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Patient DischargeIMPROVE-ITNCT04077281

Improving Medication Prescribing-Related Outcomes for Vulnerable Elderly in Transitions

A study testing Medication Coordinated care in people with Patient Discharge and Drug-Related Side Effects and Adverse Reactions, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Medication Coordinated care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteCanada
Study dates
1 Jun 2023to 7 Nov 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N 4A6

Other trials in Canada

About this study

Official title: 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.

Being tested
Medication Coordinated care
Keywords
Polypharmacy
Medical subject headings
Drug-Related Side Effects and Adverse Reactions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medication Coordinated careOther

    • 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)
Study groups in NCT04077281
Study groupRoleWhat they receive
Intervention ArmExperimentalClinical 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.
Receives: Other: Medication Coordinated care
Control Arm (Usual care)No interventionPatients will receive a best possible medication history (BPMH) as do the intervention patients, then usual care by their primary team.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Through the study completion, an average of 2 years

  2. 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.

    Measured: 2 months post discharge

Secondary outcomes (5)

  1. 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.

    Measured: Through the study completion, an average of 2 years

  2. 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.

    Measured: Through the study completion, an average of 2 years

  3. 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.

    Measured: Through the study completion, an average of 2 years

  4. 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).

    Measured: 2 months post discharge

  5. 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.

    Measured: 2 months post discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2019
  2. Study start1 Jun 2023
  3. Primary completion12 Jun 2024
  4. Study completion7 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04077281
Sponsor's protocol ID
CIHR#419518
Acronym
IMPROVE-IT
Status last verified
Nov 2024
First submitted
7 Aug 2019
Last updated
3 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38600599

Questions about this trial

What is this clinical trial studying?

A study testing Medication Coordinated care in people with Patient Discharge and Drug-Related Side Effects and Adverse Reactions, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility Outcome: Recruitment rate for eligible patients. (time frame: Through the study completion, an average of 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04077281, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.

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