Remote Patient Monitoring - Telehealth for Management of Women With Postpartum Hypertension
Phase: NA
Conditions: Hypertension, Pregnancy-Induced
Sponsor: University of Wisconsin, Madison

Study #2017-003: Remote Patient Monitoring 
Version 1.16.October 11, 2019 
Page 1 of 21 
Remote Patient Monitoring: Telehealth for management of postpartum hypertension 
Principal Investigator: Kara K Hoppe 
University of Wisconsin-Madison 
Clinical Trial Protocol 
NCT03111095

Study #2017-003: Remote Patient Monitoring 
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Page 2 of 21 
Abstract 
 
Aim 1: Conduct an initial phase study for postpartum women at risk for severe hypertension to 
estimate the rates of willingness to participate in and utilize remote mobile health applications to 
monitor home blood pressures and weights, medication adherence after hospital discharge, to 
inform a trial to decrease postpartum maternal morbidity and readmission.  
Sub Aim 1: Conduct a survey regarding patient satisfaction using mobile health 
technology 
 Hypothesis: We hypothesize that the mobile health application will be implemented with strong 
fidelity, have positive patient acceptability, and demonstrate a meaningful reduction in home 
blood pressures and postpartum hospital readmission.  
  
Aim 2: Obtain prospective daily monitoring of blood pressures in the Peripartum period (initial 
hospital admission through 6 weeks postpartum) to understand natural history of development 
and resolution of postpartum hypertension using all patients utilizing the mobile health program 
over year 1. Specifically, this data will be used to estimate standard deviations of SBP and DBP 
in the intrapartum compared to 24-96 hours postpartum to inform a future trial regarding the 
threshold blood pressure to prevent development of severe hypertension or hospital 
readmission.   
Hypothesis: We hypothesize women with severe intrapartum hypertension will predict 
development of severe hypertension within 7 days of delivery more often than blood pressures 
obtained in the first 24-96 hours after delivery.  
 
Aim 3: Compare the maternal outcomes in the cohort utilizing remote patient monitoring to the 
cohort of patients with hypertension related disorders discharged with routine care. This would 
include all patients from Aim 1 as well as the remaining from the entire 1-year experimental 
period.  
 
Hypothesis: We hypothesize women utilizing the mobile health program will have less hospital 
readmission and a lower incidence of reported severe hypertension compared to the control 
group utilizing standard of care. 
 
Aim 4: Perform a cost effectiveness modeling will be performed to determine whether it is cost-
effective to use remote patient modeling for women with postpartum hypertension in comparison 
to standard outpatient care in women with hypertension-related disorders of pregnancy. 
 
Hypothesis: Patient care utilizing mobile health surveillance postpartum will demonstrate a 
significant cost savings compared to routine care in patients with postpartum hypertension. 
 
Aim 5: Compare the maternal outcomes in the cohort utilizing remote patient monitoring to the 
cohort of patients with hypertension related disorders discharged with routine care. This would 
include all patients from Aim 1 as well as the remaining from the entire 1-year experimental 
period.  
 
Hypothesis: We hypothesize that women utilizing the mobile health program will have less 
hospital readmission and a lower incidence of reported severe hypertension compared to the 
control group utilizing standard of care.  

Study #2017-003: Remote Patient Monitoring 
Version 1.16.October 11, 2019 
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Sub-Aim 5A: Graph the weight loss trajectory of the cohort utilizing remote patient 
monitoring with daily weights over 6 weeks.  
 
Hypothesis: This is a descriptive sub-aim. We hypothesize that the majority of fluid-
related weight loss will occur within the first week postpartum.  
 
Sub-Aim 5B: Compare the 6 week postpartum weight loss of the cohort utilizing remote 
patient monitoring with daily weights to the net 6 week postpartum weight loss of the 
cohort of patients with hypertension related disorders discharged with routine care who 
attended their 6 week postpartum visit.  
 
Hypothesis: We hypothesize that women utilizing remote patient monitoring with daily 
weights will lose more weight in the immediate 6 week postpartum period than women 
with hypertension related disorders discharged with routine care.  
 
Sub-Aim 5C: Compare the 6 week postpartum breastfeeding rates of the cohort utilizing 
remote patient monitoring to the cohort of patients with hypertension related disorders 
discharged with routine care.  
 
Hypothesis: We hypothesize that women utilizing remote patient monitoring will have 
higher rates of ongoing breastfeeding than women with hypertension related disorders 
discharged with routine care.  
 
Sub-Aim 5D: Compare the 6 week postpartum depression rates of the cohort utilizing 
remote patient monitoring to the cohort of patients with hypertension related disorders 
discharged with routine care.  
 
Hypothesis: We hypothesize that women utilizing remote patient monitoring will have 
lower rates of depression than women with hypertension related disorders discharged 
with routine care.  
 
Sub-Aim 5E: Correlate the results of the HoneyWell Biometrics Questionnaire question 
number 42 to the result of the Edinburgh Depression Scale recorded at the 6 week 
postpartum visit.  (Question number 42 is: Has your mood been more depressed this 
week compared to a normal week? (Rated from 1-7)) 
 
Hypothesis: We hypothesize that the HoneyWell Biometrics Questionnaire question 
number 42 will capture more postpartum depression than the 6 week Edinburgh 
Depression Scale, but that it will correlate well.  
 
Sub-Aim 5F: Graph the blood pressure trajectory of the cohort utilizing remote patient 
monitoring with daily weights over 6 weeks.  
 
Hypothesis: This is a descriptive sub-aim. We hypothesize that the postpartum blood 
pressure will peak at 5-7 days postpartum. 
 
Sub-Aim 5G: Compare the 6 week postpartum blood pressure of the cohort utilizing 
remote patient monitoring to the cohort of patients with hypertension related disorders 
discharged with routine care who attended their 6 week postpartum visit.  
 

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Hypothesis: We hypothesize that women utilizing remote patient monitoring will have 
lower blood pressures at their 6 week postpartum visit than women with hypertension 
related disorders discharged with routine care. 
 
Specific Aim 6: Conduct a follow-up satisfaction from a medical provider perspective in having 
their patients cared through this study, as well as the betterment of the telehealth monitoring 
system for future clinical use. This will be collected anonymously from providers. 
 
Hypothesis: We hypothesize that providers of patients enrolled in this study will have had a 
positive experience while caring for their subject. 
 
Specific Aim 7: Descriptive analysis of exactly what happens to women who end up with 
developing a hypertensive disorder in pregnancy and blood pressure trend from baseline 
pregnancy through 6 weeks postpartum. Baseline BP refers to the first blood pressure 
measurement during the subject’s pregnancy. 
 
Hypotheses: 
1) Baseline BP is lower than the 6 week postpartum after having a hypertension problem in 
pregnancy. 
2) Postpartum blood pressure is highest in labor and then normalizes through 3days postpartum 
with an abrupt increase 3-7days postpartum. 
3) Woman who normalize their blood pressure will do so by 14 days postpartum. 
 
Specific Aim 8:  Descriptive comparison of TeleHealth screening for depression, based on 
change of screening test from single question to Patient Health Questionnaire-9 (PHQ-9) in April 
2019. 
  
Hypothesis: We hypothesize that the change of screening test for depression from a single 
question to the PHQ-9 will be a more objective predictor of depression in TeleHealth patients. 
 
Aim 1: A total of 55 subjects will be enrolled.  
 
Aim 2-5: A maximum total of 440 patients will potentially be enrolled through the 1-year 
experimental period (220 experimental and 220 matched controls for chart review)  
 
Aim 7-8: The original study is closed to accrual, with a total of 214 subjects enrolled, along with 214 
matched controls. With the success of the study, UPH-Meriter decided to incorporate the home 
monitoring program into its standard clinical services as of January 1, 2019. Through UPH-Meriter, 
358 patients received services through this clinical program.  
 
We would like to retrospectively review the patient data in Peridata for these 358 patients. We will 
collect home vital sign data to assess blood pressure trends from early pregnancy through 
pregnancy and postpartum. This additional data would help to increase our sample size in this 
evaluation. The same data would be collected from the clinical patients.  
 
 
 
 

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Trial Schema 
Aim 1 
 
Aim2-5 
 
 

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Strategic plan 
Year 1 (2017) 
Jan Feb Mar 
April 
May June 
July Aug Sept Oct 
Nov 
Dec 
Submit IRB 
X 
X 
 
 
 
 
 
 
 
 
 
 
Meriter foundation grant 
funding cycle begins 
 
X 
 
 
 
 
 
 
 
 
 
 
Construction of 
Database 
 
X 
X 
 
 
 
 
 
 
 
 
 
Staff training 
 
X 
X 
 
 
 
 
 
 
 
 
 
Patient enrollment: Aim1 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Patient enrollment: Aim 2-5 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Patient satisfaction 
assessment survey 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
Data analysis: aim 1 
 
 
 
 
 
 
X 
X 
X 
X 
X 
X 
 
Year 2 (2018-2019) 
Jan 
Feb Mar April 
May June July 
Aug Sept Oct 
Nov 
Dec 
Patient enrollment Aim 
2-5 
X 
X 
 
 
 
 
 
 
 
 
 
 
Patient satisfaction 
assessment survey 
X 
X 
X 
X 
 
 
 
 
 
 
 
 
Data analysis : aim 2-8 
 
 
 
 
X 
X 
X 
X 
 
 
 
 
SMFM abstract 
submission 
 
 
 
 
 
 
 
 
 
 
 
X 
Manuscript development 
 
 
 
 
 
 
 
 
X 
X 
X 
X 
Submission of ICTR pilot 
grant 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 

Study #2017-003: Remote Patient Monitoring 
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1. Introduction 
1.1. Background 
1.2. Innovation 
1.3. Motivation for this study 
2. Objectives 
3. Sample size calculation 
4. Cost determination  
4.1. Personnel 
4.2. Materials and supplies 
4.3. Other 
4.4. Potential cost savings 
5. Selection criteria 
5.1. Treatment center inclusion 
5.2. Patient inclusion and exclusion 
5.3. Classification/diagnosis of hypertension related disorders in pregnancy 
5.4. Subgroups 
5.5. Outcome variables: see attached data dictionary 
6. Pre-enrollment evaluation 
7. Intervention and follow up 
8. Data Monitoring 
9. Non-compliance policies 
10. Statistical analysis 
11. Conclusion 
 
 

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1. Introduction  
1.1 Background 
 
Almost 10% of pregnancies are affected by hypertension related disorders.1 Hypertension in 
the postpartum period is one of the leading indications for hospital readmission.  Data from 
Wisconsin demonstrate hypertensive disorders affect approximately 22% of pregnancies.2 
Furthermore, hypertension is the most common cause for readmission within the University 
of Wisconsin-Madison/Unity Point-Meriter Obstetric unit.  There is no reliable data regarding 
prevention or treatment of postpartum hypertension.3  
 
There is limited data regarding the natural history of postpartum hypertension.  Many 
patients discharged from the hospital with mildly elevated blood pressures (SBP) of <150 or 
diastolic blood pressure (DBP) of <100 will not be seen by their obstetrical providers until 6 
weeks postpartum.  Furthermore, only those who develop symptoms of hypertension such 
as headache or blurred vision will be seen more urgently in an emergency or triage 
department rather than with routine outpatient care.  It is known in women with hypertension 
related disorders of pregnancy will have a decrease in their blood pressure in the first 48 
hours postpartum, however the blood pressure will then start increasing between days 3-6 
postpartum. 5 Podymow and August published on the postpartum course of gestational 
hypertension and preeclampsia and demonstrated the mean time for blood pressure 
normalization in the postpartum period for those who normalized was 5.4 + 3.7 weeks post-
delivery.6 An additional study, by Ferrazzani, demonstrated that the majority of patients with 
hypertension related disorders of pregnancy normalized by 6-16 days postpartum. 7   
 
The current ACOG guidelines recommend treating postpartum hypertension at a systolic 
blood pressure of >150 mmHg or diastolic blood pressure of >100 mmHg. 1 There have 
been three small trials that treated patients with mild to moderate hypertension.   Out of a 
total of 189 participants, they did not demonstrate any adverse events with treatment. 
However, other outcomes amongst the studies were not consistent.8,9,10,11 There is 
retrospective data demonstrating postpartum readmissions were less likely in those treated 
for mild hypertension upon discharge. 12 The significance of understanding the natural time 
course of development and resolution of pregnancy related hypertension and identifying the 
optimum blood pressure threshold for treating postpartum hypertension is important.  
Furthermore, identifying a low-cost and highly effective mechanism for tracking postpartum 
blood pressures outpatient during the period that a new mother is at high risk of not being 
able to comply with medical care or follow-up due to child care responsibilities, may support 
the development of new management strategies.   
 
Recent ACOG guidelines recommend blood pressure monitoring via routine follow-up office 
visits within 72 hours of discharge and again at seven to ten days after childbirth.1 However, 
non-compliance is high in the postpartum period, and many do not attend these first follow-
up appointments. Subsequently, the only other routine visit is 6 weeks postpartum.  Home 
blood pressure monitoring has been demonstrated to be useful in the long-term follow-up 
and treatment of hypertension in non-obstetrical populations.5 There is less experience 
regarding the optimal application for tracking home blood pressure monitoring and cost-
effectiveness of this intervention.5  There is limited experience with home blood pressure 
monitoring in pregnancy, in particular with postpartum patients.6,7,8   
 
In addition, postpartum weight loss is a significant challenge and impacts the well-being of 
the mother. There is limited and conflicting research the most effective strategy for weight 
loss in the general population. Some lower intensity interventions, such as daily self-

Study #2017-003: Remote Patient Monitoring 
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weighing, have been found to be an effective strategy for weight loss in the non-obstetric 
population using either regular or “smart” scales in the non-obstetric population.17-19 
However, such interventions have not yet been studied in the postpartum population. There 
has also been interest in using technology to promote postpartum weight loss which have 
demonstrated some success.20-22 Furthermore, several studies have demonstrated that 
breastfeeding is associated with lower postpartum weight retention in women.23-25 
Breastfeeding has also been associated with cardiovascular health benefits, but has not 
specifically been investigated in the immediate postpartum period.26 
 
The development of the maternal/infant bonding and breastfeeding is very important and 
likely one of the most important barriers for new mothers to seek care.  Furthermore, most 
women have access to a mobile device with capabilities allowing for direct communication 
with the medical community.  This proposed project would provide robust data to understand 
blood pressure values that best predict development of severe hypertension after discharge 
from the hospital, optimal outcomes to evaluate in future studies, and precise development 
of a mobile application that patient’s find user friendly and effective in managing their care.  
The ultimate goal is to improve patient compliance, surveillance, medication initiation or 
management while the patient remains outpatient to decrease severe maternal morbidity 
and avoids the need for a readmission that disrupts maternal/infant bonding. Our 
prospective feasibility will assess a novel approach to outpatient maternal postpartum 
hypertension surveillance and treatment in the first 6 weeks postpartum and support the 
development of a future study testing new strategies. 
 
1.2 Innovation 
Postpartum hypertension has been a recent area of interest and target for quality 
improvement projects nationwide.  Home blood pressure surveillance has been 
demonstrated as an effective strategy in hypertension management in non-obstetric 
patients.  Utilizing remote patient monitoring and the Honeywell mobile application device to 
assist with postpartum hypertension surveillance is a novel concept.  The ability to work with 
the UnityPoint Health- Meriter Foundation will support the development of the infrastructure 
needed for the use of this technology to enhance patient care and overall outcomes. 
 
A novel approach to treat postpartum hypertension first requires well-defined threshold 
values for blood pressure.  Tracking and recording daily blood pressures, weight 
measurements and medication use, at home after discharge serves multiple purposes. The 
prospectively collected data will also allow for further understanding of the natural time 
course of postpartum hypertension serving as preliminary data for future studies.  If this 
management strategy is found to be feasible and effective it will have large impacts on 
improving the quality of maternal care not only at our institution, but also on a national level.   
   
1.3 Motivation for this study 
Hospital readmission was more common in patients with mild hypertension prior to their 
primary delivery discharge.  In addition, Hirshberg, et al discovered postpartum patients 
were less likely to be readmitted due to hypertension related complications if they were 
discharged on antihypertensive medication therapy.  Treatment or surveillance strategies 
have been understudied for postpartum patients with hypertension.  Demonstration of a 
decrease in hospital readmission with a novel mobile application may provide an effective 
method of preventing severe maternal postpartum hypertension related hospital readmission 
and associated maternal morbidities.  
 
2. Objectives 

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Aim 1: Conduct an initial phase study for postpartum women at risk for severe hypertension to 
estimate the rates of willingness to participate in and utilize remote mobile health applications to 
monitor home blood pressures and weights, medication adherence after hospital discharge, to 
inform a trial to decrease postpartum maternal morbidity and readmission.  
Sub Aim 1: Conduct a survey regarding patient satisfaction using mobile health technology 
 
Hypothesis: We hypothesize that the mobile health application will be implemented with strong 
fidelity, have positive patient acceptability, and demonstrate a meaningful reduction in home 
blood pressures and postpartum hospital readmission.  
  
Aim 2: Obtain prospective daily monitoring of blood pressures in the Peripartum period (initial 
hospital admission through 6 weeks postpartum) to understand natural history of development 
and resolution of postpartum hypertension using all patients utilizing the mobile health program 
over year 1. Specifically, this data will be used to estimate standard deviations of SBP and DBP 
in the intrapartum compared to 24-96 hours postpartum to inform a future trial regarding the 
threshold blood pressure to prevent development of severe hypertension or hospital 
readmission.   
 
Hypothesis: We hypothesize women with severe intrapartum hypertension will predict 
development of severe hypertension within 7 days of delivery more often than blood pressures 
obtained in the first 24-96 hours after delivery.  
 
Aim 3: Compare the maternal outcomes in the cohort utilizing remote patient monitoring to the 
cohort of patients with hypertension related disorders discharged with routine care. This would 
include all patients from Aim 1 as well as the remaining from the entire 1-year experimental 
period. 
 
Hypothesis: We hypothesize women utilizing the mobile health program will have less hospital 
readmission and a lower incidence of reported severe hypertension compared to the control 
group utilizing standard of care. 
 
Aim 4: Perform a cost effectiveness modeling will be performed to determine whether it is cost-
effective to use remote patient modeling for women with postpartum hypertension in comparison 
to standard outpatient care in women with hypertension-related disorders of pregnancy. 
 
Hypothesis: Patient care utilizing mobile health surveillance postpartum will demonstrate a 
significant cost savings compared to routine care in patients with postpartum hypertension. 
 
Aim 5: Compare the maternal outcomes in the cohort utilizing remote patient monitoring to the 
cohort of patients with hypertension related disorders discharged with routine care. This would 
include all patients from Aim 1 as well as the remaining from the entire 1-year experimental 
period.  
 
Hypothesis: We hypothesize that women utilizing the mobile health program will have less 
hospital readmission and a lower incidence of reported severe hypertension compared to the 
control group utilizing standard of care.  
Sub-Aim 5A: Graph the weight loss trajectory of the cohort utilizing remote patient 
monitoring with daily weights over 6 weeks.  
 
Hypothesis: This is a descriptive sub-aim. We hypothesize that the majority of fluid-
related weight loss will occur within the first week postpartum.  

Study #2017-003: Remote Patient Monitoring 
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Sub-Aim 5B: Compare the 6 week postpartum weight loss of the cohort utilizing remote 
patient monitoring with daily weights to the net 6 week postpartum weight loss of the 
cohort of patients with hypertension related disorders discharged with routine care who 
attended their 6 week postpartum visit.  
 
Hypothesis: We hypothesize that women utilizing remote patient monitoring with daily 
weights will lose more weight in the immediate 6 week postpartum period than women 
with hypertension related disorders discharged with routine care.  
 
Sub-Aim 5C: Compare the 6 week postpartum breastfeeding rates of the cohort utilizing 
remote patient monitoring to the cohort of patients with hypertension related disorders 
discharged with routine care.  
 
Hypothesis: We hypothesize that women utilizing remote patient monitoring will have 
higher rates of ongoing breastfeeding than women with hypertension related disorders 
discharged with routine care.  
 
Sub-Aim 5D: Compare the 6 week postpartum depression rates of the cohort utilizing 
remote patient monitoring to the cohort of patients with hypertension related disorders 
discharged with routine care.  
 
Hypothesis: We hypothesize that women utilizing remote patient monitoring will have 
lower rates of depression than women with hypertension related disorders discharged 
with routine care.  
 
Sub-Aim 5E: Correlate the results of the HoneyWell Biometrics Questionnaire question 
number 42 to the result of the Edinburgh Depression Scale recorded at the 6 week 
postpartum visit.  (Question number 42 is: Has your mood been more depressed this 
week compared to a normal week? (Rated from 1-7)) 
 
Hypothesis: We hypothesize that the HoneyWell Biometrics Questionnaire question 
number 42 will capture more postpartum depression than the 6 week Edinburgh 
Depression Scale, but that it will correlate well.  
 
Sub-Aim 5F: Graph the blood pressure trajectory of the cohort utilizing remote patient 
monitoring with daily weights over 6 weeks.  
 
Hypothesis: This is a descriptive sub-aim. We hypothesize that the postpartum blood 
pressure will peak at 5-7 days postpartum. 
 
Sub-Aim 5G: Compare the 6 week postpartum blood pressure of the cohort utilizing 
remote patient monitoring to the cohort of patients with hypertension related disorders 
discharged with routine care who attended their 6 week postpartum visit.  
 
Hypothesis: We hypothesize that women utilizing remote patient monitoring will have 
lower blood pressures at their 6 week postpartum visit than women with hypertension 
related disorders discharged with routine care. 
 

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Specific Aim 6: Conduct a follow-up satisfaction from a medical provider perspective in having 
their patients cared through this study, as well as the betterment of the telehealth monitoring 
system for future clinical use. This will be collected anonymously from providers. 
 
Hypothesis: We hypothesize that providers of patients enrolled in this study will have had a 
positive experience while caring for their subject. 
 
Specific Aim 7: Descriptive analysis of exactly what happens to women who end up with 
developing a hypertensive disorder in pregnancy and blood pressure trend from baseline 
pregnancy through 6 weeks postpartum. 
 
The original study closed to accrual, with a total of 214 subjects enrolled, on June 11, 2018. With the 
success of the study, UPH-Meriter decided to incorporate the home monitoring program into its 
standard clinical services as of January 1, 2019. Through UPH-Meriter, 358 patients received 
services through this clinical program.  
 
We would like to retrospectively review the patient data in Peridata for these 358 patients. We will 
collect home vital sign data to assess blood pressure trends from early pregnancy through 
pregnancy and postpartum. This additional data would help to increase our sample size in this 
evaluation. The same data would be collected from the clinical patients.  
 
Hypotheses: 
1) Baseline BP is lower than the 6 week postpartum after having a hypertension problem in 
pregnancy. 
2) Postpartum blood pressure is highest in labor and then normalizes through 3 days 
postpartum with an abrupt increase 3-7 days postpartum. 
3) Woman who normalize their blood pressure will do so by 14 days postpartum. 
 
Specific Aim 8:  Descriptive comparison of TeleHealth screening for depression, based on 
change of screening test from single question to Patient Health Questionnaire-9 (PHQ-9) in April 
2019. 
 
Hypothesis: We hypothesize that the change of screening test for depression from a single 
question to the PHQ-9 will be a more objective predictor of depression in TeleHealth patients. 
 
 
ENDPOINTS: 
Aim 1 primary endpoint: The primary endpoint is enrollment of 55 patients using the mobile 
health program each for a total 42 days postpartum.   
 
Aim 2-5 primary endpoint: The primary endpoint is enrollment of up to 40 patients at all times 
(for a total of 42 days) over one year (220 experimental and 220 matched controls for chart 
review) of the funded period for this project utilizing the proposed mobile health program 
as an option for postpartum hypertension surveillance.  
 
3. Selection criteria 
3.1. Treatment Center Inclusion 
Subjects will be enrolled in from Unity Point Health-Meriter Hospital Labor & Delivery.  
Patients will be approached for recruitment in the postpartum period. 
 
3.2. Patient inclusion and exclusion  

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• 
Aim 1:  
3.2.1.1 Inclusion 
• 
Hypertensive disorders of pregnancy including gestational, chronic, or preeclampsia 
diagnosed in the antenatal (primary admission for delivery of the baby (planned or 
due to hypertension) or postpartum period as determined by SBP >140 or DBP >90 
on two occasions >4 hours apart.  (Refer to section 3.3 for diagnosis criteria). 
• 
Gestational age at time of delivery > 23 weeks gestation  
• 
Primary hospital admission for the delivery of the neonate(s). 
• 
Age >18 years. 
 
3.2.1.2 Exclusion 
• 
Inability to obtain informed consent 
 
• 
Aim2-5: 
3.2.1.3 Experimental  
3.2.1.3.1 Inclusion 
• 
Hypertensive disorders of pregnancy including gestational, chronic, or preeclampsia 
diagnosed in the antenatal (primary admission for delivery of the baby (planned or 
due to hypertension) or postpartum period as determined by SBP >140 or DBP >90 
on two occasions >4 hours apart.  (Refer to section 3.3 for diagnosis criteria). 
• 
Gestational age at time of delivery >23 weeks gestation  
• 
Primary hospital admission for the delivery of the neonate(s). 
• 
Age >18years. 
 
3.2.1.3.2 Exclusion 
• 
Inability to obtain informed consent 
 
3.2.1.4 Control group: 
3.2.1.4.1 Inclusion: we will have an opt out policy (see 4.4.1 below) to 
maximize all patients to be included to provide an adequate 
1:1 comparison control group (see form). 
 
3.2.1.4.2 The same inclusion criteria from 3.2.1.3 will be used to 
define the control group subjects included.  
• 
Hypertensive disorders of pregnancy including gestational, chronic, or preeclampsia 
diagnosed in the antenatal (primary admission for delivery of the baby (planned or 
due to hypertension) or postpartum period as determined by SBP >140 or DBP >90 
on two occasions >4 hours apart.  (Refer to section 3.3 for diagnosis criteria). 
• 
Gestational age at time of delivery >23 weeks gestation  
• 
Primary hospital admission for the delivery of the neonate(s). 
• 
Age >18years. 
 
3.2.1.5 Exclusion 
• 
Inability to obtain informed consent 
 
3.3. Classification/diagnosis of hypertension related disorders in pregnancy 
 
CHRONIC HYPERTENSION 
 
• 
SBP ≥140 mmHg or DBP ≥90 mm Hg 
• 
Pre-pregnancy or before 20 weeks  

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GESTATIONAL 
HYPERTENSION 
• 
SBP ≥140 mm Hg or DBP ≥90 mm Hg 
• 
Occurs after 20 weeks 
• 
Absence of proteinuria or systemic 
signs/symptoms consistent with preeclampsia 
PRE-ECLAMPSIA 
• 
New onset BP after 20 weeks 
• 
Two BPs SBP≥140 or DBP ≥90 on two 
occasions at least 4 hours apart 
• 
AND Proteinuria with or without 
signs/symptoms* 
• 
OR in the absence of proteinuria new onset of 
any systemic finding: 
-Thrombocytopenia (platelets <100,000K) 
-Renal insufficiency (serum creatinine >1.1 mg/dL) 
-Impaired liver function (↑LFT 2x normal) 
Eclampsia 
• 
New onset grand mal seizures in woman with 
preeclampsia 
• 
New onset seizures 48-72 hours postpartum 
Chronic Hypertension + 
SUPERIMPOSED 
PREECLAMPSIA 
• 
Chronic  hypertension in association with 
preeclampsia 
PREECLAMPSIA  WITH 
SEVERE FEATURES (one or 
more of the listed criteria)  
• 
SBP ≥160 mm Hg or ≥110 mm Hg on at least 2 
occasions at least 4 hours apart  
-Thrombocytopenia (platelets <100,000K) 
-Renal insufficiency (serum creatinine >1.1 mg/dL) 
-Impaired liver function (↑LFT 2x normal) 
                - Pulmonary edema  
                - New-onset cerebral or visual disturbances 
*Proteinuria >5g  is no longer considered for diagnosis nor is 
IUGR for ‘severe’  
 
3.4. Outcome variables: see attached data dictionary (Appendix I).  I will plan to work 
with my prior IRB application request (IRB number 2016-006) using Peridata and 
Meriter for variables and have a prospective report built to extract patient data 
from for patients enrolled in this study.   
 
 
4. Study procedures  
4.1. Training and certification of staff and centers 
Training of staff and pilot testing of procedures are crucial to standardized study 
procedures including BP measurement, quality control and data quality.  We will provide 
central training for study staff.  Additionally, any staff members consenting patients will 
undergo training specific to the current consenting procedures.  Refresher courses will be 
provided through webinar technology on a yearly basis or as needed. All training related 
to the study will be logged in the study’s regulatory binder. 
 
Clinical site initiation to enroll and randomize participants is dependent upon completion 
of preliminary tasks.  These tasks include completion of appropriate regulatory approvals 

Study #2017-003: Remote Patient Monitoring 
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(IRB) and letters of agreement.  Site training receipt of study equipment and development 
of a recruitment plan will be necessary. 
 
4.2. Screening for eligibility and consent 
For aims 1-5 
Inpatient 
 We will screen for subjects on a daily basis by reviewing the patients admitted to 
postpartum unit. Patients will be approached if the electronic medical record indicates a 
diagnosis of hypertension or the patient meets the blood pressure criteria for enrollment.  
This screening will be performed by the mobile health nurse providing support for this 
program or the research coordinator as needed. If a patient is identified, the patient’s 
nurse or care provider will be contacted to ask the patient if they are interested in 
learning more about the study.  
 
Outpatient 
I have also met with the providers providing obstetrical care to patients (midwives and 
physicians who practice at UW Health- 20 S Park, UW Health- Fitchburg. UW Health- 
West, UW Health- West Towne, UW Health- Union Corners, Associated Physicians) who 
express interest in providing this experimental clinical program for their patients.  
Providers may discuss this project with their patients who have hypertension affecting 
their pregnancy.  They will also have access to the patient brochure and can give this to 
the patients they believe meet criteria for the study.  If they identify a patient who is 
interested in participating they will directly contact a member of the research team to 
further discuss enrollment with the patient.  In addition, the floor nurses will know the 
inclusion criteria and may contact a member of the research team for recruitment, 
however this is not expected.   
 
Finally, a patient can inquire and express interest in participating the program and 
contact the research coordinator directly with the phone number contact provided in the 
study flier.  The patient inclusion and exclusion criteria will be verified as well as the 
participant’s interest in the study.  The informed consent process will be conducted by 
trained research staff and will include all aspects of the study and full disclosure of the 
risks, benefits, and alternatives.  The study consent and HIPPA authorization form (see 
appendix) will be signed after all questions have been discussed and answered.   
 
4.3. Data management:  
Data variables will be stored in REDCap.  REDCap (Research Electronic Data Capture) is a 
browser-based, metadata-driven software solution and workflow methodology for designing 
clinical and translational research databases.  It is a HIPAA compliant system exclusively 
used for investigator initiated studies and has wide use in the academic research 
community. You can learn more about REDCap at: 
https://en.wikipedia.org/wiki/Redcap_(Research_Electronic_Data_Capture) 
Study management will be maintained using Oncore. OnCore is a centralized clinical 
research management software program that allows researchers to use one program to 
manage all components of clinical research while maintaining consistency, data integrity and 
compliance across the institution. 
 
4.4. Recruitment and retention 
• 
Staff 

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4.4.1. Staff training and education prior to initiation of the trial for active members of 
the study team.   
4.4.2. General education regarding the trial to all staff providers (physicians, nurses, 
medical assistants to enhance support of the trial).  
4.4.3. Staff education on a 6-month schedule for new staff and further training as 
needed.   
4.4.4. Interval reports back to participating faculty/nurses to share stories of success 
or patient feedback to encourage continued participation. 
 
• 
Study subjects 
4.4.1. We will place a study information sheet titled “The UnityPoint Health-Meriter 
Hypertensive Study” in the patient enrollment paperwork for all patients 
admitted to Labor and Delivery.  This will sheet will allow research staff to 
collect data on all patients with respect to their hypertension diagnosis in the 
Peripartum period.  We will be using this data primarily for the control group 
for aims 2-3. 
4.4.2. Once a patient is identified and agrees to participate we will give them a 
separate patient brochure to further detail the study. This will be directly given 
to the patients by their nurse once admitted to the postpartum unit.  
4.4.3. A member of the research team trained in consenting procedures will then 
meet with the subject to review the informed consent document. After the 
researcher reviews the document, the subject will be allowed to ask questions 
and given sufficient time to contemplate participation. If the patient chooses to 
participate, they will sign the informed consent document.  
4.4.4. Incentives: Subjects will be given a pack of diapers at enrollments and a $15 
gift card at completion of the study (6 weeks PP visit) to encourage completion 
of the trial endpoint. 
4.4.5. Care reminders will be sent via the Honeywell Genesis Device by the 
UnityPoint at Home telehealth nurse. The purpose of this is to remind and 
encourage daily vital reporting. 
4.4.6. Patient surveys for understanding how to improve the system 
 
5. Pre-enrollment evaluation 
5.1.  Prior to enrollment, the mobile health nurse or research staff will confirm diagnoses 
utilizing the table above. 
5.2. If the subject agrees to participate, the research coordinator will obtain informed 
consent.   
5.3.  To review eligibility, the patient will have a general physical exam, review of their vital 
signs, and pertinent laboratory assessments (hematocrit, platelet count, creatinine, 
urine protein volume, liver function tests) performed as standard of care and will be 
reviewed in the electronic medical record. 
5.4.  This baseline information will be obtained and entered into the study database and if 
the subject meets inclusion criteria the subject will be considered on study.  
5.5. Enrollment is expected to occur over a 1-year time period. 
 
6. Intervention and Follow-up 
Patients will be identified for potential enrollment starting in the antepartum period (time of 
admission for delivery of baby) if they meet criteria for a hypertensive related disorder of 
pregnancy as deemed by the minimum criteria of SBP >140 or DBP >90 on two occasions 

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at least 4 hours apart. The planned consent can occur on admission prior to delivery or 
postpartum, however will not occur if the patient has any evidence of labor.  The preference 
will be consenting postpartum.  The exception may be for patients with known chronic 
hypertension or a diagnosis of preeclampsia and they are admitted with this diagnosis.  
Patients may be given the program brochure to read and would have adequate time to 
express interest or hear more about the project if they desire.  If the patients then meet 
criteria for treatment of hypertension postpartum as deemed by the threshold inclusion 
criteria for this study, SBP >140 or DBP >90 or standard of care (SBP >150 or DBP >100) 
on two occasions at least 4 hours apart then medication will be initiated prior to discharge 
from the hospital. 
Devices and instructions will be provided by UnityPoint at Home. They will be given 
instructions on proper techniques for blood pressure by the labor & delivery nurses, the 
mobile health nurse or research coordinator if needed.  It will be expected if the teaching 
cannot be performed by one of the nurses they will contact the research coordinator to 
provide this training. All individuals will have had training for proper blood pressure 
measurement technique prior to providing this training.  The patients will be required to take 
the blood pressures in a seated position with their arm at heart level. Three values should 
be obtained and an average of these values will be used in our assessment of daily blood 
pressure. The patient will also be given instructions on warning signs of preeclampsia or 
severe hypertension and blood pressure thresholds to call the mobile health nurse or their 
primary obstetric clinical provider or nurse.  
 
