NCT03414398

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
273

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

December 26, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 30, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

March 13, 2019

Status Verified

March 1, 2019

Enrollment Period

3 years

First QC Date

December 26, 2017

Last Update Submit

March 11, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Assess if portal hypertension quality metric adherence equates to less hospitalizations

    2 years

  • Association of quality metric adherence with survival

    2 years

Study Arms (1)

Experimental

Qualitative interview

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cirrhosis, aged 18-80.

You may qualify if:

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

You may not qualify if:

  • no documentation of cirrhosis
  • unable to confirm diagnosis of cirrhosis by imaging or pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Presbyterian Hospital - Weill Cornell Medicine

New York, New York, 10021, United States

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Robert S Brown, MD, MPH

    New York Presbyterian Hospital - Weill Cornell

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole T Shen, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 26, 2017

First Posted

January 30, 2018

Study Start

December 26, 2017

Primary Completion

January 1, 2021

Study Completion

July 1, 2021

Last Updated

March 13, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations