Deprescribing Intervention for Patients With Chronic Kidney Disease
NCT ID: NCT06324045
Last Updated: 2025-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
424 participants
INTERVENTIONAL
2024-02-19
2026-03-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
After obtaining informed consent, patients will be randomized into one of the two study arms. Randomization will be stratified by dialysis dependency (dialysis vs. pre-dialysis); randomly permuted balanced block sizes of 4 for dialysis patients and 1 for pre-dialysis will be used. Neither the practitioners nor the patients will be blinded to the patients' allocated groups due to the nature of the intervention. Due to feasibility and practicalities, selecting the patients will be consecutive as per their availability during the time of the recruitment (non-probabilistic).
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Control arm
Includes patients who will receive usual ambulatory, and at discharge care
No interventions assigned to this group
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)
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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Qatar University
OTHER
Winchester District Memorial Hospital
OTHER
Hamad Medical Corporation
INDUSTRY
Responsible Party
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Abdullah Ibrahim Hamad
Lead Principal Investigator
Principal Investigators
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Hasan Al-Malki, MD
Role: STUDY_CHAIR
Head of Nephrology Division, Hamad Medical Corporation
Abdullah Hamad, MD
Role: STUDY_DIRECTOR
Division of Nephrology, Hamad Medical Corporation
Ahmed Awaisu, Ph.D.
Role: STUDY_DIRECTOR
Head of Department of Clinical Pharmacy and Practice, College of Pharmacy, Qatar University
Locations
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Hamad Medical Corporation
Doha, , Qatar
Countries
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Central Contacts
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Facility Contacts
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References
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Lv JC, Zhang LX. Prevalence and Disease Burden of Chronic Kidney Disease. Adv Exp Med Biol. 2019;1165:3-15. doi: 10.1007/978-981-13-8871-2_1.
Manski-Nankervis JA, McMorrow R, Nelson C, Jesudason S, Sluggett JK. Prescribing and deprescribing in chronic kidney disease. Aust J Gen Pract. 2021 Apr;50(4):183-187. doi: 10.31128/AJGP-11-20-5752.
Johansson T, Abuzahra ME, Keller S, Mann E, Faller B, Sommerauer C, Hock J, Loffler C, Kochling A, Schuler J, Flamm M, Sonnichsen A. Impact of strategies to reduce polypharmacy on clinically relevant endpoints: a systematic review and meta-analysis. Br J Clin Pharmacol. 2016 Aug;82(2):532-48. doi: 10.1111/bcp.12959. Epub 2016 May 7.
Reeve E, Thompson W, Farrell B. Deprescribing: A narrative review of the evidence and practical recommendations for recognizing opportunities and taking action. Eur J Intern Med. 2017 Mar;38:3-11. doi: 10.1016/j.ejim.2016.12.021. Epub 2017 Jan 5.
Zidan A, Awaisu A, El-Hajj MS, Al-Abdulla SA, Figueroa DCR, Kheir N. Medication-Related Burden among Patients with Chronic Disease Conditions: Perspectives of Patients Attending Non-Communicable Disease Clinics in a Primary Healthcare Setting in Qatar. Pharmacy (Basel). 2018 Aug 13;6(3):85. doi: 10.3390/pharmacy6030085.
Al-Mansouri A, Al-Ali FS, Hamad AI, Mohamed Ibrahim MI, Kheir N, Ibrahim RA, AlBakri M, Awaisu A. Assessment of treatment burden and its impact on quality of life in dialysis-dependent and pre-dialysis chronic kidney disease patients. Res Social Adm Pharm. 2021 Nov;17(11):1937-1944. doi: 10.1016/j.sapharm.2021.02.010. Epub 2021 Feb 13.
Stewart D, Mair A, Wilson M, Kardas P, Lewek P, Alonso A, McIntosh J, MacLure K; SIMPATHY consortium. Guidance to manage inappropriate polypharmacy in older people: systematic review and future developments. Expert Opin Drug Saf. 2017 Feb;16(2):203-213. doi: 10.1080/14740338.2017.1265503. Epub 2016 Dec 4.
Kurczewska-Michalak M, Lewek P, Jankowska-Polanska B, Giardini A, Granata N, Maffoni M, Costa E, Midao L, Kardas P. Polypharmacy Management in the Older Adults: A Scoping Review of Available Interventions. Front Pharmacol. 2021 Nov 26;12:734045. doi: 10.3389/fphar.2021.734045. eCollection 2021.
Gazarin M, Devin B, Tse D, Mulligan E, Naciuk M, Duncan S, Burnett S, Hall L, Elbeddini A. Evaluating an inpatient deprescribing initiative at a rural community hospital in Ontario. Can Pharm J (Ott). 2020 Jun 9;153(4):224-231. doi: 10.1177/1715163520929734. eCollection 2020 Jul-Aug.
Ibrahim K, Cox NJ, Stevenson JM, Lim S, Fraser SDS, Roberts HC. A systematic review of the evidence for deprescribing interventions among older people living with frailty. BMC Geriatr. 2021 Apr 17;21(1):258. doi: 10.1186/s12877-021-02208-8.
Kemp A, Preen DB, Glover J, Semmens J, Roughead EE. How much do we spend on prescription medicines? Out-of-pocket costs for patients in Australia and other OECD countries. Aust Health Rev. 2011 Aug;35(3):341-9. doi: 10.1071/AH10906.
Hays RD, Kallich JD, Mapes DL, Coons SJ, Carter WB. Development of the kidney disease quality of life (KDQOL) instrument. Qual Life Res. 1994 Oct;3(5):329-38. doi: 10.1007/BF00451725.
Tran VT, Harrington M, Montori VM, Barnes C, Wicks P, Ravaud P. Adaptation and validation of the Treatment Burden Questionnaire (TBQ) in English using an internet platform. BMC Med. 2014 Jul 2;12:109. doi: 10.1186/1741-7015-12-109.
Anghel LA, Farcas AM, Oprean RN. An overview of the common methods used to measure treatment adherence. Med Pharm Rep. 2019 Apr;92(2):117-122. doi: 10.15386/mpr-1201. Epub 2019 Apr 25.
Bijlsma MJ, Janssen F, Hak E. Estimating time-varying drug adherence using electronic records: extending the proportion of days covered (PDC) method. Pharmacoepidemiol Drug Saf. 2016 Mar;25(3):325-32. doi: 10.1002/pds.3935. Epub 2015 Dec 21.
Kripalani S, Risser J, Gatti ME, Jacobson TA. Development and evaluation of the Adherence to Refills and Medications Scale (ARMS) among low-literacy patients with chronic disease. Value Health. 2009 Jan-Feb;12(1):118-23. doi: 10.1111/j.1524-4733.2008.00400.x.
Other Identifiers
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MRC-01-22-314
Identifier Type: -
Identifier Source: org_study_id
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