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| Name | Class |
|---|---|
| Philips Healthcare | INDUSTRY |
| New York Presbyterian Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | 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. | |
| Remote Patient Monitoring | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote Patient Monitoring | Device | Bluetooth-enabled blood pressure cuff to assess whether this technology helps providers collect more data regarding their patients' blood pressures in the postpartum period. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure (BP) Surveillance Adherence | Percentage of recommended twice-daily blood pressures reported between hospital discharge and first outpatient blood pressure assessment | Up to 14 days from delivery hospitalization discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Total Percentage of Elevated Blood Pressure Readings | Of all blood pressure (BP) recordings collected per arm, the total percentage of those that were elevated will be reported. Elevated blood pressure defined as >/=140 systolic or >/=90 diastolic) by time of first outpatient blood pressure assessment (or 14 days from discharge, whichever came first). | Up to 14 days from delivery hospitalization discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leslie Moroz, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24150027 | 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. | |
| 26416810 | Background | 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. |
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Subjects were recruited from the inpatient postpartum service after delivery. Recruitment began on November 9, 2018. The last participant was recruited on July 10, 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Blood Pressure (BP) Surveillance Adherence | Percentage of recommended twice-daily blood pressures reported between hospital discharge and first outpatient blood pressure assessment | Posted | Median | Full Range | percentage of recommended BPs reported | Up to 14 days from delivery hospitalization discharge |
|
Adverse event data were collected through the end of the study period, which ended at the time of participants' postpartum visit or 8 weeks postpartum, whichever came first.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Readmission | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | This metric refers to hospital readmissions after delivery hospitalization discharge. This was also a secondary outcome metric of this study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Leslie Moroz | Columbia University | 646-532-8208 | lm3000@cumc.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 22, 2020 | Aug 23, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D014115 | Toxemia |
| D011225 | Pre-Eclampsia |
| D046110 | Hypertension, Pregnancy-Induced |
| ID | Term |
|---|---|
| D007239 | Infections |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Randomized Control Trial with 2 arms
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| Number of Participants With Outpatient BP Assessment Within 14 Days | Number of participants who had a documented outpatient BP assessment within 14 days of hospital discharge (excluding measurements taken at home) | Up to 14 days from delivery hospitalization discharge |
| Percentage of Participants With Elevated BP After Discharge | Incidence of elevated blood pressure (>140 systolic or >90 diastolic) at outpatient blood pressure assessment | Up to 14 days from delivery hospitalization discharge |
| Number of Participants With Outpatient PP Assessment | Number of participants who had an outpatient postpartum (PP) assessment | Up to 8 weeks from delivery |
| Percentage of Participants With Elevated Blood Pressure at the Postpartum Visit | Incidence of elevated blood pressure (>140 systolic or >90 diastolic) at the postpartum visit | Up to 8 weeks from delivery |
| Time to Medication Initiation | Time to initiation of antihypertensive medications (in patients who were not on medications at time of discharge) | Up to 8 weeks from delivery |
| Number of Participants Initiated on Antihypertensive Therapy After Hospital Discharge | Number of participants discharged from delivery hospitalization without antihypertensive therapy, who were subsequently started on antihypertensive therapy | Up to 8 weeks from delivery |
| Number of Participants Readmitted | Number of participants who were readmitted after delivery hospitalization discharge | Up to 8 weeks from delivery |
| Number of Participants With ED Visit | Number of participants who had an Emergency Department (ED) visit after delivery hospitalization discharge | Up to 8 weeks from delivery |
| Number of Participants Who Developed Preeclampsia-associated Complications | Number of patients who experienced preeclampsia-related morbidity (eg: stroke, seizure, posterior reversible encephalopathy syndrome (PRES) , pulmonary edema, liver function abnormality, reversible cerebral vasoconstriction syndrome (RCVS) , renal insufficiency, thrombocytopenia) after delivery hospitalization discharge. | Up to 8 weeks from delivery |
