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Preeclampsia complicates approximately 8% of all pregnancies. A critical factor of outpatient monitoring is patient education; specifically, education regarding nature of the disease, ongoing short- and long-term risks, and warning signs and symptoms for worsening of disease. This study aims to compare patient knowledge using a novel illustration based app compared to standard discharge instructions.
Preeclampsia complicates approximately 8% of all pregnancies. While many patients improve following delivery, the disease process remains a leading cause for postpartum morbidity and mortality. A critical factor of outpatient monitoring is patient education; specifically, education regarding nature of the disease, ongoing short- and long-term risks, and warning signs and symptoms for worsening of disease. There is a gap in the literature regarding effective, patient-centered educational tools specifically addressing these elements, especially in the postpartum period.
The investigators propose a pilot, randomized controlled trial of postpartum patients with preeclampsia. The intervention of interest is an illustration-based, educational mobile device application (app) focused on the short- and long-term risks associated with preeclampsia and warning signs and symptoms of worsening disease postpartum. The control for this study will be the same information in a text-only format, also accessed through a mobile device app.
The investigators central hypothesis is that an illustration-based app will improve knowledge of preeclampsia among postpartum patients compared to text-only educational material.
Specific Aim 1: Compare the difference in preeclampsia knowledge score from text-only versus illustration-based education 24 hours post intervention (short-term). The investigators hypothesize that patients who receive illustration-based education will have a) higher preeclampsia knowledge scores at 24 hours post-intervention compared to text-only educational materials and b) a greater increase in preeclampsia knowledge score from baseline (pre-test) compared to text-only education.
Specific Aim 2: Compare the difference in preeclampsia knowledge score from text-only versus illustration-based education >4 weeks post intervention (long-term). The investigators hypothesize that patients who receive illustration-based education will have a) higher preeclampsia knowledge scores at > 4 weeks post-intervention compared to text-only educational materials and b) a greater increase in preeclampsia knowledge score from baseline (pre-test) compared to text-only education.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Illustration | Experimental | This study arm will receive education via an illustration based application |
|
| Text | Active Comparator | This study arm will receive education via text based application |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Illustration based application | Other | Illustrations regarding the cause, risks, and warning signs of preeclampsia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Preeclampsia knowledge score - short | Short term preeclampsia knowledge score. Scored from 0-24, with 24 demonstrating the most correct answers to the assessment | Measured at 24 hours postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Preeclampsia knowledge score - long | Long term preeclampsia knowledge score. Scored from 0-24, with 24 demonstrating the most correct answers to the assessment | Measured between 4 - 6 weeks postpartum |
| GAD-7 score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Megan Oakes, MD MSCI | Magella Medical Group, MemorialCare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MemorialCare Long Beach Medical Center | Long Beach | California | 90806 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35849460 | Background | Bruno AM, Allshouse AA, Metz TD, Theilen LH. Trends in Hypertensive Disorders of Pregnancy in the United States From 1989 to 2020. Obstet Gynecol. 2022 Jul 1;140(1):83-86. doi: 10.1097/AOG.0000000000004824. Epub 2022 Jun 7. | |
| 35916004 | Background | Dol J, Hughes B, Bonet M, Dorey R, Dorling J, Grant A, Langlois EV, Monaghan J, Ollivier R, Parker R, Roos N, Scott H, Shin HD, Curran J. Timing of maternal mortality and severe morbidity during the postpartum period: a systematic review. JBI Evid Synth. 2022 Sep 1;20(9):2119-2194. doi: 10.11124/JBIES-20-00578. |
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Text based application | Other | Standard preeclampsia discharge instructions |
|
Generalized anxiety score. A score of 0-4 demonstrating none or minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety, 15-21 severe anxiety
| Measured between 4-6 weeks postpartum |
| 72 hour BP check | Adherence to a blood pressure check | Measured 72 hours after hospital discharge |
| Number of participants who attend a postpartum visit | Adherence to one postpartum visit | Measured within 6 weeks postpartum |
| Daily BP recordings | Percent of daily blood pressure recordings at home | Measured within 6 weeks postpartum |
| Accessed material | Number of times information accessed postpartum | Measured at 6 weeks postpartum |
| Unplanned readmission | Number of unplanned readmissions related to preeclampsia | Measured at 6 weeks postpartum |
| 34724906 | Background | Shree R, Hatfield-Timajchy K, Brewer A, Tsigas E, Vidler M. Information needs and experiences from pregnancies complicated by hypertensive disorders: a qualitative analysis of narrative responses. BMC Pregnancy Childbirth. 2021 Nov 2;21(1):743. doi: 10.1186/s12884-021-04219-0. |
| 22542120 | Background | 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. |
| 20860492 | 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. |
| 12066093 | Background | Chames MC, Livingston JC, Ivester TS, Barton JR, Sibai BM. Late postpartum eclampsia: a preventable disease? Am J Obstet Gynecol. 2002 Jun;186(6):1174-7. doi: 10.1067/mob.2002.123824. |
| 31575778 | Background | Collier AY, Molina RL. Maternal Mortality in the United States: Updates on Trends, Causes, and Solutions. Neoreviews. 2019 Oct;20(10):e561-e574. doi: 10.1542/neo.20-10-e561. |
| 29133363 | Background | Ditisheim A, Wuerzner G, Ponte B, Vial Y, Irion O, Burnier M, Boulvain M, Pechere-Bertschi A. Prevalence of Hypertensive Phenotypes After Preeclampsia: A Prospective Cohort Study. Hypertension. 2018 Jan;71(1):103-109. doi: 10.1161/HYPERTENSIONAHA.117.09799. Epub 2017 Nov 13. |
| 32443079 | Background | Gestational Hypertension and Preeclampsia: ACOG Practice Bulletin, Number 222. Obstet Gynecol. 2020 Jun;135(6):e237-e260. doi: 10.1097/AOG.0000000000003891. |