Liver CirrhosisNCT03414398
Assessing Cirrhosis Quality of Care While Accounting for Cost
An observational study of Liver Cirrhosis, run by New York Presbyterian Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Cirrhosis
- How many people
- 273 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Dec 2017to 1 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: Cirrhosis, aged 18-80.
Who may be able to join
- primary liver cirrhosis
- receiving care at the study cite
- no evidence of hepatic encephalopathy if the subject is providing consent
Who cannot join
- no documentation of cirrhosis
- unable to confirm diagnosis of cirrhosis by imaging or pathology
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
New York Presbyterian Hospital - Weill Cornell Medicine
New York, New York, 10021
Nicole T Shen, MD, 314-609-5911, nts9004@nyp.org
Cecilia M Mero, (646) 962-9358, cmm2002@med.cornell.edu
About this study
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
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.
Read the 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.
- Conditions
- Liver Cirrhosis
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Qualitative interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant perceptions of care
Qualitative interview performed where the participant describes their experience of the quality of care they have received.
Measured: 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
Measured: 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)).
Measured: 2 years
Secondary outcomes (2)
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.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start26 Dec 2017
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 273 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York Presbyterian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicole T Shen, New York Presbyterian Hospital
- Investigators
- Robert S Brown, MD, MPH, Principal investigator, New York Presbyterian Hospital - Weill Cornell
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03414398
- Sponsor's protocol ID
- 1710018603
- Status last verified
- Mar 2019
- First submitted
- 26 Dec 2017
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03414398
- Acronym / sponsor ID
- 1710018603
- Conditions
- Liver Cirrhosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 273 participants (estimated)
- Lead sponsor
- New York Presbyterian HospitalUniversity, hospital or other
- Study start
- 26 Dec 2017 (actual)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 30 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | – | –Qualitative interview |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Cirrhosis, aged 18-80.
Key inclusion criteria (3 listed)
- primary liver cirrhosis
- receiving care at the study cite
- no evidence of hepatic encephalopathy if the subject is providing consent
Key exclusion criteria (2 listed)
- no documentation of cirrhosis
- unable to confirm diagnosis of cirrhosis by imaging or pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
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)).
2 secondary outcomes
Assess if portal hypertension quality metric adherence equates to less hospitalizations
Time frame: 2 years
Association of quality metric adherence with survival
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert S Brown, MD, MPH principal investigator
New York Presbyterian Hospital - Weill Cornell
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis, run by New York Presbyterian Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicole T Shen, MD (3146095911, nts9004@nyp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant perceptions of care (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2019.