Once discharged from the hospital the patient will initiate their home blood pressure/weight 
measurements.  They will be asked to take a total of three blood pressures everyday 
(spread out no more than five minutes apart) to validate there are not erroneous values 
submitted.  The blood pressures and weight values will be submitted via the Honeywell 
device and these values will be delivered to the mobile health nurse platform.  These values 
will need to be manually uploaded into the study database program in REDCap.  The values 
and patient concerns will be reviewed daily by the mobile health nurse with a flowsheet 
algorithm that directs them when to continue with current care plan or the need to contact 
the physician for the patient.  The patient will be contacted by a mobile health nurse on days 
2 and 7 post discharge. Additionally the patient may be contacted by the mobile health 
nurse based on the flowsheet algorithms and patient concerns (if applicable).  A telehealth 
note will be put into EPIC when contact with the patient is had by phone or video 
teleconferencing.  This note will be cc’d to the primary provider for review. Daily vital signs 
will eventually be an automated process into EPIC, however until this is possible it will be a 
manual entry performed daily by the mobile nurse. 
 
Follow Up Procedures for Patients 
Patients will receive continued care surveillance whether they are on or off medication if 
their blood pressures remain (SBP <150 or DBP <100) and they are not having any 
concerning symptoms.  If they are on treatment with antihypertensive medication at 
discharge from the hospital the goal is for patients to remain with normal to mild range blood 
pressures and they will require the medication be titrated upwards to achieve adequate 
control (SBP <140 -150 or DBP < 90-100) as needed. If severe hypertension develops after 
discharge, and the blood pressures are SBP >150 or DBP >100 and the patient is not on 
medication we will recommend initiating medication as an outpatient. Alternatively, the 
medication may need to be titrated downward or discontinued if indicated due to the patient 
development of hypotension (SBP <90 or DBP < 60).   
The mobile health nurse will be reviewing the incoming blood pressures daily.  Options for 
the enrolled patients care management are to report the concerning vital signs to the 

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patients primary provider or the primary provider can agree to have the Perinatal Service 
providers manage the abnormal vital signs.  All providers for the enrolled patients are 
contacted and informed of enrollment and then typically they plan for the patients to be 
followed and managed with the mobile health team and any concerning vitals are addressed 
by the Perinatal Service and then communicated regarding any management decisions by 
EPIC-electronic medical charting. 
Concerning vital signs are SBP >150 or DBP >100 or SBP <90 or DBP < 60, which is the 
same as prior to discharge from the hospital.  After the program began using the above 
paragraph which outlines need for medication initiation or management – it was 
acknowledged patients were requiring the initiation and management of their vital signs or 
medications often, i.e. approximately 40-50% of the patients.  Therefore, the mobile health 
nurses needed a written document with the standard practice to determine the thresholds 
patients would need to initiate or titrate medications up or down.  Therefore we developed 
algorithms as proposed in this modification that would help manage this care.  In addition, 
as needed the patient will be instructed to call their provider as needed for any concerning 
vital signs or symptoms if the nurses are not available or as needed. If the patient does not 
have any concerning symptoms the abnormal vital signs will be discussed with the patient 
by the patient’s provider or the nurse.  If the patient is asymptomatic then there is the ability 
to refer to the management algorithm and then initiate medication or increase/decrease the 
dose of the medication per the algorithm.  The algorithm is based off the standard of care – 
it is just to ease the communication and care coordination of the patients.  The mobile health 
nurse will notify a doctor with initiation of medication.  
 
It is expected that the patients with gestational hypertension or preeclampsia diagnoses will 
be able to titrate off of the antihypertensive medication between 14 -42 days postpartum.  
The recommendation to discontinue the antihypertensive medication can be performed if the 
patient has (SBP <120 or DBP < 80) by the 14-day follow-up visit.  If they are unable to do 
so by the 42-day follow-up visit they will likely be diagnosed with chronic hypertension 
(persistent elevation of blood pressure SBP >140 or DBP >90 by 12 weeks postpartum. It is 
expected that patients with chronic hypertension may need to continue this therapy beyond 
the study endpoint of 42 days.    
 
Due to current ACOG recommendations, the patients will be recommended to remain in the 
hospital for 3 days postpartum when they have a diagnosis of hypertensive related disorders 
in pregnancy.  If the patient is discharged prior to 3 days they will have an outpatient office 
visit for a blood pressure evaluation at day 3.  If they are discharged on day 3 they will then 
have planned outpatient clinic blood pressure evaluations on days 5-7 and at 14 days 
postpartum.  As long as the patient is normotensive and clinically stable then the patient will 
have the last scheduled follow-up exam at approximately 6 weeks (42days) postpartum.   
 
A planned patient satisfaction survey will be administered at 6 weeks (42) post-discharge 
using email or in person at their clinic visit.  This may be sent electronically through the 
mobile app system if possible to allow for best patient access if they are following up at 
numerous different clinics, vs at the actual clinic visit. We will assure all participating clinics 
have the survey and a sealed box to protect the patient’s identity. 
 
The patients will be instructed to call their primary provider once discharged from the 
hospital if they do not achieve adequate continued blood pressure control after discharge or 
they have concerns of developing severe symptoms concerning for worsening disease- 
listed below-if not addressed through the surveillance as discussed above through the 
mobile health surveillance and management algorithm.  Hospital readmission will be 

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dependent on provider discretion, however indications would depend on evaluation of 
patients’ clinical symptoms of severe hypertension with SBP >160 or DBP >110, with the 
addition of end-organ effects (cerebral or vision disturbances, neurologic symptoms, 
pulmonary edema, or lab abnormalities as defined in table 4.3) that cannot be explained by 
medication non-compliance or inability to increase the dose of the medication to achieve 
adequate control. 
 
If the situation dictates another antihypertensive due to other medical comorbidities (such as 
asthma) then another antihypertensive medication can be considered.  Our recommendation 
would be to consider use of a calcium channel blocker (specifically Nifedipine).  
 
Provider Survey: 
The Office Supervisor for the Perinatal Administration at UPH - Meriter hospital will generate 
a list of providers with delivery privileges for the research team.  Each provider will be invited 
by email to complete the survey. We are requesting a Waiver of Consent and an Exemption 
from HIPAA as a completed survey implies consent, and there is no private health 
information involved in this part of the research. 
 
A Provider survey (uploaded in iRIS) will be linked within an email (script attached as 
separate study document). This email will be sent by UPH-Meriter staff, to their identified list 
of providers (those who have delivery privileges at UPH-Meriter). They will complete the 
survey in Qualtrics in which no identifying information will be collected. The email will be 
sent a total of 3 times. 
 
UPH-Meriter Telehealth Clinical Program: 
We will retrospectively review the patient data in Peridata for these 358 patients. We will 
collect home vital sign data to assess blood pressure trends from early pregnancy through 
pregnancy and postpartum. No new data fields will be added to the data collection. 
 
Subject withdrawal policy 
Withdrawals are considered subjects that have been enrolled but are deliberately omitted 
from the analysis. This study will be analyzed on the intention-to-treat principle, so that all 
subjects who were enrolled will be included in the analysis. To minimize the amount of 
missing data, subjects will only be randomized after they have undergone appropriate 
diagnostic tests, eligibility has been confirmed by the research coordinators. If a subject is 
randomized but later decides to discontinue study participation, they are asked in the 
consent form to allow follow-up via medical record review. For further information on 
subjects who discontinue participation, see Section 9.2. Every effort will be made to follow 
all patient outcomes via medical records. 
    
7. Statistical considerations 
7.1. Sample size calculation 
Aim1:  
Our sample size calculation is based on numerous assumptions.   
To estimate rates of participation and retention a sample size of 50 subjects we will be able 
to estimate a participation rate of 80% to within a 95% confidence interval of +/- 10% and a 
retention rate of 60% to within a 95% confidence interval of +/- 13%.  13,14,15,16 Adjusting for 
up to a 10% drop out rate we increased the sample size to 55 subjects. 
 

