Comparing Different Methods of Patient Education on Preeclampsia

NCT02765906 | Completed

• 1 other identifier: 2016-0116
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Preeclampsia; Anxiety; Hypertension; Pregnancy; Eclampsia; HELLP

Keywords

video; educational tool; preeclampsia; hypertension; pregnancy; patient education; graphic card; eclampsia; HELLP; anxiety; anxiety assessment; STAI 6

Outcome Measures

Primary Outcomes (1)

• Change in percentage of correct responses of preeclampsia knowledge survey score at follow-up assessment

  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 Outcomes (1)

• Change in anxiety level after educational intervention as measured by the STAI 6

  5 minutes

Study Arms (3)

No intervention

NO INTERVENTION

No additional education

Graphic card

EXPERIMENTAL

Education with graphic card

Other: Graphic card

Video

EXPERIMENTAL

Education with video

Other: Video

Interventions

Graphic card OTHER

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).

Also known as: Preeclampsia graphic card

Graphic card

Video OTHER

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.

Also known as: 7 Symptoms Every Pregnant Woman Should Know

Video

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Geisinger Clinic: lead

Study Sites (2)

Geisinger Medical Center: Maternal Fetal Medicine and Prenatal Clinics

Danville, Pennsylvania, 17821, United States

Location

Geisinger Maternal Fetal Medicine

Forty Fort, Pennsylvania, 18704, United States

Location

Related Publications (11)

• You WB, Wolf MS, Bailey SC, Grobman WA. Improving patient understanding of preeclampsia: a randomized controlled trial. Am J Obstet Gynecol. 2012 May;206(5):431.e1-5. doi: 10.1016/j.ajog.2012.03.006. Epub 2012 Mar 13.

  PMID: 22542120 BACKGROUND

• Firoz T, Sanghvi H, Merialdi M, von Dadelszen P. Pre-eclampsia in low and middle income countries. Best Pract Res Clin Obstet Gynaecol. 2011 Aug;25(4):537-48. doi: 10.1016/j.bpobgyn.2011.04.002. Epub 2011 May 17.

  PMID: 21592865 BACKGROUND

• Tsigas E, Magee LA. Advocacy organisations as partners in pre-eclampsia progress: patient involvement improves outcomes. Best Pract Res Clin Obstet Gynaecol. 2011 Aug;25(4):523-36. doi: 10.1016/j.bpobgyn.2011.03.001. Epub 2011 May 12.

  PMID: 21570359 BACKGROUND

• Ogunyemi D, Benae JL, Ukatu C. Is eclampsia preventable? A case control review of consecutive cases from an urban underserved region. South Med J. 2004 May;97(5):440-5. doi: 10.1097/00007611-200405000-00005.

  PMID: 15180017 BACKGROUND

• Walker MG, Windrim C, Ellul KN, Kingdom JCP. Web-based education for placental complications of pregnancy. J Obstet Gynaecol Can. 2013 Apr;35(4):334-339. doi: 10.1016/S1701-2163(15)30961-0.

  PMID: 23660041 BACKGROUND

• You WB, Wolf M, Bailey SC, Pandit AU, Waite KR, Sobel RM, Grobman W. Factors associated with patient understanding of preeclampsia. Hypertens Pregnancy. 2012;31(3):341-9. doi: 10.3109/10641955.2010.507851. Epub 2010 Sep 22.

  PMID: 20860492 BACKGROUND

• Maimburg RD, Vaeth M, Hvidman L, Durr J, Olsen J. Women's worries in first pregnancy: results from a randomised controlled trial. Sex Reprod Healthc. 2013 Dec;4(4):129-31. doi: 10.1016/j.srhc.2013.10.001. Epub 2013 Oct 9.

  PMID: 24216040 BACKGROUND

• Muller C, Cameron LD. Trait anxiety, information modality, and responses to communications about prenatal genetic testing. J Behav Med. 2014 Oct;37(5):988-99. doi: 10.1007/s10865-014-9555-8. Epub 2014 Jan 31.

  PMID: 24481564 BACKGROUND

• Muthusamy AD, Leuthner S, Gaebler-Uhing C, Hoffmann RG, Li SH, Basir MA. Supplemental written information improves prenatal counseling: a randomized trial. Pediatrics. 2012 May;129(5):e1269-74. doi: 10.1542/peds.2011-1702. Epub 2012 Apr 9.

  PMID: 22492766 BACKGROUND

• Marteau TM, Bekker H. The development of a six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI). Br J Clin Psychol. 1992 Sep;31(3):301-6. doi: 10.1111/j.2044-8260.1992.tb00997.x.

  PMID: 1393159 BACKGROUND

• Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013 Nov;122(5):1122-1131. doi: 10.1097/01.AOG.0000437382.03963.88. No abstract available.

  PMID: 24150027 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Pre-Eclampsia; Anxiety Disorders; Hypertension; Eclampsia

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Mental Disorders; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Study Officials

• Michael J Paglia, MD, PhD

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2016
• First Posted: May 9, 2016
• Study Start: May 1, 2016
• Primary Completion: July 30, 2017
• Study Completion: July 30, 2017
• Last Updated: July 16, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)