MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
NCT Number: NCT04486170
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.
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Notify Me18 year and older
Female
Interventional
Not applicable
Washington D.C., District of Columbia, 20010, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Education provided in a pamphlet
Time frame: This outcome will be evaluated within 10 days of discharge
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
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
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
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
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 upon hospital admission
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
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
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 weeks of delivery
The investigators will retrospectively review if the study participant suffered a stroke
Time frame: This outcome will be evaluated within 6 weeks of delivery
The investigators will retrospectively review maternal death during this study period
Time frame: This outcome will be evaluated at time of recruitment, within 48hours
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
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.
Medstar Health Research Institute
Other
Assessment of Patient Education as a Method of Optimizing Postpartum Care in Women With Hypertension
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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