Deprescribing Intervention for Patients With Chronic Kidney Disease

September 26, 2025 updated by: Abdullah Ibrahim Hamad, Hamad Medical Corporation

Development and Evaluation of a Multidisciplinary Team Delivered Deprescribing Intervention for Patients With Chronic Kidney Disease in Qatar: A Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

424

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 Contact

Study Contact Backup

Study Locations

  • Qatar
      • Doha, Qatar, 3050
        • Recruiting
        • Hamad Medical Corporation
        • Contact:
        • Contact:
        • Principal Investigator:
          • Abdulla Hamad, MD
        • Principal Investigator:
          • Ahmed Awaisu, Ph.D.
        • Principal Investigator:
          • Daoud Al-Badriyeh, Ph.D.
        • Principal Investigator:
          • Muhammad Abdul Hadi, Ph.D.
        • Sub-Investigator:
          • Ali Elbeddini, Pharm D
        • Sub-Investigator:
          • Rania Ibrahim, MSc.
        • Sub-Investigator:
          • Amani Zidan, MSc.
        • Sub-Investigator:
          • Kheloud Khaled, Pharm D

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control arm
Includes patients who will receive usual ambulatory, and at discharge care
Experimental: Intervention arm
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants with at least one Potentially inappropriate medications (PIMs)
Time Frame: At baseline, 3 months, and at the end of 6 months follow-up.
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.
At baseline, 3 months, and at the end of 6 months follow-up.
Number of Potentially inappropriate medications (PIMs)
Time Frame: At baseline, 3 months, and at the end of 6 months follow-up.
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.
At baseline, 3 months, and at the end of 6 months follow-up.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unanticipated adverse effects
Time Frame: At the end of 6 months follow-up
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.
At the end of 6 months follow-up
Cost avoidance
Time Frame: At the end of 6 months follow-up
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.
At the end of 6 months follow-up
Cost savings
Time Frame: At the end of 6 months follow-up
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.
At the end of 6 months follow-up
Pill burden
Time Frame: At baseline, 3 months, and at the end of 6 months follow-up.
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.
At baseline, 3 months, and at the end of 6 months follow-up.
Health-related quality of life (HRQoL)
Time Frame: At baseline, 3 months, and at the end of 6 months follow-up.
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
At baseline, 3 months, and at the end of 6 months follow-up.
Treatment burden
Time Frame: At baseline, 3 months, and at the end of 6 months follow-up.
This will be assessed using the Treatment Burden Questionnaire (TBQ). Validated English and Arabic versions of the tool will also be used
At baseline, 3 months, and at the end of 6 months follow-up.
Self-reported adherence
Time Frame: At baseline, 3 months, and at the end of 6 months follow-up
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.
At baseline, 3 months, and at the end of 6 months follow-up
Emergency department visits and hospitalizations
Time Frame: At baseline (indicating 6 months pre-intervention), 3 months, and at the end of 6 months follow-up.
The total number of hospitalizations and ED visits. This will be obtained from medical records (CERNER)
At baseline (indicating 6 months pre-intervention), 3 months, and at the end of 6 months follow-up.

Collaborators and Investigators

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

Sponsor

Hamad Medical Corporation

Collaborators

Qatar University
Winchester District Memorial Hospital

Investigators

  • Study Chair: Hasan Al-Malki, MD, Head of Nephrology Division, Hamad Medical Corporation
  • Study Director: Abdullah Hamad, MD, Division of Nephrology, Hamad Medical Corporation
  • Study Director: Ahmed Awaisu, Ph.D., Head of Department of Clinical Pharmacy and Practice, College of Pharmacy, Qatar University

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)

February 19, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

February 28, 2024

First Submitted That Met QC Criteria

March 15, 2024

First Posted (Actual)

March 21, 2024

Study Record Updates

Last Update Posted (Estimated)

October 1, 2025

Last Update Submitted That Met QC Criteria

September 26, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRC-01-22-314

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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