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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
Sponsor:
Collaborator:
Canadian Frailty Network
Information provided by (Responsible Party):
Emily, Nova Scotia Health Authority

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.


Condition or disease Intervention/treatment Phase
Sedative Adverse Reaction Anticholinergic Adverse Reaction Other: Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
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:

  • 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)
Masking: None (Open Label)
Primary Purpose: Other
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

Arm Intervention/treatment
No Intervention: Retrospective Chart Review

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)
Active Comparator: Intervention
  • A before/after intervention
  • A multiple case study (a sub-study of the before/after intervention)
Other: 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).




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Total number of medications [ Time Frame: 90 days ]
    Total number of medications at hospital discharge and at 3 months

  3. Clinical outcomes during hospitalization [ Time Frame: Up to 12 weeks ]

    Proportion of inpatients who experience a clinical outcome during hospitalization

    • New adverse drug reactions
    • Falls
    • Pressure ulcers

  4. 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

  5. Pharmacist time [ Time Frame: Up to 12 weeks ]
    Time taken by clinical pharmacists to integrate DBI Calculator© into regular clinical activities per patient



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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Contacts
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Contact: Emily Reeve, PhD 902-473-4993 emily.reeve@unisa.edu.au

Locations
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Canada, Nova Scotia
Nova Scotia Health Authority QE2/DGH Recruiting
Halifax, Nova Scotia, Canada, B3H 2E1
Contact: Emily Reeve, PhD    902-473-4993    emily.reeve@unisa.edu.au   
Sponsors and Collaborators
Emily
Canadian Frailty Network
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Emily, Affiliate Scientist, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT03698487    
Other Study ID Numbers: CAT2017-13
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in manuscripts, after deidentification (text, tables, figures and appendices) may be made available where proposed use of the data has been approved by an independent ethics review committee.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Frailty
Pathologic Processes