protected from improper use and disclosure via storage in a secured/locked 
department office  and electronic data on a secure SharePointe site.  
‐ 
Only study key personnel on the study roster will have access to patient identifiers 
‐ 
Identifiers will be destroyed at the earliest opportunity, by shredding of paper documents and  
deletion of electronic data  
‐ 
The list of identifiers will be destroyed  
o  Upon manuscript acceptance   
o When deemed ineligible   
o  Upon declining participation  
  
 
 

Appendix:  
1. Patient Recruitment Brochure 
2. Patient reminder letter 
3. Control participant refrigerator reminder sheet 
4. Intervention participant refrigerator reminder sheet 
5. Intervention participant refrigerator sheet pharm 1 visit 
6. Intervention participant refrigerator sheet pharm 2‐6 visits 
7. Baseline Characteristics data collection tool 
8. Outcomes data collection tool 
9. Diabetes 39 QOL data collection tool 
10. WHO BREF QOL questionnaire 

 
 
 
 
 
 
 
IRB NUMBER: 2017-494 
 
 
 
 
 
 
 
IRB APPROVAL DATE: 01/23/2019 
 
 
 
 
Dear _____________________________ 
 
 
Thank you for your participation in the Beaumont study entitled: Pharm-MD; an Open-Label 
Randomized Controlled Phase II Study to Evaluate the Efficacy of a Pharmacist Managed 
Diabetes Clinic in High-Risk Diabetes Patients. 
 
As part of the study you enrolled in, there was a follow-up survey to be completed at your 6-
month Primary Care Physician appointment. If you could please take the time to fill out the 
enclosed survey and return it in the prepaid envelope it would be greatly appreciated. 
 
As a reminder the surveys are voluntary and if you feel uncomfortable answering any questions 
you may skip it and go on to the next question. We hope you will complete all the questions in 
the survey and return it to us as it will give us important information for the study. 
 
Thank you for your participation in this study. If you have any questions, please do not hesitate 
to call Kathleen Bradley, CRA II at (248) 964-8529. 
 
 
Thank you, 
 
Alexandra Halalau, M.D., F.A.C.P. 
Principle Investigator 
Beaumont Hospital 
3601 West 13 Mile Road 
Royal Oak, MI 48073 
IRB NUMBER: 2017-494
IRB APPROVAL DATE: 02/21/2019

beaumont.org
P19334d1_20867_021119
PHARMACIST 
MANAGED 
DIABETES TRIAL
Beaumont Hospital, Royal Oak 
Medical Office Building  
3535 West 13 Mile Road  
Royal Oak, MI 48073
IRB NUMBER: 2017-494
IRB APPROVAL DATE: 02/21/2019

ABOUT THE STUDY 
• The purpose is to investigate the impact  
of a pharmacist managed diabetes clinic  
in helping to control your diabetes and 
improve your quality of life. 
• You will be assigned to one of two groups 
and appointments will be scheduled with 
your primary care resident and/or the 
pharmacy clinic. 
• Group 1 will be scheduled with a primary  
care resident at three months and six months.
• Group 2 will be scheduled with a primary 
care resident at three months and six months 
plus an additional six visits with the pharmacy 
clinic over the six month period.
• You will be compensated for your time  
and travel.
• This study will be conducted in the outpatient 
clinic at Beaumont Hospital, Royal Oak.
• The study will last approximately six months. 
YOU MAY BE ELIGIBLE TO 
PARTICIPATE IN THIS STUDY IF:
• you are between the ages of 18 and 75
• you have a diagnosis of Type 2 diabetes 
mellitus with a hemoglobin A1c equal  
to or greater than 9 percent
• are an established patient with a primary  
care resident at Beaumont, Royal Oak
TYPE 2 DIABETES MELLITUS
Millions of Americans are currently living with 
diabetes. Approximately 1.5 million cases are 
being diagnosed each year, causing diabetes  
to be the seventh leading cause of death in  
the United States. 
People with diabetes are twice as likely  
to have heart disease or stroke compared  
to those without diabetes. Diabetes is also  
the leading cause of kidney failure and  
can lead to permanent visual impairment. 
IF YOU’RE INTERESTED IN PARTICIPATING  
IN THIS STUDY, CONTACT KATHLEEN BRADLEY  
AT 248-964-8529.
IRB NUMBER: 2017-494
IRB APPROVAL DATE: 02/21/2019

IRB NUMBER: 2017-494
IRB APPROVAL DATE: 03/01/2018
Version 1   1/29/18
PHARM-MD; an Open-Label, Randomized Controlled Phase II Study to Evaluate the Efficacy of 
a Pharmacist Managed Diabetes Clinic in High-Risk Diabetes Patients
Principal Investigator: Dr. Alexandra Halalau
STANDARD OF CARE (SOC) Schedule
 PARTICIPANT ID NUMBER ___________
PHYSICIAN VISIT 2        DATE: ____________ TIME: ____________ 
PHYSICIAN VISIT 3        DATE: ___________      TIME: ____________ 
If you are unable to make your appointment, please call 248-551-3000 so we can 
reschedule as soon as possible. Being part of a study is very important. The data we collect 
from you will help us learn how to better care for our diabetic patients. 
THANK YOU FOR PARTICIPATING 
PHARM-MD; an Open-Label, Randomized Controlled Phase II Study to Evaluate the Efficacy of 
a Pharmacist Managed Diabetes Clinic in High-Risk Diabetes Patients
Principal Investigator: Dr. Alexandra Halalau
STANDARD OF CARE (SOC) Schedule
 PARTICIPANT ID NUMBER ___________
PHYSICIAN VISIT 2        DATE: ____________ TIME: ____________ 
PHYSICIAN VISIT 3        DATE: ___________      TIME: ____________ 
If you are unable to make your appointment, please call 248-551-3000 so we can 
reschedule as soon as possible. Being part of a study is very important. The data we collect 
from you will help us learn how to better care for our diabetic patients. 
THANK YOU FOR PARTICIPATING 

IRB NUMBER: 2017-494
IRB APPROVAL DATE: 03/01/2018
PHARM-MD; an Open-Label, Randomized Controlled Phase II Study to Evaluate the Efficacy of 
a Pharmacist Managed Diabetes Clinic in High-Risk Diabetes Patients
Principal Investigator: Dr. Alexandra Halalau
STANDARD OF CARE (SOC) Schedule
                          PARTICIPANT ID NUMBER ___________
PHARMACY VISIT 2   DATE: ____________________        TIME: ____________
PHARMACY VISIT 3   DATE: ____________________        TIME: ____________
PHARMACY VISIT 4   DATE: ___________________          TIME: ____________
PHARMACY VISIT 5   DATE: ____________________        TIME: ____________
PHARMACY VISIT 6   DATE: ____________________        TIME: ____________
If you are unable to make your appointment, please call 248-551-3000 so we can 
reschedule as soon as possible. Being part of a study is very important. The data we collect 
from you will help us learn how to better care for our diabetic patients. 
THANK YOU FOR PARTICIPATING 
PHARM-MD; an Open-Label, Randomized Controlled Phase II Study to Evaluate the Efficacy of 
a Pharmacist Managed Diabetes Clinic in High-Risk Diabetes Patients
Principal Investigator: Dr. Alexandra Halalau
STANDARD OF CARE (SOC) Schedule
                          PARTICIPANT ID NUMBER ___________
PHARMACY VISIT 2   DATE: ____________________        TIME: ____________
PHARMACY VISIT 3   DATE: ____________________        TIME: ____________
PHARMACY VISIT 4   DATE: ___________________          TIME: ____________
PHARMACY VISIT 5   DATE: ____________________        TIME: ____________
PHARMACY VISIT 6   DATE: ____________________        TIME: ____________
If you are unable to make your appointment, please call 248-551-3000 so we can 
reschedule as soon as possible. Being part of a study is very important. The data we collect 
from you will help us learn how to better care for our diabetic patients. 

IRB NUMBER: 2017-494
IRB APPROVAL DATE: 03/01/2018
IRB NUMBER: 2017-494
IRB APPROVAL DATE: 03/01/2018
PHARM-MD; an Open-Label, Randomized Controlled Phase II Study to Evaluate the Efficacy of 
a Pharmacist Managed Diabetes Clinic in High-Risk Diabetes Patients
Principal Investigator: Dr. Alexandra Halalau
STANDARD OF CARE PLUS PHARMACY MANAGED DIABETES CLINIC (SOC+PMDC) Schedule
                          PARTICIPANT ID NUMBER ___________
PHARMACY VISIT 1             DATE: __________________   TIME: ____________
3 Month PHYSICIAN VISIT   DATE: __________________   TIME: _____________
6 Month PHYSICIAN VISIT   DATE: __________________   TIME: ______________
If you are unable to make your appointment, please call 248-551-3000 so we can 
reschedule as soon as possible. Being part of a study is very important. The data we collect 
from you will help us learn how to better care for our diabetic patients. 
THANK YOU FOR PARTICIPATING 
PHARM-MD; an Open-Label, Randomized Controlled Phase II Study to Evaluate the Efficacy of 
a Pharmacist Managed Diabetes Clinic in High-Risk Diabetes Patients
Principal Investigator: Dr. Alexandra Halalau
STANDARD OF CARE PLUS PHARMACY MANAGED DIABETES CLINIC (SOC+PMDC) Schedule
                          PARTICIPANT ID NUMBER ___________
PHARMACY VISIT 1             DATE: __________________   TIME: ____________
3 Month PHYSICIAN VISIT   DATE: __________________   TIME: _____________
6 Month PHYSICIAN VISIT   DATE: __________________   TIME: ______________
If you are unable to make your appointment, please call 248-551-3000 so we can 
reschedule as soon as possible. Being part of a study is very important. The data we collect 
from you will help us learn how to better care for our diabetic patients. 
THANK YOU FOR PARTICIPATING 

IRB NUMBER: 2017-494
IRB APPROVAL DATE: 03/01/2018
PHARM-MD; an Open-Label, Randomized Controlled Phase II Study to Evaluate the Efficacy of 
a Pharmacist Managed Diabetes Clinic in High-Risk Diabetes Patients
Principal Investigator: Dr. Alexandra Halalau
STANDARD OF CARE PLUS PHARMACY MANAGED DIABETES CLINIC (SOC+PMDC) Schedule
                          PARTICIPANT ID NUMBER ___________
PHARMACY VISIT 2   DATE: ____________________        TIME: ____________
PHARMACY VISIT 3   DATE: ____________________        TIME: ____________
PHARMACY VISIT 4   DATE: ___________________          TIME: ____________
PHARMACY VISIT 5   DATE: ____________________        TIME: ____________
PHARMACY VISIT 6   DATE: ____________________        TIME: ____________
If you are unable to make your appointment, please call 248-551-3000 so we can 
reschedule as soon as possible. Being part of a study is very important. The data we collect 
from you will help us learn how to better care for our diabetic patients. 
THANK YOU FOR PARTICIPATING 
 

Patient Baseline Characteristics Data Collection Tool 
 
Patient name 
 
MRN 
 
Group allocation (0 or 1) 
 
HgA1c 
 
Age 
 
Gender 
 
Race 
 
BMI 
 
SBP 
 
DBP 
 
Creatinine 
 
eGFR 
 
Microalbumin 
 
Total cholesterol 
 
LDL 
 
HDL 
 
Triglicerides 
 
Tobacco (current, former never) 
 
Neuropathy 
 
Retinopathy 
 
Nephropathy 
 
Macrovascular complications (MI, stroke)  
Oral agents only 
 
Insulin combination 
 
 

Patient Outcomes Data Collection Tool 
 
Patient name 
 
MRN
 
Group allocation
 
Baseline HgA1c
 
HgA1c 6 months 
 
HgA1c 12 months
 
HgA1c<8
 
Lipid panel
 
SBP at 6 mos
 
DBP at 6 mos
 
SBP at 12 mos
 
DBP at 12 mos
 
Retinopathy screening
 
Nephropathy screening
 
Neuropathy screening
 
Influenza
 
Pneumonia
 
Quality of life baseline
 
Quality of life at 6 - 9 months
 
Number EC visits for hyper and 
hypoglycemia 
 
Number of inpatient visits
 
Number of outpatient visits
 
Number of no-show visits
 
 

IRB NUMBER: 2017-494
IRB APPROVAL DATE: 03/01/2018
Subject ID:______________
Date: __________________
Version Date 2/7/2018
Diabetes-39
Quality of Life Questionnaire – Baseline   /   6 Months
IRB# 2017-494 - Study Name________________
A person’s quality of life is affected by many things.  These things might include health, the opportunity 
for recreation and holidays, friends and family, work and the hassles and inconveniences of diabetes.  
This questionnaire is designed to help us learn more about what affects the quality of life of people with 
diabetes.  
How to complete the questionnaire.

For each of the following questions we want to know how much your quality of life has been 
affected. Please circle a number which you think best describes how your quality of life has been 
affected in the past month.

If you have any questions about how to complete the questionnaire, please ask the research 
coordinator 
During the past month how much was the quality of your life affected by:
1. Your daily medication for your diabetes
Not affected 
          Extremely
       At all                        1                2              3               4                5              6                 7                    Affected
 
2. Worries about money matters
 
Not affected 
          Extremely
       At all                          1               2               3               4               5               6               7                    Affected
3. Limited energy levels
Not affected 
          Extremely
       At all                          1               2               3               4               5               6               7                     Affected
4. Following your doctor’s prescribed treatment plan for diabetes
Not affected 
          Extremely
       At all                          1               2               3               4               5               6               7                     Affected
5. Food restrictions to control your diabetes
Not affected 
          Extremely
       At all                          1               2               3               4               5               6               7                     Affected

IRB NUMBER: 2017-494
IRB APPROVAL DATE: 03/01/2018
Subject ID:______________
Date: __________________
Version Date 2/7/2018
6. Concerns about your future
Not affected 
          Extremely
       At all                          1               2               3               4               5               6               7                     Affected
7. Other health problems besides diabetes
Not affected 
          Extremely
       At all                          1               2               3               4               5               6               7                     Affected
8. Stress or pressure in your life
Not affected 
          Extremely
       At all                          1               2               3               4               5               6               7                     Affected
During the past month how much was the quality of your life affected by:
9. Feelings of weakness
Not affected 
          Extremely
       At all                          1               2               3               4               5               6               7                     Affected
10. Restrictions on how far you can walk
Not affected 
          Extremely
       At all                          1               2               3               4               5               6               7                     Affected
11. Any daily exercises for your diabetes
Not affected 
          Extremely
       At all                          1               2               3               4               5               6               7                     Affected
12. Loss or blurring of vision
Not affected 
          Extremely
       At all                          1               2               3               4               5               6               7                     Affected
13. Not being able to do what you want to do
Not affected 
          Extremely
       At all                          1               2               3               4               5               6               7                     Affected

IRB NUMBER: 2017-494
IRB APPROVAL DATE: 03/01/2018
Subject ID:______________
Date: __________________
Version Date 2/7/2018
14. Having diabetes 
Not affected 
          Extremely
       At all                          1               2               3               4               5               6               7                     Affected
15. Losing control of your blood sugar levels
Not affected 
          Extremely
       At all                          1               2               3               4               5               6               7                     Affected
16. Other illnesses besides diabetes
Not affected 
          Extremely
       At all                          1               2               3               4               5               6               7                     Affected
During the past month how much was the quality of your life affected by:
17. Testing your blood sugar levels
Not affected 
          Extremely
       At all                          1               2               3               4               5               6               7                     Affected
18. The time required to control your diabetes
Not affected 
          Extremely
       At all                          1               2               3               4               5               6               7                     Affected
19. The restrictions your diabetes places on your family and friends
Not affected 
          Extremely
       At all                          1               2               3               4               5               6               7                     Affected
20. Being embarrassed because you have diabetes
Not affected 
          Extremely
       At all                          1               2               3               4               5               6               7                     Affected
21. Diabetes interfering with your sex life
Not affected 
          Extremely
       At all                          1               2               3               4               5               6               7                     Affected

