Comparing Different Methods of Patient Education on Preeclampsia
| Status: | Completed |
|---|---|
| Conditions: | Anxiety, Anxiety, High Blood Pressure (Hypertension), Women's Studies |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Psychiatry / Psychology, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 8/4/2018 |
| Start Date: | May 2016 |
| End Date: | July 30, 2017 |
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.
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.
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.
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.
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
We found this trial at
2
sites
100 North Academy Avenue
Danville, Pennsylvania 17821
Danville, Pennsylvania 17821
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