Liver Transplant Recipients
Conditions
Keywords
liver transplant, medication adherence, intervention
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.
Interventions
BEHAVIORALBehavioral 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
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
United States
Outcome results
None listed