Clinical trial NCT04078750: PLATO - Medication Adherence in Transplant Recipients
Official title: Pre-Transplant Multidisciplinary Assessment on Medication Adherence and Transplant Outcomes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Kidney Disease, Chronic
Medication Adherence
Renal Disease
Kidney Rejection Transplant
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 99
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Non-adherence with immunosuppressant drugs is a major reason for premature kidney transplant failure. Currently, patient education and compliance aids (e.g bubble packing) are commonly used to assist patients. This is a study involving patients expected to undergo a kidney transplant within 6 months. One group will undergo a one-month formal assessment of adherence before transplantation using mock immunosuppressant medication. Standardized surveys will also be administered to assess risk factors for non-adherence. A plan will be developed for use after the transplant. The other group will undergo usual care. Kidney function and rejection rates will be compared between two groups.

Detailed description: Phase I - Control group.

1. The standard of care will be provided to the control group pre- and post-transplant. This does not involve any direct pre-transplant assessment of medication adherence or risk factors for non-adherence.
2. Tacrolimus capsules (standard of care immunosupression medication) will be dispensed in Medication Event Monitoring System (MEMS) caps for 3 months post-transplant for the purpose of measuring adherence after transplantation.
3. Patients will be asked to complete Basel Assessment of Adherence to Immunosuppressive Medication instrument (BAASIS) self-report questionnaire and Long-term Medication Behaviour Self-efficacy self-report Scale at 3 months after transplantation.

Phase II - Interventional Group.

I. Pre-transplant phase:

1. Measurement of Adherence to Medications Patients will be given lactose containing white- and yellow-colored gelatin capsules stored in (MEMS®) bottles for a 1-month adherence trial. Yellow-colored gelatin capsules represent tacrolimus 0.5mg capsules while white-colored gelatin capsules represent tacrolimus 1mg capsules. MEMS® is designed to record the date/time of opening and closure of the drug vial. Patients will be asked to take a certain dose and expected to remove the correct number of white and yellow capsules from respective vial at the correct time each day. Phone calls will be made to patients to change the 'dose' at various times throughout the month to mimic the frequent need to make tacrolimus dosing changes early post-transplant. For patients who are lactose intolerance, they will be instructed to remove the correct number of capsules from the vials but there is no need to take the capsules. Pill count and MEMS record will be reviewed at the end of the 1-month trial period to assess adherence.
2. Health literacy: Assessments to completed by the participant:

   1. Short Literacy Survey (SLS), a self-report 3 question survey, has been validated in kidney transplant recipients and shown to correlate well with the Rapid Estimate of Adult Literacy in Medicine (REALM) and the shortened Test of Functional Health Literacy in Adults (S-TOFHLA). The three questions are: 1) "How often do you have someone help you read hospital materials?"; 2) "How confident are you filling out medical forms by yourself?"; and 3) "How often do you have problems learning about your medical condition because of difficulty understanding written information?"
   2. Newest Vital Signs - transplant version (NVS-T) The original NVS consists of a prescription label with 6 questions that measures health literacy and numeracy skills but is not specific to any particular area of medicine. The modified transplant version consists of 2 prescription labels and has been validated. The first label is for an antibiotic, amoxicillin, and the second label is for a cream, fluocinolone acetonide. There are 3 questions for each label, and the number of correct answers correlates with a health literacy category.
3. Cognition will be assessed using the Montreal Cognitive Assessment (MoCA), a 30-question screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.
4. Self-efficacy will be assessed using the Long-term Medication Behaviour Self-efficacy Scale, a 27-item questionnaire about skills related to medication use. It assesses the following themes regarding patient's self-efficacy: personal attributions (7 items), environmental factors (13 items), task-related and behavioral factors (7 items).
5. Customized post-transplant care plan prior to transplantation The post-transplant team will devise a tailored care plan based on assessment findings and discussed with the patient and/or caregivers prior to transplant. The post-transplant care plans will be common to both transplant programs.

II. Post-transplant phase:

1. The post-transplant team will implement the tailored care plan as discussed with patient and/or caregiver(s).
2. Tacrolimus capsules will be dispensed in MEMS caps for 3 months post-transplant for the purpose of measuring adherence after transplantation.
3. Patients will be asked to complete BAASIS questionnaire and Long-term Medication Behaviour Self-efficacy Scale at 3 months.

Current standard of care does not include any element of pharmacy evaluation of a person's ability to follow medication regimens.

At the conclusion of the use of MEMS caps subjects in either group will return the MEMS caps to the pharmacists at a regularly scheduled follow-up appointment.This will not require an additional trip to the hospital.

Eligibility criteria: Inclusion Criteria:

* Kidney transplant candidates anticipated to undergo transplantation from a deceased or living donor within 6 months of enrolment

Exclusion Criteria:

* There are no exclusion criteria. All eligible patients will be approached by a research assistant. Patients with limited English language fluency will be asked to participate with the assistance of a translator.

Primary outcomes:
measure: Comparison of mean daily medication adherence between intervention and control groups over 3 months, as measured by MEMS caps.
timeFrame: 3 month duration
Secondary outcomes:
measure: Self-reported adherence rates as measured by BAASIS
timeFrame: 3-12 months
measure: The coefficient of variation (CV) of tacrolimus trough levels
timeFrame: 3-12 months
measure: Proportion of patients within target tacrolimus trough levels
timeFrame: 3-12 months
measure: Comparison of post-transplant test results between intervention and control group
timeFrame: 3 months
measure: Medication Behaviour for intervention group only
timeFrame: 3 months
measure: Staff resource utilization
timeFrame: Through study completion, an average of 1 year
measure: Medication nonadherence-related hospital readmissions
timeFrame: 12 months
measure: Biopsy proven acute rejection (BPAR) rate
timeFrame: 12 months
measure: Kidney allograft function
timeFrame: 12 months
measure: Kidney allograft survival
timeFrame: 12 months
measure: Patient survival
timeFrame: 12 months
measure: Health Literacy for intervention group only
timeFrame: 3 months
measure: Montreal Cognitive Assessment for intervention group only
timeFrame: 3 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
Study officials:
affiliation: St. Paul's Hospital
name: Marianna Leung, Pharm D
role: PRINCIPAL_INVESTIGATOR
References: