Deprescribing Intervention for Patients With Chronic Kidney Disease

NCT06324045 | Recruiting DMC

• 1 other identifier: MRC-01-22-314
• Study Type: interventional
• Target: 424
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases

Keywords

Deprescribing; Inappropriate polypharmacy; Treatment burden; Multidisciplinary; Clinical pharmacy

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (8)

• Pill burden

  At baseline, 3 months, and at the end of 6 months follow-up.

• Health-related quality of life (HRQoL)

  At baseline, 3 months, and at the end of 6 months follow-up.

• Treatment burden

  At baseline, 3 months, and at the end of 6 months follow-up.

• Self-reported adherence

  At baseline, 3 months, and at the end of 6 months follow-up

• Emergency department visits and hospitalizations

  At baseline (indicating 6 months pre-intervention), 3 months, and at the end of 6 months follow-up.

Study Arms (2)

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)

Other: Deprescribing

Interventions

Deprescribing OTHER

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.

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hamad Medical Corporation: lead
• Qatar University: collaborator
• Winchester District Memorial Hospital: collaborator

Study Sites (1)

Hamad Medical Corporation

Doha, 3050, Qatar

RECRUITING

Related Publications (17)

• 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.

  PMID: 31399958 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.

  PMID: 33786539 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.

  PMID: 27059768 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.

  PMID: 28063660 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.

  PMID: 30104554 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.

  PMID: 33612446 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.

  PMID: 27885844 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.

  PMID: 34899294 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.

  PMID: 33193924 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.

  PMID: 33865310 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.

  PMID: 21871197 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.

  PMID: 7841967 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.

  PMID: 24989988 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.

  PMID: 31086837 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.

  PMID: 26687394 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.

  PMID: 19911444 BACKGROUND

• 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.

  PMID: 41358144 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Deprescriptions

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Hasan Al-Malki, MD

  Head of Nephrology Division, Hamad Medical Corporation

  STUDY CHAIR

• Abdullah Hamad, MD

  Division of Nephrology, Hamad Medical Corporation

  STUDY DIRECTOR

• Ahmed Awaisu, Ph.D.

  Head of Department of Clinical Pharmacy and Practice, College of Pharmacy, Qatar University

  STUDY DIRECTOR

Central Study Contacts

Abdullah Hamad, MD

CONTACT

+97444394888; Ahamad9@hamad.qa

Ahmed Awaisu, Ph.D.

CONTACT

+974 4403 5596; aawaisu@qu.edu.qa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lead Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 21, 2024
• Study Start: February 19, 2024
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

QA (1)