Clinical trial NCT03689049: SPIDER: A Research & QI Collaboration Supporting Practices in Improving Care for Complex Elderly Patients
Official title: SPIDER: A Structured Process Informed by Data, Evidence and Research - A Research and Quality Improvement Collaboration Supporting Practices in Improving Care for Complex Elderly Patients
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Polypharmacy
Inappropriate Prescribing
Aged
Primary Health Care
Quality Improvement
Electronic Health Records
Keywords: Polypharmacy
Deprescribing
Aged Adult
Elderly Patient
Primary Health Care
Quality Improvement
Practice Facilitation
Learning Collaborative
Electronic Medical Records (EMR)
Lead sponsor: University of Toronto Practice Based Research Network
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: University of Toronto
name: North York General Hospital
name: College of Family Physicians of Canada
name: University of Ottawa
name: University of Alberta
name: University of Calgary
name: University of Manitoba
name: Research Manitoba
name: Fonds de la Recherche en Santé du Québec
name: Université de Montréal
name: Nova Scotia Health Authority
name: Dalhousie University
name: Dalhousie Medical Research Foundation
name: Doctors Nova Scotia
name: Memorial University of Newfoundland
name: University of British Columbia
First posted: 2018-09-28
Enrollment: 104
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention will first be tested for feasibility using a single-arm, prospective, explanatory mixed approach. What we learn from the feasibility will then be applied to a 2-arm pragmatic cluster RCT where practices enrolled in the intervention group will be compared with those enrolled in the usual care group. Randomization will be at the practice level to avoid potential contamination where physicians practicing at the same location are enrolled in different arms.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of Potentially Inappropriate Prescriptions (PIPs).
timeFrame: 12 months
Secondary outcomes:
measure: Patient perception of SPIDER
timeFrame: 12 months
measure: Care provider perception of SPIDER
timeFrame: 12 months
measure: Cost-utility of SPIDER
timeFrame: 12 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Southern Alberta Primary Care Research Network (SAPCReN)
state: Alberta
city: Edmonton
country: Canada
facility: Northern Alberta Primary Care Research Network (NAPCReN)
state: Alberta
city: Vancouver
country: Canada
facility: British Columbia node of the pan-Canadian CPCSSN (BC-CPCSSN)
state: British Columbia
city: Winnipeg
country: Canada
facility: Manitoba Primary Care Research Network (MaPCReN)
state: Manitoba
city: St. John's
country: Canada
facility: Atlantic Practice Based Research Network (APBRN)
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Maritime Family Practice Research Network (MaRNet-FP)
state: Nova Scotia
city: Ottawa
country: Canada
facility: Ottawa Practice Enhancement Network (OPEN )
state: Ontario
city: Toronto
country: Canada
facility: University of Toronto Practice Based Research Network
state: Ontario
city: Laval
country: Canada
facility: Réseau de recherche en soins primaires de l'Université de Montréal (RRSPUM)
state: Quebec
Study officials:
affiliation: North York General Hospital
name: Michelle Greiver, MD
role: PRINCIPAL_INVESTIGATOR
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