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Completed

NCT Number: NCT04077281

Improving Medication Prescribing-Related Outcomes for Vulnerable Elderly in Transitions

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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)

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Feasibility Outcomes of CPT consultation volume capacity and potential to apply the intervention entirely through telemedicine.

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

    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.

  2. Feasibility Outcomes of patient retention rate.

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

    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.

  3. Feasibility Outcomes of likelihood of the intervention proving cost-effective.

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

    This will be measured using Healthcare resource utilization questionnaire, which will determine whether the intervention reduced healthcare costs compared to the control group.

  4. Patient-important outcomes: Participant ratings of coordination and continuity of transitions in care.

    Time frame: 2 months post discharge

    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).

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

    Time frame: 2 months post discharge

    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.

Sponsors and collaborators

Lead sponsor

St. Joseph's Healthcare Hamilton

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

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

Acronym: IMPROVE-IT

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 4, 2019
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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