NCT03522909

Brief Summary

In January 2017 investigators started a Center for Peripartum Optimization (CPO) with the aim of optimizing a patient's clinical status in an outpatient setting to minimize unnecessary laboratory tests and studies, costly inpatient consultations, the likelihood of post-surgical adverse events, escalations in level of care, inpatient admissions and readmissions. This research project seeks to evaluate the impact of this innovative concept on patient outcomes during the last 12 months. Investigators will accomplish this by collecting retrospective data from patients' electronic medical records in the intervention group and comparing it to data gathered from a controlled group of patients with similar comorbidities but who were not evaluated at the CPO clinic.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 11, 2018

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

September 13, 2021

Status Verified

July 1, 2020

Enrollment Period

1 year

First QC Date

May 1, 2018

Last Update Submit

September 9, 2021

Conditions

Keywords

obstetric anesthesiatelemedicine

Outcome Measures

Primary Outcomes (1)

  • Hospital length of stay

    Total days of hospital admission

    1 year

Secondary Outcomes (8)

  • Number of admissions from outside hospitals

    1 year

  • ICU admissions

    1 year

  • Opioids use

    1 year

  • Neonatal Intensive Care Unit (NICU) admissions

    1 year

  • Patient satisfaction

    1 year

  • +3 more secondary outcomes

Study Arms (2)

Study

We will be reviewing records of parturients seen at Johns Hopkins Hospital in the Center for Peripartum Optimization (CPO) clinic between January 2017 to January 2018

Other: Seen in clinic

Control

A matched controlled group patients not seen at the CPO clinic

Interventions

We will be doing a retrospective chart review of patients seen in the Center for Peripartum Optimization to look for: 1. Primary outcome variable. \- Hospital length of stay 2. Secondary outcome variables. * Number of admissions from outside hospitals * Adverse outcomes * Intensive Care Unit admissions * Opioid use * NICU admissions * Patient satisfaction * Cost of inpatient admission * Cost of outpatient care * Hospital readmissions rate

Study

Eligibility Criteria

AgeUp to 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant patients
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

This will be a retrospective study design utilizing the Johns Hopkins Hospital (JHH) electronic medical record system (EMR) "EPIC". We will be reviewing records of parturients seen at JHH in the Center for Peripartum Optimization (CPO) clinic between January 2017 to January 2018 and comparing outcome data with a matched controlled group patients not seen at the CPO clinic. This matched controlled parturient group will be identified utilizing the JHH EMR and ICD-10 comorbidity codes. These patients will be female of child-bearing age that fits into the inclusion criteria.

You may qualify if:

  • Records of all female, obstetric patients of child-bearing age who were evaluated in the Center for Peripartum Optimization during the period between January 2017 and January 2018.
  • Controlled group will include parturients with match high risk comorbidities or history of nonobstetric surgery during pregnancy who delivered at Johns Hopkins Hospital (JHH) during July 1, 2016 - Dec 31, 2016
  • Patients with any one or more of these high risk comorbidities:
  • Complex spine pathologies (Scoliosis, vertebral fusion, disc disease, spinal canal defects, neuropathies, and nerve disease, etc.)
  • Neurological pathology (Cerebral ischemia, tumor, increased intracranial pressure, cerebral vascular disease, etc.)
  • Cardiac disease (Congenital, valvular, pulmonary hypertension, cardiomyopathy, ischemic disease, arrhythmia, etc.)
  • Pulmonary disease (History of pulmonary embolism, interstitial lung disease, severe asthma, cancer, etc.)
  • Morbid Obesity (Obstructive Sleep Apnea, equipment considerations)
  • Hematologic Disorders (Thrombophilias, coagulopathies, patients on anticoagulation)
  • Cancer
  • Abnormal placentation (Previa, accreta / increta / percreta)
  • Anesthetic concerns (Airway abnormalities, history of adverse anesthetic reactions or experiences (i.e. recall, anaphylaxis))
  • Fetal therapy patients requiring specialized management (Ex utero intrapartum treatment (EXIT), Fetoscopic endotracheal occlusion (FETO), Twin-to-twin transfusion syndrome (TTTS), Percutaneous Umbilical Blood Sampling (PUBS), etc.)
  • Chronic Pain

You may not qualify if:

  • Records of CPO participating parturients outside the specified timeframe.
  • Records of patients seen in CPO clinic that did not deliver at our institution

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Communication

Interventions

Ambulatory Care Facilities

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Health FacilitiesHealth Care Facilities Workforce and Services

Study Officials

  • Jamie D Murphy, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2018

First Posted

May 11, 2018

Study Start

January 1, 2017

Primary Completion

January 1, 2018

Study Completion

December 1, 2020

Last Updated

September 13, 2021

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations