Clinical trial NCT04077281: Improving Medication Prescribing-Related Outcomes for Vulnerable Elderly in Transitions
Official title: Improving Medication Prescribing-Related Outcomes for Vulnerable Elderly in Transitions (IMPROVE-IT): a Pilot Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Discharge
Drug-Related Side Effects and Adverse Reactions
Aged
Health Care Costs
Keywords: Polypharmacy
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2019-09-04
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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).

Primary outcomes:
measure: Feasibility Outcome: Recruitment rate for eligible patients.
timeFrame: Through the study completion, an average of 2 years
measure: Clinical Outcome: The number of TRIIM-Meds successfully deprescribed.
timeFrame: 2 months post discharge
Secondary outcomes:
measure: Feasibility Outcomes of CPT consultation volume capacity and potential to apply the intervention entirely through telemedicine.
timeFrame: Through the study completion, an average of 2 years
measure: Feasibility Outcomes of patient retention rate.
timeFrame: Through the study completion, an average of 2 years
measure: Feasibility Outcomes of likelihood of the intervention proving cost-effective.
timeFrame: Through the study completion, an average of 2 years
measure: Patient-important outcomes: Participant ratings of coordination and continuity of transitions in care.
timeFrame: 2 months post discharge
measure: Patient-important outcomes: Health related quality of life: EQ-5D-5L
timeFrame: 2 months post discharge
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
affiliation: St. Joseph's Healthcare Hamilton
name: Anne Holbrook
role: PRINCIPAL_INVESTIGATOR
affiliation: SJHH
name: Anne Holbrook
role: PRINCIPAL_INVESTIGATOR
References: