Clinical trial NCT06324045: Deprescribing Intervention for Patients With Chronic Kidney Disease
Official title: Development and Evaluation of a Multidisciplinary Team Delivered Deprescribing Intervention for Patients With Chronic Kidney Disease in Qatar: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Kidney Diseases
Keywords: Deprescribing
Inappropriate polypharmacy
Treatment burden
Multidisciplinary
Clinical pharmacy
Lead sponsor: Hamad Medical Corporation
Sponsor class: INDUSTRY
Collaborators: name: Qatar University
name: Winchester District Memorial Hospital
First posted: 2024-03-21
Enrollment: 424
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: CKD patients will be screened using medical records. Eligible patients will be approached during their routine visits to FBJ Kidney Center and other ambulatory kidney centers. Due to feasibility and practicality issues, selecting the patients will be consecutive case series as per their availability during the time of the recruitment (nonprobabilistic).

After obtaining informed consent, patients will be randomized into one of the two study arms. Randomization will be stratified by dialysis dependency (dialysis vs. pre-dialysis); randomly permuted balanced block sizes of 4 for dialysis patients and 1 for pre-dialysis will be used. Neither the practitioners nor the patients will be blinded to the patients' allocated groups due to the nature of the intervention. Due to feasibility and practicalities, selecting the patients will be consecutive as per their availability during the time of the recruitment (non-probabilistic).
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Chronic Kidney Disease (CKD) is recognized as a leading health problem globally. It is associated with multiple consequences such as cardiovascular diseases, infections, reduced cognitive function, and higher mortality rates. In Qatar, it is estimated that 13% of the population suffers from CKD. Management of CKD is associated with polypharmacy (the use of multiple medications), which burdens the patients and leads to adverse health and economic outcomes. As documented by previous studies, CKD setting is associated with a high medication burden, which leads to non-adherence, reduced quality of life, and other negative sequelae. These consequences can be minimized or averted by implementing a deprescribing program. Deprescribing is defined as the supervised process of intentionally stopping a medication, altering the dose or introducing a safer alternative to improve a person's clinical and quality of life outcomes. Previous deprescribing initiatives in inpatient and outpatient hospital settings were successfully implemented.

In general, there are limited deprescribing initiatives in CKD settings. There is a need to provide evidence of the impact of deprescribing programs on improving clinical and economic outcomes in this setting. In Qatar, there is no evidence of the effectiveness of implementing deprescribing programs in clinical settings. Therefore, we have built a team of researchers, clinicians, and stakeholders, and initiated a collaboration with deprescribing experts to fit into the Qatar healthcare system. This project aims to initiate a deprescribing multidisciplinary team and to evaluate the impact of providing such services on the clinical and economic outcomes among CKD patients in Qatar using a randomized controlled trial approach. The findings could have a potential positive impact on the professional practice and patient safety represented by health and economic outcomes.

Detailed description: Medication burden and polypharmacy are evident problems among patients with CKD worldwide and in Qatar. The consequences of this problem are enormous and include high rates of adverse health and economic outcomes. Although there have been multiple initiatives to overcome polypharmacy in CKD and other chronic conditions, these initiatives still lack providing strong evidence of impact on tangible outcomes and cost-effectiveness.

In addition, most initiatives are uni-professional or fragmented. This project will initiate a multidisciplinary deprescribing program for Chronic Kidney Disease patients in Qatar. The study will also provide strong evidence of the effect of such intervention on humanistic and clinical outcomes following best practices. Undertaking deprescribing in the real world, however, is problematic; whereby, for strategic planning throughout HMC and to ensure the sustainability of the practice, including the utilization of resources and the hiring of personnel in practice sites, healthcare systems must demonstrate the return on investments made in their services. It is important, therefore, that the current study includes a cost-benefit analysis of the proposed program, to evaluate the trade-off between operational costs and the generated cost savings. The results of the study will provide an opportunity for the healthcare system in Qatar to adopt such a program among different settings that include patients prone to inappropriate polypharmacy.

Goals of the study

The goals of the proposed project are to:

1. develop and validate a deprescribing program that includes a well-trained multidisciplinary team to provide the needed care for patients with advanced stages of chronic kidney disease (CKD) who experience inappropriate polypharmacy.
2. evaluate the impact of providing a structured deprescribing program on clinical, humanistic (quality of life), and economic outcomes of advanced stages CKD patients who experience inappropriate polypharmacy.

The objectives of the study are to:

1. develop and validate an intervention framework, deprescribing guide and documents, and deprescribing training materials.
2. implement and assess the clinical and humanistic impact of the deprescribing intervention program.
3. assess the economic impact of the deprescribing intervention program on the healthcare provider institution.

The proposed project will develop and study the effect of multidisciplinary deprescribing program for patients with advanced stages of CKD and will be conducted in three consecutive phases:

* Phase I (Pre-Intervention Phase) to prepare an intervention framework and build the capacity of a multidisciplinary deprescribing team.
* Phase II (Intervention Phase) to implement and assess the clinical and humanistic impact of the deprescribing intervention program.
* Phase III (Post-Intervention Phase) to assess the economic impact of the deprescribing intervention program on the healthcare provider (i.e. HMC).

Eligibility criteria: Inclusion Criteria:

Patients who are:

* diagnosed with ESRD receiving hemodialysis treatment or pre-dialysis patients who are followed up at a low clearance clinic.
* receiving treatment at one of the ambulatory kidney centers in Qatar for at least two months.
* able to communicate in Arabic and/or English.

Exclusion Criteria:

* Unstable or has a psychiatric condition.
* Presents with uncontrolled behaviors or exit-seeking behaviors (i.e., seeking to leave the premises out of confusion, frustration, or anger).
* Critically ill patients, pregnant women, children, mentally ill, dementia, and unconscious patients.
* Patients with limited life expectancy (less than 6 months).

Primary outcomes:
measure: Percentage of participants with at least one Potentially inappropriate medications (PIMs)
timeFrame: At baseline and at the end of 6 months follow-up.
measure: Number of Potentially inappropriate medications (PIMs)
timeFrame: At baseline and at the end of 6 months follow-up.
Secondary outcomes:
measure: Pill burden
timeFrame: At baseline and at the end of 6 months follow-up.
measure: Health-related quality of life (HRQoL)
timeFrame: At baseline and at the end of 6 months follow-up.
measure: Treatment burden
timeFrame: At baseline and at the end of 6 months follow-up.
measure: Self-reported adherence
timeFrame: At baseline and at the end of 6 months follow-up
measure: Medication Refills adherence
timeFrame: At baseline and at the end of 6 months follow-up
measure: Emergency department visits and hospitalizations
timeFrame: At baseline (indicating 6 months pre-intervention) and at the end of 6 months follow-up.
measure: Unanticipated adverse effects
timeFrame: At the end of 6 months follow-up
measure: Cost avoidance
timeFrame: At the end of 6 months follow-up
measure: Cost savings
timeFrame: At the end of 6 months follow-up
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: Hamad Medical Corporation
state: Unlisted (UL)
Study officials:
affiliation: Head of Nephrology Division, Hamad Medical Corporation
name: Hasan Al-Malki, MD
role: STUDY_CHAIR
affiliation: Division of Nephrology, Hamad Medical Corporation
name: Abdullah Hamad, MD
role: STUDY_DIRECTOR
affiliation: Head of Department of Clinical Pharmacy and Practice, College of Pharmacy, Qatar University
name: Ahmed Awaisu, Ph.D.
role: STUDY_DIRECTOR
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