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

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...

Full description

Bibliographic Details
Main Authors: 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
Format: Article
Language:English
Published: BMC 2024-04-01
Series:Pilot and Feasibility Studies
Subjects:
Online Access:https://doi.org/10.1186/s40814-024-01484-6
Description
Summary: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.
ISSN:2055-5784