A Pharmacist Intervention to Improve Mother and Child Health
Phase: NA
Conditions: Hypertension
Sponsor: University of Iowa

A Pharmacist Intervention to Improve Mother and 
Child Health 
 
Study Protocol 
 
 
Date: 7/15/2023 
Version: 1.0 
 
Principal Investigator: Hao Tran, MD 
 
Grant Number: UM1TR004403 
 
Project/Grant Period: 4/1/2023 – 3/31/2025 
 
Clinical Trials Number: NCT06073054 
 
 
 

Protocol Version and Amendment Tracking 
 
Study Title: A Pharmacist Intervention to Improve Mother and Child Health 
 
 
Version Number/Amendment 
 
 
Approval Date 
 
Original Protocol, Version 1.0 
 
 
07/15/2023 
 
 
 
 

Protocol Synopsis 
 
 
Protocol Title 
 
 
A Pharmacist Intervention to Improve Mother and Child 
Health 
 
 
Main Criteria for Inclusion 
 
 
Biological mother of a baby attending 1-week to 6-month 
well-child visit.  
 
 
Study Objective 
 
To learn if a research pharmacist can improve the health of 
new mothers and their babies.  
 
 
Research Questions 
 
1) Will postpartum women who had elevated blood 
pressure during pregnancy be willing to participate in 
the study, talk to the pharmacist about their health 
and the health of their child, and text us their blood 
pressure measurements?  
2) Will contact with the pharmacist improve the health of 
the mother and/or child?  
 
 
 
 

Table of Contents 
 
 
Protocol Version and Amendment Tracking ..................................................................... 2 
Protocol Synopsis............................................................................................................ 3 
Table of Contents ............................................................................................................ 4 
1. Introduction .............................................................................................................. 5 
1.1 Background ........................................................................................................ 5 
2. Objective and Aim .................................................................................................... 6 
2.1 Objective ............................................................................................................ 6 
2.2 Specific Aims ...................................................................................................... 6 
3. Subject Inclusion/Exclusion Criteria ......................................................................... 6 
3.1 Inclusion Criteria ................................................................................................ 6 
3.3 Exclusion Criteria ............................................................................................... 6 
4. Study Design ........................................................................................................... 7 
4.1 Overview ............................................................................................................ 7 
4.2 Recruitment/Screening Procedures ................................................................... 7 
4.3 Visit Procedures ................................................................................................. 7 
4.4 Statistical Analysis Plan ..................................................................................... 8 
 
 
 
 
 

1. Introduction 
1.1 Background 
 
After delivery, women are frequently lost to follow-up, and 48% do not transition to primary 
care.1 In contrast, women are more likely to attend well-child visits for their children. Accordingly, 
well-child visits are used to screen mothers for postpartum depression.2-4 Indeed, many 
pediatricians, in addition to caring for children, are ideally suited to assess the health and 
behavior of other family members as well.5 Members of our group have pioneered the use of 
remote pharmacy teams to improve hypertension treatment. First, in 32 primary care offices 
throughout the U.S. we tested whether an on-site pharmacist intervention for hypertension could 
be implemented.13,14 Following the success of this study, we performed two additional studies 
using centralized, off-site pharmacists: one was implemented in 12 small, rural clinics 
throughout Iowa,15 and another was implemented in 20 large, university-based clinics.16 In 
addition, we showed that our bi-directional texting approach is superior to asking subjects to use 
an electronic medical record (EMR) web portal17 and that it is more effective for collecting home 
BP measurements than usual care.18 Currently, we are combining our remote pharmacist 
intervention with bi-directional texting to improve BP control among rural populations.19 
 
1. Bennett WL, Chang HY, Levine DM, et al. Utilization of primary and obstetric care after 
medically complicated pregnancies: an analysis of medical claims data. Journal of general 
internal medicine. Apr 2014;29(4):636-45. doi:10.1007/s11606-013-2744-2  
2. Kallem S, Matone M, Boyd RC, Guevara JP. Mothers' Mental Health Care Use After 
Screening for Postpartum Depression at Well-Child Visits. Acad Pediatr. Aug 2019;19(6):652-
658. doi:10.1016/j.acap.2018.11.013  
3. Young CA, Burnett H, Ballinger A, et al. Embedded Maternal Mental Health Care in a 
Pediatric Primary Care Clinic: A Qualitative Exploration of Mothers' Experiences. Acad Pediatr. 
Nov-Dec 2019;19(8):934-941. doi:10.1016/j.acap.2019.08.004  
4. van der Zee-van den Berg AI, Boere-Boonekamp MM, Groothuis-Oudshoorn CGM, MJ IJ, 
Haasnoot-Smallegange RME, Reijneveld SA. Post-Up Study: Postpartum Depression 
Screening in Well-Child Care and Maternal Outcomes. Pediatrics. Oct 
2017;140(4)doi:10.1542/peds.2017-0110  
5. Schor EL. Family pediatrics: report of the Task Force on the Family. Pediatrics. 2003;111(6 Pt 
2):1541-1571.  
13. Polgreen LA, Han J, Carter BL, et al. Cost-Effectiveness of a Physician-Pharmacist 
Collaboration Intervention to Improve Blood Pressure Control. Hypertension. Dec 
2015;66(6):1145-51. doi:10.1161/hypertensionaha.115.06023  
14. Carter BL. Will Team-Based Care Really be Implemented? Journal of clinical hypertension 
(Greenwich, Conn). Sep 2015;17(9):692-3. doi:10.1111/jch.12578  
15. Carter BL, Levy B, Gryzlak B, et al. Cluster-Randomized Trial to Evaluate a Centralized 
Clinical Pharmacy Service in Private Family Medicine Offices. Circulation Cardiovascular quality 
and outcomes. Jun 2018;11(6):e004188. doi:10.1161/circoutcomes.117.004188  
16. Carter BL, Coffey CS, Chrischilles EA, et al. A Cluster-Randomized Trial of a Centralized 
Clinical Pharmacy Cardiovascular Risk Service to Improve Guideline Adherence. 
Pharmacotherapy. Jul 2015;35(7):653-62. doi:10.1002/phar.1603  
17. Anthony CA, Polgreen LA, Chounramany J, et al. Outpatient blood pressure monitoring 
using bi-directional text messaging. Journal of the American Society of Hypertension : JASH. 
May 2015;9(5):375-81. doi:10.1016/j.jash.2015.01.008  

18. Zahr RS, Anthony CA, Polgreen PM, et al. A texting-based blood pressure surveillance 
intervention. J Clin Hypertens (Greenwich). Oct 2019;21(10):1463-1470. doi:10.1111/jch.13674 
19. Polgreen LA, Carter BL, Polgreen PM, et al. A pharmacist intervention for monitoring and 
treating hypertension using bidirectional texting: PharmText BP. Contemp Clin Trials. Nov 
2020;98:106169. doi:10.1016/j.cct.2020.106169 
 
2. Objective and Aim  
2.1 Objective 
 
The goal of this clinical trial is to learn if a research pharmacist can improve the health of new 
mothers and their babies. 
  
 
2.2 Speciﬁc Aims 
 
1) Will postpartum women who had elevated blood pressure during pregnancy be willing to 
participate in the study, talk to a pharmacist about their health and the health of their child, and 
text us their blood pressure measurements? 
 
2) Will contact with the pharmacist improve the health of the mother and/or the child? 
 
3. Subject Inclusion/Exclusion Criteria 
3.1 Inclusion Criteria  
 
• 
Age 18 – 55 years 
• 
biological mother of a baby attending a 1-week to 6-month well-child visit, 
• 
received prenatal care at University of Iowa Hospitals and Clinics, 
• 
had at least 2 elevated blood pressures (>= 130 mmHg systolic or >= 80 mmHg 
diastolic) during pregnancy, 
• 
owns a smartphone 
 
3.3 Exclusion Criteria 
• 
arm circumference > 17 inches, 
• 
prisoner status 
• 
unable to provide own written informed consent 
 

4. Study Design 
4.1 Overview 
 
We propose an intervention in collaboration with a virtual pharmacist. Specifically, we will enroll 
new mothers in UIHC Pediatric Clinics who had two high blood pressure readings during 
pregnancy. We will give them a home blood pressure cuff and text them to send us their 
measurements for 7 days initially, and 3 days the following month. The pharmacist will 
determine if the mother has health insurance and a primary care provider for herself. If not, the 
pharmacist will work with the patient to establish care. The pharmacist will address the mother’s 
health concerns and monitor her blood pressure. The pharmacist will also answer questions 
about infant health and stress the importance of well child-visits, child immunizations, and 
breastfeeding. The pharmacist will work closely and collaboratively with the child’s pediatrician. 
 
4.2 Recruitment/Screening Procedures 
 
A member of the research team will screen the schedule of the participating clinic each day for 
infants attending their 1-2-week to 6-month well-child visits. Alternatively, clinic staff who are not 
on the research team, but are aware of the study may notify the research team of a potentially 
eligible family visiting the clinic. If an infant in the correct age range is identified by either 
method, the research team member will see if the infant's biological mother has an Epic medical 
record, received her prenatal care at UIHC, and had at least 2 elevated blood pressures (≥ 130 
mmHg systolic or ≥ 80 mmHg diastolic) during her pregnancy. If all of these are confirmed, the 
research team member will inform the medical team that the mother is eligible for the study and 
ask when the best time will be to approach the mother about the study. When the medical team 
approves, the research team member will approach the mother and ask if she has a 
smartphone. If she does, they will tell her about the study. If she is interested in participating, 
they will present her with the informed consent, answer any questions she may have, and get 
her written informed consent.  
If the mother is not interested in participating at that time and she is not attending the 6-month 
well-child visit, we will ask her if we can approach her again at a later date. If she answers "no", 
we will not approach her again. If she answers, "yes", we will attempt to approach her at the 
next well-child visit. 
 
4.3 Visit Procedures 
 
After consent, participants will complete a baseline demographic survey interview-style with the 
research team member. Then, they will be provided with a blood pressure cuff and taught how 

to use it. They will be scheduled in Boomerang (the research team's bi-directional text 
messaging system) to complete baseline blood pressure measurements 2 times per day for 7 
days and to return them to the research team via text message. This enrollment visit is expected 
to last 20-30 minutes. After this visit, the research team will collect the mother's co-morbidities 
from her medical record. 
 
After the 7 days of baseline blood pressure values have been obtained, the participants will be 
contacted by the research pharmacist. The pharmacist will help the mother find a primary care 
physician if she doesn't have one, obtain health insurance if she doesn't have any, and discuss 
any health-related information about herself or her child, as needed. These pharmacist 
interactions will occur 7 days after baseline and again 1 month later (the participant will be 
asked to measure and text their blood pressure again 1 time per day for 3 days during the 
follow-up month). If the participant's blood pressures become elevated, the pharmacist will 
provide behavioral and lifestyle interventions to attempt to lower the blood pressure. They may 
also recommend medications to the participant's physician. The pharmacist will have access to 
the participant's electronic medical record to obtain any blood pressure-related medications that 
the mother is prescribed as well as throughout the follow up to ensure any health-related 
conditions can be discussed, as necessary. Each monthly call is expected to last 5 to 20 
minutes. 
 
At the end of the study, we will send the participants a link to an exit survey where they can 
provide their feedback about the study. We expect this exit survey to take less than 10 minutes 
to complete. 
 
4.4 Statistical Analysis Plan 
 
We will compute descriptive statistics related to the number of eligible participants, the number 
of participants approached, the number of women who agree to participate, the number of 
participants who talk to the pharmacist, the number of participants who visit a primary care 
physician, the mother's BP, the number of well-child visits attended, and the number of 
vaccinations received by the child. 
 
We will stratify these outcomes by time of enrollment: before the 2-month well-child visit versus 
during the 2-month well-child visit or later. 
This is a pilot project, so no power analysis was performed. The results from this study will be 
used to inform future power analyses. We have chosen 25 participants as this is a reasonable 
number to enroll during the funding window and will provide enough data to inform future 
studies.