Improving Medication Prescribing-Related Outcomes for Vulnerable Elderly In Transitions on High Risk Medications (IMPROVE-IT HRM): A Pilot Randomized Trial Protocol

Rationale Transitions in, through, and out of hospital define the highest risk periods for patient safety. Hospitalized senior high-cost health care users taking high risk medications, are a large group of patients, usually highly complex with polypharmacy, and at high risk of serious adverse medication events. We will assess whether an expert Clinical Pharmacology 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. Design Pragmatic pilot randomized trial at SJHH with 1:1 patient-level concealed randomization with blinded outcome assessment and data analysis. Participants Adults 65 years of age and older, admitted to Internal Medicine services for more than 2 days, who are high-cost users defined as at least one other hospitalization in the prior year, taking 5 or more chronic medications including at least one high risk medication. Intervention CPT consult service identifies medication target(s), 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 integrated virtual visits to consolidate the care plan in the community. Control group receives usual care as provided by admitting services. Outcomes Include a) Feasibility Outcomes and b) Clinical Outcomes including the number of drug therapy problems improved, medication appropriateness and safety, the quality and coordination of transitions in care, quality of life, and health care utilization and costs by 3-month follow-up. Impact 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. RESEARCH QUESTION Our detailed research question is ‘In a randomized pilot trial, can an expert Clinical Pharmacology team coordinate and improve medication management during the very high-risk transition period from hospitalization through post-hospital discharge follow-up for senior high-cost users of healthcare taking high risk medications, meeting key feasibility outcomes while improving patient-important outcomes and health care costs sufficiently to warrant a large subsequent trial?’ ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial Clinical Trial ID [NCT04077281][1] ### Funding Statement This study was funded by the Canadian Institutes of Health Research, Funding Reference Number TEG-165595. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Hamilton Integrated Research Ethics Board of Hamilton Ontario gave ethical approval for this work (study #7598). I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT04077281&atom=%2Fmedrxiv%2Fearly%2F2023%2F03%2F25%2F2023.03.24.23287691.atom