Pharmacist Led Intervention to Improve Medication Use in Older In-patients Living With Frailty: the Drug Burden Index
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|ClinicalTrials.gov Identifier: NCT03698487|
Recruitment Status : Recruiting
First Posted : October 9, 2018
Last Update Posted : September 4, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Sedative Adverse Reaction Anticholinergic Adverse Reaction||Other: Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||
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:
|Masking:||None (Open Label)|
|Official Title:||Pharmacist Led Intervention to Improve Medication Use in Older In-patients Living With Frailty: the Drug Burden Index|
|Actual Study Start Date :||February 6, 2019|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||August 2020|
No Intervention: Retrospective Chart Review
Specifically, it consists of:
Active Comparator: Intervention
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).
- Number of participants with changed or unchanged DBI score at discharge compared to admission [ Time Frame: Up to 12 weeks ]• Proportion of inpatients in whom DBI is decreased, unchanged or increased at discharge, compared to on admission to hospital
- Number of participants with changed (or unchanged) DBI score [ Time Frame: 90 days ]• Proportion of inpatients in whom DBI is decreased, unchanged or increased at 3 months after discharge, compared to hospital discharge
- Total number of medications [ Time Frame: 90 days ]Total number of medications at hospital discharge and at 3 months
- Clinical outcomes during hospitalization [ Time Frame: Up to 12 weeks ]
Proportion of inpatients who experience a clinical outcome during hospitalization
- New adverse drug reactions
- Pressure ulcers
- Clinical outcomes after hospitalization [ Time Frame: 90 days ]
Emergency visit, re-hospitalization and mortality within 3 months of discharge
- Re-hospitalization within 3 months of discharge
- Mortality within 3 months of discharge
- Pharmacist time [ Time Frame: Up to 12 weeks ]Time taken by clinical pharmacists to integrate DBI Calculator© into regular clinical activities per patient
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03698487
|Contact: Emily Reeve, PhDfirstname.lastname@example.org|
|Canada, Nova Scotia|
|Nova Scotia Health Authority QE2/DGH||Recruiting|
|Halifax, Nova Scotia, Canada, B3H 2E1|
|Contact: Emily Reeve, PhD 902-473-4993 email@example.com|