Improving Medication Safety for Kidney Disease with a Digital Drug Dosing Tool in Nova Scotia Community Pharmacy Practice.

NCT06820372 | Not Yet Recruiting

• 1 other identifier: Nova Scotia Health Authority
• Study Type: observational
• Target: 125
• Locations: 0 countries
• Sites: N/A

Brief Summary

Chronic kidney disease (CKD) is a common condition. It occurs in approximately 7 out of 100 Canadians and is highest in rural settings. The kidneys are responsible for the removal of many drugs from the body. These drugs may require adjustment to avoid buildup. Individuals with CKD also tend to have multiple chronic conditions, are older, and are on many medications. Considering these factors, the risk for unwanted drug effects or harm are high. A recent medication review of a group of Nova Scotians with CKD referred from primary care to a specialist kidney clinic revealed that nearly 20% of high-risk medications should have been dose-adjusted or avoided. In Nova Scotia, community pharmacists' scope of practice now enables them to modify a prescription or prescribe a medication for a chronic condition except CKD. They are in an ideal position to protect or preserve kidney function through appropriate prescribing. Interviews of Nova Scotia community pharmacists in 2022 identified barriers and facilitators for kidney function assessment, medication dose adjustment and prescribing. Key findings indicated the need to develop a tool which would include agreed upon drug dosing based on kidney function, monitoring, medication specific benefits and harms, appropriate alternatives considering drug coverage and ideal medication prescribing to protect and preserve the kidneys. This study objective is to develop, validate, implement, and evaluate an electronic drug dosing and decision support kidney tool (eDoseCKD) in community pharmacy to improve medication safety and optimize kidney health. This project will consist of three phases. Phase one encompassed developing the tool based on evidence, clinician expertise and information learned from a previous study of pharmacists' interviews. Phase two will entailed tool validation or consensus by community pharmacists. In the present study, phase three, the implementation and evaluation of the tool in community pharmacies in Nova Scotia will be undertaken. We aim to answer, will this tool improve medication safety and prescribing in Nova Scotians with CKD? Participating patients will be surveyed to determine satisfaction with quality of care. Participating pharmacists will be interviewed after 6 months to assess barriers to and faciliators for using the computerized decision support alogirthms in community pharmacy practice.

Conditions

Chronic Kidney Disease Stage 4; Chronic Kidney Disease Stage 5

Keywords

Chronic Kidney Disease; Community Pharmacy; Medication; Tool; mediation safety; decision support algorithms

Outcome Measures

Primary Outcomes (1)

• Effectiveness: Intervention Success and Intervention Safety

  Quantitative measures of the number and type of target medications changed by community pharmacists with the tool or not changed including reasons, the number of patients who accept or decline the medication change including reasons, the number of potential level of harm or clinical impact as described by the Cornish classification system, and the number of unexpected clinically significant adverse events from medication changes with the tool.

  After 6 months of tool introduction.

Interventions

Electronic Drug Dosing and Decision Support Kidney (eDoseCKD) Tool OTHER

Thirty evidence, expert informed and validated computerized drug decision support algorithms of high risk medications will be utilized by community pharmacists for individuals with an eGFR \< 60 ml/min who are on one of the 30 target algorithms. The will be followed up to 3 months to assess effectivess, safety and whether the dose change was maintained.

Eligibility Criteria

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

Study Population

The study participants will be individuals over the age of 18 years who have been diagnosed with chronic kidney disease (CKD). Specifically, participants will have an estimated glomerular filtration rate (eGFR) of less than 60 ml/min/1.73m², which indicates the presence of CKD. These individuals will be receiving one of the 30 target medications prescribed via a digital dosing tool. Participants will be selected from a sample of patients attending 10-12 community pharmacy sites spread across the province. These pharmacies will act as the study's recruitment hubs, providing access to participants who meet the inclusion criteria.

You may qualify if:

• individuals with an eGFR \< 60 mL/min/1.73m2 AND
• receiving at least 1 tool target medication

You may not qualify if:

• individuals on dialysis
• unable to provide informed consent

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Related Publications (2)

• Tran J, Shaffelburg C, Phelan E, Neville H, Lively A, Poyah P, Tennankore K, More K, Soroka S, Harpell D, Wilson JA. Community pharmacists' perspectives on assessing kidney function and medication dosing for patients with advanced chronic kidney disease: A qualitative study using the theoretical domains framework. Can Pharm J (Ott). 2023 Jul 7;156(5):272-281. doi: 10.1177/17151635231176530. eCollection 2023 Sep-Oct.

  PMID: 38222892 BACKGROUND

• Wilson JA, Ratajczak N, Halliday K, Battistella M, Naylor H, Sheffield M, Marin JG, Pitman J, Kennie-Kaulbach N, Trenaman S, Gillis L. Medications for community pharmacists to dose adjust or avoid to enhance prescribing safety in individuals with advanced chronic kidney disease: a scoping review and modified Delphi. BMC Nephrol. 2024 Oct 29;25(1):386. doi: 10.1186/s12882-024-03829-y.

  PMID: 39472832 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Equipment and Supplies

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

Central Study Contacts

Jo-Anne Wilson, BSc.Pharm, ACPR, M.ED, PharmD

CONTACT

9024886623; Jo-Anne.wilson@dal.ca

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Pharmacy, Faculty of Health, College of Pharmacy, Dalhousie University; Scientific Affiliate, Nova Scotia Health Research and Innovation, Associate Scientist, MSSU

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 11, 2025
• Study Start: June 1, 2025
• Primary Completion: March 31, 2026
• Study Completion: May 1, 2026
• Last Updated: February 11, 2025

Record last verified: 2025-01