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Assessment of Postpartum Education to Improve Compliance

Primary Purpose

Hypertension in Pregnancy, Postpartum Preeclampsia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Education provided via a video format
Sponsored by
Medstar Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypertension in Pregnancy

Eligibility Criteria

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

Inclusion Criteria:

  • Postpartum with diagnosis of Hypertension is defined as chronic hypertension, gestational hypertension, preeclampsia without severe features, preeclampsia with severe features, chronic hypertension with superimposed preeclampsia with and without severe features.
  • At least 18 years or older
  • English speaking patient and also able to read in English
  • Plan to receive postpartum care at Washington Hospital Center

Exclusion Criteria:

  • Women who do not intend to follow up at Washington Hospital Center
  • Suffered from intrauterine fetal demise

Sites / Locations

  • MedStar Washington Hospital Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group: Current hospital education practices

Intervention group: Standardized video and pamphlet

Arm Description

The control group will receive standard of care postpartum educational materials provided by the nursing and resident physician staff. The will be asked to complete a brief questionnaire to determine if they would be interested in receiving education in a video formal.

The subjects enrolled in the invention group will be shown a 5 minute educational video on hypertension in the postpartum period. The patients will be shown the video on the ipad while they are in the comfort of their room. They will also be provided with a pamphlet with similar information that was discussed in the video. They will also be asked to complete a brief, anonymous survey to assess patient satisfaction with the video shown, no patient identifiers will be collected.

Outcomes

Primary Outcome Measures

Compliance with postpartum care
The investigators will perform a retrospective chart review to determine if the study participant attended the postpartum BP check appointment
Compliance with postpartum care
The investigators will perform a retrospective chart review to determine if the study participant attended the postpartum BP check appointment

Secondary Outcome Measures

Incidence of postpartum re-admission for hypertension related concerns
The investigators will retrospectively review if the study participants are re-admitted for hypertension related concerns
Incidence of postpartum labor and delivery triage visits
The investigators will retrospectively review if the study participants are evaluated in the labor and delivery triage for hypertension related concerns
Incidence of postpartum emergency department visits
The investigators will retrospectively review if the study participants are evaluated in the emergency department for hypertension related concerns
Evaluate weight (kg) change
The investigators will retrospectively compare the participants weight upon delivery admission to weight upon discharge and within 6 weeks of delivery
Evaluate weight (kg) change
The investigators will retrospectively compare the participants weight upon delivery admission to weight upon discharge and within 6 weeks of delivery
Evaluate weight (kg) change
The investigators will retrospectively compare the participants weight upon delivery admission to weight upon discharge and within 6 weeks of delivery
Incidence of stroke
The investigators will retrospectively review if the study participant suffered a stroke
Incidence of maternal death
The investigators will retrospectively review maternal death during this study period
Participant satisfaction with postpartum education using likert scale
A likert scale survey will be administered by the investigator to the intervention and control group, the satisfaction score will be compared between both groups. The scale is reported as follows: 1 (Strongly disagree) 2 3 (neutral) 4 5 (strongly agree).
Participant satisfaction with postpartum education
A survey will be administered by the investigator to the intervention and control group, the satisfaction score will be compared between both groups. The responses are either Yes or No. For most questions, answering yes would be a favorable response.

Full Information

First Posted
July 8, 2020
Last Updated
March 18, 2022
Sponsor
Medstar Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04486170
Brief Title
Assessment of Postpartum Education to Improve Compliance
Official Title
Assessment of Patient Education as a Method of Optimizing Postpartum Care in Women With Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
September 14, 2020 (Actual)
Primary Completion Date
June 25, 2021 (Actual)
Study Completion Date
December 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medstar Health Research Institute

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
This is a prospective single centered randomized control study for postpartum patients diagnosed with hypertension. Participants that meet inclusion criteria will be approached while they are inpatient. After enrollment, all study subjects will receive an automated blood pressure cuff and instructions on how to use it. Study participants in the intervention group will be provided with educational material. The investigators hypothesize education in postpartum women with hypertension can improve patient compliance with attendance at postpartum care appointments.
Detailed Description
The study group: postpartum women with a diagnosis of either chronic hypertension, gestational hypertension, preeclampsia without severe features, preeclampsia with severe features, chronic hypertension with superimposed preeclampsia with and without severe features. Recruitment: postpartum patients that meet the inclusion criteria will be approached postpartum while they are still hospitalized. Once the study subjects are enrolled, they will receive the same automatic blood pressure cuff and basic teaching on how to use it. All study subjects will be asked to check their blood pressure once a day. The study subjects will be advised that if systolic blood pressure is > 160 or the diastolic blood pressure >110, the study subjects are asked to remain seated and repeat the BP measurement in 15 minutes, if still elevated the study subject will be advised to call labor and delivery or proceed to labor and delivery triage for further evaluation. All study subjects will be asked to follow up for a blood pressure check 3-10 days after discharge home. All study subjects will be weighed prior to discharge. The study subject is then randomized to the control or intervention group. Both groups will receive a survey. After the intervention group undergoes the educational component, this will be the last time the study subjects meet with the investigator. The data will be collected on an excel spreadsheet. Patient identifiers will be removed once the study is completed. However, de-identified data may be used for future studies. The database will be password protected on an excel spreadsheet and secured behind the Medstar Washington Hospital Center firewall computers. Access to these databases is restricted to the PI and the co-investigators. The data will be statistically analyzed in order to answer the primary and secondary outcomes. Power analysis: At Washington hospital center, the current attendance within 10 day postpartum follow up appointments is 40% and at the 6 week appointment it is 70%. Based on this data the investigator wants to evaluate if this postpartum education intervention can cause a 100% difference in attendance within 10 days postpartum: 40% attendance which is the current attendance rate (control) versus 80% (goal for the intervention group): enrollment of 46 patients is required.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension in Pregnancy, Postpartum Preeclampsia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group: Current hospital education practices
Arm Type
No Intervention
Arm Description
The control group will receive standard of care postpartum educational materials provided by the nursing and resident physician staff. The will be asked to complete a brief questionnaire to determine if they would be interested in receiving education in a video formal.
Arm Title
Intervention group: Standardized video and pamphlet
Arm Type
Experimental
Arm Description
The subjects enrolled in the invention group will be shown a 5 minute educational video on hypertension in the postpartum period. The patients will be shown the video on the ipad while they are in the comfort of their room. They will also be provided with a pamphlet with similar information that was discussed in the video. They will also be asked to complete a brief, anonymous survey to assess patient satisfaction with the video shown, no patient identifiers will be collected.
Intervention Type
Other
Intervention Name(s)
Education provided via a video format
Other Intervention Name(s)
Education provided in a pamphlet
Intervention Description
The intervention group will be shown a 5 minute educational video on hypertension in the postpartum period. The patients will be shown the video on the ipad while they are in the comfort of their room and the investigator will step outside. At the conclusion of the video, the investigator will return into the patient room and provide a pamphlet with similar information that was discussed in the video for them to take home.
Primary Outcome Measure Information:
Title
Compliance with postpartum care
Description
The investigators will perform a retrospective chart review to determine if the study participant attended the postpartum BP check appointment
Time Frame
This outcome will be evaluated within 10 days of discharge
Title
Compliance with postpartum care
Description
The investigators will perform a retrospective chart review to determine if the study participant attended the postpartum BP check appointment
Time Frame
This outcome will be evaluated within 6 weeks of delivery
Secondary Outcome Measure Information:
Title
Incidence of postpartum re-admission for hypertension related concerns
Description
The investigators will retrospectively review if the study participants are re-admitted for hypertension related concerns
Time Frame
This outcome will be evaluated within 6 weeks of delivery
Title
Incidence of postpartum labor and delivery triage visits
Description
The investigators will retrospectively review if the study participants are evaluated in the labor and delivery triage for hypertension related concerns
Time Frame
This outcome will be evaluated within 6 weeks of delivery
Title
Incidence of postpartum emergency department visits
Description
The investigators will retrospectively review if the study participants are evaluated in the emergency department for hypertension related concerns
Time Frame
This outcome will be evaluated within 6 weeks of delivery
Title
Evaluate weight (kg) change
Description
The investigators will retrospectively compare the participants weight upon delivery admission to weight upon discharge and within 6 weeks of delivery
Time Frame
This outcome will be evaluated upon hospital admission
Title
Evaluate weight (kg) change
Description
The investigators will retrospectively compare the participants weight upon delivery admission to weight upon discharge and within 6 weeks of delivery
Time Frame
This outcome will be evaluated upon hospital discharge
Title
Evaluate weight (kg) change
Description
The investigators will retrospectively compare the participants weight upon delivery admission to weight upon discharge and within 6 weeks of delivery
Time Frame
This outcome will be evaluated within 6 week after delivery
Title
Incidence of stroke
Description
The investigators will retrospectively review if the study participant suffered a stroke
Time Frame
This outcome will be evaluated within 6 weeks of delivery
Title
Incidence of maternal death
Description
The investigators will retrospectively review maternal death during this study period
Time Frame
This outcome will be evaluated within 6 weeks of delivery
Title
Participant satisfaction with postpartum education using likert scale
Description
A likert scale survey will be administered by the investigator to the intervention and control group, the satisfaction score will be compared between both groups. The scale is reported as follows: 1 (Strongly disagree) 2 3 (neutral) 4 5 (strongly agree).
Time Frame
This outcome will be evaluated at time of recruitment, within 48hours
Title
Participant satisfaction with postpartum education
Description
A survey will be administered by the investigator to the intervention and control group, the satisfaction score will be compared between both groups. The responses are either Yes or No. For most questions, answering yes would be a favorable response.
Time Frame
This outcome will be evaluated at time of recruitment, within 48hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Postpartum with diagnosis of Hypertension is defined as chronic hypertension, gestational hypertension, preeclampsia without severe features, preeclampsia with severe features, chronic hypertension with superimposed preeclampsia with and without severe features. At least 18 years or older English speaking patient and also able to read in English Plan to receive postpartum care at Washington Hospital Center Exclusion Criteria: Women who do not intend to follow up at Washington Hospital Center Suffered from intrauterine fetal demise
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Iqbal, MD
Organizational Affiliation
Medstar Washington Hospital Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Assessment of Postpartum Education to Improve Compliance

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