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Assessing Cirrhosis Quality of Care While Accounting for Cost

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03414398
Recruitment Status : Unknown
Verified March 2019 by Nicole T Shen, New York Presbyterian Hospital.
Recruitment status was:  Recruiting
First Posted : January 30, 2018
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Nicole T Shen, New York Presbyterian Hospital

Study Description
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Brief Summary:
The objective of this study is to determine what influences the patient and caregiver perception of care, and if this perception associates with the percentage of and what quality metrics are being met and outcomes. The investigators also plan to capture the cost of providing quality metrics and the cost of monitoring adherence to quality metrics.

Condition or disease
Liver Cirrhosis

Detailed Description:
This study will be conducted using mixed-methods. The qualitative part will consist of in person, 1:1, open ended in depth interviews using a standard interview guide with probes. The quantitative part will document subjects meeting or not meeting the quality metrics supported by strong evidence, clinical outcomes, and medical bills.
Study Design
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Study Type : Observational
Estimated Enrollment : 273 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessing Cirrhosis Quality of Care While Accounting for Cost: Is the Patient and/or Caregiver Perspective Associated With Outcomes or Quality Metrics, and What is the Cost of Implementing and Measuring Quality Metrics
Actual Study Start Date : December 26, 2017
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Experimental
Qualitative interview


Outcome Measures
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Primary Outcome Measures :
  1. Participant perceptions of care [ Time Frame: 2 years ]
    Qualitative interview performed where the participant describes their experience of the quality of care they have received.

  2. Relationship of perceptions of quality of care to recent hospitalizations [ Time Frame: 2 years ]
    Assess associations of qualitative themes that emerge from the qualitative interview with hospitalization frequency

  3. Relationship of perceptions of quality of care to portal hypertension quality metric adherence [ Time Frame: 2 years ]
    Assess associations of qualitative themes that emerge from the qualitative interview with physician meeting of portal hypertension quality metric (i.e., physician follows the recommended management (yes/no)).


Secondary Outcome Measures :
  1. Assess if portal hypertension quality metric adherence equates to less hospitalizations [ Time Frame: 2 years ]
    To see if there is an association of portal hypertension quality metric adherence (i.e. physician follows the recommended management of portal hypertension (yes/no)) to frequency of hospitalizations.

  2. Association of quality metric adherence with survival [ Time Frame: 2 years ]
    We will explore adherence with proposed portal hypertension quality metric (physician follows the management (yes/no)) to see if there is an association with survival. The quality metric will be identified as either being met or not met, and survival will also be identified as having occurred or not.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Cirrhosis, aged 18-80.
Criteria

Inclusion Criteria:

  • primary liver cirrhosis
  • receiving care at the study cite
  • no evidence of hepatic encephalopathy if the subject is providing consent

Exclusion Criteria:

  • no documentation of cirrhosis
  • unable to confirm diagnosis of cirrhosis by imaging or pathology
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03414398


Contacts
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Contact: Nicole T Shen, MD 3146095911 nts9004@nyp.org

Locations
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United States, New York
New York Presbyterian Hospital - Weill Cornell Medicine Recruiting
New York, New York, United States, 10021
Contact: Nicole T Shen, MD    314-609-5911    nts9004@nyp.org   
Contact: Cecilia M Mero    (646) 962-9358    cmm2002@med.cornell.edu   
Sponsors and Collaborators
New York Presbyterian Hospital
Investigators
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Principal Investigator: Robert S Brown, MD, MPH New York Presbyterian Hospital - Weill Cornell
More Information
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Responsible Party: Nicole T Shen, Principal Investigator, New York Presbyterian Hospital
ClinicalTrials.gov Identifier: NCT03414398    
Other Study ID Numbers: 1710018603
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases