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SPIDER: A Research & QI Collaboration Supporting Practices in Improving Care for Complex Elderly Patients

U

University of Toronto Practice Based Research Network

Status

Invitation-only

Conditions

Quality Improvement
Polypharmacy
Electronic Health Records
Inappropriate Prescribing
Primary Health Care
Aged

Treatments

Procedure: SPIDER
Procedure: Usual Care

Study type

Interventional

Funder types

Other

Identifiers

NCT03689049
KPG-156886

Details and patient eligibility

About

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.

Full description

Polypharmacy is pervasive amongst elderly patients living with multiple chronic conditions and the prevalence is increasing. The Canadian Institute for Health Information recently reported that 26.5% Canadian seniors were prescribed ten or more different drugs in 2016. A member of our team (S. Dahrouge) has found that number of prescription proved to be the most reliable index of persistent complexity and high cost in patients 65 years or older. There is also an association between number of prescription and potentially inappropriate prescriptions (PIPs). Analyses conducted on 86 practices affiliated with the University of Toronto Practice Based Research Network (UTOPIAN) have found that family physicians look after a mean of 24 older patients prescribed ten or more medications each year. Polypharmacy in the elderly is associated with elevated risks of adverse drug reactions, frailty and falls. It also increases healthcare, drug, and hospitalization costs. While several medications can be problematic, the following four classes of PIPs have been specifically identified by Choosing Wisely Canada and the Canadian Deprescribing Network as targets for wiser uses in elders: proton pump inhibitors (PPIs), sedative hypnotics such as benzodiazepines, antipsychotics for agitation and medications with a higher risk of hypoglycemia such as long-acting sulfonylureas. To improve care for elderly patients living with polypharmacy, we propose SPIDER: a Structured Process Informed by Data, Evidence and Research. Leveraging existing Quality Improvement (QI) capacity and provision of validated EMR data, SPIDER will engage inter-professional practice teams. They will participate in Learning Collaboratives and work with QI Coaches to identify areas of improvement, develop strategies and implement changes to improve care. The study aims to assess whether SPIDER can reduce PIPs in older patients prescribed ten or more medications. Patient experience, provider satisfaction and cost-effectiveness of SPIDER will also be evaluated. The study will first be tested for feasibility in Toronto, Edmonton and Montreal. Findings will then guide a pragmatic cluster RCT in Calgary, Winnipeg, Ottawa, Montreal and Halifax where practices enrolled in the SPIDER intervention will be compared with those in usual care.

Enrollment

104 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. At practice level: a) contributes EMR data to the repository of a Practice Based Research Network (PBRN) that participates in CPCSSN; and b) includes a primary care provider (PCP) who consents to participate and lead the practice QI team.
  2. At PCP level: a) practices comprehensive family medicine in an office setting (academic or non-academic); and b) consents to participate and allow the research staff to provide study information to their eligible patients.
  3. At patient level: a) 65 years or older; b) has at least one office visit during the past 2 years; and c) has received ten or more different prescription medications (as indicated in the EMR) in the past year.

Exclusion criteria

  1. At practice level: a) Does not use EMR; b) does not contributes EMR data to the repository of a PBRN that participates in CPCSSN; or c) none of the PCPs at the practice consents to participate.
  2. At PCP level: a) does not practice comprehensive family medicine in an office setting; b) does not consent to participate; c) does not allow the research staff to contact or provide study information to their eligible patients; or d) has left the practice.
  3. At patient level: a) younger than 65 years of age; b) has not visited a practice over the past 2 years; or c) has received fewer than ten different prescription medications in the past year.

(Note:

  • PBRN: Practice Based Research Network;
  • CPCSSN: the Canadian Primary Care Sentinel Surveillance Network)

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

104 participants in 2 patient groups, including a placebo group

SPIDER
Experimental group
Description:
QI Learning Collaboratives.
Treatment:
Procedure: Usual Care
Procedure: SPIDER
Usual Care
Placebo Comparator group
Description:
Standard primary care.
Treatment:
Procedure: Usual Care

Trial documents
1

Trial contacts and locations

9

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Data sourced from clinicaltrials.gov

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