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Comprehensive Postpartum Management for Women With Hypertensive Disorders of Pregnancy

Primary Purpose

Hypertension, Pregnancy-Induced, Postpartum Preeclampsia, Hypertension; Maternal

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blood Pressure Control Targets
Hypertension Management
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hypertension, Pregnancy-Induced focused on measuring Hypertension, Postpartum hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria Age >18 years Diagnosed with a Hypertensive Disorder of Pregnancy (HDP), which includes chronic hypertension, preeclampsia, gestational hypertension, HELLP Syndrome (Hemolysis, Elevated Liver enzymes, Low Platelets), or eclampsia (O10, O11, O13, O14, O15, O16) Exclusion Criteria 1. Not able or willing to receive electronic surveys 2. Deemed inappropriate for study enrollment by the bedside nurse 3. Non-English speaking 4. Contraindication to ACOG-recommended hypertension control (i.e. chronic kidney disease, stroke)

Sites / Locations

  • Vanderbilt University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

A) Standard BP Control, Clinician Monitoring

B) Tight BP Control, Clinician Monitoring

C) Standard BP Control, Care Navigation

D) Tight BP Control, Care Navigation

Arm Description

Target blood pressure will be less than 150/100. Participants will be instructed to check their blood pressures twice a day for two weeks and daily for weeks 3-6 after delivery and report abnormal blood pressures or symptoms to their obstetric clinicians. Additional postpartum visits beyond the blood pressure check will be directed by their obstetric clinician.

Target blood pressure will be less than 140/90. Participants will be instructed to check their blood pressures twice a day for two weeks and daily for weeks 3-6 after delivery and report abnormal blood pressures or symptoms to their obstetric clinicians. Additional postpartum visits beyond the blood pressure check will be directed by their obstetric clinician.

Target blood pressure will be less than 150/100. Participants will check blood pressures twice daily for 14 days and daily for weeks 3-6. A nurse navigator will review their blood pressures M-F for Weeks 1-2 and weekly for weeks 3-6 and will provide feedback on blood pressure values and recommend initiating or escalating medications as needed. The nurse navigator will communicate progress to the participant's clinicians and will remind the participant of their appointments. The nurse navigator will facilitate a visit around 3 months with a primary care clinician or a cardiologist for hypertension follow up.

Target blood pressure will be less than 140/90. Participants will check blood pressures twice daily for 14 days and daily for weeks 3-6. A nurse navigator will review their blood pressures M-F for Weeks 1-2 and weekly for weeks 3-6 and will provide feedback on blood pressure values and recommend initiating or escalating medications as needed. The nurse navigator will communicate progress to the participant's clinicians and will remind the participant of their appointments. The nurse navigator will facilitate a visit around 3 months with a primary care clinician or a cardiologist for hypertension follow up.

Outcomes

Primary Outcome Measures

Proportion of participants with recorded blood pressure values in office
Proportion of participants with blood pressure values recorded in the office

Secondary Outcome Measures

Proportion of participants with recorded blood pressure values, any reporting
Proportion of participants with blood pressure values recorded through any means
Mean systolic blood pressure, 7-10 days
Mean systolic blood pressure
Mean diastolic blood pressure, 7-10 days
Mean diastolic blood pressure
Mean systolic blood pressure, 4-6 weeks post delivery
Mean systolic blood pressure
Mean diastolic blood pressure, 4-6 weeks post delivery
Mean diastolic blood pressure
Proportion of patients who initiated or increased medications
Initiated or increased medications
Number of contacts with the health care team
Number of contacts with the health care team
Proportion of patients with sustained severe hypertension
Two blood pressures >=160/100 at least 15 minutes apart
Proportion of patients with obstetric triage or emergency department visit
Obstetric triage or emergency department visit
Proportion of patients with hospital readmission for hypertension
Hospital readmission for hypertension
Proportion of patients with postpartum visit attendance
Postpartum visit attendance
Proportion of patients with primary care visit attendance
Primary care visit attendance

Full Information

First Posted
April 10, 2023
Last Updated
May 27, 2023
Sponsor
Vanderbilt University Medical Center
Collaborators
Sarah Osmundson, MD, MS, Alex Phelps, MD, Julia Phillippi, PhD, CNM, Soha Patel, MD, MSPH, Etoi Garrison, MD, PhD, Kathryn Lindley, MD
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1. Study Identification

Unique Protocol Identification Number
NCT05849103
Brief Title
Comprehensive Postpartum Management for Women With Hypertensive Disorders of Pregnancy
Official Title
Comprehensive Postpartum Management for Women With Hypertensive Disorders of Pregnancy: A Randomized Controlled
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 8, 2023 (Actual)
Primary Completion Date
April 1, 2027 (Anticipated)
Study Completion Date
April 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
Sarah Osmundson, MD, MS, Alex Phelps, MD, Julia Phillippi, PhD, CNM, Soha Patel, MD, MSPH, Etoi Garrison, MD, PhD, Kathryn Lindley, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Investigators propose a comprehensive management program for postpartum patients with HDP who are at risk for severe maternal morbidity and mortality. Our program will emphasize three key components: 1) self-monitoring of blood pressures with app-based reporting connected to our electronic health record, 2) blood pressure management directed by a program navigator with guideline and physician support and 3) facilitated transitions of care to primary care clinicians for hypertension management. Investigators will randomize 300 patents with HDP on postpartum day one with follow up through 3 months postpartum. Primary outcome will be blood pressure reporting at 7-10 postpartum. Secondary outcomes include blood pressure control at 7-10 days postpartum, identification and treatment of severe blood pressures, severe maternal morbidity, hospital readmission, triage visits for hypertension, postpartum and primary care visit attendance, and multiple patient-reported outcome measures. All outcomes will be stratified by race (Black and non-Black) to evaluate disparities and by tight versus usual blood pressure control to evaluate the impact of strict postpartum blood pressure control on outcomes. Investigators hypothesize that a comprehensive postpartum HDP management program will improve hypertension control for all patients and reduce disparities that affect Black patients, and that stricter blood pressure control will be associated with fewer adverse outcomes.
Detailed Description
Hypertension complicates 10% of pregnancies in the U.S., directly accounting for 7% of pregnancy-related deaths and 38% of severe maternal morbidity. Hypertensive disorders of pregnancy (HDP) include chronic hypertension, gestational hypertension, preeclampsia, hemolysis-elevated-liver enzymes-low platelets (HELLP), and eclampsia, and occur 2.5 times more frequently among Black compared to non-Black patients. The weeks after delivery are crucial for maternal health, severe maternal morbidity, and hypertension-associated morbidity. Half of all pregnancy-related deaths occur in this time and Black patients are impacted disproportionally by these morbidities including pulmonary edema, stroke, and renal failure. The American College of Obstetricians and Gynecologists (ACOG) recently redefined postpartum care to encompass 12 months after birth and stressed the importance of connecting postpartum patients to primary care clinicians to manage chronic conditions. This handoff is critical as 50% of patients with HDP develop chronic hypertension, and patients affected by HDP have twice the risk of later cardiovascular-related death. Recently, Tennessee expanded Medicaid coverage to 12 months postpartum. Given that most obstetric clinicians do not provide comprehensive primary care, investigators urgently need models for bridging gaps in care after pregnancy. While interventions such as telemedicine and peer navigation demonstrate promise to improve patient engagement in care and reduce postpartum racial disparities,15-18 no randomized trials address system-level initiatives to improve postpartum care for patients with HDP. Another area of active investigation relates to establishing appropriate blood pressure targets for patients in and around the time of pregnancy. Recent findings from the Chronic Hypertension and Pregnancy Trial suggest that stricter control of antepartum blood pressure is beneficial in reducing the incidence of a composite adverse perinatal outcome which included preeclampsia with severe features, medically indicated preterm birth at less than 35 weeks of gestation, placental abruption, and fetal or neonatal death. This trial has been practice-changing, lowering the historic antepartum blood pressure target from 160/110mmHg (millimeter of mercury) to less than 140/90mmHg. However, this trial did not contemplate the management of maternal blood pressure in the postpartum period. ACOG presently endorses a postpartum goal of less than 150/100mmHg which, notably, is higher than the newly established antepartum goal. Furthermore, the blood pressure target set for non-pregnant adults by the American College of Cardiology and American Heart Association is even lower, at less than 120/80mmHg to minimize the cardiovascular disease risk associated with chronic hypertension. Investigators propose a comprehensive management program for postpartum patients with HDP who are at risk for severe maternal morbidity and mortality. Our program will emphasize three key components: 1) self-monitoring of blood pressures with app-based reporting connected to our electronic health record, 2) blood pressure management directed by a program navigator with guideline and physician support and 3) facilitated transitions of care to primary care clinicians for hypertension management. Investigators will randomize 300 patents with HDP on postpartum day one with follow up through 3 months postpartum. Primary outcome will be blood pressure reporting at 7-10 postpartum. Secondary outcomes include blood pressure control at 7-10 days postpartum, identification and treatment of severe blood pressures, severe maternal morbidity, hospital readmission, triage visits for hypertension, postpartum and primary care visit attendance, and multiple patient-reported outcome measures. All outcomes will be stratified by race (Black and non-Black) to evaluate disparities and by tight versus usual blood pressure control to evaluate the impact of strict postpartum blood pressure control on outcomes. Investigators hypothesize that a comprehensive postpartum HDP management program will improve hypertension control for all patients and reduce disparities that affect Black patients, and that stricter blood pressure control will be associated with fewer adverse outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Pregnancy-Induced, Postpartum Preeclampsia, Hypertension; Maternal
Keywords
Hypertension, Postpartum hypertension

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
A factorial study design will be used where participants will be randomized in a 1:1:1:1 ratio to two intervention types (blood pressure target, hypertension care model) or four total interventions.
Masking
Outcomes Assessor
Masking Description
Research personnel assessing outcomes will be masked to the intervention
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A) Standard BP Control, Clinician Monitoring
Arm Type
Active Comparator
Arm Description
Target blood pressure will be less than 150/100. Participants will be instructed to check their blood pressures twice a day for two weeks and daily for weeks 3-6 after delivery and report abnormal blood pressures or symptoms to their obstetric clinicians. Additional postpartum visits beyond the blood pressure check will be directed by their obstetric clinician.
Arm Title
B) Tight BP Control, Clinician Monitoring
Arm Type
Active Comparator
Arm Description
Target blood pressure will be less than 140/90. Participants will be instructed to check their blood pressures twice a day for two weeks and daily for weeks 3-6 after delivery and report abnormal blood pressures or symptoms to their obstetric clinicians. Additional postpartum visits beyond the blood pressure check will be directed by their obstetric clinician.
Arm Title
C) Standard BP Control, Care Navigation
Arm Type
Active Comparator
Arm Description
Target blood pressure will be less than 150/100. Participants will check blood pressures twice daily for 14 days and daily for weeks 3-6. A nurse navigator will review their blood pressures M-F for Weeks 1-2 and weekly for weeks 3-6 and will provide feedback on blood pressure values and recommend initiating or escalating medications as needed. The nurse navigator will communicate progress to the participant's clinicians and will remind the participant of their appointments. The nurse navigator will facilitate a visit around 3 months with a primary care clinician or a cardiologist for hypertension follow up.
Arm Title
D) Tight BP Control, Care Navigation
Arm Type
Active Comparator
Arm Description
Target blood pressure will be less than 140/90. Participants will check blood pressures twice daily for 14 days and daily for weeks 3-6. A nurse navigator will review their blood pressures M-F for Weeks 1-2 and weekly for weeks 3-6 and will provide feedback on blood pressure values and recommend initiating or escalating medications as needed. The nurse navigator will communicate progress to the participant's clinicians and will remind the participant of their appointments. The nurse navigator will facilitate a visit around 3 months with a primary care clinician or a cardiologist for hypertension follow up.
Intervention Type
Other
Intervention Name(s)
Blood Pressure Control Targets
Intervention Description
This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90
Intervention Type
Other
Intervention Name(s)
Hypertension Management
Intervention Description
This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant.
Primary Outcome Measure Information:
Title
Proportion of participants with recorded blood pressure values in office
Description
Proportion of participants with blood pressure values recorded in the office
Time Frame
7-10 days post delivery
Secondary Outcome Measure Information:
Title
Proportion of participants with recorded blood pressure values, any reporting
Description
Proportion of participants with blood pressure values recorded through any means
Time Frame
7-10 days post delivery
Title
Mean systolic blood pressure, 7-10 days
Description
Mean systolic blood pressure
Time Frame
7-10 days post delivery
Title
Mean diastolic blood pressure, 7-10 days
Description
Mean diastolic blood pressure
Time Frame
7-10 days post delivery
Title
Mean systolic blood pressure, 4-6 weeks post delivery
Description
Mean systolic blood pressure
Time Frame
4-6 weeks post delivery
Title
Mean diastolic blood pressure, 4-6 weeks post delivery
Description
Mean diastolic blood pressure
Time Frame
4-6 weeks post delivery
Title
Proportion of patients who initiated or increased medications
Description
Initiated or increased medications
Time Frame
6 weeks post delivery
Title
Number of contacts with the health care team
Description
Number of contacts with the health care team
Time Frame
6 weeks post delivery
Title
Proportion of patients with sustained severe hypertension
Description
Two blood pressures >=160/100 at least 15 minutes apart
Time Frame
6 weeks post delivery
Title
Proportion of patients with obstetric triage or emergency department visit
Description
Obstetric triage or emergency department visit
Time Frame
6 weeks post delivery
Title
Proportion of patients with hospital readmission for hypertension
Description
Hospital readmission for hypertension
Time Frame
6 weeks post delivery
Title
Proportion of patients with postpartum visit attendance
Description
Postpartum visit attendance
Time Frame
3-6 weeks post delivery
Title
Proportion of patients with primary care visit attendance
Description
Primary care visit attendance
Time Frame
3 months post delivery
Other Pre-specified Outcome Measures:
Title
Satisfaction with postpartum care
Description
Scale of 1-10
Time Frame
6 weeks post delivery
Title
Satisfaction with blood pressure care
Description
Scale of 1-10
Time Frame
6 weeks post delivery
Title
Proportion of patients who respond 'yes' to feeling that their voice is heard
Description
Feeling that their voice is heard
Time Frame
2 weeks post delivery
Title
Perceived Stress (NIH Toolbox)
Description
mean T-score (Range 1-100)
Time Frame
2 weeks post delivery
Title
Self-Efficacy (PROMIS measure)
Description
mean T-score (Range 1-100)
Time Frame
2 weeks post delivery
Title
Edinburgh Postpartum Depression Scale
Description
Mean score (range 1-30)
Time Frame
2 weeks post delivery
Title
Mothers on Respect Index Score
Description
mean score (range 14-84)
Time Frame
6 weeks post delivery

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women who have recently given birth. The aim of this study evaluate post-partum hypertension care.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Age >18 years Diagnosed with a Hypertensive Disorder of Pregnancy (HDP), which includes chronic hypertension, preeclampsia, gestational hypertension, HELLP Syndrome (Hemolysis, Elevated Liver enzymes, Low Platelets), or eclampsia (O10, O11, O13, O14, O15, O16) Exclusion Criteria 1. Not able or willing to receive electronic surveys 2. Deemed inappropriate for study enrollment by the bedside nurse 3. Non-English speaking 4. Contraindication to ACOG-recommended hypertension control (i.e. chronic kidney disease, stroke)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Osmundson, MD
Phone
615-343-5700
Email
sarah.osmundson@vumc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Ashudee Kirk
Phone
6153439933
Email
ashudee.kirk@vumc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Osmundson, MD
Organizational Affiliation
Associate Professor Maternal-Fetal Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Osmundson, MD MS
Phone
615-343-7869
Email
sarah.osmundson@vanderbilt.edu

12. IPD Sharing Statement

Learn more about this trial

Comprehensive Postpartum Management for Women With Hypertensive Disorders of Pregnancy

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