Assessment of Postpartum Education to Improve Compliance

Sponsor
Medstar Health Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT04486170
Collaborator
(none)
46
1
2
15
3.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Education provided via a video format
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
46 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Assessment of Patient Education as a Method of Optimizing Postpartum Care in Women With Hypertension
Actual Study Start Date :
Sep 14, 2020
Actual Primary Completion Date :
Jun 25, 2021
Actual Study Completion Date :
Dec 15, 2021

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control group: Current hospital education practices

The control group will receive standard of care postpartum educational materials provided by the nursing and resident physician staff. The will be asked to complete a brief questionnaire to determine if they would be interested in receiving education in a video formal.

Experimental: Intervention group: Standardized video and pamphlet

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.

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.
Other Names:
  • Education provided in a pamphlet
  • Outcome Measures

    Primary Outcome Measures

    1. Compliance with postpartum care [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

    2. 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

    1. 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

    2. 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

    3. 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

    4. Evaluate weight (kg) change [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

    5. Evaluate weight (kg) change [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

    6. 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

    7. 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

    8. 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

    9. 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).

    10. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 MedStar Washington Hospital Center Washington District of Columbia United States 20010

    Sponsors and Collaborators

    • Medstar Health Research Institute

    Investigators

    • Principal Investigator: Sara Iqbal, MD, Medstar Washington Hospital Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medstar Health Research Institute
    ClinicalTrials.gov Identifier:
    NCT04486170
    Other Study ID Numbers:
    • IRB STUDY 00001865
    First Posted:
    Jul 24, 2020
    Last Update Posted:
    Mar 21, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 21, 2022