SPIDER Approach for Overmedication in Elderly

(SPIDER Trial)

Enrolling by invitation at 8 trial locations

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Toronto Practice Based Research Network

Disqualifiers: Under 65, Fewer than ten meds, others

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new method can reduce unnecessary or harmful medications for elderly patients. Seniors with multiple chronic conditions often take many medications, leading to poorer health and higher costs. The study will test a new approach called SPIDER, a collaborative method to improve prescribing practices, involving health teams working together. It suits seniors aged 65 and over who have been prescribed ten or more different medications in the past year. The trial will begin in a few Canadian cities to evaluate the method's effectiveness before expanding further. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance medication management for seniors.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications. However, it focuses on reducing potentially inappropriate prescriptions, so changes to your medication may be discussed with your healthcare provider.

What prior data suggests that the SPIDER approach is safe for elderly patients?

Research has shown that the SPIDER approach could effectively manage multiple medications in older adults. Studies have found that taking many medications can lead to health problems and increased hospital visits. SPIDER aims to reduce these issues by facilitating collaboration among healthcare teams to review and adjust prescriptions.

Direct data on SPIDER's safety is unavailable because it is a strategy, not a drug. However, it focuses on improving medication management to avoid the risks of unnecessary drugs. This suggests that SPIDER is a safe method, as it aims to reduce harm from overmedication rather than introducing new treatment risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SPIDER Approach for overmedication in the elderly because it offers a fresh take on managing medication use. Unlike the standard care, which often just maintains existing prescriptions, SPIDER uses Quality Improvement (QI) Learning Collaboratives to actively engage healthcare professionals in optimizing and reducing unnecessary medications. This method emphasizes collaboration and continuous learning among practitioners, potentially leading to more personalized and effective care for elderly patients. The hope is that this approach will reduce medication-related issues and improve overall patient well-being.

What evidence suggests that the SPIDER approach is effective for reducing potentially inappropriate prescriptions in elderly patients?

Research has shown that the SPIDER method, which participants in this trial may receive, can help reduce unnecessary prescriptions for older adults taking many medications. Studies indicate that Electronic Medical Records (EMR) can identify patients with complex needs due to multiple drugs. By focusing on quality improvement and teamwork, SPIDER aims to make prescribing safer. Early results suggest that using SPIDER to guide medication reduction can improve health and quality of life for older adults. Meanwhile, other participants in this trial will receive Usual Care, the standard primary care approach. ^{1 5 6 7 8}

Who Is on the Research Team?

Michelle Greiver, MD

Principal Investigator

North York General Hospital

Are You a Good Fit for This Trial?

The SPIDER trial is for elderly patients aged 65 or older who have visited their family doctor at least once in the past two years and are on ten or more medications. Family doctors, nurses, pharmacists, and staff from practices that use electronic health records and are part of a research network can join if they agree to participate.

Inclusion Criteria

I am 65 or older, visited a doctor in the last 2 years, and had 10+ different prescriptions last year.

At PCP level: Practices comprehensive family medicine in an office setting (academic or non-academic) and consents to participate and allow the research staff to provide study information to their eligible patients

At practice level: Contributes EMR data to the repository of a Practice Based Research Network (PBRN) that participates in CPCSSN and includes a primary care provider (PCP) who consents to participate and lead the practice QI team

Exclusion Criteria

At practice level: Does not use EMR, does not contribute EMR data to the repository of a PBRN that participates in CPCSSN, or none of the PCPs at the practice consents to participate

I am under 65, haven't seen a doctor in 2 years, or had less than 10 prescriptions last year.

At PCP level: Does not practice comprehensive family medicine in an office setting, does not consent to participate, does not allow the research staff to contact or provide study information to their eligible patients, or has left the practice

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Feasibility Testing

The SPIDER intervention is tested for feasibility in Toronto, Edmonton, and Montreal

3 months

Randomized Controlled Trial (RCT)

A pragmatic cluster RCT is conducted in Calgary, Winnipeg, Ottawa, Montreal, and Halifax to compare SPIDER intervention with usual care

12 months

Follow-up

Participants are monitored for safety and effectiveness after the intervention

12 months

What Are the Treatments Tested in This Trial?

Interventions

• SPIDER
• Usual Care

Trial Overview

SPIDER aims to reduce potentially inappropriate prescriptions among elderly patients through a quality improvement process supported by data from Electronic Medical Records. Practices will learn collaboratively to improve care strategies tailored to local needs versus usual care methods.

How Is the Trial Designed?

Group I: SPIDER Experimental Treatment 2 Interventions

QI Learning Collaboratives.

Group II: Usual Care Placebo Group 1 Intervention

Standard primary care.

Who Is Running the Clinical Trial?

University of Toronto Practice Based Research Network

Lead Sponsor

Trials

4

Recruited

340+

Fonds de la Recherche en Santé du Québec

Collaborator

Trials

84

Recruited

46,700+

Université de Montréal

Collaborator

Trials

223

Recruited

104,000+

Dalhousie University

Collaborator

Trials

177

Recruited

402,000+

University of British Columbia

Collaborator

Trials

1,506

Recruited

2,528,000+

Doctors Nova Scotia

Collaborator

Trials

1

Recruited

100+

Memorial University of Newfoundland

Collaborator

Trials

73

Recruited

1,836,000+

Dalhousie Medical Research Foundation

Collaborator

Trials

2

Recruited

200+

University of Calgary

Collaborator

Trials

827

Recruited

902,000+

University of Manitoba

Collaborator

Trials

628

Recruited

209,000+

Published Research Related to This Trial

The MOVING program, a virtual interdisciplinary geriatric consultation service, effectively reduced the number of potentially inappropriate medications prescribed to older adults, with significant decreases noted in prescriptions identified by the Beers and STOPP criteria.

While the overall number of prescriptions did not significantly change, the program led to a notable reduction in 'as needed' prescriptions, suggesting improved medication management for older patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of a Medication Optimization Virtual Interdisciplinary Geriatric Specialist (MOVING) Program: A Feasibility Study. Ho, JM., To, E., Sammy, R., et al.[2023]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03689049

SPIDER: A Research & QI Collaboration Supporting ...

The study aims to assess whether SPIDER can reduce PIPs in older patients prescribed ten or more medications. Patient experience, provider satisfaction and cost ...

2.

reseau1quebec.ca

reseau1quebec.ca/wp-content/uploads/2018/09/SPIDER-Poster_V5.pdf

SPIDER Quality Improvement (QI) and Research ...

EMR data can be used to identify elderly patients living with complex care needs and having polypharmacy. Background. SPIDER: Structured Process Informed by ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6551894/

Improving care for elderly patients living with polypharmacy

We will evaluate the feasibility of the SPIDER approach across eight dimensions: acceptability to stakeholders, demand, implementation, ...

4.

researchgate.net

researchgate.net/figure/Plan-Do-Study-Act-cycle-supported-by-SPIDER-OPEN-Ottawa-Practice-Enhancement-Network_fig1_333653924

Plan-Do-Study-Act cycle supported by SPIDER. OPEN ...

This article explores deprescribing within interprofessional teams emphasizing collaborative efforts to address polypharmacy and improve patient outcomes. It ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8149355/

Polypharmacy in older adults: a narrative review of ...

This narrative review aims to find and summarize recent publications on definitions, epidemiology and clinical consequences of polypharmacy.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8661120/

Polypharmacy Management in the Older Adults: A Scoping ...

Polypharmacy paves the way for non-adherence, adverse drug reactions, negative health outcomes, increased use of healthcare services and rising costs.

7.

implementationscience.biomedcentral.com

implementationscience.biomedcentral.com/articles/10.1186/s13012-019-0904-4

Improving care for elderly patients living with polypharmacy

We will evaluate the feasibility of the SPIDER approach across eight dimensions: acceptability to stakeholders, demand, implementation, ...

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S1525861019307741

Adverse Outcomes of Polypharmacy in Older People

We aim to synthesize current evidence on the adverse health, social, medicines management, and health care utilization outcomes of polypharmacy in older people.