Comparing Different Methods of Patient Education on Preeclampsia

July 14, 2020 updated by: Geisinger Clinic

Comparing Different Methods of Patient Education on Preeclampsia: A Randomized Controlled Trial

Preeclampsia is a life-threatening condition unique to pregnancy which occurs in 5-8% of all pregnancies. It contributes to a large proportion of maternal mortality worldwide and these deaths largely result from delayed diagnosis.

A number of studies have shown that patient knowledge about preeclampsia is poor and that patient education can improve patient awareness. The investigators would like to find out what type of patient education is most effective. The investigators propose a three arm randomized controlled trial (RCT) where the first arm will receive a graphic card depicting signs and symptoms of preeclampsia, the second arm will watch an educational video on preeclampsia, and the third arm will have no visual form of patient education; they will be exposed only to the counseling they receive with their routine prenatal care. The card and video were both developed by the Preeclampsia Foundation and in a prior RCT the card was shown to be a useful educational intervention. This study would expand on this previous data by comparing the graphic card to an informational video available on the Preeclampsia Foundation's website (http://www.preeclampsia.org/component/allvideoshare/video/featured/7-symptoms-every-pregnant-woman-should-know?Itemid=479). The effectiveness of this video has not yet been tested as an educational tool. Patients in the arm receiving the graphic card for educational intervention will be allowed to keep this card. Primiparous patients seen in the ambulatory prenatal clinic and Maternal Fetal Medicine (MFM) clinic will be enrolled at 18w0d-24w6d gestation. At the time of enrollment baseline preeclampsia knowledge, demographics, and patient anxiety before and after initial exposure to the educational interventions will be assessed. A follow up assessment of knowledge of preeclampsia will be obtained at 32-36 weeks gestation to measure retention of knowledge. Patient medical records will be reviewed for delivery outcomes which will be recorded and compared.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a three-arm prospective randomized controlled trial to evaluate patient knowledge of preeclampsia after different forms of education. In the first arm participants will be given a graphic card depicting signs and symptoms of preeclampsia; they will be permitted to keep this card. In the second arm participants will be shown an educational video on preeclampsia. In the third arm participants will have no visual form of patient education; they will be exposed only to the counseling they receive with their routine prenatal care. Participants will be primiparous patients recruited from the prenatal clinic at 18-24 weeks gestation. At time of consent, baseline anxiety assessment with the STAI-6 questionnaire will be obtained followed by a short demographic survey. Participants will be given a short survey on preeclampsia knowledge. They will then be randomized to either preeclampsia education with educational video, graphic card or no visual educational intervention. The participants will be randomized by computer-generated randomization schema (1:1:1). Those randomized to the card will be given a few minutes to review the card. Those randomized to the educational video will watch the video which runs two minutes and 45 seconds. For those randomized to no further intervention, the initial interview will then be over. For the first two arms receiving the graphic card or watching the video, the STAI 6 assessment will be re-administered immediately after the educational intervention and then the interview will be over. Medical record numbers from every participant will be collected for chart review of demographics, preeclampsia risk factors, pregnancy follow up (including triage calls and visits) and delivery outcomes. The participants will be approached again at 32w0d-36w6d gestation to complete a follow up preeclampsia knowledge survey to assess retention of knowledge. This follow-up survey will be collected via phone interview. Participants in the control arm receiving routine prenatal care will also complete a follow up knowledge survey as a control.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17821
        • Geisinger Medical Center: Maternal Fetal Medicine and Prenatal Clinics
      • Forty Fort, Pennsylvania, United States, 18704
        • Geisinger Maternal Fetal Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Primiparous pregnant women
  • English speaking
  • Patients at Geisinger Medical Center prenatal clinic
  • Patients at Geisinger Medical Center and Forty Fort Maternal Fetal Medicine clinics

Exclusion Criteria:

  • Multiparous pregnant women
  • Non-English speaking
  • Significant hearing loss/disability
  • Blind or with severe visual impairment
  • Do not have adequate capacity to give consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No intervention
No additional education
Experimental: Graphic card
Education with graphic card
Other: Graphic card
A randomized controlled trial comparing patient education on preeclampsia with a graphic card vs. patient education with a written pamphlet vs. no patient education showed that patient education improved significantly when patients were provided with a graphic card depicting signs and symptoms of preeclampsia and that this improvement occurred regardless of health literacy score (You WB, Wolf MS, Bailey SC, Grobman WA. Improving patient understanding of preeclampsia: a randomized controlled trial. American Journal of Obstetrics & Gynecology. 2012;206:431.e1-431.e5.). The graphic card is now available on the Preeclampsia Foundation's website (http://www.preeclampsia.org/market-place/educational-illustrated-signs-symptoms-pad-detail).
Other Names:
  • Preeclampsia graphic card
Experimental: Video
Education with video
Other: Video
This an informational video available on the Preeclampsia Foundation's website (http://www.preeclampsia.org/component/allvideoshare/video/featured/7-symptoms-every-pregnant-woman-should-know?Itemid=479). The effectiveness of this video has not yet been tested as an educational tool.
Other Names:
  • 7 Symptoms Every Pregnant Woman Should Know

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in percentage of correct responses of preeclampsia knowledge survey score at follow-up assessment
Time Frame: 12-16 weeks
This survey was previously tested in a study by You et al (You WB, Wolf M, Bailey SC, et al. Factors associated with patient understanding of preeclampsia. Hypertension in pregnancy. 2012;31:341.) and found to have a Cronbach alpha of 0.86. The same survey used in a follow up study by You et al (You WB, Wolf MS, Bailey SC, Grobman WA. Improving patient understanding of preeclampsia: a randomized controlled trial. American Journal of Obstetrics & Gynecology. 2012;206:431.e1-431.e5. )
12-16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in anxiety level after educational intervention as measured by the STAI 6
Time Frame: 5 minutes
The Spielberger State-Trait Anxiety Inventory (STAI) is a reliable and sensitive measure of anxiety at a given moment in time. A shorter form, the STAI-6, was created for efficiency and has been verified as comparable in reliability and validity to the full STAI assessment (Marteau, TM and Beckker, H. The development of a six-item short form of the State Scale of the Spielberger State Trait Anxiety Inventory (STAI). British Journal of Clinical Psychology. 1991: 31: 301-306).
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Geisinger Clinic

Investigators

  • Principal Investigator: Michael J Paglia, MD, PhD, Geisinger Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

July 30, 2017

Study Completion (Actual)

July 30, 2017

Study Registration Dates

First Submitted

May 5, 2016

First Submitted That Met QC Criteria

May 5, 2016

First Posted (Estimate)

May 9, 2016

Study Record Updates

Last Update Posted (Actual)

July 16, 2020

Last Update Submitted That Met QC Criteria

July 14, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-0116

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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