The Center for Peripartum Optimization

Communication Clinical Trial

Official title:

The Center for Peripartum Optimization: An Innovative Approach to Care Coordination

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03522909
• Other study ID #: IRB00163559
• Status: Completed
• Start date: January 2017
• Est. completion date: December 2020

Study information

• Verified date: July 2020
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: December 2020
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Communication
• High Risk Pregnancy
• Multidisciplinary Communication
• Obstetric Complication

Intervention

Other:
• Seen in clinic
We will be doing a retrospective chart review of patients seen in the Center for Peripartum Optimization to look for: Primary outcome variable. - Hospital length of stay 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

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital length of stay	Total days of hospital admission	1 year
Secondary	Number of admissions from outside hospitals	The total number of admissions to any other hospitals prior to admission or after discharge	1 year
Secondary	ICU admissions	Whether patient needed ICU admission or transfer	1 year
Secondary	Opioids use	To determine if patient require opioid use	1 year
Secondary	Neonatal Intensive Care Unit (NICU) admissions	Number of times a neonate got admitted to the NICU	1 year
Secondary	Patient satisfaction	Whether patient was satisfied (yes/no) with treatment course based on survey filled out by patient.	1 year
Secondary	Cost of inpatient admission	the entire admission cost of admission during hospital stay	1 year
Secondary	Cost of outpatient care	The cost for outpatient care incurred by patient	1 year
Secondary	Hospital readmissions rate	The number of times a patient got readmitted after discharge	1 year