CirrhosisNCT02313896
Cirrhosis Readmission Telehealth Project
A study testing Phone calls in people with Cirrhosis, run by Yale University at 1 site in United States.
Trial summary
This is a 2 year research study to study if post discharge phone calls can help lengthen time to hospital readmissions for patients with encephalopathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis
- What is being tested?
- Phone calls
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Jun 2016
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of at least 18
- Patients with known cirrhosis
- Current hospitalization for overt hepatic encephalopathy as categorized by West Haven encephalopathy score of 2 or more
- Current hospitalization found no precipitants triggering encephalopathy as determined by the primary team
- Encephalopathy resolved at time of enrollment
- Has a telephone
- Able to obtain medications
Who cannot join
- Altered mental status unrelated to cirrhosis
- Acute liver failure
- Expectation of liver transplant within 1 month after enrollment
- Chronic kidney disease with Cr > 2 mg/dL
- Respiratory insufficiency:moderate to sever COPD on pulmonary function test
- Electrolyte imbalances not corrected at enrollment
Show all 12Show fewer
- Sodium less than 125 mmol/L
- Calcium greater than 10mg/dL
- Potassium < 2.5mmol/L
- Unable to give legal consent
- Deafness
- Infection, spontaneous bacterial peritonitis, gastrointestinal bleeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital
New Haven, Connecticut, 06510
About this study
This is a 2 year research study to study if post discharge phone calls can help lengthen time to hospital readmissions for patients with encephalopathy.
Read the detailed description
The purpose of this randomized prospective pilot study is to decrease hospital readmissions for patients with hepatic encephalopathy. Patients who were admitted at YNHH with hepatic encephalopathy will be enrolled. Patients will then be randomized to one of two groups upon discharge. The control group will receive usual standard of care for hepatic encephalopathy (encephalopathy education, cirrhosis brochure, stool chart, and routine follow up with their primary care provider and hepatologist). The intervention group will receive usual standard of care as discussed above and phone calls for a 3-month period after their hospitalization.
- Conditions
- Cirrhosis
- Being tested
- Phone calls
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone callsBehavioural
Phone calls from medical staff assess confusion of the patient, and recommend immediate changes to dosage of lactulose.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Patients recieve standard care. On discharge they receive an information packet about cirrhosis and hepatic encephalopathy. They will continue to follow with their doctor as usual. |
| Phone calls | Experimental | On discharge, patients will receive an information package about cirrhosis and hepatic encephalopathy. In addition to regular visits with the doctor, they will receive phone calls from one of our research providers who will be a nurse practitioner, doctor, or physician assistant. In the first 2 weeks after discharge, they will receive phone calls every other day. For the following 10 weeks, they will receive phone calls once a week. Receives: Behavioral: Phone calls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Readmission
Time to hospital readmission after discharge during the 3 month study period for hepatic encephalopathy
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2014 (estimated)
- Study startJul 2014
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: Poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guadalupe Garcia-Tsao, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02313896
- Sponsor's protocol ID
- 1403013528
- Status last verified
- Oct 2016
- First submitted
- 8 Dec 2014
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cirrhosis Readmission Telehealth Project
- ClinicalTrials.gov ID
- NCT02313896
- Acronym / sponsor ID
- 1403013528
- Conditions
- Cirrhosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor enrollment
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 10 Dec 2014 (estimated)
- 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.
This is a 2 year research study to study if post discharge phone calls can help lengthen time to hospital readmissions for patients with encephalopathy.
Detailed description
The purpose of this randomized prospective pilot study is to decrease hospital readmissions for patients with hepatic encephalopathy. Patients who were admitted at YNHH with hepatic encephalopathy will be enrolled. Patients will then be randomized to one of two groups upon discharge. The control group will receive usual standard of care for hepatic encephalopathy (encephalopathy education, cirrhosis brochure, stool chart, and routine follow up with their primary care provider and hepatologist). The intervention group will receive usual standard of care as discussed above and phone calls for a 3-month period after their hospitalization.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Patients recieve standard care. On discharge they receive an information packet about cirrhosis and hepatic encephalopathy. They will continue to follow with their doctor as usual. |
| Phone calls | Experimental | Behavioral: Phone callsOn discharge, patients will receive an information package about cirrhosis and hepatic encephalopathy. In addition to regular visits with the doctor, they will receive phone calls from one of our research providers who will be a nurse practitioner, doctor, or physician assistant. In the first 2 weeks after discharge, they will receive phone calls every other day. For the following 10 weeks, they will receive phone calls once a week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age of at least 18
- Patients with known cirrhosis
- Current hospitalization for overt hepatic encephalopathy as categorized by West Haven encephalopathy score of 2 or more
- Current hospitalization found no precipitants triggering encephalopathy as determined by the primary team
- Encephalopathy resolved at time of enrollment
Key exclusion criteria (12 listed)
- Altered mental status unrelated to cirrhosis
- Acute liver failure
- Expectation of liver transplant within 1 month after enrollment
- Chronic kidney disease with Cr > 2 mg/dL
- Respiratory insufficiency:moderate to sever COPD on pulmonary function test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phone callsPhone calls from medical staff assess confusion of the patient, and recommend immediate changes to dosage of lactulose. | Behavioural | Phone calls |
Primary outcome
Hospital Readmission
Time frame: up to 3 months
Time to hospital readmission after discharge during the 3 month study period for hepatic encephalopathy
Results and safety
The study was stopped early (reason given: Poor enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2016.
Related trials for Cirrhosis
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Recruiting
CirrhosisRx CDS System
Cirrhosis, Decision Support Systems, Clinical
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
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.
Guadalupe Garcia-Tsao, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phone calls in people with Cirrhosis, run by Yale University 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 7 inclusion and 12 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: stopped early, as of the sponsor's last update on 14 Oct 2016. 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?
The study was stopped early (reason given: Poor enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Readmission (time frame: up to 3 months). 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 14 Oct 2016.