SPIDER Approach for Overmedication in Elderly

(SPIDER Trial)

Recruiting 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

104 Participants Needed

Trial Summary

What is the purpose of this trial?

Elders living with multiple chronic conditions often take many drugs (polypharmacy); some of the drugs may not benefit them or may be harmful. The Canadian Institute for Health Information has reported that about one-quarter of Canadian seniors are prescribed ten or more different drugs each year. Polypharmacy can result in poorer health, reduced quality of life and high healthcare costs. Choosing Wisely Canada and the Canadian Deprescribing Network have suggested wiser uses for the following four Potentially Inappropriate Prescriptions (PIPs): drugs that reduce stomach acid; reduce anxiety and induce sleep; treat agitation; and treat type 2 diabetes but have a high risk of low blood sugar. To improve care for elderly patients living with polypharmacy, we propose SPIDER: a Structured Process Informed by Data, Evidence and Research. Using quality improvement (QI) and supported by Electronic Medical Record (EMR) data, SPIDER will invite family doctors, nurses, pharmacists and front desk staff to participate in Learning Collaboratives and learn from each other. The practice teams will work with a QI Coach to identify areas to improve, develop strategies and implement changes tailored to the local practice context. The objective of this study is to determine whether SPIDER will reduce PIPs for patients 65 years or older who are on ten or more different drugs. The study will also explore patient experience and provider satisfaction with SPIDER and assess the cost of running SPIDER. The study will first be tested for feasibility in Toronto, Edmonton and Montreal. Findings will then guide a Randomized Controlled Trial (RCT) in Calgary, Winnipeg, Ottawa, Montreal and Halifax where practices enrolled in the SPIDER intervention will be compared with those in usual care.

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 data supports the effectiveness of the SPIDER treatment for overmedication in elderly patients?

Research shows that pharmacist-led interventions, such as deprescribing anticholinergic and sedative drugs, can improve health outcomes in older adults by reducing unnecessary medications. Additionally, community-based programs like the Medication Reduction Project have helped older adults take fewer medications, feel better, and become more independent. ^{1 2 3 4 5}

Is the SPIDER approach for deprescribing in elderly patients safe?

The SPIDER approach for deprescribing in elderly patients appears to be feasible and was well-received by healthcare teams, but specific safety data is not detailed in the study. The focus was on the feasibility and integration of the approach rather than direct safety outcomes. ^{6 7 8 9 10}

How does the SPIDER treatment differ from usual care for overmedication in the elderly?

The SPIDER treatment is unique because it specifically targets overmedication in the elderly by optimizing drug prescriptions, potentially involving a structured medication review process led by pharmacists, which is not typically part of usual care. ^{11 12 13 14 15}

Research Team

Michelle Greiver, MD

Principal Investigator

North York General Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The Medication Reduction Project: combating polypharmacy in South Dakota elders through community-based interventions. [2014]

2. United States pubmed.ncbi.nlm.nih.gov

Deprescribing Anticholinergic and Sedative Drugs to Reduce Polypharmacy in Frail Older Adults Living in the Community: A Randomized Controlled Trial. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical impact of an interdisciplinary patient safety program for managing drug-related problems in a long-term care hospital. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Provision of annual wellness visits with comprehensive medication management by a clinical pharmacist practitioner. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Reducing cost by reducing polypharmacy: the polypharmacy outcomes project. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Applying QI-focused SPIDER approach to safer deprescribing for geriatric patients: Results of the Toronto Feasibility Study. [2023]

7. England pubmed.ncbi.nlm.nih.gov

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). [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Outcomes of a Medication Optimization Virtual Interdisciplinary Geriatric Specialist (MOVING) Program: A Feasibility Study. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Is inappropriate medication use a major cause of adverse drug reactions in the elderly? [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Reducing the risk of adverse drug events in older adults. [2015]

11. Netherlands pubmed.ncbi.nlm.nih.gov

[Prescription to elderly patients: reducing underuse and adverse drug reactions and improving adherence]. [2013]

12. United States pubmed.ncbi.nlm.nih.gov

Clinician-Level Variation in Three Measures Representing Overuse Based on the American Geriatrics Society Choosing Wisely Statement. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Appropriateness of Medications in Older Adults Living With Frailty: Impact of a Pharmacist-Led Structured Medication Review Process in Primary Care. [2020]

14. United States pubmed.ncbi.nlm.nih.gov

Suboptimal prescribing in older inpatients and outpatients. [2022]

15. United States pubmed.ncbi.nlm.nih.gov

Avoiding Overmedication of Elderly Patients. [2019]