Clinical trial NCT04486170: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension in Pregnancy
Postpartum Preeclampsia
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2020-07-24
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Compliance with postpartum care
timeFrame: This outcome will be evaluated within 10 days of discharge
measure: Compliance with postpartum care
timeFrame: This outcome will be evaluated within 6 weeks of delivery
Secondary outcomes:
measure: Incidence of postpartum re-admission for hypertension related concerns
timeFrame: This outcome will be evaluated within 6 weeks of delivery
measure: Incidence of postpartum labor and delivery triage visits
timeFrame: This outcome will be evaluated within 6 weeks of delivery
measure: Incidence of postpartum emergency department visits
timeFrame: This outcome will be evaluated within 6 weeks of delivery
measure: Evaluate weight (kg) change
timeFrame: This outcome will be evaluated upon hospital admission
measure: Evaluate weight (kg) change
timeFrame: This outcome will be evaluated upon hospital discharge
measure: Evaluate weight (kg) change
timeFrame: This outcome will be evaluated within 6 week after delivery
measure: Incidence of stroke
timeFrame: This outcome will be evaluated within 6 weeks of delivery
measure: Incidence of maternal death
timeFrame: This outcome will be evaluated within 6 weeks of delivery
measure: Participant satisfaction with postpartum education using likert scale
timeFrame: This outcome will be evaluated at time of recruitment, within 48hours
measure: Participant satisfaction with postpartum education
timeFrame: This outcome will be evaluated at time of recruitment, within 48hours
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
Study officials:
affiliation: Medstar Health Research Institute
name: Sara Iqbal, MD
role: PRINCIPAL_INVESTIGATOR
References: