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)

Joanne Man-Wai Ho^{1

2

3}, Jennifer Tung³, Janine Maitland⁴, Derelie Mangin⁵, Lehana Thabane⁶, J Michael Pavlin⁷, Jeffrey Alfonsi⁸, Anne Holbrook^{6

9}, Sharon Straus^{10

11}, Sophiya Benjamin^{1

3}

Affiliations

¹ 1Waterloo Regional Campus, McMaster University DeGroote School of Medicine, 10B Victoria St S, Kitchener, ON Canada.
² Schlegel Research Institute for Aging, 250 Laurelwood Drive, Waterloo, ON Canada.
³ 3Grand River Hospital, 835 King St W, Kitchener, ON Canada.
⁴ St. Joseph's Health Centre Guelph, 100 Westmount Ave, Guelph, ON Canada.
⁵ 5Department of Family Medicine, McMaster University, 6th floor, 100 Main St W, Hamilton, ON Canada.
⁶ 6Department of Health Research Methods, Evidence and Impact, McMaster University, H325, 50 Charlton Ave E, Hamilton, ON Canada.
⁷ 7Lazaridis School of Business and Economics, Wilfrid Laurier University, 64 University Ave W, Waterloo, ON Canada.
⁸ Ontario Telemedicine Network, 1100-105 Moatfield Drive, Toronto, ON Canada.
⁹ 9Division of Clinical Pharmacology and Toxicology, McMaster University, 1280 Main St W, Hamilton, ON Canada.
¹⁰ 10Li Ka Shing Knowledge Institute, St. Michael's Hospital, 30 Bond St Toronto, Toronto, ON Canada.
¹¹ 11Division of Geriatric Medicine, Department of Medicine, University of Toronto, 190 Elizabeth Street, R. Fraser Elliott Building, 3-805, Toronto, ON Canada.

PMID: 29951221
PMCID: PMC6011190
DOI: 10.1186/s40814-018-0300-x

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)

Joanne Man-Wai Ho et al. Pilot Feasibility Stud. 2018.

. 2018 Jun 20:4:116.

doi: 10.1186/s40814-018-0300-x. eCollection 2018.

Authors

Affiliations

¹ 1Waterloo Regional Campus, McMaster University DeGroote School of Medicine, 10B Victoria St S, Kitchener, ON Canada.
² Schlegel Research Institute for Aging, 250 Laurelwood Drive, Waterloo, ON Canada.
³ 3Grand River Hospital, 835 King St W, Kitchener, ON Canada.
⁴ St. Joseph's Health Centre Guelph, 100 Westmount Ave, Guelph, ON Canada.
⁵ 5Department of Family Medicine, McMaster University, 6th floor, 100 Main St W, Hamilton, ON Canada.
⁶ 6Department of Health Research Methods, Evidence and Impact, McMaster University, H325, 50 Charlton Ave E, Hamilton, ON Canada.
⁷ 7Lazaridis School of Business and Economics, Wilfrid Laurier University, 64 University Ave W, Waterloo, ON Canada.
⁸ Ontario Telemedicine Network, 1100-105 Moatfield Drive, Toronto, ON Canada.
⁹ 9Division of Clinical Pharmacology and Toxicology, McMaster University, 1280 Main St W, Hamilton, ON Canada.
¹⁰ 10Li Ka Shing Knowledge Institute, St. Michael's Hospital, 30 Bond St Toronto, Toronto, ON Canada.
¹¹ 11Division of Geriatric Medicine, Department of Medicine, University of Toronto, 190 Elizabeth Street, R. Fraser Elliott Building, 3-805, Toronto, ON Canada.

PMID: 29951221
PMCID: PMC6011190
DOI: 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).

Keywords: Appropriate prescribing; Clinical trial; Cluster randomized controlled trial; Feasibility; Geriatrics; Telemedicine.

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Conflict of interest statement

The Hamilton Integrated Research Ethics Board granted the approval for this study protocol 2017-2812. Following ethics approval, we will start recruiting LTC sites by proactively approaching the LTC site manager and their clinicians (February to May 2017). We will hold scheduled information sessions at each LTC site to describe the intervention and project. The study coordinator will obtain written consent from willing participants (referring clinicians). Participants may also provide verbal and written consent when they call into GeriMedRisk to request a consultation. For participating sites, we will advertise the trial through posters displayed in common clinical staff areas and directly send a flyer to patients and their caregivers which describes the option and procedure to opt out of the intervention. We will track patients who opted out (personally or by caregiver proxy) of GeriMedRisk and inform their clinician of their decision.The authors declare that they have no competing interests.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

**Fig. 1**
Schematic of study protocol. Each step from T0 to T3 will be approximately 8 weeks in length. Each cell starting at T0 represents a data collection point. Prior to T0, secondary outcomes will be collected retrospectively collected using the RAI-MDS 2.0. Yellow-shaded cells represent the recruitment period. During this time, LTCs will be invited to participate and will be provided trial information. Consent will be obtained from each LTC. Subsequently, investigator will provide in-person and online information sessions about the trial to potential participants (i.e., clinicians of the participating LTC site), and consent will also be obtained. Randomization (red line) will occur at the beginning of the first step, T0. The GeriMedRisk intervention (dark blue cells) will then be introduced to each LTC in random order. At the beginning of each step, a sealed envelope will be opened to reveal the next LTC to receive the intervention. An interim analysis (green line) will be performed at 16 weeks

See this image and copyright information in PMC

References

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1. Canadian Institute for Health Information (CIHI) Adverse drug reaction-related hospitalizations among seniors, 2006 to 2011. 2013. p. 22.
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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)

Affiliations

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)

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

LinkOut - more resources

Full Text Sources

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