GeriMedRisk, a telemedicine geriatric pharmacology consultation service to address adverse drug events in long-term care: a stepped-wedge cluster randomized feasibility trial protocol (ISRCTN17219647)

• Main Authors: Joanne Man-Wai Ho, Jennifer Tung, Janine Maitland, Derelie Mangin, Lehana Thabane, J. Michael Pavlin, Jeffrey Alfonsi, Anne Holbrook, Sharon Straus, Sophiya Benjamin
• Format: Article
• Language: English
• Published: BMC 2018-06-01
• Series: Pilot and Feasibility Studies
• Subjects: Geriatrics; Appropriate prescribing; Telemedicine; Clinical trial; Feasibility; Cluster randomized controlled trial
• Online Access: http://link.springer.com/article/10.1186/s40814-018-0300-x

Abstract Background Multimorbidity, polypharmacy, and older age predispose seniors to adverse drug events (ADE). Seniors with an ADE experience greater morbidity, mortality, and health care utilization compared to their younger counterparts. To mitigate and manage ADEs among this vulnerable population, we designed a geriatric pharmacology consultation service connecting clinicians with specialist physicians and pharmacists and will investigate the feasibility and acceptability of this complex intervention in the long-term care setting, prior to conducting a larger efficacy trial. Methods/Design We will conduct a cluster randomized feasibility trial and qualitative analysis of GeriMedRisk among four long-term care homes in the Waterloo-Wellington region from May 1 to December 31, 2017. The primary outcome is the feasibility and acceptability of GeriMedRisk and the stepped-wedge cluster randomized controlled trial design. We hypothesize that GeriMedRisk is a feasible intervention and its potential to decrease falls and drug-related hospital visits can be evaluated with a stepped-wedge cluster randomized controlled trial design. Discussion This mixed methods study will inform a larger efficacy trial of GeriMedRisk’s ability to decrease adverse drug events among seniors in the long-term care setting. Ethics and dissemination The Hamilton Integrated Research Ethics Board granted the approval for this study protocol 2812. We plan to disseminate the results of this study in peer-reviewed journals and also to our partners and stakeholders. Trial registration ISRCTN clinical trials registry, ISRCTN17219647 (March 27, 2017)