Assessing Cirrhosis Quality of Care While Accounting for Cost

• Conditions: Liver Cirrhosis

• Registration Number: NCT03414398
• Lead Sponsor: New York Presbyterian Hospital

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.

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 Timeline

• Study Start: 2017-12-26
• Study First Submitted: 2017-12-26
• Study First Submitted QC: 2018-01-19
• Study First Posted: 2018-01-30
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-11
• Last Update Posted: 2019-03-13
• Primary Completion: 2021-01-01
• Study Completion: 2021-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 273

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Name	Time	Method
Assess if portal hypertension quality metric adherence equates to less hospitalizations	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.
Association of quality metric adherence with survival	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.

Trial Locations

Locations (1)

New York Presbyterian Hospital - Weill Cornell Medicine; 🇺🇸 New York, New York, United States