protocolSection identificationModule nctId: NCT06324045, orgStudyIdInfo id: MRC-01-22-314, briefTitle: Deprescribing Intervention for Patients With Chronic Kidney Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2025-08-31, completionDateStruct date: 2025-08-31, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Hamad Medical Corporation, class: INDUSTRY, collaborators name: Qatar University, collaborators name: Winchester District Memorial Hospital, descriptionModule briefSummary: 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., conditionsModule conditions: Chronic Kidney Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 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)., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 424, type: ESTIMATED, armsInterventionsModule interventions name: Deprescribing, outcomesModule primaryOutcomes measure: Percentage of participants with at least one Potentially inappropriate medications (PIMs), primaryOutcomes measure: Number of Potentially inappropriate medications (PIMs), secondaryOutcomes measure: Pill burden, secondaryOutcomes measure: Health-related quality of life (HRQoL), secondaryOutcomes measure: Treatment burden, secondaryOutcomes measure: Self-reported adherence, secondaryOutcomes measure: Medication Refills adherence, secondaryOutcomes measure: Emergency department visits and hospitalizations, secondaryOutcomes measure: Unanticipated adverse effects, secondaryOutcomes measure: Cost avoidance, secondaryOutcomes measure: Cost savings, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hamad Medical Corporation, status: RECRUITING, city: Doha, state: Unlisted (UL), zip: 00000, country: Qatar, contacts name: Abdulla Hamad, MD, role: CONTACT, phone: +97444394804, email: ahamad9@hamad.qa, contacts name: Rania Ibrahim, MSc., role: CONTACT, phone: +9744394808, email: ribrahim4@hamad.qa, contacts name: Abdulla Hamad, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Ahmed Awaisu, Ph.D., role: PRINCIPAL_INVESTIGATOR, contacts name: Daoud Al-Badriyeh, Ph.D., role: PRINCIPAL_INVESTIGATOR, contacts name: Muhammad Abdul Hadi, Ph.D., role: PRINCIPAL_INVESTIGATOR, contacts name: Ali Elbeddini, Pharm D, role: SUB_INVESTIGATOR, contacts name: Rania Ibrahim, MSc., role: SUB_INVESTIGATOR, contacts name: Amani Zidan, MSc., role: SUB_INVESTIGATOR, contacts name: Kheloud Khaled, Pharm D, role: SUB_INVESTIGATOR, geoPoint lat: 25.28545, lon: 51.53096, hasResults: False