Improving Adherence in Nonadherent Kidney Transplant Patients

July 29, 2020 updated by: Imperial College London

A Pharmacist Led, Patient Tailored Intervention to Improve Immunosuppressant Medication Adherence in Nonadherent Kidney Transplant Patients

Organs for transplantation remain a scarce and precious resource with over 5000 patients currently on the kidney transplant waiting list. A kidney transplant costs approximately £17,000 in the first year and £5,000 per subsequent year. If the transplant fails, the patient must return to dialysis at an estimated cost of £30,800 per year or be retransplanted. While short term outcomes have improved steadily over the last 15-20 years, longer term outcomes haven't and after 10 years approximately 30% of kidney transplants have failed. Nonadherence to immunosuppressive medication is increasingly being associated with these poor long term outcomes and studies have estimated that 30- 50% of transplant patients are nonadherent to their immunosuppressive medication. The investigators want to determine whether immunosuppression medication adherence can be improved in a group of patients receiving tailored medication adherence support form a pharmacist. Adherence support will be provided for one year and will be individualised to each patient in the intervention group after identifying both their practical and perceptual barriers to adherence. The adherence interventions offered may include additional education and medication counselling, setting alarms, provision of a medication list, the use of a medications adherence app on a smart phone, reducing the number and frequency of tablets a patient takes or referral on to another health professional such as a social worker or psychologist for additional support. A range of clinical outcomes will be assessed for all patients on a regular basis in order to determine whether the provision of effective medication adherence support for our kidney transplant patients may help to optimise the long-term outcomes of these transplants

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will be undertaken using a prospective, multidimensional design. 42 nonadherent kidney transplant patients will be included in the intervention group. The nonadherent patients will be identified through Imperial College Renal and Transplant Centre (ICRTC) Outpatient Clinic based at Hammersmith Hospital. Standard and transplant specific demographics will be collected for all patients. All kidney transplant patients have their tacrolimus levels measured at each clinic visit. The variability of these levels can be used as a marker of their adherence. Patients with a high intrapatient variability (IPV) of their levels are said to be nonadherent. The Chief Investigator or another member of the research team will approach individual patients directly in the transplant out-patient clinic where they are members of the multidisciplinary clinical care team. The Chief Investigator or another member of the research team may also telephone patients to invite them to clinic to discuss participation in the trial. The Chief Investigator or another member of the research team will describe the study to the patient, answer any questions they have and provide them with a participant information sheet (PIS). Patients will be given the opportunity to take the PIS away and think about whether they would like to participate. A follow up discussion either in clinic or on the phone will be arranged with the patient to answer any queries they have within two weeks of providing them with the PIS; during that discussion, the Chief Investigator or other member of the research team will arrange an appointment in the transplant clinic with the patient to sign the consent form if they do decide to participate. Patients recruited into the study will receive pharmacist led, patient tailored interventions to improve immunosuppressant medication adherence. Patients will be included in the study for one year from recruitment.

The pharmacist led, patient tailored intervention will involve regular, intensive, personalised support from a pharmacist to improve adherence to immunosuppressive medications. The pharmacist will meet with the patient on a regular basis in the transplant clinic to identify their perceptual and practical barriers to adherence and agree a support plan that is tailored to them.

Within the first two weeks of recruitment, the study pharmacist will meet with the patient in transplant clinic to:

  • Undertake a full medication history
  • Discuss self-reported medication nonadherence
  • Undertake the BAASIS questionnaire
  • Ask the patient to complete a Beliefs about Medicines Questionnaire (BMQ)
  • Undertake a socioeconomic and educational assessment
  • Undertake to gain collateral reporting of nonadherence by clinicians, relatives, friends or carers
  • Perform a tacrolimus pill count
  • Check in-house dispensing records of tacrolimus
  • Identify barriers to adherence
  • Tailor interventions and support to the needs of the patient
  • Complete a motivational interview
  • Agree to meet again during an outpatient clinic visit within an agreed time which is appropriate for the patient needs and within 3 months.

This first visit will provide a baseline assessment of the patient's medication adherence.

Tailored support may include:

  • Setting alarms
  • Medication diary card or calendar
  • Medication compliance aid filled by the patient, family/carers or by a pharmacy professional
  • Adherence app
  • Reducing the complexity of the medication regime
  • Positioning medication within their daily routine eg. by toothbrush
  • Changing formulations
  • Additional education regarding need for medication / timing of doses
  • Referral to a social worker to assist with affordability of medicines
  • Referral to a psychologist to explore deeper psychological issues regarding medicines taking

The structure of each follow up adherence review will be the same as the first formal adherence review with the exception that the BMQ will only be repeated at the end of the one year follow-up and the socioeconomic and educational assessment will only be undertaken at the first assessment review. Every patient will have a formal adherence assessment at recruitment and then at 3, 6, 9 and 12 months. At the end of one year of follow-up, the specific benefits perceived by the patient of intensive adherence support from a pharmacist will be determined through a questionnaire.

Baseline nonadherence will be measured at the first visit with the study pharmacist within two weeks of recruitment and then at 3, 6, 9 and 12 months. The IPV of their tacrolimus levels and their outpatient clinic nonattendance rate will be measured retrospectively in the 12 months prior to recruitment to the study and then prospectively at the end of the intervention year. The IPV is calculated from the tacrolimus levels measured for an individual patient using the coefficient of variance mathematical formula - Coefficient of variance (COV) defined as: SD x 100 / Mean. The outpatient clinic nonattendance for each participant will be taken from the hospital integrated computer system.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, W12 0HS
        • Imperial College Renal and Transplant Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • Adult kidney transplant patients (18 years of age and above)
  • Kidney transplant patients with an IPV of tacrolimus levels of greater than 18.15% in the previous 12 months

Exclusion Criteria:

  • Antibody incompatible transplants including patients with preformed HLA and blood group incompatible
  • Previous rejection
  • Donor specific antibody positive
  • HIV positive patients
  • Simultaneous pancreas and kidney patients
  • Paediatric patients (less than 18 years of age)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Medication adherence interventions
Pharmacist led medication adherence interventions which will be tailored to individual patient need
Behavioral: Pharmacist led medication adherence interventions
Medication adherence interventions which will be tailored to individual patient need

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in immunosuppression medication adherence before and after the intervention
Time Frame: One year
Medication adherence will be assessed and compared using the BAASIS questionnaire at recruitment and at the end of the study. The BAASIS questionnaire is validated for assessing immunosuppression nonadherence in transplant patients. Any patient answering yes to any of the questions is assessed to be nonadherent
One year
Change in the median IPV before and after the intervention
Time Frame: One year
Intrapatient variability of tacrolimus levels will be measured and compared
One year
Change in outpatient clinic nonattendance rate before and after the intervention
Time Frame: One year
Outpatient clinic nonattendance rate will be assessed and compared during the 12 months prior to recruitment to the study and during the study
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biopsy proven ACR / AMR
Time Frame: One year
Number of patients who develop biopsy proven ACR/AMR
One year
The number of readmissions
Time Frame: One year
The number of readmissions and their reasons why during the study will be recorded
One year
Donor specific antibody (DSA) or transplant glomerulopathy
Time Frame: One year
Number of patients who develop a DSA or transplant glomerulopathy (CNI) toxicity or diabetic change on biopsy
One year
Fibrosis, hyalinosis, calcineurin inhibitor (CNI) toxicity or diabetic change on toxicity
Time Frame: One year
Number of patients who develop fibrosis, hyalinosis, calcineurin inhibitor
One year
Graft loss
Time Frame: One year
Number of patients who lose their graft
One year
Death
Time Frame: One year
Number of patients who die
One year
Serum creatinine
Time Frame: One year
Change in serum creatinine at the end of the study
One year
eGFR
Time Frame: One year
Change in eGFR at the end of the study
One year
Proteinuria
Time Frame: One year
Change in proteinuria at the end of the study
One year
Haematocrit
Time Frame: One year
Change in haematocrit at the end of the study
One year
Haemoglobin
Time Frame: One year
Change in haemoglobin at the end of the study
One year
Albumin
Time Frame: One year
Change in albumin at the end of the study
One year
Tacrolimus levels
Time Frame: One year
Change in tacrolimus levels at the end of the study
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Investigators

  • Principal Investigator: Dawn Goodall, Imperial College Healthcare NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2018

Primary Completion (Actual)

July 27, 2020

Study Completion (Actual)

July 27, 2020

Study Registration Dates

First Submitted

October 5, 2018

First Submitted That Met QC Criteria

March 25, 2019

First Posted (Actual)

March 27, 2019

Study Record Updates

Last Update Posted (Actual)

July 30, 2020

Last Update Submitted That Met QC Criteria

July 29, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 17HH4287

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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