Pharmacist Led Intervention to Improve Medication Use in Older In-patients Living With Frailty: the Drug Burden Index

NCT03698487 | Active Not Recruiting

• 1 other identifier: CAT2017-13
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Older people in Canada commonly take multiple medicines for their health conditions. Certain medicines, especially when taken together can lead to serious harms, such as falls. As people age and their health changes, medicines that were once helpful may become harmful. Healthcare professionals recognise that better tools and procedures are needed to make sure that people are taking the right medicines at the right time. A tool has been recently created, called the Drug Burden Index (DBI) Calculator©, to be used by hospital pharmacists. It helps them identify which medicines (and combinations of medicines) are harmful to older people. This tool also produces reports for the doctor and for the older person and their family. In this study, hospital pharmacists will use the DBI calculator© during their normal activities. The investigators will measure what effect this has on the medicines used and health outcomes in older adults. The investigators are also interested in what influences use and impact of the calculator. For example, there may be differences in use in older males compared to females or in the benefits seen in people living with frailty compared to those who are not frail. Use of the DBI calculator© may lead to improvements in how medicines are managed in hospital. This would mean less drug costs and drug side effects. Overall, the project may lead to improving the quality of life for older Canadians. Hypothesis: Implementation of a ward-based, pharmacist-led intervention utilizing the DBI Calculator© will lead to optimization of medications, reduced DBI and improved health outcomes in frail and non-frail older adults.

Conditions

Sedative Adverse Reaction; Anticholinergic Adverse Reaction

Outcome Measures

Primary Outcomes (1)

• Number of participants with changed or unchanged DBI score at discharge compared to admission

  • Proportion of inpatients in whom DBI is decreased, unchanged or increased at discharge, compared to on admission to hospital

  Up to 12 weeks

Secondary Outcomes (5)

• Number of participants with changed (or unchanged) DBI score

  90 days

• Total number of medications

  90 days

• Clinical outcomes during hospitalization

  Up to 12 weeks

• Clinical outcomes after hospitalization

  90 days

• Pharmacist time

  Up to 12 weeks

Study Arms (2)

Retrospective Chart Review

NO INTERVENTION

Specifically, it consists of: * A retrospective study (NB: ethics for this part of the overall study has been sought separately and already approved, file number 1023666). * A before/after intervention * A multiple case study (a sub-study of the before/after intervention)

Intervention

ACTIVE COMPARATOR

* A before/after intervention * A multiple case study (a sub-study of the before/after intervention)

Other: Intervention

Interventions

Intervention OTHER

Pharmacist-led medication optimization intervention using an electronic tool (DBI Calculator©). The DBI Calculator is an electronic tool which calculates a score from the medication reconciliation list (medications taken prior to admission). It also creates a 'DBI report' which includes their full medication list, their DBI score, an explanation of the risks associated with their DBI score and highlighted medications which are contributing to their DBI score (that is, high risk medications which may be suitable for deprescribing).

Intervention

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥70 years old
• DBI score \>0 (taking ≥1 regular medication with a sedative or anticholinergic effect prior to admission)
• Informed consent able to be obtained from patient or substitute decision maker as per hospital policy
• Able to communicate in English (as DBI report only available in English)

You may not qualify if:

• Expected discharge within 24 hours of recruitment or 48 hours of admission
• Terminal phase of illness (expected to die during current admission) OR noted to be 'palliative care'
• Usual residence outside Nova Scotia

Sponsors & Collaborators

• Emily: lead
• Canadian Frailty Network: collaborator

Study Sites (1)

Nova Scotia Health Authority QE2/DGH

Halifax, Nova Scotia, B3H 2E1, Canada

Location

Related Publications (2)

• Dearing ME, Bowles S, Isenor J, Kits O, Kouladjian O'Donnell L, Neville H, Hilmer S, Toombs K, Sirois C, Hajizadeh M, Negus A, Rockwood K, Reeve E. Pharmacist-led intervention to improve medication use in older inpatients using the Drug Burden Index: a study protocol for a before/after intervention with a retrospective control group and multiple case analysis. BMJ Open. 2020 Feb 20;10(2):e035656. doi: 10.1136/bmjopen-2019-035656.

  PMID: 32086361 BACKGROUND

• Dearing M, Bowles SK, Isenor JE, Weir KR, O'Donnell LK, Kits O, Hilmer SN, Neville H, Rockwood K, Sirois C, Hajizadeh M, Toombs K, Susin A, Reeve E. Effectiveness of a pharmacist-led deprescribing intervention in older inpatients: an implementation study with retrospective control group. Eur Geriatr Med. 2026 Jan 29. doi: 10.1007/s41999-025-01371-0. Online ahead of print.

  PMID: 41609981 DERIVED

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Affiliate Scientist

Model Details: This project is a prospective interventional implementation study with a pre-intervention control cohort; mixed methods will be used to explore the success and moderators of implementation. Specifically, it consists of: * A retrospective study (NB: ethics for this part of the overall study has been sought separately and already approved, file number 1023666). * A before/after intervention * A multiple case study (a sub-study of the before/after intervention)

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 9, 2018
• Study Start: February 6, 2019
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Immediately after publication of final manuscript and up to 5 years after.
• Access Criteria: Requests to access the data can be made by email to the corresponding author.

Locations

CA (1)