Optimizing Cardiovascular Preventive Care for Women Following Hypertensive Disorders of Pregnancy

Cardiovascular disease is the leading cause of death among women in the United States, and women with hypertensive disorders of pregnancy have a 2-fold higher risk for cardiovascular disease later in life compared to women with uncomplicated pregnancies. This research investigates a patient-centered intervention during the postpartum period to promote engagement in cardiovascular preventive care.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiovascular Diseases; Patient Engagement; Preeclampsia; Hypertension, Pregnancy Induced; Hypertension Complicating Pregnancy
• Intervention / Treatment: Other: Decision aid

Detailed Description

Current evidence demonstrates that women with hypertensive disorders of pregnancy have 2-fold higher risk for the later development of cardiovascular disease (CVD) compared to women with healthy pregnancies. CVD prevention is a high priority for women's health, as it is the leading cause of death among women in the United States. In order to improve women's cardiovascular health, interventions for cardiovascular prevention could be initiated shortly after a pregnancy complicated by a hypertensive disorder. However, patient-centered interventions to promote preventive care engagement among postpartum women are lacking. Our objective is to address current gaps in knowledge regarding needs, values, and barriers regarding cardiovascular prevention among postpartum women with hypertensive disorders of pregnancy, and to remedy the lack of available evidence-based interventions for this at-risk population. To this end, we will conduct a pilot study to demonstrate feasibility and preliminary efficacy of a patient decision aid to improve patient knowledge and self-efficacy regarding CVD prevention during the postpartum period

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lauren Theilen, MD; Phone Number: 801-581-8425; Email: lauren.theilen@hsc.utah.edu

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Hospital
      • Contact: Lauren Theilen, MD; Phone Number: 801-581-8425; Email: lauren.theilen@hsc.utah.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Delivered a pregnancy complicated by a hypertensive disorder of pregnancy at the University of Utah during the current hospital admission
• Ability to speak and read English or Spanish
• Written informed consent obtained

Exclusion Criteria:

• Cardiovascular disease diagnosis (history of peripheral artery disease, stroke, or myocardial infarction)
• Impairment of cognitive function or vision that prohibits communication and/or reading the decision aid.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Decision aid; Participants will use the decision aid in the postpartum period	Other: Decision aid; A decision aid will be developed based on qualitative data from Aim 1 and iterative refinement with input from stakeholders from Aim 2. Anticipated content includes: 1) information about cardiovascular risk following hypertensive disorders of pregnancy; 2) goal-setting exercises for blood pressure, weight management, glucose control, physical activity, and smoking cessation; 3) self-care steps to achieve management targets; 4) values clarification exercises to identify values related to cardiovascular risk management and identify priority areas for focus and improvement; and 5) discussion of how to communicate questions and goals of treatment to their provider.
No Intervention: Usual care; Participants will receive standard postpartum care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decisional conflict	Measured via the validated Decisional Conflict Scale. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict)	6-8 weeks postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decisional conflict	Measured via the validated Decisional Conflict Scale. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict)	One month after the initial assessment

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2025
• Primary Completion (Anticipated): August 1, 2027
• Study Completion (Anticipated): August 1, 2027

Study Registration Dates

• First Submitted: April 10, 2023
• First Submitted That Met QC Criteria: April 10, 2023
• First Posted (Actual): April 24, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Infections; Toxemia; Hypertension; Cardiovascular Diseases; Pre-Eclampsia; Pregnancy Complications; Hypertension, Pregnancy-Induced
• Other Study ID Numbers: 00151518; K23HL159316 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No