Remote BP Monitoring in the PP Period

Overview

The purpose of this study is to trial remote patient monitoring (RPM) in the postpartum hypertensive population in a randomized control design, with an aim to increase the number of blood pressure measurements taken during the fragile and under-monitored postpartum period and to thereby improve postpartum blood pressure control and reduce severe morbidity and mortality. The investigators plan to compare the number of blood pressures recorded in the first 10 days postpartum between patients who have been enrolled in an RPM trial to those who are being treated with the usual care.

Full Title of Study: “Remote Blood Pressure Monitoring in the Postpartum (PP) Period”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 28, 2019

Detailed Description

Many women develop high blood pressure as a complication of pregnancy. This high blood pressure can often take many weeks to resolve, and for some women it never resolves completely. If untreated, high blood pressure of pregnancy can lead to serious consequences, such as seizure or stroke. Unfortunately, because most women are sent home from the hospital just 2-3 days after having a baby, the best way of monitoring blood pressure at home is still unknown. Most women are given a prescription for a blood pressure cuff to use at home and an appointment to see their doctor at about one week after delivery to review their blood pressures, but many women have trouble checking their blood pressures, sometimes because they have a new baby at home and sometimes for other reasons like transportation or difficult social situations. Using a Bluetooth blood pressure monitoring system might help women have better blood pressure monitoring after they are discharged from the hospital after delivery, and therefore help to prevent some of the complications that can happen because of high blood pressure related to pregnancy.

Interventions

  • Device: Remote Patient Monitoring
    • Bluetooth-enabled blood pressure cuff to assess whether this technology helps providers collect more data regarding their patients’ blood pressures in the postpartum period.

Arms, Groups and Cohorts

  • No Intervention: Usual Care
    • Usual care group patients will be assigned to the usual care given to patients with hypertensive disorders of pregnancy at Columbia University Irving Medical Center (CUIMC). This involves a prescription for a blood pressure cuff if they do not already have one, with which they will be asked to measure their blood pressure twice per day. They will be asked to keep a log of their blood pressure measurements and to bring that log to their next provider visit.
  • Experimental: Remote Patient Monitoring
    • Remote Patient Monitoring patients will use a Bluetooth-enabled blood pressure cuff, which will transmit blood pressure measurements via Bluetooth from the monitor to a tablet, which is able to be accessed by nurses staffing a remote clinical care center. Patients will also be prompted to answer surveys assessing symptoms of preeclampsia. The nurses will review measurements and survey results, which will be flagged in order of urgency. The measurements uploaded into the remote monitoring system will also be reviewed at the patient’s next provider visit.

Clinical Trial Outcome Measures

Primary Measures

  • Blood Pressure Measurement Percentage
    • Time Frame: Up to 10 days from delivery
    • Percentage of the recommended twice daily blood pressures recorded between hospital discharge and the 7-10 day postpartum blood pressure check in-person visit.

Secondary Measures

  • Elevated Blood Pressure Percentage
    • Time Frame: Up to 10 days from delivery
    • Percentage of recorded blood pressure values in 7-10 days postpartum that are elevated (>140 systolic OR >90 diastolic)
  • Percentage of Elevated Blood Pressure Leading to Conversation between Patient and Provider
    • Time Frame: Up to 10 days from delivery
    • Percentage of elevated blood pressures that triggered a phone call or conversation with an obstetric provider
  • Visit Compliance Rate
    • Time Frame: Up to 10 days from delivery
    • Rate of attendance at 7-10 day blood pressure check visit
  • Incidence of BP Elevations
    • Time Frame: Up to 10 days from delivery
    • Incidence of elevated blood pressure at the 7-10 day blood pressure check visit
  • Visit Compliance Rate
    • Time Frame: 6 weeks from delivery
    • Rate of attendance at 6 week postpartum visit
  • Incidence of BP Elevations
    • Time Frame: 6 weeks from delivery
    • Incidence of elevated blood pressure (BP) at the 6-week postpartum visit
  • Time to Medication Initiation
    • Time Frame: 6 weeks from delivery
    • Time to initiation of antihypertensive medications (in patients who were not on medications at time of discharge)
  • Final Antihypertensive Dosage
    • Time Frame: 6 weeks from delivery
    • Final dosage of antihypertensive medications at 6 weeks postpartum
  • Readmission Rate
    • Time Frame: 6 weeks from delivery
    • Rate of readmission in the postpartum period
  • ED Visit Rate
    • Time Frame: 6 weeks from delivery
    • Rate of emergency department (ED) visits
  • Rate of Morbidity
    • Time Frame: 6 weeks from delivery
    • Incidence of hypertension-related morbidities (eg: stroke, seizure, PRES)
  • Percentage with Primary Care Referrals
    • Time Frame: 6 weeks from delivery
    • Percentage of patients who require a referral to primary care physicians after being discharged from obstetric care at the 6-week postpartum visit
  • Score on the Modified Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ)
    • Time Frame: 6 weeks from delivery
    • The modified TSUQ is an 18-item survey that will be used to measure patient satisfaction with remote blood pressure monitoring. Individuals score each of the items based on their satisfaction, with 1=strongly disagree to 5=strongly agree. The responses would then be used to calculate a mean score on the 5-point scale, with 5 indicating the most satisfaction.
  • Change in Score on the Philips Program Survey
    • Time Frame: 6 weeks from delivery
    • The Philips program start survey is a 4 question survey to gauge how patients relate to their care and their doctors prior to initiation of their blood pressure monitoring program. Individuals score each of the items based on the perception of their care, with 5 being best and 1 being worst. The responses would then be used to calculate a mean score on the 5-point scale, with 5 indicating the most satisfaction, and compared between the 2 groups. The Philips program end survey is a 6 question survey to gauge how patients related to their care and their doctors after the completion of their blood pressure monitoring program. Individuals score each of the items based on the perception of their care, with 5 being best and 1 being worst. The responses would then be used to calculate a mean score on the 5-point scale, with 5 indicating the most satisfaction, and compared between the 2 groups.

Participating in This Clinical Trial

Inclusion Criteria

  • Postpartum women
  • Documented blood pressure of ≥140 systolic or ≥90 diastolic on at least 2 occasions at least 4 hours apart
  • At least 18 years of age
  • English or Spanish speakers

Exclusion Criteria

  • Non-English or Spanish speakers
  • Women who are not planning on obtaining their postpartum follow up at CUIMC
  • Women who remain hospitalized (as part of their delivery hospitalization) at 7 days postpartum
  • Women who are physically unable to hold or use the tablet
  • Women who do not have a working phone

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Columbia University
  • Collaborator
    • Philips Healthcare
  • Provider of Information About this Clinical Study
    • Principal Investigator: Leslie Moroz, Assistant Professor of Obstetrics & Gynecology – Columbia University
  • Overall Official(s)
    • Leslie Moroz, MD, Principal Investigator, Columbia University

References

American College of Obstetricians and Gynecologists; Task Force on Hypertension in Pregnancy. Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists’ Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013 Nov;122(5):1122-31. doi: 10.1097/01.AOG.0000437382.03963.88.

Goel A, Maski MR, Bajracharya S, Wenger JB, Zhang D, Salahuddin S, Shahul SS, Thadhani R, Seely EW, Karumanchi SA, Rana S. Epidemiology and Mechanisms of De Novo and Persistent Hypertension in the Postpartum Period. Circulation. 2015 Nov 3;132(18):1726-33. doi: 10.1161/CIRCULATIONAHA.115.015721. Epub 2015 Sep 28.

Creanga AA, Berg CJ, Syverson C, Seed K, Bruce FC, Callaghan WM. Pregnancy-related mortality in the United States, 2006-2010. Obstet Gynecol. 2015 Jan;125(1):5-12. doi: 10.1097/AOG.0000000000000564.

Levine LD, Nkonde-Price C, Limaye M, Srinivas SK. Factors associated with postpartum follow-up and persistent hypertension among women with severe preeclampsia. J Perinatol. 2016 Dec;36(12):1079-1082. doi: 10.1038/jp.2016.137. Epub 2016 Sep 1.

Bryant AS, Haas JS, McElrath TF, McCormick MC. Predictors of compliance with the postpartum visit among women living in healthy start project areas. Matern Child Health J. 2006 Nov;10(6):511-6.

Albini F, Xiaoqiu Liu, Torlasco C, Soranna D, Faini A, Ciminaghi R, Celsi A, Benedetti M, Zambon A, di Rienzo M, Parati G. An ICT and mobile health integrated approach to optimize patients' education on hypertension and its management by physicians: The Patients Optimal Strategy of Treatment(POST) pilot study. Conf Proc IEEE Eng Med Biol Soc. 2016 Aug;2016:517-520. doi: 10.1109/EMBC.2016.7590753.

Sibai BM. Etiology and management of postpartum hypertension-preeclampsia. Am J Obstet Gynecol. 2012 Jun;206(6):470-5. doi: 10.1016/j.ajog.2011.09.002. Epub 2011 Sep 16. Review.

Walters BN, Thompson ME, Lee A, de Swiet M. Blood pressure in the puerperium. Clin Sci (Lond). 1986 Nov;71(5):589-94.

Clark SL, Belfort MA, Dildy GA, Englebright J, Meints L, Meyers JA, Frye DK, Perlin JA. Emergency department use during the postpartum period: implications for current management of the puerperium. Am J Obstet Gynecol. 2010 Jul;203(1):38.e1-6. doi: 10.1016/j.ajog.2010.02.033. Epub 2010 Apr 24.

Clapp MA, Little SE, Zheng J, Robinson JN. A multi-state analysis of postpartum readmissions in the United States. Am J Obstet Gynecol. 2016 Jul;215(1):113.e1-113.e10. doi: 10.1016/j.ajog.2016.01.174.

Al-Safi Z, Imudia AN, Filetti LC, Hobson DT, Bahado-Singh RO, Awonuga AO. Delayed postpartum preeclampsia and eclampsia: demographics, clinical course, and complications. Obstet Gynecol. 2011 Nov;118(5):1102-7. doi: 10.1097/AOG.0b013e318231934c.

Bushnell C, McCullough LD, Awad IA, Chireau MV, Fedder WN, Furie KL, Howard VJ, Lichtman JH, Lisabeth LD, Piña IL, Reeves MJ, Rexrode KM, Saposnik G, Singh V, Towfighi A, Vaccarino V, Walters MR; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology; Council on Epidemiology and Prevention; Council for High Blood Pressure Research. Guidelines for the prevention of stroke in women: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 May;45(5):1545-88. doi: 10.1161/01.str.0000442009.06663.48. Epub 2014 Feb 6. Review. Erratum in: Stroke. 2014 Oct;45(10);e214. Stroke.2014 May;45(5):e95.

Wenger NK, Arnold A, Bairey Merz CN, Cooper-DeHoff RM, Ferdinand KC, Fleg JL, Gulati M, Isiadinso I, Itchhaporia D, Light-McGroary K, Lindley KJ, Mieres JH, Rosser ML, Saade GR, Walsh MN, Pepine CJ. Hypertension Across a Woman's Life Cycle. J Am Coll Cardiol. 2018 Apr 24;71(16):1797-1813. doi: 10.1016/j.jacc.2018.02.033. Review.

Hirshberg A, Downes K, Srinivas S. Comparing standard office-based follow-up with text-based remote monitoring in the management of postpartum hypertension: a randomised clinical trial. BMJ Qual Saf. 2018 Nov;27(11):871-877. doi: 10.1136/bmjqs-2018-007837. Epub 2018 Apr 27.

Tully KP, Stuebe AM, Verbiest SB. The fourth trimester: a critical transition period with unmet maternal health needs. Am J Obstet Gynecol. 2017 Jul;217(1):37-41. doi: 10.1016/j.ajog.2017.03.032. Epub 2017 Apr 5.

ACOG Committee Opinion No. 736: Optimizing Postpartum Care. Obstet Gynecol. 2018 May;131(5):e140-e150. doi: 10.1097/AOG.0000000000002633.

Too G, Wen T, Boehme AK, Miller EC, Leffert LR, Attenello FJ, Mack WJ, DʼAlton ME, Friedman AM. Timing and Risk Factors of Postpartum Stroke. Obstet Gynecol. 2018 Jan;131(1):70-78. doi: 10.1097/AOG.0000000000002372.

Gandapur Y, Kianoush S, Kelli HM, Misra S, Urrea B, Blaha MJ, Graham G, Marvel FA, Martin SS. The role of mHealth for improving medication adherence in patients with cardiovascular disease: a systematic review. Eur Heart J Qual Care Clin Outcomes. 2016 Oct 1;2(4):237-244. doi: 10.1093/ehjqcco/qcw018. Review.

Arnhold M, Quade M, Kirch W. Mobile applications for diabetics: a systematic review and expert-based usability evaluation considering the special requirements of diabetes patients age 50 years or older. J Med Internet Res. 2014 Apr 9;16(4):e104. doi: 10.2196/jmir.2968. Review.

Rhoads SJ, Serrano CI, Lynch CE, Ounpraseuth ST, Gauss CH, Payakachat N, Lowery CL, Eswaran H. Exploring Implementation of m-Health Monitoring in Postpartum Women with Hypertension. Telemed J E Health. 2017 Oct;23(10):833-841. doi: 10.1089/tmj.2016.0272. Epub 2017 May 5.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.