Clinical trial NCT02320422: Adult Liver Transplant Enhanced Care
Official title: An Intervention to Improve Adherence to Medications in Adults With Liver Transplants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Transplant Recipients
Keywords: liver transplant
medication adherence
intervention
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2014-12-19
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Medication Level Variability Index (MLVI)
timeFrame: up to 1 year
Secondary outcomes:
measure: Incidence of biopsy-proven rejection
timeFrame: up to 1 year
measure: ALT
timeFrame: up to 1 year
measure: Incidence of hospitalizations
timeFrame: up to 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Eyal Shemesh, MD
role: PRINCIPAL_INVESTIGATOR
References: