Assessing Cirrhosis Quality of Care While Accounting for Cost

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

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.

Study Overview

• Status: Unknown
• Conditions: 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 Type: Observational
• Enrollment (Anticipated): 273

Contacts and Locations

• Study Contact: Name: Nicole T Shen, MD; Phone Number: 3146095911; Email: nts9004@nyp.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Recruiting
      • New York Presbyterian Hospital - Weill Cornell Medicine
      • Contact: Nicole T Shen, MD; Phone Number: 314-609-5911; Email: nts9004@nyp.org
      • Contact: Cecilia M Mero; Phone Number: (646) 962-9358; Email: cmm2002@med.cornell.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Cirrhosis, aged 18-80.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Experimental; Qualitative interview

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant perceptions of care	Qualitative interview performed where the participant describes their experience of the quality of care they have received.	2 years
Relationship of perceptions of quality of care to recent hospitalizations	Assess associations of qualitative themes that emerge from the qualitative interview with hospitalization frequency	2 years
Relationship of perceptions of quality of care to portal hypertension quality metric adherence	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)).	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess if portal hypertension quality metric adherence equates to less hospitalizations	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 years
Association of quality metric adherence with survival	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.	2 years

Collaborators and Investigators

• Sponsor: New York Presbyterian Hospital
• Investigators: Principal Investigator: Robert S Brown, MD, MPH, New York Presbyterian Hospital - Weill Cornell

Study record dates

Study Major Dates

• Study Start (Actual): December 26, 2017
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: December 26, 2017
• First Submitted That Met QC Criteria: January 19, 2018
• First Posted (Actual): January 30, 2018

Study Record Updates

• Last Update Posted (Actual): March 13, 2019
• Last Update Submitted That Met QC Criteria: March 11, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: 1710018603

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