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Clinical Trials/NCT04077281
NCT04077281
Completed
Not Applicable

Improving Medication Prescribing-Related Outcomes for Vulnerable Elderly in Transitions (IMPROVE-IT): a Pilot Randomized Trial

St. Joseph's Healthcare Hamilton1 site in 1 country60 target enrollmentJune 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patient Discharge
Sponsor
St. Joseph's Healthcare Hamilton
Enrollment
60
Locations
1
Primary Endpoint
Clinical Outcome: The number of TRIIM-Meds successfully deprescribed.
Status
Completed
Last Updated
last year

Overview

Brief Summary

Medication safety is a crucial health issue for every older Canadian since many of the medications causing serious harm are those which also have life-saving or important symptom-relieving benefits. Very few specialists can accurately advise seniors which medications provide more benefit than harm for them personally, and make changes safely as this requires a very large breadth and depth of knowledge about the patient, the conditions they have and their therapies. Now that telemedicine is compatible with smart phones, this extends the ability of scarce specialists to 'see' any patient in Canada in a way that is more convenient for the patient and may be less expensive than current care. This project will find out whether a unique Clinical Pharmacology specialist team in Hamilton, Ontario can improve medication safety (stop medications no longer needed, reduce doses where appropriate, change to safer medications) for a high risk group of older hospitalized Canadians taking many medications. The hospital where this pilot study will take place was the first to install the world's leading electronic health record and set it up to facilitate and support high quality research. Patients who volunteer will be assigned to their usual care, or to the intervention which is the Clinical Pharmacology specialist team approach starting in hospital and following up with the patient at home using telemedicine and detailed communication with them, their caregiver, family physician, community pharmacist and other specialists. The investigators will study whether the intervention is effective and cost-effective at reducing harmful medication burden, reducing the need to return to hospital, or improving the patient's ratings of their care coordination. The results will determine whether a subsequent large trial is worthwhile.

Registry
clinicaltrials.gov
Start Date
June 1, 2023
End Date
November 7, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Anne Holbrook

Director, Division of Clinical Pharmacology & Toxicology Professor, Department of Medicine, McMaster University Medical Staff, Hamilton Health Sciences and St Joseph's Healthcare Hamilton

St. Joseph's Healthcare Hamilton

Eligibility Criteria

Inclusion Criteria

  • Adults over the age of 65 years.
  • Admitted to Medicine or Surgery services for more than 2 days.
  • High cost users (defined as):
  • Have at least one other hospitalization within the previous year.
  • Taking 5 or more chronic medications including at least one TRIIM-Med.
  • Provide informed consent.

Exclusion Criteria

  • Patients with "do not approach status".
  • Patient or Caregiver not fluent in English.
  • Patients who do not provide informed consent.
  • Patients admitted for \< 2 days.
  • Patients \< 65 years of age.
  • Not a high cost user (as defined above).

Outcomes

Primary Outcomes

Clinical Outcome: The number of TRIIM-Meds successfully deprescribed.

Time Frame: 2 months post discharge

The number of TRIIM-Meds successfully deprescribed (dose reduction or discontinued) at 2 months post-hospital discharge, aiming to be able to detect a mean difference of 0.5.

Feasibility Outcome: Recruitment rate for eligible patients.

Time Frame: Through the study completion, an average of 2 years

The main trial will be considered feasible if we are able to recruit at least 50% of eligible patients in this pilot.

Secondary Outcomes

  • Feasibility Outcomes of CPT consultation volume capacity and potential to apply the intervention entirely through telemedicine.(Through the study completion, an average of 2 years)
  • Feasibility Outcomes of patient retention rate.(Through the study completion, an average of 2 years)
  • Patient-important outcomes: Health related quality of life: EQ-5D-5L(2 months post discharge)
  • Feasibility Outcomes of likelihood of the intervention proving cost-effective.(Through the study completion, an average of 2 years)
  • Patient-important outcomes: Participant ratings of coordination and continuity of transitions in care.(2 months post discharge)

Study Sites (1)

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