Improving Medication Prescribing-Related Outcomes for Vulnerable Elderly In Transitions (IMPROVE-IT)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Drug-Related Side Effects and Adverse Reactions; Aged; Health Care Costs; Patient Discharge
• Intervention / Treatment: Other: Medication Coordinated care

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne Holbrook; Phone Number: 35269 905-522-1155; Email: holbrook@mcmaster.ca
• Study Contact Backup: Name: Victoria Telford; Phone Number: 35269 905-522-1155; Email: vtelford@stjoes.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • Recruiting
      • St. Joseph's Healthcare Hamilton
      • Contact: Victoria Telford; Phone Number: 35269 905-522-1155; Email: vtelford@stjoes.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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)
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility Outcomes of CPT consultation volume capacity and potential to apply the intervention entirely through telemedicine.	This will be measured based on the number of successfully enrolled patients, and the number of patients that will entirely undergo the intervention through telemedicine.	Through the study completion, an average of 2 years
Feasibility Outcomes of patient retention rate.	This will be measured by looking at the number of patients enrolled, the number of patients that dropped out, and the number of patients that completed the study.	Through the study completion, an average of 2 years
Feasibility Outcomes of likelihood of the intervention proving cost-effective.	This will be measured using Healthcare resource utilization questionnaire, which will determine whether the intervention reduced healthcare costs compared to the control group.	Through the study completion, an average of 2 years
Patient-important outcomes: Participant ratings of coordination and continuity of transitions in care.	This outcome will be measured using the Coordination and Continuity of Care Questionnaire (CCCQ). Which is a questionnaire we adapted from the brief prepared questionnaire (B-PREPARED) and the three-question care transitions measure questionnaire (CTM-3).	2 months post discharge
Patient-important outcomes: Health related quality of life: EQ-5D-5L	This outcome will be measured using the EuroQol five-dimensional, five-level descriptive system (EQ-5D-5L) that asks patients to self-assess their own health quality related quality of life. Whereas a scoring metric is used to assess the overall health related quality of life based on the answers to the questions. The questionnaire scale considers 1 as the best possible health and 5 as the worst health possible.	2 months post discharge

Collaborators and Investigators

• Sponsor: St. Joseph's Healthcare Hamilton
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Anne Holbrook, St. Joseph's Healthcare Hamilton; Principal Investigator: Anne Holbrook, SJHH

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): November 19, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: August 7, 2019
• First Submitted That Met QC Criteria: September 3, 2019
• First Posted (Actual): September 4, 2019

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Polypharmacy
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: CIHR#419518

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No