Assessment of Postpartum Education to Improve Compliance
- Conditions
- Postpartum PreeclampsiaHypertension in Pregnancy
- Interventions
- Other: Education provided via a video format
- Registration Number
- NCT04486170
- Lead Sponsor
- Medstar Health Research Institute
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 46
- 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
- Women who do not intend to follow up at Washington Hospital Center
- Suffered from intrauterine fetal demise
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group: Standardized video and pamphlet Education provided via a video format 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.
- Primary Outcome Measures
Name Time Method Compliance with postpartum care 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
- Secondary Outcome Measures
Name Time Method Incidence of stroke This outcome will be evaluated within 6 weeks of delivery The investigators will retrospectively review if the study participant suffered a stroke
Incidence of postpartum re-admission for hypertension related concerns 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
Participant satisfaction with postpartum education using likert scale 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).
Incidence of postpartum emergency department visits 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
Evaluate weight (kg) change 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
Incidence of maternal death This outcome will be evaluated within 6 weeks of delivery The investigators will retrospectively review maternal death during this study period
Incidence of postpartum labor and delivery triage visits 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
Participant satisfaction with postpartum education 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.
Trial Locations
- Locations (1)
MedStar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States