An interventional study of Deprescribing in Chronic Kidney Diseases, sponsored by Hamad Medical Corporation. Recruiting at 1 site in Qatar. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-01.
Sponsored by Hamad Medical Corporation · Not applicable, Interventional, and Health services research
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.
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:
The objectives of the study are to:
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:
3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.
This study's planned enrollment of 424 is above the median of 73 across 2,157 interventional studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →Hamad Medical Corporation is the lead sponsor of 139 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Patients who are:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Includes patients who will receive usual ambulatory, and at discharge care
Includes patients who will receive a structured deprescribing intervention by the multidisciplinary team during patients' time at the center, and discharge (as applicable)
Other: Deprescribing
1. The clinical pharmacist will review the patient's medications using validated screening tools, draft a deprescribing plan of the potential problematic medications, consult with the physician (MDT-CKD nephrologist), make the needed amendments, and document in the medical records. 2. The plan will be implemented and monitored during the patient's appointments for 1- 2 weeks at the center by the nephrologist. 3. The medication plan will be reconciled before discharge from dialysis or a planned appointment, and patients will be given a deprescribing card containing medication information. A note will be posted on CERNER as well. The primary care physician might also be contacted by the MDT-CKD team for consultation or any inquiries regarding the patient's condition or medications. 4. The MDT-CKD specialist nurse will conduct 3 post-appointment follow-up phone calls on day 2, day 7, and day 28 to enquire about any withdrawal symptoms or any concerns of the patient.
Percentage of participants with at least one Potentially inappropriate medications (PIMs)
The percentage of participants with one or more PIMs. PIMs are drugs for which use should be avoided due to the high risk of adverse reactions for this population and/or insufficient evidence of their benefits when safer and equally or more effective therapeutic alternatives are available. This will be determined by outcome assessors through medical records and screening tools.
Time frame: At baseline, 3 months, and at the end of 6 months follow-up.
Number of Potentially inappropriate medications (PIMs)
The number of events and non-events in each of the study groups. PIMs are drugs for which use should be avoided due to the high risk of adverse reactions for this population and/or insufficient evidence of their benefits when safer and equally or more effective therapeutic alternatives are available. This will be determined by outcome assessors through medical records and screening tools.
Time frame: At baseline, 3 months, and at the end of 6 months follow-up.
Pill burden
The frequency and total number of daily medications at baseline, and total medications that were successfully removed, dose-reduced, substituted, or restarted after intervention, categorized by targeted pharmacological drug classification.
Time frame: At baseline, 3 months, and at the end of 6 months follow-up.
Health-related quality of life (HRQoL)
This will be measured using the self-administered Kidney Disease Quality of Life (KDQOL™) questionnaire. Validated English and Arabic versions of the tool will also be used
Time frame: At baseline, 3 months, and at the end of 6 months follow-up.
Treatment burden
This will be assessed using the Treatment Burden Questionnaire (TBQ). Validated English and Arabic versions of the tool will also be used
Time frame: At baseline, 3 months, and at the end of 6 months follow-up.
Self-reported adherence
The Adherence to Refills and Medications Scale (ARMS) is a validated self-administered adherence measuring tool. Validated English and Arabic versions of the tool will also be used.
Time frame: At baseline, 3 months, and at the end of 6 months follow-up
Emergency department visits and hospitalizations
The total number of hospitalizations and ED visits. This will be obtained from medical records (CERNER)
Time frame: At baseline (indicating 6 months pre-intervention), 3 months, and at the end of 6 months follow-up.
Unanticipated adverse effects
Deprescribing is safe intervention. However, withdrawal symptoms and the need for drug re-initiation could be encountered in some cases. Each class of medications has different expected withdrawal symptoms. For example: dyspepsia after stopping PPIs. These types of events or any other unanticipated events will be documented and reported to IRB as per IRB SOP-09.
Time frame: At the end of 6 months follow-up
Cost avoidance
The cost avoided by reducing emergency department visits and hospitalization as unintended consequences of the polypharmacy use of medications. All costs will be in Qatari Riyal.
Time frame: At the end of 6 months follow-up
Cost savings
The reduced cost of therapy associated with the reduction in utilization of the targeted drugs (by deprescribing) because of the intervention program. All costs will be in Qatari Riyal.
Time frame: At the end of 6 months follow-up
Started Feb 2024 (actual). Primary completion is estimated for Dec 2025, 22 months after the start.
Of 40 industry-sponsored interventional studies with no phase under Renal Insufficiency, Chronic, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 22 months is close to that.
Counting every sponsor, half of 616 studies reached it within 23 months; a quarter within 10 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
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