Improving Medication Prescribing-Related Outcomes for Vulnerable Elderly in Transitions

NCT04077281 | Completed

• 1 other identifier: CIHR#419518
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient Discharge; Drug-Related Side Effects and Adverse Reactions; Aged; Health Care Costs

Keywords

Polypharmacy

Outcome Measures

Primary Outcomes (2)

• Feasibility Outcome: Recruitment rate for eligible patients.

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

  Through the study completion, an average of 2 years

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

  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.

  2 months post discharge

Secondary Outcomes (5)

• 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

• 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

• Patient-important outcomes: Health related quality of life: EQ-5D-5L

  2 months post discharge

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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.

Other: Medication Coordinated care

Control Arm (Usual care)

NO INTERVENTION

Patients will receive a best possible medication history (BPMH) as do the intervention patients, then usual care by their primary team.

Interventions

Medication Coordinated care OTHER

* Clinical Pharmacology \& Toxicology consult * CPT team completes detailed circle of care communication * Telemedicine followup by CPT team (approximately 48 hrs post-discharge \& 1 week to1 month post-discharge)

Intervention Arm

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Related Publications (1)

• Holbrook A, Perri D, Levine M, Mbuagbaw L, Jarmain S, Thabane L, Tarride JE, Dolovich L, Hyland S, Telford V, Silva J, Nieuwstraten C. Improving medication prescribing-related outcomes for vulnerable elderly in transitions on high-risk medications (IMPROVE-IT HRM): a pilot randomized trial protocol. Pilot Feasibility Stud. 2024 Apr 10;10(1):60. doi: 10.1186/s40814-024-01484-6.

  PMID: 38600599 DERIVED

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

• Anne Holbrook

  St. Joseph's Healthcare Hamilton

  PRINCIPAL INVESTIGATOR

• Anne Holbrook

  SJHH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Division of Clinical Pharmacology & Toxicology Professor, Department of Medicine, McMaster University Medical Staff, Hamilton Health Sciences and St Joseph's Healthcare Hamilton

Study Record Dates

• First Submitted: August 7, 2019
• First Posted: September 4, 2019
• Study Start: June 1, 2023
• Primary Completion: June 12, 2024
• Study Completion: November 7, 2024
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)