Adult Liver Transplant Enhanced Care
- Conditions
- Liver Transplant Recipients
- Registration Number
- NCT02320422
- Lead Sponsor
- Icahn School of Medicine at Mount Sinai
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Medication Level Variability Index (MLVI) up to 1 year The degree of fluctuation of tacrolimus blood levels (calculated as the standard deviation, SD, of tacrolimus).
- Secondary Outcome Measures
Name Time Method Incidence of biopsy-proven rejection up to 1 year The number of incidences of liver transplant rejection (as proven by biopsy).
ALT up to 1 year Liver enzyme levels - mean/maximum levels of ALT
Incidence of hospitalizations up to 1 year
Trial Locations
- Locations (1)
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Icahn School of Medicine at Mount Sinai🇺🇸New York, New York, United States