Assessment of Postpartum Education to Improve Compliance

Hypertension in Pregnancy Clinical Trial

Official title:

Assessment of Patient Education as a Method of Optimizing Postpartum Care in Women With Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04486170
• Other study ID #: IRB STUDY 00001865
• Status: Completed
• Phase: N/A
• Start date: September 14, 2020
• Est. completion date: December 15, 2021

Study information

• Verified date: March 2022
• Source: Medstar Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 15, 2021
• Est. primary completion date: June 25, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension in Pregnancy
• Hypertension, Pregnancy-Induced
• Postpartum Preeclampsia
• Pre-Eclampsia

Intervention

Other:
• Education provided via a video format
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.

Locations

Country	Name	City	State
United States	MedStar Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Medstar Health Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance with postpartum care	The investigators will perform a retrospective chart review to determine if the study participant attended the postpartum BP check appointment	This outcome will be evaluated within 10 days of discharge
Primary	Compliance with postpartum care	The investigators will perform a retrospective chart review to determine if the study participant attended the postpartum BP check appointment	This outcome will be evaluated within 6 weeks of delivery
Secondary	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	This outcome will be evaluated within 6 weeks of delivery
Secondary	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	This outcome will be evaluated within 6 weeks of delivery
Secondary	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	This outcome will be evaluated within 6 weeks of delivery
Secondary	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	This outcome will be evaluated upon hospital admission
Secondary	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	This outcome will be evaluated upon hospital discharge
Secondary	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	This outcome will be evaluated within 6 week after delivery
Secondary	Incidence of stroke	The investigators will retrospectively review if the study participant suffered a stroke	This outcome will be evaluated within 6 weeks of delivery
Secondary	Incidence of maternal death	The investigators will retrospectively review maternal death during this study period	This outcome will be evaluated within 6 weeks of delivery
Secondary	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).	This outcome will be evaluated at time of recruitment, within 48hours
Secondary	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.	This outcome will be evaluated at time of recruitment, within 48hours