Chronic Kidney DiseasesNCT06324045
Deprescribing Intervention for Patients With Chronic Kidney Disease
A study testing Deprescribing in people with Chronic Kidney Diseases, run by Hamad Medical Corporation at 1 site in Qatar.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Deprescribing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 424 participants
- Where
- 1 siteQatar
- Study dates
- 19 Feb 2024to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Qatar1 site, 1 recruiting
- Recruiting
Hamad Medical Corporation
Doha, 3050
Abdulla Hamad, MD, +97444394804, ahamad9@hamad.qa
Rania Ibrahim, MSc., +9744394808, ribrahim4@hamad.qa
About this study
Official title: Development and Evaluation of a Multidisciplinary Team Delivered Deprescribing Intervention for Patients With Chronic Kidney Disease in Qatar: A Randomized Controlled Trial
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.
Read the 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:
- 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.
- 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:
- develop and validate an intervention framework, deprescribing guide and documents, and deprescribing training materials.
- implement and assess the clinical and humanistic impact of the deprescribing intervention program.
- 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
- Being tested
- Deprescribing
- Keywords
- Deprescribing, Inappropriate polypharmacy, Treatment burden, Multidisciplinary, Clinical pharmacy
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeprescribingOther
- 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.
- The plan will be implemented and monitored during the patient's appointments for 1- 2 weeks at the center by the nephrologist.
- 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.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Deprescribing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At baseline, 3 months, and at the end of 6 months follow-up.
Secondary outcomes (8)
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.
Measured: At baseline, 3 months, and at the end of 6 months follow-up.
Health-related quality of life (HRQoL)
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
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the end of 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start19 Feb 2024
- Primary completionDec 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 424 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Qatar University, Winchester District Memorial Hospital
- Responsible party
- Principal investigator, Abdullah Ibrahim Hamad, Hamad Medical Corporation
- Investigators
- Hasan Al-Malki, MD, Study chair, Head of Nephrology Division, Hamad Medical CorporationAbdullah Hamad, MD, Study director, Division of Nephrology, Hamad Medical CorporationAhmed Awaisu, Ph.D., Study director, Head of Department of Clinical Pharmacy and Practice, College of Pharmacy, Qatar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324045
- Sponsor's protocol ID
- MRC-01-22-314
- Status last verified
- Sep 2025
- First submitted
- 28 Feb 2024
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31399958Manski-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.
PubMed 33786539Johansson 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.
PubMed 27059768Reeve 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.
PubMed 28063660Zidan 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.
PubMed 30104554Al-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.
PubMed 33612446Stewart 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.
PubMed 27885844Kurczewska-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.
PubMed 34899294Gazarin 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.
PubMed 33193924Ibrahim 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.
PubMed 33865310Kemp 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.
PubMed 21871197Hays 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.
PubMed 7841967Tran 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.
PubMed 24989988Anghel 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.
PubMed 31086837Bijlsma 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.
PubMed 26687394
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Multidisciplinary Team Delivered Deprescribing Intervention for Patients With Chronic Kidney Disease in Qatar: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06324045
- Acronym / sponsor ID
- MRC-01-22-314
- Conditions
- Chronic Kidney Diseases
- Keywords
- Deprescribing, Inappropriate polypharmacy, Treatment burden, Multidisciplinary, Clinical pharmacy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 424 participants (estimated)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Qatar University, Winchester District Memorial Hospital
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 21 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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:
- develop and validate an intervention framework, deprescribing guide and documents, and deprescribing training materials.
- implement and assess the clinical and humanistic impact of the deprescribing intervention program.
- 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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –Includes patients who will receive usual ambulatory, and at discharge care |
| Intervention arm | Experimental | Other: DeprescribingIncludes patients who will receive a structured deprescribing intervention by the multidisciplinary team during patients' time at the center, and discharge (as applicable) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deprescribing1. 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. | Other | Intervention arm |
Primary outcome
Percentage of participants with at least one Potentially inappropriate medications (PIMs)
Time frame: At baseline, 3 months, 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)
Time frame: At baseline, 3 months, 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.
8 secondary outcomes
Pill burden
Time frame: At baseline, 3 months, and at the end of 6 months follow-up.
Health-related quality of life (HRQoL)
Time frame: At baseline, 3 months, and at the end of 6 months follow-up.
Treatment burden
Time frame: At baseline, 3 months, and at the end of 6 months follow-up.
Self-reported adherence
Time frame: At baseline, 3 months, and at the end of 6 months follow-up
Emergency department visits and hospitalizations
Time frame: At baseline (indicating 6 months pre-intervention), 3 months, and at the end of 6 months follow-up.
Unanticipated adverse effects
Time frame: At the end of 6 months follow-up
Cost avoidance
Time frame: At the end of 6 months follow-up
Cost savings
Time frame: At the end of 6 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Background: PubMed 31399958Lv 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.
- Background: PubMed 33786539Manski-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.
- Background: PubMed 27059768Johansson 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.
- Background: PubMed 28063660Reeve 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.
- Background: PubMed 30104554Zidan 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.
- Background: PubMed 33612446Al-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.
- Background: PubMed 27885844Stewart 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.
- Background: PubMed 34899294Kurczewska-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.
- Background: PubMed 33193924Gazarin 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.
- Background: PubMed 33865310Ibrahim 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.
- Background: PubMed 21871197Kemp 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.
- Background: PubMed 7841967Hays 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hasan Al-Malki, MD study chair
Head of Nephrology Division, Hamad Medical Corporation
Abdullah Hamad, MD study director
Division of Nephrology, Hamad Medical Corporation
Ahmed Awaisu, Ph.D. study director
Head of Department of Clinical Pharmacy and Practice, College of Pharmacy, Qatar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deprescribing in people with Chronic Kidney Diseases, run by Hamad Medical Corporation at 1 site in Qatar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdullah Hamad, MD (+97444394888, Ahamad9@hamad.qa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with at least one Potentially inappropriate medications (PIMs) (time frame: At baseline, 3 months, and at the end of 6 months follow-up.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06324045, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.