A Pharmacist Led, Patient Tailored Intervention to Improve Immunosuppressant Medication Adherence in Nonadherent Kidney Transplant Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Change in Number of Patients Being Adherent/Non-aherent After the Intervention
研究概览
简要总结
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 the kidney transplant patients may help to optimise the long-term outcomes of these transplants
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Change in Number of Patients Being Adherent/Non-aherent After the Intervention
时间窗: One year
Immunosuppression Medication adherence will be assessed and compared using the BAASIS questionnaire at recruitment and at the end of the study. The BAASIS questionnaire is a closed question questionnaire (either adherent or non-adherent); it is validated for assessing immunosuppression nonadherence in transplant patients. Any patient answering yes to any of the questions is assessed to be nonadherent
Change in the Median IPV Before and After the Intervention
时间窗: One year
Intrapatient variability of tacrolimus levels will be measured and compared and reported as percentage difference
Change in Outpatient Clinic Nonattendance Rate Before and After the Intervention
时间窗: One year
Data for this outcome measure has not been analysed: originally the outpatient clinic nonattendance rate was to be assessed and compared during the 12 months prior to recruitment to the study and during the study
次要结局
- Biopsy Proven ACR / AMR(One year)
- The Number of Readmissions(One year)
- Donor Specific Antibody (DSA) or Transplant Glomerulopathy(One year)
- Fibrosis, Hyalinosis, Calcineurin Inhibitor (CNI) Toxicity or Diabetic Change on Toxicity(One year)
- Graft Loss(One year)
- Death(One year)
- Serum Creatinine(One year)
- eGFR(One year)
- Proteinuria(One year)
- Haematocrit(One year)
- Haemoglobin(One year)
- Albumin(One year)