Improving medication prescribing-related outcomes for vulnerable elderly in transitions on high-risk medications (IMPROVE-IT HRM): a pilot randomized trial protocol

Anne Holbrook; Dan Perri; Mitch Levine; Lawrence Mbuagbaw; Sarah Jarmain; Lehana Thabane; Jean-Eric Tarride; Lisa Dolovich; Sylvia Hyland; Victoria Telford; Jessyca Silva; Carmine Nieuwstraten

doi:10.1186/s40814-024-01484-6

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.

Authors

Anne Holbrook^{1

2

3}, Dan Perri^{4

5}, Mitch Levine^{4

6}, Lawrence Mbuagbaw^{6

7

8

9

10

11}, Sarah Jarmain¹², Lehana Thabane^{6

9

13}, Jean-Eric Tarride^{6

14

15}, Lisa Dolovich^{16

17}, Sylvia Hyland¹⁸, Victoria Telford¹⁹, Jessyca Silva¹⁹, Carmine Nieuwstraten²⁰

Affiliations

¹ Division of Clinical Pharmacology and Toxicology, Department of Medicine, McMaster University, Hamilton, ON, Canada. holbrook@mcmaster.ca.
² Clinical Pharmacology Research, Research Institute of St. Joes Hamilton, Hamilton, ON, Canada. holbrook@mcmaster.ca.
³ Department of Health Research Methods, Evidence and Impact (HEI), McMaster University, Hamilton, ON, Canada. holbrook@mcmaster.ca.
⁴ Division of Clinical Pharmacology and Toxicology, Department of Medicine, McMaster University, Hamilton, ON, Canada.
⁵ Digital Solutions, St. Joseph's Healthcare Hamilton, Hamilton, Canada.
⁶ Department of Health Research Methods, Evidence and Impact (HEI), McMaster University, Hamilton, ON, Canada.
⁷ Department of Anesthesia, McMaster University, Hamilton, ON, Canada.
⁸ Department of Pediatrics, McMaster University, Hamilton, ON, Canada.
⁹ Biotatistics Unit, Research Institute of St. Joes Hamilton, Hamilton, ON, Canada.
¹⁰ Centre for Development of Best Practices in Health (CDBPH), Yaoundé Central Hospital, Yaoundé, Cameroon.
¹¹ Division of Epidemiology and Biostatistics, Department of Global Health, Stellenbosch University, Cape Town, South Africa.
¹² Medical and Academic Affairs, St. Joseph's Healthcare Hamilton, Hamilton, ON, Canada.
¹³ Faculty of Health Sciences, University of Johannesburg, Johannesburg, South Africa.
¹⁴ Center for Health Economic and Policy Analysis, McMaster University, Hamilton, ON, Canada.
¹⁵ Programs for Assessment of Technology in Health (PATH), The Research Institute of St. Joes Hamilton, Hamilton, ON, Canada.
¹⁶ Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, ON, Canada.
¹⁷ Department of Family Medicine, McMaster University, Hamilton, ON, Canada.
¹⁸ Institute for Safe Medication Practices Canada, North York, ON, Canada.
¹⁹ Clinical Pharmacology Research, Research Institute of St. Joes Hamilton, Hamilton, ON, Canada.
²⁰ Pharmacy Services, St. Joseph's Healthcare Hamilton, Hamilton, ON, Canada.

Abstract

Background: Seniors with recurrent hospitalizations who are taking multiple medications including high-risk medications are at particular risk for serious adverse medication events. We will assess whether an expert Clinical Pharmacology and Toxicology (CPT) medication management intervention during hospitalization with follow-up post-discharge and communication with circle of care is feasible and can decrease drug therapy problems amongst this group.

Methods: The design is a pragmatic pilot randomized trial with 1:1 patient-level concealed randomization with blinded outcome assessment and data analysis. Participants will be adults 65 years and older admitted to internal medicine services for more than 2 days, who have had at least one other hospitalization in the prior year, taking five or more chronic medications including at least one high-risk medication. The CPT intervention identifies medication targets; completes consult, including priorities for improving prescribing negotiated with the patient; starts the care plan; ensures a detailed discharge medication reconciliation and circle-of-care communication; and sees the patient at least twice after hospital discharge via virtual visits to consolidate the care plan in the community. Control group receives usual care. Primary outcomes are feasibility - recruitment, retention, costs, and clinical - number of drug therapy problems improved, with secondary outcomes examining coordination of transitions in care, quality of life, and healthcare utilization and costs. Follow-up is to 3-month posthospital discharge.

Discussion: If results support feasibility of ramp-up and promising clinical outcomes, a follow-up definitive trial will be organized using a developing national platform and medication appropriateness network. Since the intervention allows a very scarce medical specialty expertise to be offered via virtual care, there is potential to improve the safety, outcomes, and cost of care widely.

Trial registration number: ClinicalTrials.gov identifier: NCT04077281.

Keywords: Clinical pharmacology; High-cost user; High-risk medications; Hospital discharge; Major polypharmacy; Medication management; Medication safety; Pilot RCT; Seniors.

Associated data

ClinicalTrials.gov/NCT04077281

Grants and funding

TEG-165595)/CAPMC/ CIHR/Canada