Assessing Cirrhosis Quality of Care While Accounting for Cost

Liver Cirrhosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03414398
• Other study ID #: 1710018603
• Status: Recruiting
• Start date: December 26, 2017
• Est. completion date: July 1, 2021

Study information

• Verified date: March 2019
• Source: New York Presbyterian Hospital
• Contact: Nicole T Shen, MD
• Phone: 3146095911
• Email: nts9004[@]nyp.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 273
• Est. completion date: July 1, 2021
• Est. primary completion date: January 1, 2021
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis

Locations

Country	Name	City	State
United States	New York Presbyterian Hospital - Weill Cornell Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York Presbyterian Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant perceptions of care	Qualitative interview performed where the participant describes their experience of the quality of care they have received.	2 years
Primary	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
Primary	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	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
Secondary	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