Improving Medication Prescribing-Related Outcomes for Vulnerable Elderly in Transitions

NCT ID: NCT04077281

Last Updated: 2024-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2024-11-07

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: TRIPLE

Study Groups

Intervention Arm

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.

Group Type: EXPERIMENTAL

Medication Coordinated care

Intervention Type: 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)

Control Arm (Usual care)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Medication Coordinated care

• 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 Type: OTHER

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).

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role: lead

Responsible Party

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne Holbrook

Role: PRINCIPAL_INVESTIGATOR

St. Joseph's Healthcare Hamilton

Anne Holbrook

Role: PRINCIPAL_INVESTIGATOR

SJHH

Locations

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 38600599 (View on PubMed)

Other Identifiers

CIHR#419518

Identifier Type: -

Identifier Source: org_study_id