IRB NUMBER: 2017-494
IRB APPROVAL DATE: 03/01/2018
Subject ID:______________
Date: __________________
Version Date 2/7/2018
22. Feeling depressed or low
Not affected 
          Extremely
       At all                          1               2               3               4               5               6               7                     Affected
23. Problems with sexual functioning 
Not affected 
          Extremely
       At all                          1               2               3               4               5               6               7                     Affected
24. Getting your diabetes well controlled
Not affected 
          Extremely
       At all                          1               2               3               4               5               6               7                     Affected
During the past month how much was the quality of your life affected by:
25. Complications from your diabetes 
Not affected 
          Extremely
       At all                          1               2               3               4               5               6               7                     Affected
26. Doing things that your family and friends don’t do 
Not affected 
          Extremely
       At all                          1               2               3               4               5               6               7                     Affected
27. Keeping a record of your blood sugar levels 
Not affected 
          Extremely
       At all                          1               2               3               4               5               6               7                     Affected
28. The need to eat at regular intervals
Not affected 
          Extremely
       At all                          1               2               3               4               5               6               7                     Affected
29. Not being able to do housework or other jobs around the house
Not affected 
          Extremely
       At all                          1               2               3               4               5               6               7                     Affected

IRB NUMBER: 2017-494
IRB APPROVAL DATE: 03/01/2018
Subject ID:______________
Date: __________________
Version Date 2/7/2018
30. A decreased interest in sex
Not affected 
          Extremely
       At all                          1               2               3               4               5               6               7                     Affected
31. Having to organize your daily life around diabetes
Not affected 
          Extremely
       At all                          1               2               3               4               5               6               7                     Affected
32. Needing to rest often
Not affected 
          Extremely
       At all                          1               2               3               4               5               6               7                     Affected
During the past month how much was the quality of your life affected by:
33. Problems in climbing stairs or walking up steps
Not affected 
          Extremely
       At all                          1               2               3               4               5               6               7                     Affected
34. Having trouble caring for yourself (dressing, bathing, or using the toilet)
Not affected 
          Extremely
       At all                          1               2               3               4               5               6               7                     Affected
35. Restless sleep
Not affected 
          Extremely
       At all                          1               2               3               4               5               6               7                     Affected
36. Walking more slowly than others
Not affected 
          Extremely
       At all                          1               2               3               4               5               6               7                     Affected
37. Being identified as a diabetic 
Not affected 
          Extremely
       At all                          1               2               3               4               5               6               7                     Affected

IRB NUMBER: 2017-494
IRB APPROVAL DATE: 03/01/2018
Subject ID:______________
Date: __________________
Version Date 2/7/2018
38. Having diabetes interfere with your family life
Not affected 
          Extremely
       At all                          1               2               3               4               5               6               7                     Affected
39. Diabetes in general 
Not affected 
          Extremely
       At all                          1               2               3               4               5               6               7                     Affected
OVERALL RATINGS
1. Please circle below to indicate your overall rating of quality of life
Not affected 
          Extremely
       At all                          1               2               3               4               5               6               7                     Affected
2. Please circle below to show how severe you think your diabetes is
Not affected 
          Extremely
       At all                          1               2               3               4               5               6               7                     Affected
Disclaimer:
Permission for use of this questionnaire was granted by Dr. Gregory Boyer, PhD
          
 
               

WHOQOL-BREF, Questionnaire, June 1997, Updated 1/10/2014 
2 
WHOQOL-BREF 
About You 
Before you begin we would like to ask you to answer a few general questions 
about yourself by circling the correct answer or by filling in the space 
provided. 
1. What is your gender 
Male 
Female 
 
