NCT06324045

Deprescribing Intervention for Patients With Chronic Kidney Disease

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 424 (estimated)
• Sponsor: Hamad Medical Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Chronic Kidney Diseases

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-02-19
• Primary completion: 2025-12-01
• Completion: 2026-03-01
• First posted: 2024-03-21
• Last updated: 2025-10-01

Locations

1 site across 1 country: Qatar