| Number of Participants Referred to Primary Care for Continued Blood Pressure Management | Number of participants who require a referral to primary care physicians for continued blood pressure management after being discharged from obstetric care at the postpartum visit | Up to 8 weeks from delivery |
| Score on the Modified Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ) | 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. | Up to 8 weeks from delivery |
| Score on the Philips Program Start Survey and the Philips Program End Survey | 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. The number reported is the average score for each group. | Baseline, program end (up to 8 weeks from delivery) |
| Communications | Number of communications between patient and obstetric provider | Up to 14 days post delivery hospitalization discharge |
| 25560097 | Background | 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. |
| 27583396 | Background | 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. |
| 16807794 | Background | 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. doi: 10.1007/s10995-006-0128-5. |
| 28324932 | Background | 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. Annu Int Conf IEEE Eng Med Biol Soc. 2016 Aug;2016:517-520. doi: 10.1109/EMBC.2016.7590753. |
| 21963308 | Background | 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. |
| 3769407 | Background | Walters BN, Thompson ME, Lee A, de Swiet M. Blood pressure in the puerperium. Clin Sci (Lond). 1986 Nov;71(5):589-94. doi: 10.1042/cs0710589. |
| 20417492 | Background | 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. |
| 27829570 | Background | 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. |
| 21979459 | Background | 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):1102-1107. doi: 10.1097/AOG.0b013e318231934c. |
| 24503673 | Background | Bushnell C, McCullough LD, Awad IA, Chireau MV, Fedder WN, Furie KL, Howard VJ, Lichtman JH, Lisabeth LD, Pina 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. |
| 29673470 | Background | 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. |
| 29703800 | Background | 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. |
| 28390671 | Background | 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. |
| 29683911 | Background | ACOG Committee Opinion No. 736: Optimizing Postpartum Care. Obstet Gynecol. 2018 May;131(5):e140-e150. doi: 10.1097/AOG.0000000000002633. |
| 29215510 | Background | Too G, Wen T, Boehme AK, Miller EC, Leffert LR, Attenello FJ, Mack WJ, D'Alton ME, Friedman AM. Timing and Risk Factors of Postpartum Stroke. Obstet Gynecol. 2018 Jan;131(1):70-78. doi: 10.1097/AOG.0000000000002372. |
| 29474713 | Background | 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. |
| 24718852 | Background | 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. |
| 28475431 | Background | 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. |
| BG001 | 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. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Multiparous | Count of Participants | Participants |
|
| Married/Partnered | Number | participants |
|
| Highest level of education | Highest level of maternal education completed | Count of Participants | Participants |
|
| Employment status | Count of Participants | Participants |
|
| Type of insurance | Count of Participants | Participants |
|
| Born outside of United States | Count of Participants | Participants |
|
| Religion | Count of Participants | Participants |
|
| Type of prenatal care | Count of Participants | Participants |
|
| Smoking status | Count of Participants | Participants |
|
| Drug use status | Count of Participants | Participants |
|
| Time of initiation of prenatal care | Count of Participants | Participants |
|
| Diabetes diagnosis | Count of Participants | Participants |
|
| Gestational age at delivery | Count of Participants | Participants |
|
| Type of delivery | Count of Participants | Participants |
|
| Neonatal disposition | Count of Participants | Participants |
|
| Type of hypertension | Count of Participants | Participants |
|
| Exposure to magnesium sulfate | Count of Participants | Participants |
|
| Urgent antihypertensive medication antepartum or intrapartum | Count of Participants | Participants |
|
| Discharged on antihypertensive medication | Count of Participants | Participants |
|
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. 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. |
|
|
| Secondary | Total Percentage of Elevated Blood Pressure Readings | Of all blood pressure (BP) recordings collected per arm, the total percentage of those that were elevated will be reported. Elevated blood pressure defined as >/=140 systolic or >/=90 diastolic) by time of first outpatient blood pressure assessment (or 14 days from discharge, whichever came first). | The analyzed population only includes participants who recorded at least one blood pressure at home after hospital discharge. | Posted | Number | percentage of elevated BP readings | Up to 14 days from delivery hospitalization discharge |
|
|
|
| Secondary | Number of Participants With Outpatient BP Assessment Within 14 Days | Number of participants who had a documented outpatient BP assessment within 14 days of hospital discharge (excluding measurements taken at home) | Posted | Count of Participants | Participants | Up to 14 days from delivery hospitalization discharge |
|
|
|
| Secondary | Percentage of Participants With Elevated BP After Discharge | Incidence of elevated blood pressure (>140 systolic or >90 diastolic) at outpatient blood pressure assessment | 1 participant in the Usual Care group attended but did not have BP recorded at outpatient visit. 2 participants in the Remote Patient Monitoring group attended but did not have BP recorded at outpatient visit. | Posted | Number | percentage of participants | Up to 14 days from delivery hospitalization discharge |
|
|
|
| Secondary | Number of Participants With Outpatient PP Assessment | Number of participants who had an outpatient postpartum (PP) assessment | Posted | Count of Participants | Participants | Up to 8 weeks from delivery |
|
|
|
| Secondary | Percentage of Participants With Elevated Blood Pressure at the Postpartum Visit | Incidence of elevated blood pressure (>140 systolic or >90 diastolic) at the postpartum visit | The analyzed population only includes participants who had an outpatient postpartum assessment. | Posted | Number | percentage of participants | Up to 8 weeks from delivery |
|
|
|
| Secondary | Time to Medication Initiation | Time to initiation of antihypertensive medications (in patients who were not on medications at time of discharge) | The analyzed population only includes participants in each arm who were not on medications at the time of discharge. | Posted | Median | Inter-Quartile Range | days | Up to 8 weeks from delivery |
|
|
|
| Secondary | Number of Participants Initiated on Antihypertensive Therapy After Hospital Discharge | Number of participants discharged from delivery hospitalization without antihypertensive therapy, who were subsequently started on antihypertensive therapy | The analyzed population only includes participants who were not on medications at the time of discharge. | Posted | Count of Participants | Participants | Up to 8 weeks from delivery |
|
|
|
| Secondary | Number of Participants Readmitted | Number of participants who were readmitted after delivery hospitalization discharge | Posted | Count of Participants | Participants | Up to 8 weeks from delivery |
|
|
|
| Secondary | Number of Participants With ED Visit | Number of participants who had an Emergency Department (ED) visit after delivery hospitalization discharge | Posted | Count of Participants | Participants | Up to 8 weeks from delivery |
|
|
|
| Secondary | Number of Participants Who Developed Preeclampsia-associated Complications | Number of patients who experienced preeclampsia-related morbidity (eg: stroke, seizure, posterior reversible encephalopathy syndrome (PRES) , pulmonary edema, liver function abnormality, reversible cerebral vasoconstriction syndrome (RCVS) , renal insufficiency, thrombocytopenia) after delivery hospitalization discharge. | Posted | Count of Participants | Participants | Up to 8 weeks from delivery |
|
|
|
| Secondary | Number of Participants Referred to Primary Care for Continued Blood Pressure Management | Number of participants who require a referral to primary care physicians for continued blood pressure management after being discharged from obstetric care at the postpartum visit | Posted | Count of Participants | Participants | Up to 8 weeks from delivery |
|
|
|
| Secondary | Score on the Modified Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ) | 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. | This questionnaire was not given to the Usual Care group since they did not participate in a telemedicine program. There were 52 respondents to the survey in the remote patient monitoring group. | Posted | Mean | Standard Deviation | score on a scale | Up to 8 weeks from delivery |
|
|
|
| Secondary | Score on the Philips Program Start Survey and the Philips Program End Survey | 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. The number reported is the average score for each group. | The analyzed population only includes participants who completed both the Start Survey and the End Survey. | Posted | Mean | Standard Deviation | score on a scale | Baseline, program end (up to 8 weeks from delivery) |
|
|
|
| Secondary | Communications | Number of communications between patient and obstetric provider | Posted | Mean | Full Range | Communications | Up to 14 days post delivery hospitalization discharge |
|
|
|
| 0 |
| 112 |
| 7 |
| 112 |
| 0 |
| 112 |
| EG001 | 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. 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. | 0 | 101 | 13 | 101 | 0 | 101 |
|
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| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |