Assessment of Patient Education as a Method of Optimizing Postpartum Care in Women With Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Compliance with postpartum care
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Women who do not intend to follow up at Washington Hospital Center
- •Suffered from intrauterine fetal demise
结局指标
主要结局
Compliance with postpartum care
时间窗: 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
次要结局
- Incidence of stroke(This outcome will be evaluated within 6 weeks of delivery)
- Incidence of postpartum re-admission for hypertension related concerns(This outcome will be evaluated within 6 weeks of delivery)
- Participant satisfaction with postpartum education using likert scale(This outcome will be evaluated at time of recruitment, within 48hours)
- Incidence of postpartum emergency department visits(This outcome will be evaluated within 6 weeks of delivery)
- Evaluate weight (kg) change(This outcome will be evaluated within 6 week after delivery)
- Incidence of maternal death(This outcome will be evaluated within 6 weeks of delivery)
- Incidence of postpartum labor and delivery triage visits(This outcome will be evaluated within 6 weeks of delivery)
- Participant satisfaction with postpartum education(This outcome will be evaluated at time of recruitment, within 48hours)