Deprescribing Intervention for Patients With Chronic Kidney Disease
- Conditions
- Chronic Kidney Diseases
- Interventions
- Other: Deprescribing
- Registration Number
- NCT06324045
- Lead Sponsor
- Hamad Medical Corporation
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 424
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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention arm Deprescribing Includes patients who will receive a structured deprescribing intervention by the multidisciplinary team during patients' time at the center, and discharge (as applicable)
- Primary Outcome Measures
Name Time Method Percentage of participants with at least one Potentially inappropriate medications (PIMs) At baseline 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.
Number of Potentially inappropriate medications (PIMs) At baseline 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.
- Secondary Outcome Measures
Name Time Method Pill burden At baseline 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.
Health-related quality of life (HRQoL) At baseline 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
Treatment burden At baseline 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
Emergency department visits and hospitalizations At baseline (indicating 6 months pre-intervention) 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)
Self-reported adherence At baseline 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.
Medication Refills adherence At baseline and at the end of 6 months follow-up (1) The proportion of days covered (PDC) will be used as an objective measure: (this is measured using medication refill data from electronic health records and calculated using the formula: sum of days covered in the period of interest) ÷ (number of days in the same period) × 100.
Cost avoidance 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.
Cost savings 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.
Unanticipated adverse effects 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.
Trial Locations
- Locations (1)
Hamad Medical Corporation
🇶🇦Doha, Unlisted (UL), Qatar