Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06324045
Status:
RECRUITING
Last Update Posted:
2024-03-21
First Post:
2024-02-28
Brief Title:
Deprescribing Intervention for Patients With Chronic Kidney Disease
Sponsor:
Hamad Medical Corporation
Organization:
Hamad Medical Corporation
Study Overview
Official Title:
Development and Evaluation of a Multidisciplinary Team Delivered Deprescribing Intervention for Patients With Chronic Kidney Disease in Qatar A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 persons 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
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 ie HMC
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 ie HMC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None