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| Name | Class |
|---|---|
| Qatar University | OTHER |
| Winchester District Memorial Hospital | OTHER |
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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.
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:
The objectives of the study are to:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control arm | No Intervention | Includes patients who will receive usual ambulatory, and at discharge care | |
| Intervention arm | Experimental | Includes patients who will receive a structured deprescribing intervention by the multidisciplinary team during patients' time at the center, and discharge (as applicable) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deprescribing | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with at least one Potentially inappropriate medications (PIMs) | 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) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pill burden | 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. |
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Inclusion Criteria:
Patients who are:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abdullah Hamad, MD | Contact | +97444394888 | Ahamad9@hamad.qa | |
| Ahmed Awaisu, Ph.D. | Contact | +974 4403 5596 | aawaisu@qu.edu.qa |
| Name | Affiliation | Role |
|---|---|---|
| Hasan Al-Malki, MD | Head of Nephrology Division, Hamad Medical Corporation | Study Chair |
| Abdullah Hamad, MD | Division of Nephrology, Hamad Medical Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamad Medical Corporation | Recruiting | Doha | 3050 | Qatar |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31399958 | Background | 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. | |
| 33786539 | Background | 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. |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D000069340 | Deprescriptions |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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CKD patients will be screened using medical records. Eligible patients will be approached during their routine visits to FBJ Kidney Center and other ambulatory kidney centers. Due to feasibility and practicality issues, selecting the patients will be consecutive case series as per their availability during the time of the recruitment (nonprobabilistic).
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).
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|
| Health-related quality of life (HRQoL) |
This will be measured using the self-administered Kidney Disease Quality of Life (KDQOLâ„¢) 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 | 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 | 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 | 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. |
| Unanticipated adverse effects | 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 | 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 | 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 |
| Ahmed Awaisu, Ph.D. |
| Head of Department of Clinical Pharmacy and Practice, College of Pharmacy, Qatar University |
| Study Director |
| 27059768 | Background | 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. |
| 28063660 | Background | 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. |
| 30104554 | Background | 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. |
| 33612446 | Background | 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. |
| 27885844 | Background | 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. |
| 34899294 | Background | 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. |
| 33193924 | Background | 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. |
| 33865310 | Background | 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. |
| 21871197 | Background | 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. |
| 7841967 | Background | 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. |
| 24989988 | Background | 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. |
| 31086837 | Background | 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. |
| 26687394 | Background | 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. |
| 19911444 | Background | 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. |
| 41916794 | Derived | Zidan A, Hamad A, Ibrahim R, Habib S, Alesnawi M, Al-Malki H, Alkadi M, Babiker F, Hadi MA, Al-Badriyeh D, Awaisu A. Multidisciplinary Team Delivered Deprescribing Intervention for Patients Receiving Maintenance Hemodialysis: A Pilot Randomized Controlled Trial. Clin Ther. 2026 May;48(5):399-406. doi: 10.1016/j.clinthera.2026.03.003. Epub 2026 Mar 30. |
| 41358144 | Derived | Zidan A, Hamad A, Ibrahim R, El-Kadi M, El-Malki H, Al-Esnawi M, Habib S, Abdul Hadi M, Babiker F, Al-Badriyeh D, Awaisu A. Effectiveness of a multidisciplinary team-delivered deprescribing intervention for patients with chronic kidney disease: a protocol for a randomised controlled trial. J Pharm Policy Pract. 2025 Nov 26;18(1):2588928. doi: 10.1080/20523211.2025.2588928. eCollection 2025. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |