Adult Liver Transplant Enhanced Care (ALTER)

An Intervention to Improve Adherence to Medications in Adults With Liver Transplants

The purpose of this study is to pilot-test a tailored telemetric intervention to improve adherence to medications in adults who had a liver transplant and are presently non-adherent (as measured by tacrolimus levels).

Study Overview

• Status: Completed
• Conditions: Liver Transplant Recipients
• Intervention / Treatment: Behavioral: Behavioral Telehealth

Detailed Description

Adult patients who received a liver transplant and for whom there are at least 3 tacrolimus blood levels within the last year are eligible for the study. Patients will be recruited from amongst the roster of liver transplant recipients treated at the Recanati-Miller Transplant Institute at Mount Sinai. The intervention will be pilot-tested on up to 15 non-adherent patients. Patients will be identified using an innovative biomarker for non-adherence-by calculating the degree of fluctuation between individual medication blood levels. The telemetric intervention (administered via telephone, or interactive video chat applications such as FaceTime ® or Skype ®) will enable the intervention team (IT) to address non-adherence from a remote location, using a structured, tailored approach that accommodates specific patient needs. The approach includes a focus on psychological avoidance.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School Of Medicine At Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The patient is at least 18 years of age.
• The patient received a liver transplant at least 2 years prior to initiation of the research protocol.
• The patient is able to provide consent (i.e. is not encephalopathic or does not have significant cognitive impairment). Consent may be obtained either by phone or in person (following a script) and is documented by the researcher.
• The patient is prescribed tacrolimus (either brand or generic formulation).
• The patient is not receiving Hepatitis C treatment during the intervention (given this can affect levels of tacrolimus and adherence behaviors)
• Thee patient has been seen in the liver transplant clinic at least once in the last two years.
• The patient's MLVI value was ≥ 2, with at least 3 levels present to make this determination. Only tacrolimus levels drawn in the outpatient setting will be included in SD calculations. Tacrolimus levels in the inpatient setting (i.e. during a hospitalization) will be excluded.
• The patient speaks English or Spanish at a level that allows him/her to understand the study procedures and consent to the study.

Exclusion Criteria:

• The patient received a liver transplant less than 2 years prior to enrollment.
• The patient received a dual transplant (i.e. liver and kidney).
• The treating physician has instructed the patient not to obtain tacrolimus levels for at least one year in the past year.
• The patient does not understand the study procedures. This will be verified by asking the patient to repeat the study procedures.
• The patient is actively psychotic or severely disoriented due to any cause, including hepatic encephalopathy (temporary exclusion) or severe cognitive impairment.
• The patient is not medically stable or is hospitalized (temporary exclusion until stabilized).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Behavioral Telehealth	Behavioral: Behavioral Telehealth; The telemetric intervention (administered via telephone, or interactive video chat applications such as FaceTime ® or Skype ®) will enable the intervention team (IT) to address non-adherence from a remote location, using a structured, tailored approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Level Variability Index (MLVI)	The degree of fluctuation of tacrolimus blood levels (calculated as the standard deviation, SD, of tacrolimus).	up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of biopsy-proven rejection	The number of incidences of liver transplant rejection (as proven by biopsy).	up to 1 year
ALT	Liver enzyme levels - mean/maximum levels of ALT	up to 1 year
Incidence of hospitalizations		up to 1 year

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: December 16, 2014
• First Submitted That Met QC Criteria: December 18, 2014
• First Posted (Estimate): December 19, 2014

Study Record Updates

• Last Update Posted (Estimate): December 9, 2016
• Last Update Submitted That Met QC Criteria: December 8, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: intervention; medication adherence; liver transplant
• Other Study ID Numbers: GCO 14-1876