The Center for Peripartum Optimization

September 9, 2021 updated by: Johns Hopkins University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

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
Control
A matched controlled group patients not seen at the CPO clinic

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hospital length of stay
Time Frame: 1 year
Total days of hospital admission
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of admissions from outside hospitals
Time Frame: 1 year
The total number of admissions to any other hospitals prior to admission or after discharge
1 year
ICU admissions
Time Frame: 1 year
Whether patient needed ICU admission or transfer
1 year
Opioids use
Time Frame: 1 year
To determine if patient require opioid use
1 year
Neonatal Intensive Care Unit (NICU) admissions
Time Frame: 1 year
Number of times a neonate got admitted to the NICU
1 year
Patient satisfaction
Time Frame: 1 year
Whether patient was satisfied (yes/no) with treatment course based on survey filled out by patient.
1 year
Cost of inpatient admission
Time Frame: 1 year
the entire admission cost of admission during hospital stay
1 year
Cost of outpatient care
Time Frame: 1 year
The cost for outpatient care incurred by patient
1 year
Hospital readmissions rate
Time Frame: 1 year
The number of times a patient got readmitted after discharge
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jamie D Murphy, MD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 1, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 11, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 13, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00163559

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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