Clinical trial NCT03522909: The Center for Peripartum Optimization
Official title: The Center for Peripartum Optimization: An Innovative Approach to Care Coordination
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: High Risk Pregnancy
Multidisciplinary Communication
Communication
Obstetric Complication
Keywords: obstetric anesthesia
telemedicine
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2018-05-11
Enrollment: 250
Sex: FEMALE
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_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.

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Records of CPO participating parturients outside the specified timeframe.
* Records of obstetric patients of child-bearing age without high-risk comorbid conditions described in inclusion criteria.
* Records of patients seen in CPO clinic that did not deliver at our institution

Primary outcomes:
measure: Hospital length of stay
timeFrame: 1 year
Secondary outcomes:
measure: Number of admissions from outside hospitals
timeFrame: 1 year
measure: ICU admissions
timeFrame: 1 year
measure: Opioids use
timeFrame: 1 year
measure: Neonatal Intensive Care Unit (NICU) admissions
timeFrame: 1 year
measure: Patient satisfaction
timeFrame: 1 year
measure: Cost of inpatient admission
timeFrame: 1 year
measure: Cost of outpatient care
timeFrame: 1 year
measure: Hospital readmissions rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Jamie D Murphy, MD
role: PRINCIPAL_INVESTIGATOR
References: