A Pharmacist Intervention to Improve Mother and Child Health

Study Overview
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Brief Summary
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The goal of this clinical trial is to learn if a research pharmacist can improve the health of new mothers and their babies. The main questions it aims to answer are: 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? Will contact with the pharmacist improve the health of the mother and/or the child? Participants will: complete a baseline demographic survey, be given a blood pressure cuff and taught how to use it, be asked to text us their blood pressure values 2 times per day for 7 days after enrollment, complete a phone call with a pharmacist discussing their health and the health of their baby, text us their blood pressure 1 time per day for 3 days 1 month after enrollment, have a 1 month follow-up phone call with the research pharmacist, and complete an exit survey to provide feedback about the study.

Official Title
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A Pharmacist Intervention to Improve Mother and Child Health

Conditions
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Hypertension

Intervention / Treatment
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* Behavioral: Research Pharmacist


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: biological mother of a baby attending a 1-week to 4-month well-child visit, received prenatal care at University of Iowa Hospitals and Clinics, had at least 2 elevated blood pressures (>= 140 mmHg systolic or >= 90 mmHg diastolic) during pregnancy, owns a smartphone Exclusion Criteria: arm circumference > 17 inches, prisoner status unable to provide own written informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Research Pharmacist Monitoring<br>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. | Behavioral: Research Pharmacist<br>* The goal of this intervention is to determine if contact with the research pharmacist will improve the health of the mother and/or child.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Talk to Research Pharmacist | We will calculate the number of participants who talk to the research pharmacist during the course of the intervention. | Through study completion, an average of 30 days | 
| Number of Participants Who Return BP Measurements | We will calculate the number of participants who return blood pressure measurements via text message. | Through study completion, an average of 30 days | 
| Percentage of Well-Child Visits Attended | We will calculate the percentage of well-child visits that are attended by each family. | Through study completion, an average of 30 days | 
| Percentage of Vaccinations Received | We will calculate the percentage of vaccinations received by each child. | Through study completion, an average of 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of BP Measurements Submitted | We will calculate the number of blood pressure values that are submitted by each participant. | Through study completion, an average of 30 days | 
| Blood Pressure Control | We will determine how many participants' blood pressure is controlled after the intervention. | Through study completion, an average of 30 days | 
| Study Satisfaction | We will measure participant satisfaction with the study using an exit survey. | Through study completion, an average of 30 days |