Improving Medication Prescribing-Related Outcomes for Vulnerable Elderly In Transitions (IMPROVE-IT)
Primary Purpose
Patient Discharge, Drug-Related Side Effects and Adverse Reactions, Aged
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Medication Coordinated care
Sponsored by
About this trial
This is an interventional health services research trial for Patient Discharge focused on measuring Polypharmacy
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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Arm
Control Arm (Usual care)
Arm Description
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.
Patients will receive a best possible medication history (BPMH) as do the intervention patients, then usual care by their primary team.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
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).
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.
Full Information
NCT ID
NCT04077281
First Posted
August 7, 2019
Last Updated
April 10, 2023
Sponsor
St. Joseph's Healthcare Hamilton
Collaborators
Canadian Institutes of Health Research (CIHR)
1. Study Identification
Unique Protocol Identification Number
NCT04077281
Brief Title
Improving Medication Prescribing-Related Outcomes for Vulnerable Elderly In Transitions
Acronym
IMPROVE-IT
Official Title
Improving Medication Prescribing-Related Outcomes for Vulnerable Elderly In Transitions (IMPROVE-IT): A Pilot Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2023 (Anticipated)
Primary Completion Date
November 19, 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Joseph's Healthcare Hamilton
Collaborators
Canadian Institutes of Health Research (CIHR)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient Discharge, Drug-Related Side Effects and Adverse Reactions, Aged, Health Care Costs
Keywords
Polypharmacy
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Arm (Usual care)
Arm Type
No Intervention
Arm Description
Patients will receive a best possible medication history (BPMH) as do the intervention patients, then usual care by their primary team.
Intervention Type
Other
Intervention Name(s)
Medication Coordinated care
Intervention Description
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 Outcome Measure Information:
Title
Feasibility Outcome: Recruitment rate for eligible patients.
Description
The main trial will be considered feasible if we are able to recruit at least 50% of eligible patients in this pilot.
Time Frame
Through the study completion, an average of 2 years
Title
Clinical Outcome: The number of TRIIM-Meds successfully deprescribed.
Description
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.
Time Frame
2 months post discharge
Secondary Outcome Measure Information:
Title
Feasibility Outcomes of CPT consultation volume capacity and potential to apply the intervention entirely through telemedicine.
Description
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.
Time Frame
Through the study completion, an average of 2 years
Title
Feasibility Outcomes of patient retention rate.
Description
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.
Time Frame
Through the study completion, an average of 2 years
Title
Feasibility Outcomes of likelihood of the intervention proving cost-effective.
Description
This will be measured using Healthcare resource utilization questionnaire, which will determine whether the intervention reduced healthcare costs compared to the control group.
Time Frame
Through the study completion, an average of 2 years
Title
Patient-important outcomes: Participant ratings of coordination and continuity of transitions in care.
Description
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).
Time Frame
2 months post discharge
Title
Patient-important outcomes: Health related quality of life: EQ-5D-5L
Description
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.
Time Frame
2 months post discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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).
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Improving Medication Prescribing-Related Outcomes for Vulnerable Elderly In Transitions
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