2. What is your date of birth? 
 
 
/ 
 
/  
 
 
Day 
 
Month 
 
Year 
 
3. What is the highest education you 
received? 
None at all 
 
Elementary School 
 
High School 
 
College 
 
4. What is your marital status? 
Single 
Separated 
 
Married 
Divorced 
 
Living as Married 
Widowed 
 
5. Are you currently ill? 
Yes 
No 
6. If something is wrong with 
your health, what do you 
think it is? 
 
 
illness/problem 

WHOQOL-BREF, Questionnaire, June 1997, Updated 1/10/2014 
3 
Instructions 
This questionnaire asks how you feel about your quality of life, health, or other 
areas of your life. Please answer all the questions. If you are unsure about 
which response to give to a question, please choose the one that appears most 
appropriate. This can often be your first response. 
Please keep in mind your standards, hopes, pleasures and concerns. We ask 
that you think about your life in the last two weeks. For example, thinking 
about the last two weeks, a question might ask: 
 
 
(Please circle the number) 
For office 
use 
Not at all 
A little 
Moderately 
Mostly 
Completely 
 
Do you get the kind of 
support from others that 
you need? 
1 
2 
3 
4 
5 
You should circle the number that best fits how much support you got from 
others over the last two weeks. So you would circle the number 4 if you got a 
great deal of support from others.  ο 
 
(Please circle the number) 
For office 
use 
Not at all 
A little 
Moderately 
Mostly 
Completely 
 
Do you get the kind of 
support from others that 
you need? 
1 
2 
3 
4 
5 
You would circle number 1 if you did not get any of the support that you 
needed from others in the last two weeks.  ο 
 
(Please circle the number) 
For office 
use 
Not at all 
A little 
Moderately 
Mostly 
Completely 
 
Do you get the kind of 
support from others that 
you need? 
1 
2 
3 
4 
5 

WHOQOL-BREF, Questionnaire, June 1997, Updated 1/10/2014 
4 
Please read each question, assess your feelings, and circle the number on the 
scale that gives the best answer for you for each question. 
 
 
(Please circle the number) 
For office 
use 
Very poor 
Poor 
Neither poor 
nor good 
Good 
Very Good 
G1 / G1.1 1. 
How would you 
rate your quality of 
life? 
1 
2 
3 
4 
5 
 
 
 
(Please circle the number) 
For office 
use 
Very 
dissatisfied 
Dissatisfied 
Neither 
satisfied nor 
dissatisfied 
Satisfied 
Very satisfied 
G4 / G2.3 2. 
How satisfied are 
you with your 
health? 
1 
2 
3 
4 
5 
The following questions ask about how much you have experienced certain 
things in the last two weeks. 
 
 
(Please circle the number) 
For office 
use 
Not at  all 
A little 
A moderate 
amount 
Very much 
An extreme 
amount 
F1.4 / 
F1.2.5 3. 
To what extent do 
you feel that 
physical pain 
prevents you from 
doing what you 
need to do? 
1 
2 
3 
4 
5 
F11.3 / 
F13.1.4 4. 
How much do you 
need any medical 
treatment to 
function in your 
daily life? 
1 
2 
3 
4 
5 
F4.1 / 
F6.1.2 5. 
How much do you 
enjoy life? 
1 
2 
3 
4 
5 

WHOQOL-BREF, Questionnaire, June 1997, Updated 1/10/2014 
5 
 
 
(Please circle the number) 
For office 
use 
Not at  all 
A little 
A moderate 
amount 
Very much 
An extreme 
amount 
F24.2 / 
F29.1.3 6. 
To what extent do 
you feel your life to 
be meaningful? 
1 
2 
3 
4 
5 
 
 
 
(Please circle the number) 
For office 
use 
 
Not at all 
Slightly 
A Moderate 
amount 
Very much 
Extremely 
F5.2 / 
F7.1.6 7. 
How well are you 
able to 
concentrate? 
1 
2 
3 
4 
5 
F16.1 / 
F20.1.2 8. 
How safe do you 
feel in your daily 
life? 
1 
2 
3 
4 
5 
F22.1 / 
F27.1.2 9. 
How healthy is 
your physical 
environment? 
1 
2 
3 
4 
5 
The following questions ask about how completely you experience or were 
able to do certain things in the last two weeks. 
 
 
(Please circle the number) 
For office 
use 
Not at all 
A little 
Moderately 
Mostly 
Completely 
F2.1 / 
F2.1.1 10. Do you have 
enough energy for 
everyday life? 
1 
2 
3 
4 
5 
F7.1 / 
F9.1.2 11. Are you able to 
accept your bodily 
appearance? 
1 
2 
3 
4 
5 
F18.1 / 
F23.1.1 12. Have you enough 
money to meet 
your needs? 
1 
2 
3 
4 
5 

WHOQOL-BREF, Questionnaire, June 1997, Updated 1/10/2014 
6 
 
 
(Please circle the number) 
For office 
use 
Not at all 
A little 
Moderately 
Mostly 
Completely 
F20.1 / 
F25.1.1 13. How available to 
you is the 
information that 
you need in your 
day-to-day life? 
1 
2 
3 
4 
5 
F21.1 / 
F26.1.2 14. To what extent do 
you have the 
opportunity for 
leisure activities? 
1 
2 
3 
4 
5 
 
 
 
(Please circle the number) 
For office 
use 
Very poor 
Poor 
Neither poor 
nor well 
Well 
Very well 
F9.1 / 
F11.1.1 15. How well are you 
able to get around? 
1 
2 
3 
4 
5 
The following questions ask you to say how good or satisfied you have felt 
about various aspects of your life over the last two weeks. 
 
 
(Please circle the number) 
For office 
use 
Very 
dissatisfied 
Dissatisfied 
Neither 
satisfied nor 
dissatisfied 
Satisfied 
Very 
satisfied 
F3.3 / 
F4.2.2 16. How satisfied are 
you with your 
sleep? 
1 
2 
3 
4 
5 
F10.3 / 
F12.2.3 17. How satisfied are 
you with your 
ability to perform 
your daily living 
activities? 
1 
2 
3 
4 
5 
F12.4 / 
F16.2.1 18. How satisfied are 
you with your 
capacity for work? 
1 
2 
3 
4 
5 

WHOQOL-BREF, Questionnaire, June 1997, Updated 1/10/2014 
7 
 
 
(Please circle the number) 
For office 
use 
Very 
dissatisfied 
Dissatisfied 
Neither 
satisfied nor 
dissatisfied 
Satisfied 
Very 
satisfied 
F6.4 / 
F8.2.2 19. How satisfied are 
you with yourself? 
1 
2 
3 
4 
5 
F13.3 / 
F17.2.3 20. How satisfied are 
you with your 
personal 
relationships? 
1 
2 
3 
4 
5 
F15.3 / 
F3.2.1 21. How satisfied are 
you with your sex 
life? 
1 
2 
3 
4 
5 
F14.4 / 
F18.2.5 22. How satisfied are 
you with the 
support you get 
from your friends? 
1 
2 
3 
4 
5 
F17.3 / 
F21.2.2 23. How satisfied are 
you with the 
conditions of your 
living place? 
1 
2 
3 
4 
5 
F19.3 / 
F24.2.1 24. How satisfied are 
you with your 
access to health 
services? 
1 
2 
3 
4 
5 
F.23.3 / 
F28.2.2 25. How satisfied are 
you with your 
mode of 
transportation? 
1 
2 
3 
4 
5 

WHOQOL-BREF, Questionnaire, June 1997, Updated 1/10/2014 
8 
The follow question refers to how often you have felt or experienced certain 
things in the last two weeks. 
 
 
(Please circle the number) 
For office 
use 
 
Never 
 
Seldom 
Quite 
often 
Very 
often 
 
Always 
F8.1 / 
F10.1.2 26. How often do you 
have negative 
feelings, such as 
blue mood, despair, 
anxiety, 
depression? 
1 
2 
3 
4 
5 
 
Did someone help you to fill out this 
form? (Please circle Yes or No) 
Yes 
No 
 
How long did it take to fill out this 
form? 
 
 
THANK YOU FOR YOUR HELP