Condition category
Not Applicable
Date applied
17/03/2017
Date assigned
27/03/2017
Last edited
29/06/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Multiple illnesses, the use of multiple drugs and age increase the risk of drug toxicity (adverse reactions) in older people. Following a poisoning, they are about four times more likely to die or to require hospitalization compared to their younger counterparts. In Canada there are few clinicians who have the knowledge to prevent such events and most are found in urban areas, resulting in less access for Canadians living in rural and remote areas. GeriMedRisk® is a new technology-based consultation service that aims to improve a patient’s medications to improve cognition (thinking), mobility, function, and mental health. The aim of this study is to find out whether using GeriMedRisk decreases falls and drug-related hospital visits among seniors living in long-term care homes.

Who can participate?
All physicians, pharmacists and nurse practitioners who provide patient care in participating long-term care homes in the Waterloo-Wellington region

What does the study involve?
Participating long-term care homes start using GeriMedRisk® at a randomly allocated time point. Clinicians have access to GeriMedRisk® nurses, pharmacists, and physicians specializing in geriatric medicine, clinical pharmacology, and geriatric psychiatry by telephone or through telemedicine. Clinicians are provided with reports including short user-friendly drug information and at least one follow-up call to assess the effectiveness of the recommendations. When necessary, in-person or videoconference consultations with specialist physicians are available.

What are the possible benefits and risks of participating?
By supporting clinicians as they improve their older patients' medications, GeriMedRisk® may decrease drug-related cognitive impairment, falls, and hospital visits. The benefits of participating in this study include access to geriatric pharmacology expertise in a timely fashion without patient travel to an urban academic health centre. Participants also have the opportunity to provide feedback about GeriMedRisk to help improve the service and its impact on real-world practice. Finally, participants have access to a service that supports their continuing professional development through learning materials relevant to their patients and quarterly summaries of their learning issues generated from their consults. There is no cost for these services. Although each consultation may take up to 45 minutes on the telephone, this time could be decreased by contacting GeriMedRisk through a secure eConsult platform.

Where is the study run from?
1. University Gates Schlegel Village (Canada)
2. Winston Park Schlegel Village (Canada)
3. Riverside Glen Schlegel Village (Canada)
4. St Joseph’s Health Centre Guelph (Canada)

When is the study starting and how long is it expected to run for?
February 2017 to December 2017

Who is funding the study?
1. McMaster University (Canada)
2. Regional Geriatric Program of Hamilton (Canada)
3. Canadian Centre for Aging and Brain Health Innovation (Canada)
4. Canadian Mental Health Association Waterloo Wellington (Canada)
5. St. Joseph's Health Centre Guelph (Canada)
6. Schlegel Research Institute for Aging (Canada)
7. Ontario Telemedicine Network (Canada)

Who is the main contact?
Dr Joanne Ho

Trial website

Contact information

Type

Scientific

Primary contact

Dr Joanne Ho

ORCID ID

http://orcid.org/0000-0002-8252-2034

Contact details

3012-10B Victoria St. S
Kitchener
N2G 1C5
Canada

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

GMR-LTC feasibility v4

Study information

Scientific title

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

Acronym

Study hypothesis

GeriMedRisk (GMR) will be a feasible intervention that has the potential to decrease falls and drug-related hospital visits among seniors residing in a long term care (LTC) home. The cluster stepped wedge randomized controlled trial is a feasible study design for investigating GMR's efficacy at decreasing falls and drug-related hospital visits among LTC residents.

Ethics approval

Hamilton Integrated Research Ethics Board submission - pending approval

Study design

Multicentre stepped wedge cluster randomized controlled trial and qualitative study

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Geriatric adverse drug events

Intervention

This study is a stepped wedge cluster randomized controlled trial (simple randomization with a computer generated sequence). The intervention is access to GeriMedRisk®, a pioneering, interdisciplinary, technology-based geriatric pharmacology consultation service that aims to optimize a patient’s medications to improve cognition, mobility, function, and mental health.

Clinicians with a patient-generated geriatric pharmacotherapy question will be able to contact GeriMedRisk® and access GeriMedRisk®’s nurses, pharmacists, and physicians specializing in geriatric medicine, clinical pharmacology and geriatric psychiatry by telephone or telemedicine during business hours. There are two methods for referral:
1. Telephone: This traditional mode of person-to-person consultation can be real-time, or used as a paging service whereby the referring clinician leaves a call-back number and GeriMedRisk® calls back at a later time.
2. Ontario Telemedicine Network (OTN) e-consult: The referring clinician emails an eConsult request through the secure OTNhub (www.OTNhub.ca) to GeriMedRisk® with the necessary clinical information and within days, GeriMedRisk® team responds through eConsult with a request for additional information or recommendations. Additional support through the phone, OTN videoconference or in-person may be arranged if necessary. The GeriMedRisk® staff will collaborate with the referring clinician to perform a geriatric pharmacology consultation, based on a comprehensive geriatric assessment, which aims to optimize the patient’s medications, cognition, comorbidities, mobility, function and mental health. Videoconference telemedicine and in-person consultations with specialist physicians across Southwestern Ontario academic health centres (McMaster University, University of Toronto, University of Western Ontario) would be available if necessary. Password-protected consultation reports and knowledge user-friendly drug information materials will be securely sent to the referring clinician through OTN eConsult. GeriMedRisk® will perform at least 1 follow-up to the referring clinician to assess the effectiveness of the recommendations.

Intervention type

Other

Phase

Drug names

Primary outcome measure

The primary outcome measures of this feasibility study will scrutinize the logistics of the GeriMedRisk® intervention and study design:
1. Number of clinicians who use GeriMedRisk® (GeriMedRisk® (GMR) database) (Timing: monthly after commencement of access to GeriMedRisk):
1.1. MD
1.2. Pharmacist
1.3. NP
1.4. Through TAPERMD
2. Number of clinicians who decline GeriMedRisk® (Roster of LTC clinicians, GMR database) (Timing: monthly after commencement of access to GeriMedRisk):
2.1. MD
2.2. Pharmacist
2.3. NP
3. Number of patients/Substitute Decision Makers who decline GeriMedRisk®. Patients and their caregivers will have the opportunity to opt out of GeriMedRisk®. These will be individually reported and collected real time. (Timing: monthly after commencement of access to GeriMedRisk)
4. Number of consults (GMR database, OTN) (Timing: monthly after commencement of access to GeriMedRisk):
4.1. Telephone
4.2. Telemedicine: OTN e-consult
4.3. Through TAPERMD
4.3.1. Telephone
4.3.2. Telemedicine: OTN e-consult
5. Wait times: (telephone records, OTN) (Timing: monthly after commencement of access to GeriMedRisk):
5.1. Telephone
5.1.1. Time from the conclusion of the initial automated message to:
5.1.1.1. When GeriMedRisk® team member picks up the phone (telephone records)
5.1.1.2. When Caller hangs up (telephone records)
5.1.1.2.1. To use e-consult (telephone records, OTN)
5.1.1.2.2. To leave a call back number (telephone records)
5.1.1.2.3. No further contact in the next 7 days (dropped call) (telephone records, OTN)
5.2. E-consult: Time from e-consult request received to (OTN):
5.2.1. GeriMedRisk® team member commences consult
5.2.2. GeriMedRisk® team member provides e-consult opinion
6. Length of calls (telephone records, GMR database) (Timing: monthly after commencement of access to GeriMedRisk):
6.1. Initial consult with pharmacist/RN
6.2. Initial consult with physician
6.3. Follow up with pharmacist/RN
6.4. Follow up with physician
6.4.1. Geriatrician/clinical pharmacologist
6.4.2. Geriatric psychiatrist
6.5. Stratify above for TAPERMD referrals.
7. Time to follow-up call (GMR database, OTN) (Timing: monthly after commencement of access to GeriMedRisk):
7.1. Defined as time interval from date of initial consult to date of follow up
7.1.1. Measure discrepancies between scheduled followup dates and date of actual followup.
7.2. Number lost to follow up
8. Satisfaction (GMR database, OTN) (Timing: monthly after commencement of access to GeriMedRisk):
8.1. Adherence to recommendations (satisfaction) defined as the percentage of GeriMedRisk® recommendations which were executed by the referring clinician. (GMR database, collected during follow up call). 60% adherence is defined as a positive outcome:
8.1.1. Stratify according to referring clinician clinical background (MD, Pharmacist or NP)
8.1.2. 2 days, 7 days and 14 days post consultation
8.2. Number of times referring clinician uses service (i.e., repeat use may indicate satisfaction)
9. Number of consults requiring physician support (GMR database and OTN) (Timing: monthly after commencement of access to GeriMedRisk):
9.1. Geriatric medicine
9.2. Clinical pharmacology
9.3. Geriatric psychiatry
10. Case complexity (composite of number of consults requiring physician support, number of consults with polypharmacy defined as ≥4 medications, # of consults requiring geriatric psychiatry and ≥ 3 follow up) (Timing: monthly after commencement of access to GeriMedRisk):
10.1. For entire participating LTC site
10.2. For each consult
11. Case resolution: defined as patient discharged from GeriMedRisk® (GMR database, OTN) (Timing: monthly after commencement of access to GeriMedRisk):
11.1. Time required: Time of consult to case resolution
11.2. Number of steps required
11.3. Type of steps required
12. Number of GeriMedRisk® MDs (GMR database, OTN) (Timing: monthly after commencement of access to GeriMedRisk):
12.1. Specialty training:
12.1.1. Geriatric medicine
12.1.2. Clinical pharmacology
12.1.3. Geriatric psychiatry
13. Compensation/Cost-effectiveness (OTN, GeriMedRisk® budget) (Timing: monthly after commencement of access to GeriMedRisk):
13.1. MD: Fee-for-service billing
13.2. MD: e-consult hourly billing
13.3. Pharmacist/Nurse: Salary

Secondary outcome measures

Secondary outcomes include falls, hospital visits and medications. Completeness of secondary outcome data (RAI-MDS LTC electronic medical record). This data is regularly collected with the Minimum Data Set, as mandated by the Ministry of Health and Long-Term Care (Timing: 1 year lookback period defined as -365 to date of intervention, and following the commencement of access to GeriMedRisk, monthly)
1. Falls:
1.1. Monthly rate for entire LTC home
1.2. % of injurious falls (defined as requiring physician services, Emergency Department visit or hospitalization)
2. Emergency Hospital visits (exclude hospitalization recommended for supervised deprescription, or elective procedures):
2.1. For patients with a GeriMedRisk® consultation: Time to ED visit (defined as hours from pt consult to ED visit) (GMR database)
3. Medications:
3.1. Prevalence of potentially inappropriate medications
3.1.1. Dose reduction:
3.1.1.1. GeriMedRisk® patients (defined through TAPERMD; captured by GeriMedRisk® clinical database, pharmacy records)
3.1.1.2. All patients in the LTC site (RAI MDS 2.0, pharmacy records)
3.2. Prevalence of psychotropics per LTC site (defined as an sedative hypnotic, antidepressant, antianxiolytic, antipsychotic, Lithium) or antiseizure medication (without a diagnosed seizure disorder) (RAI MDS 2.0, LTC pharmacy records)
3.3. Prevalence of patients receiving opioids (LTC pharmacy records)

Overall trial start date

01/02/2017

Overall trial end date

31/12/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

All physicians, pharmacists and nurse practitioners who provide patient care in a participating LTC site (a convenience sample of LTC homes in the Waterloo-Wellington region)

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

4 clusters, ~15 participants

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/04/2017

Recruitment end date

31/12/2017

Locations

Countries of recruitment

Canada

Trial participating centre

University Gates Schlegel Village
N2J 0E2
Canada

Trial participating centre

Winston Park Schlegel Village
N2E 3K1
Canada

Trial participating centre

Riverside Glen Schlegel Village
N1H 8M8
Canada

Trial participating centre

St. Joseph’s Health Centre Guelph
N1H 5H8
Canada

Sponsor information

Organisation

McMaster University

Sponsor details

1280 Main St. W.
Hamilton
L8S 4L8
Canada

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

McMaster University Labarge Optimal Aging Opportunities Grant

Alternative name(s)

McMaster

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Canada

Funder name

Regional Geriatric Program of Hamilton

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Canadian Centre for Aging and Brain Health Innovation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Canadian Mental Health Association

Alternative name(s)

Association Canadienne pour la Santé Mentale, CMHA

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

Location

Canada

Funder name

St Joseph's Health Centre Guelph

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Schlegel Research Institute for Aging

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Ontario Telemedicine Network

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The trialists plan to disseminate the results of this study in a high-impact peer reviewed journal within 1 year after the overall trial end date.

IPD sharing plan
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2018

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/29951221

Publication citations

Additional files

Editorial Notes

29/06/2018: PubMed address added. 25/06/2018: Publication reference added.