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Aims 2-5; are not powered as they are exploratory outcomes that will be used for future 
study planning.  However, there may be up to 440 subjects available to include in this 
analysis.  This was determined knowing there are 30 mobile units available at all times.  The 
endpoint is at 6 weeks.  So, this would allow for 30 patients in the first month and then on a 
rolling basis approximately 20 patients could be recruited per month at max enrollment.  
This would total 220 patients using mobile health for the 1-year experimental period.  The 
control group would be subjects matched within the same month of experimental subjects 
and be a 1:1 matching.  So the control group would consist of up to 220 patients.  The 
numbers may be less due to lower rates of recruitment/participation. 
 
Aim 7-8: 
The original study is closed to accrual, with a total of 214 subjects enrolled. With the 
success of the study, UPH-Meriter decided to incorporate the home monitoring program into 
its standard clinical services as of January 1, 2019. Through UPH-Meriter, 358 patients 
received services through this clinical program.  
 
We would like to retrospectively review the patient data in Peridata for these 358 patients. 
We will collect home vital sign data to assess blood pressure trends from early pregnancy 
through pregnancy and postpartum. This additional data would help to increase our sample 
size in this evaluation. The same data would be collected from the clinical patients. 
 
Therefore, our sample size would increase. We enrolled 214 subjects in the original 
Telehealth study, with 214 matched controls. 358 patients received remote monitoring 
services from the UPH-Meriter program. 100 providers with delivery privileges at UPH-
Meriter were offered the opportunity to complete a survey regarding the research. The new 
sample size is 886 patients. We do have prior IRB approval to collect data from Peridata for 
our original study patients.   
 
1. Non-compliance policies 
 
9.1 Dropout 
 
A subject is considered to have “dropped out” of the study if they are randomized but later 
decide to discontinue participation. Because of the potential compliance issues in 
postpartum patients and possible side effects of the drugs, we anticipate a dropout of 10%. 
Participants will be asked in the consent form to allow follow-up via medical records after 
they drop out. Every effort will be made to ask subjects to complete a withdrawal form, 
which will allow us to learn more about why the subject chose to leave this study. As with 
crossover patients, all patients who drop out of the study will be included in the analysis on 
an intention to treat principle.  
 
7.2 Analysis plan 
Aim 1: Analysis of the primary outcome will be performed assessing rates of willingness to 
participate and patient retention in the study for 42 days postpartum.  Secondary outcome 
measures will be attrition rate and compliance rates to both care and medication. 
Aim 2: We will be developing an ROC curve with Youden’s index to predict the optimum 
SBP and DBP from intrapartum and postpartum to target for postpartum blood pressure 
thresholds for blood pressure management to prevent postpartum readmission due to 
severe hypertension. 

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Aim2-8: Baseline demographic and descriptive statistics will be compared to assess 
comparability of the study groups.  Continuous variables will be assessed with student t-test 
and categorical data will be analyzed using ANOVA. 
 
Aim 4: Analyses were performed to determine whether it is cost-effective to use Bluetooth-
enabled tablets for postpartum blood pressure monitoring in comparison to standard 
monitoring in women with hypertension-related disorders of pregnancy. The data for the 
analyses will be derived from a prospective study at UnityPoint Health- Meriter Hospital 
where patients with hypertensive-related disorders of pregnancy will be enrolled in either 
standard management of blood pressure (routine nurse blood pressure visit 3-5 days from 
discharge) or monitoring with a Honeywell Genesis Android Touch Bluetooth remote patient 
monitoring system. Primary outcomes examined will include cost and readmissions. 
 
8. Feasibility 
Table #. UnityPoint Health-Meriter Data 2015. Total deliveries: 3873 
 
Hypertensive 
disorder 
Maternal 
(n=476) 
Neonatal 
(n=147) 
Chronic  
87 (18%) 
30  (20%) 
Gestational, 
preeclampsia and 
SIPE 
387 (81%) 
115  (78%) 
Eclampsia 
2 (0.4%) 
2  (1.4%) 
 
** We anticipate that we will have approximately 40 patients with a hypertension related disorder 
for potential enrollment each month. At the beginning of the study, we only had 30 mobile health 
units that could have been used at any time. Effective 10/01/2017, an additional 10 mobile health 
units were acquired, making 40 mobile health units to available for study use at any time. We 
would strive to include all in the future as routine care if possible.  We believe this project will be 
very successful in improving the quality of care for postpartum women at risk of developing severe 
complications associated with hypertension.   
 
** The initial phase study is reasonable to complete in 1 year.  Estimating a total of 400 
patients annually with a hypertensive related disorder.  Only 14% of the hypertensive 
patients would be required to participate. 
 
**We had access to 30 mobile health units at the beginning of the study, and in 1 year that 
would allow for participation from 220 patients if we were using all units on a rolling basis 
(20 new recruits per month). Effective 10/01/2017, we now have access to 40 mobile health 
kits, in which we will not change the sample size, but will achieve 220 participants more 
quickly. 
 

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** To maximize patients eligible for recruitment I am reaching out to all obstetrical providers.  
I have approval to recruit patients who receive their primary obstetrical care from the 
Perinatal Center and the UW Health General Obstetrics clinics.  I will be meeting with the 
private practitioner groups to assess their willingness to utilize this program with their 
patients prior to approaching their patients for enrollment.  
 
9. Cost determination 
9.1 Personnel 
Kara Hoppe, MD (1.2 cal months - 10%, salary/fringe not requested) is Principle 
Investigator of this application. Dr. Hoppe will be developing the protocol, IRB with the 
assistance of the research coordinator, data storage development and coordination of the 
mobile application data from patients, as well as monitoring data imports, quality and patient 
satisfaction.  Dr. Hoppe will also be monitoring direct needs for patient care and coordination 
of medical management for the patients. 
Mobile Health Nurse (6 cal months-50%)- A mobile health nurse will be employed as a 
member to the Perinatal Clinic. He/she will be directly supervised by Sue Ellen Dolan, 
Clinical Nurse Manager. This nurse will be responsible for daily review of telehealth data, 
patient concerns, and telehealth video conferencing visits, and will interface with providers 
as needed to optimize patient care.  
Research Coordinator (3.6 cal months – 30%)  who will be responsible for IRB 
submission and coordination, patient consent, and patient contact/follow-up.  
 
10.  Materials and Supplies 
Android Touch full Bluetooth Kit Hardware- Per Honeywell, Android Touch tablets with 
full Bluetooth hardware are quoted at $1,800 each. The 40 units are requested to be utilized 
each month of the proposed project, with the potential for a long-term cost-sharing 
agreement.  
Patient reimbursement: 
An18 pack of diapers would be provided to each participant at enrollment. A gift card at the 
end of the 6-week participation. 
11. Other fees 
• 
UW Survey Center ($2,000) The University of Wisconsin Survey Center will be 
providing validated questions to adequately assess our patient satisfaction, 
compliance, and feedback on improvements for utilization of mobile health and 
telemedicine in their postpartum care to optimize the future use of this platform.  
• 
Connectivity, Verizon, and hotspot fees ($26,400) Connectivity fees, Verizon 
connection fees, and hotspot fees will be required monthly per participant. As 
discussed with Lisa Urban, the monthly fee is $80. Except for the first month of the 
project, where 20 participants are anticipated, and the last month where 10 active 
participants are expected, the remaining months are expected to have 30 active 
participants necessitate the monthly fee. We anticipate that our participants will be 
followed-up until 42 days post-partum and will return the equipment at that time.  

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• 
REDCap Annual Fee ($200). 50 hours for REDCap database setup and data 
management to help with data and study management, based on past database set-
up requirements and an intention to create an entry page. 
• 
IRB fees: IRB will be submitted through Meriter and will thus have no cost to this 
project.  
• 
60 hours for data analysis 
 
 11.1 Cost savings 
Based on data from the National Perinatal information center the estimated average loss per 
hospital for obstetrical readmissions are $200,000.  With 30-50% of hospital readmissions 
being related to hypertension there would be a large potential for cost savings with 
identifying effective strategies to avoid readmission.  In addition to financial cost there would 
be an emotional cost to readmission and potential interruption of maternal-neonatal bonding 
and breastfeeding. 
 
12. Investigators and research staff 
 
Kara Hoppe, DO, (PI) is an Assistant Professor in the School of Medicine and Public 
Health, Department of Obstetrics & Gynecology, Division of Maternal Fetal Medicine.  This 
proposed work builds on prior experience historical and prospective research with the goal 
to develop an expertise in prospective clinical trials. She is currently enrolled in the capstone 
certificate program for clinical investigation through the Institute for Clinical and Translational 
Research.  
 
Makeba Williams, MD (co-I) is a Clinical Assistant Professor in the School of Medicine and 
Public Health has extensive experience caring for women of all ages.  She has a particular 
interest in caring for women with high risk pregnancies and will be directly involved in 
supporting the program from the General Obstetric service. 
 
Deborah Ehrenthal, MD, MPH, (collaborator) is Associate Professor in the School of 
Medicine and Public Health with experience conducting historical and prospective cohort 
studies, using administrative and clinical data, examining predictors of adverse birth and 
child outcomes including hypertension related disorders in pregnancy. She serves as one of 
my research mentors and has dedicated her time to participate as a co-investigator in this 
project. 
 
Dinesh Shah, MD (collaborator) is a Professor in the School of Medicine and Public 
Health, Department of Obstetrics & Gynecology, Division of Maternal-Fetal Medicine.  He 
has a long standing research and clinical interest as well as expertise in the pathogenesis of 
hypertension related disorders in pregnancy.  His experience will be instrumental in 
including basic physiology and mechanisms of disease in the translation of bench to clinical 
research.  He is also dedicated to serving as a primary mentor in my endeavors to pursue 
and advance clinical research within our department. 
 

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David VanNess, PhD (collaborator) is an Associate Professor of Population Health 
Sciences (with tenure) at the University of Wisconsin School of Medicine and Public Health 
and an affiliate of the La Follette School of Public Affairs, the Department of Industrial and 
Systems Engineering, the Center for Demography and Ecology, and the UW Carbone 
Cancer Center at UW-Madison. His current research focuses on developing and applying 
innovative empirical and simulation methods for comparative effectiveness and cost-
effectiveness analysis, with a special focus on Bayesian evidence synthesis. 
 
Jennifer Dykema, PhD (collaborator) a senior survey methodologist at the UW Survey 
Center regarding development of a survey application that would be appropriate to utilize for 
postpartum women using mobile health applications. 
 
Mobile health nurse: A mobile health nurse will be employed as a member to the Perinatal 
Clinic. He/she will be directly supervised by Sue Ellen Dolan, Clinical Nurse Manager. This 
nurse will be responsible for daily review of telehealth data, patient concerns, and telehealth 
video conferencing visits, and will interface with providers as needed to optimize patient 
care. 
 
Several other collaborators and trainees will provide scientific input and guidance to this 
project, including the faculty members of the Maternal Fetal Medicine Division. There is a 
wide interest and dedication from the Unity Point-Meriter Obstetric Unit.  Key institutional 
members identified to support this work on a nursing and administrative level are: Kathy 
Kostrivas who is the Executive Director of the Mother-Baby Care, Carla Griffin, MSN, RNC, 
NE-BC who is the Director of Perinatal Services, and Sue Ellen Dolan, RN, BSN, Manager 
of the Women’s Health Outpatient Services at Unity Point Health-Meriter. 
 
13. Contingency plans 
13.1. 
Poor recruitment 
• 
May need to increase patient incentives 
• 
May need to adjust the follow-up time as patients may lose interest by 42 days 
postpartum 
• 
May need to increase patient and provider education 
 
13.2. 
High drop-out or failure to complete required daily vital sign collection 
• 
Set reminders on tablet 
• 
Call patients for direct reminders 
 
13.3. 
Technology failure 
• 
Will have 24-hour tech support that is covered by the company and UnityPoint 
Health 
 
13.4. 
Staff failure/retention  
• 
May need to hire more assistance due to need for 7 days per week surveillance. 
Will plan to have 2 staff coverage immediately.  Also, require patients to submit 
data by noon daily to avoid need for 24-hour coverage of mobile health nurse. 
 
13.5. 
Loss of equipment 

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• 
Will need to have contact information and plan to maintain and retain equipment 
return. 
 
14. Conclusion 
We propose a feasibility clinical trial of the effectiveness of a mobile application for tracking 
patients at risk of developing severe postpartum hypertension.  The primary outcome variable is 
hypertension related hospital readmission by 42 days postpartum. 
This trial is scheduled to last for approximately 1 years and enroll up to a total of 55 patients in 
aim 1 and up to 440 patients in the aims 2-5 depending on patient enrollment and patient 
willingness to participate 220(mobile health) 220(controls not participating in mobile health).   
 
 
 
 

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Trial. J Nutr Educ Behav. 2014;46(6):610-615. doi:10.1016/j.jneb.2014.06.002. 
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Facebook delivery. Transl Behav Med. 2018;(March):2-7. doi:10.1093/tbm/iby013. 
23. 
Baker JL, Gamborg M, Heitmann BL, Lissner L, Sørensen TIA, Rasmussen KM. 
Breastfeeding reduces postpartum weight retention 1 – 4. Am J Clin Nutr. 2008;(10). 
doi:10.3945/ajcn.2008.26379.1. 
24. 
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postpartum weight loss among U.S. women. Prev Med (Baltim). 2014;69(2014):146-150. 
doi:10.1016/j.ypmed.2014.09.018. 
25. 
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APPENDIX I 
Data variables to extract from EPIC Electronic Medical Records/Peridata 
1. Medical record number for mother 
2. Date of birth 
3. Link baby to mother (Medical record number) 
4. Date of birth 
Demographics Maternal 
5. Maternal age 
6. Tobacco use 
a. Yes 
b. No 
7. Date of first prenatal care visit 
8. Body mass index at first prenatal care visit 
9. Body mass index at delivery or with initial admission 
10. Body mass index at second admission 
11. Body mass index >30 at delivery 
a. Yes  
b. No 
12. Maternal weight in kilograms with first prenatal care visit 
13. Maternal weight in kilograms on initial admission 
14. Maternal weight in kilograms within 24 hours of delivery 
15. Maternal weight in kilograms within 24-48 hours of delivery 
16. Maternal weight in kilograms within 48-72 hours of delivery 
17. Maternal weight in kilograms within 72-96 hours of delivery 
18. Maternal weight in kilograms within 24 hours of initial admission discharge 
19. Maternal weight in kilograms on readmission 
20. Maternal weight in kilograms on discharge from readmission 
21. Maternal diabetes 
a. Gestational 
b. Type 1 
c. Type 2 
22. Marital status 
a. Married 
b. Single 
c. Unknown 
23. Insurance 
a. Commercial 
b. Medicaid 
c. HMO 
d. Uninsured 
e. Other 
f. 
Unknown 
24. Race 

 
a. Caucasian 
b. Hispanic 
c. African American 
d. American Indian/Alaskan Native 
e. African 
f. 
Asian American 
g. Other 
h. Unknown 
25. Ethnicity 
a. Hispanic 
26. Gravidity 
27. Parity (live children) 
28. Gestational age rounded in weeks at delivery 
29. Estimated date of delivery 
30. Singleton pregnancy 
a. Yes 
b. No 
31. Multiple pregnancy 
a. Twins 
b. Triplets 
32. Mode of delivery 
a. Normal spontaneous vaginal delivery 
b. Operative delivery 
i. Forceps 
ii. Vacuum 
c. Cesarean section 
33. Indication for cesarean section 
a. First stage arrest 
b. Second stage arrest 
c. Fetal intolerance of labor  
d. Fetal distress 
e. Repeat cesarean section 
f. 
Failed trial of labor after prior cesarean section 
g. Elective primary cesarean section 
h. Vaginal bleeding/abruption 
i. 
Placentation 
j. 
Fetal malpresentation 
k. Maternal illness 
l. 
Other 
34. Hypertension related disorder was diagnosed in pregnancy 
a. Prior to initial admission 
b. Prior to delivery of baby (intrapartum) 
c. After delivery of baby (postpartum) 
d. Only upon readmission to hospital after initial admission discharge 

 
35. Specific hypertension related disorder diagnosed in pregnancy 
a. Chronic 
b. Gestational 
c. Preeclampsia 
i. Mild 
ii. Severe features 
d. Eclampsia 
 
Demographics Neonatal 
36. Birth weight in grams 
37. Apgar score <7 at 5 minutes after birth 
38. Oxygen required after 24 hours of delivery 
a. CPAP 
b. Nasal cannula 
c. Intubation 
39. Disposition 
a. Mother baby unit 
b. Progressive care nursery 
c. Neonatal intensive care unit 
 
Outcomes Maternal 
40. Date and time of primary of admission for delivery 
41. Date and time of secondary of admission for delivery 
42. Date and time of emergency room visit for hypertension 
43. Date and time of triage room visit for hypertension 
44. Date and time of primary of discharge after delivery 
45. Date and time of secondary of discharge after delivery 
46. Number of initial admission days for length of stay 
47. Number of secondary admission days for length of stay 
48. Systolic blood pressure on admission with date and time 
49. Diastolic blood pressure on admission with date and time 
50. Date of postpartum visit 
a. Date 
51. Maternal weight in kilograms at 6 week postpartum visit (via Meriter Epic or UW Epic/ 
HealthLink) 
a. Continuous variable 
52. Breastfeeding status at the time of postpartum hospital discharge (via Meriter Epic) 
a. Exclusive breastfeeding 
b. Both breast and bottle feeding 
c. Exclusively bottle feeding 
53. Breastfeeding status at 6 week postpartum visit (via Meriter Epic or UW Epic/ HealthLink) 
a. Exclusive breastfeeding 
b. Both breast and bottle feeding 
c. Exclusively bottle feeding 

 
54. Maternal Edinburgh Depression Screen Score at 6 week postpartum visit (via Meriter Epic or UW 
Epic/ HealthLink) 
a. Score 0-30 
b. Positive or Negative 
i. Positive (>=10) 
ii. Negative 
c. Suicidal 
55. Contraception method utilized/ implemented at 6 week postpartum visit(via Meriter Epic or UW 
Epic/ HealthLink) 
a. None 
b. Natural family planning 
c. Condoms 
d. Combined oral contraceptive pills 
e. Progestin-only oral contraceptive pills 
f. 
Vaginal ring 
g. Depot medroxyprogesterone acetate 
h. Long acting reversible contraceptive 
i. Copper IUD 
ii. Levonorgestrel IUD 
iii. Nexplanon 
56. Blood pressure at 6 week postpartum visit (via Meriter Epic or UW Epic/ HealthLink) 
a. SBP 
b. DBP 
57. Whether a referral to the primary care provider is discussed in the 6 week postpartum note (via 
Meriter Epic or UW Epic/ HealthLink) 
a. Yes 
b. No 
 
Please report the top three values for the maximum values below 
58. Maximum Systolic blood pressure during labor (top three) with date and time 
59. Maximum Diastolic blood pressure during labor (top three) with date and time 
60. Maximum Systolic blood pressure within 24 hours of delivery with date and time 
61. Maximum Diastolic blood pressure within 24 hours of delivery with date and time 
62. Maximum Systolic blood pressure on admission on 24-48 hours of delivery with date and time 
63. Maximum Diastolic blood pressure on 24-48 hours of delivery with date and time 
64. Maximum Systolic blood pressure on admission on 48-72 hours of delivery with date and time 
65. Maximum Diastolic blood pressure on 48-72 hours of delivery with date and time 
66. Maximum Systolic blood pressure on admission on 72-96 hours of delivery with date and time 
67. Maximum Diastolic blood pressure on 72-96 hours of delivery with date and time 
68. Maximum Systolic blood pressure within 24 hours of discharge date and time 
69. Maximum Diastolic blood pressure within 24 hours of discharge date and time 
70. Minimum Systolic blood pressure during labor (top three) with date and time 
71. Minimum Diastolic blood pressure during labor (top three) with date and time 
72. Minimum Systolic blood pressure within 24 hours of delivery with date and time 
73. Minimum Diastolic blood pressure within 24 hours of delivery with date and time 
74. Minimum Systolic blood pressure on admission on 24-48 hours of delivery with date and time 

 
75. Minimum Diastolic blood pressure on 24-48 hours of delivery with date and time 
76. Minimum Systolic blood pressure on admission on 48-72 hours of delivery with date and time 
77. Minimum Diastolic blood pressure on 48-72 hours of delivery with date and time 
78. Minimum Systolic blood pressure on admission on 72-96 hours of delivery with date and time 
79. Minimum Diastolic blood pressure on 72-96 hours of delivery with date and time 
80. Minimum Systolic blood pressure within 24 hours of discharge date and time 
81. Minimum Diastolic blood pressure within 24 hours of discharge date and time 
82. Blood pressure medications used prior to delivery of baby (used prior to initial admission due to 
chronic or gestational hypertension) with date and time of initiation if available. 
a. Atenolol 
b. Hydralazine 
c. Lasix 
d. Clonidine 
e. Labetalol 
f. 
Nifedipine 
g. Metoprolol 
h. Enalapril 
i. 
Other medication 
j. 
No medications 
 
83. Blood pressure medications used prior to delivery of baby (started on admission) with date and 
time of initiation 
a. Atenolol 
b. Hydralazine 
c. Lasix 
d. Clonidine 
e. Labetalol 
f. 
Nifedipine 
g. Metoprolol 
h. Enalapril 
i. 
Other medication 
j. 
No medications 
84. Blood pressure medications used after delivery of baby with date and time of initiation 
a. Atenolol 
b. Hydralazine 
c. Lasix 
d. Clonidine 
e. Labetalol 
f. 
Nifedipine 
g. Metoprolol 
h. Enalapril 
i. 
Other medication 
j. 
No medications 
 

 
85. Blood pressure meds used at discharge with date and time of initiation 
a. Atenolol 
b. Hydralazine 
c. Lasix 
d. Clonidine 
e. Labetalol 
f. 
Nifedipine 
g. Metoprolol 
h. Enalapril 
i. 
Other medication 
j. 
No medications 
 
86. Blood pressure medications used upon readmission with date and time of initiation 
a. Atenolol 
b. Hydralazine 
c. Lasix 
d. Clonidine 
e. Labetalol 
f. 
Nifedipine 
g. Metoprolol 
h. Enalapril 
i. 
Other medication 
j. 
No medications 
 
87. Number of total antihypertensive medications used with initial admission 
88. Number of total antihypertensive medications used with secondary readmission 
89. Intravenous route of medication used prior to delivery of baby 
90. Intravenous route of medication used after delivery of baby 
91. Intravenous route of medication used upon readmission of baby 
92. Magnesium sulfate used prior to delivery of baby 
93. Magnesium sulfate used after delivery of baby 
94. Magnesium sulfate used upon readmission of baby 
95. Date and time of postpartum follow-up visit appointment after initial discharge (first) 
96. Date and time of postpartum follow-up visit appointment after initial discharge (second) 
97. Date and time of postpartum follow-up visit appointment after initial discharge (third) 
98. Date and time of postpartum follow-up visit appointment after secondary readmission discharge 
(first) 
99. Date and time of postpartum follow-up visit appointment after secondary readmission 
discharge(second) 
100. 
Date and time of postpartum follow-up visit appointment after secondary readmission 
discharge(third) 
101. 
Total Days calculated in-between initial discharge and secondary readmission  
102. 
Total Days calculated for initial admission 
103. 
Total Days calculated for secondary readmission 

 
104. 
Maternal admission to Intensive care unit 
a. Yes 
b. No 
 
105. 
Maternal death 
a. Yes 
b. No 
106. 
Labs drawn for preeclampsia 
a. Specific labs (report them out for each day of admission (primary and secondary) – 
Please give the maximum and minimum due to some individuals may have many values 
i. AST 
ii. ALT 
iii. Hematocrit 
iv. Platelet count 
v. Urine protein total in 24 hours 
vi. Urine protein by protein:creatinine ratio 
vii. Uric acid 
107. 
Reported maternal symptoms related to hypertension 
a. Headache 
b. Visual changes 
c. Shortness of breath 
d. Chest pain 
e. Seizure 
f. 
Abdominal pain 
g. Vomiting 
h. Nausea 
108. 
Total amount of Intravenous fluids given with initial admission 
109. 
Pulmonary edema 
110. 
Estimated blood loss volume at delivery in (cc) 
111. 
Maternal transfusion 
a. Yes 
b. No 
112. 
Maximum Systolic blood pressure during 1st trimester of pregnancy (top three) with 
date and time  
113. 
Maximum Diastolic blood pressure during 1st trimester of pregnancy (top three) with 
date and time  
114. 
Maximum Systolic blood pressure during 2nd trimester of pregnancy (top three) with 
date and time  
115. 
Maximum Diastolic blood pressure during 2nd trimester of pregnancy (top three) with 
date and time  
116. 
Maximum Systolic blood pressure during 3rd trimester of pregnancy (top three) with 
date and time  
117. 
Maximum Diastolic blood pressure during 3rd trimester of pregnancy (top three) with 
date and time  
118. 
Maximum Heart Rate during 1st trimester of pregnancy (top three) with date and time  

 
119. 
Maximum Heart Rate during 2nd trimester of pregnancy (top three) with date and time  
120. 
Maximum Heart Rate during 3rd trimester of pregnancy (top three) with date and time  
121. 
Minimum Systolic blood pressure during 1st trimester of pregnancy with date and time  
122. 
Minimum Diastolic blood pressure during 1st trimester of pregnancy with date and 
time  
123. 
Minimum Systolic blood pressure during 2nd trimester of pregnancy with date and 
time  
124. 
Minimum Diastolic blood pressure during 2nd trimester of pregnancy with date and 
time  
125. 
Minimum Systolic blood pressure during 3rd trimester of pregnancy with date and time  
126. 
Minimum  Diastolic blood pressure during 3rd trimester of pregnancy with date and 
time  
127. 
Minimum Heart Rate during 1st trimester of pregnancy with date and time  
128. 
Minimum Heart Rate during 2nd trimester of pregnancy with date and time  
129. 
Minimum Heart Rate during 3rd trimester of pregnancy with date and time 
UPH-Meriter Telehealth Screening Test 
130. self-reported response to patient's depressed mood (January - March 2019) 
a. Yes 
b. No 
131.  PHQ-9 score (April 2019 - January 2020)