Deprescribing Intervention for Patients With Chronic Kidney Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHamad Medical Corporation

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Deprescribing

    Other intervention

    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.

Treatment groups

424 Participants
are divided into 2 treatment groups
Group A: Control armNo intervention 0 interventions
Group B: Intervention armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
At baseline, 3 months, and at the end of 6 months follow-up.
2

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.

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

Secondary outcomes

1

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.

Time frame
At baseline, 3 months, and at the end of 6 months follow-up.
2

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

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

Treatment burden

This will be assessed using the Treatment Burden Questionnaire (TBQ). Validated English and Arabic versions of the tool will also be used

Time frame
At baseline, 3 months, and at the end of 6 months follow-up.
4

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.

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

Other outcomes

Sponsors and contacts

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Hamad Medical Corporation

Lead sponsor

Qatar University

Collaborator

Winchester District Memorial Hospital

Collaborator