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

Aged Clinical Trial

— SPIDER  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03689049
• Other study ID #: KPG-156886
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 26, 2018
• Est. completion date: March 31, 2027

Study information

• Verified date: November 2023
• Source: University of Toronto Practice Based Research Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 104
• Est. completion date: March 31, 2027
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Procedure:
• SPIDER
The SPIDER intervention will include a family physician-led inter-professional practice team participating in 3-4 Learning Collaboratives over a period of 12 months, reviewing validated and comparable practice EMR data and working with a QI Coach to develop strategies and implement changes to improve care for elderly patients living with complex care needs and taking ten or more unique medications.
• Usual Care
Physicians and their teams enrolled in this arm will follow the best scientific evidence available to provide standard care that is in the best interest of their patients.

Locations

Country	Name	City	State
Canada	Southern Alberta Primary Care Research Network (SAPCReN)	Calgary	Alberta
Canada	Northern Alberta Primary Care Research Network (NAPCReN)	Edmonton	Alberta
Canada	Maritime Family Practice Research Network (MaRNet-FP)	Halifax	Nova Scotia
Canada	Réseau de recherche en soins primaires de l'Université de Montréal (RRSPUM)	Laval	Quebec
Canada	Ottawa Practice Enhancement Network (OPEN )	Ottawa	Ontario
Canada	Atlantic Practice Based Research Network (APBRN)	St. John's	Newfoundland and Labrador
Canada	University of Toronto Practice Based Research Network	Toronto	Ontario
Canada	British Columbia node of the pan-Canadian CPCSSN (BC-CPCSSN)	Vancouver	British Columbia
Canada	Manitoba Primary Care Research Network (MaPCReN)	Winnipeg	Manitoba

Sponsors (18)

Lead Sponsor

Collaborator

University of Toronto Practice Based Research Network

Canadian Institutes of Health Research (CIHR), College of Family Physicians of Canada, Dalhousie Medical Research Foundation, Dalhousie University, Doctors Nova Scotia, Fonds de la Recherche en Santé du Québec, Memorial University of Newfoundland, North York General Hospital, Nova Scotia Health Authority, Research Manitoba, Université de Montréal, University of Alberta, University of British Columbia, University of Calgary, University of Manitoba, University of Ottawa, University of Toronto

Country where clinical trial is conducted

Canada, 

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* Note: There are 88 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Potentially Inappropriate Prescriptions (PIPs).	The primary outcome is the number of prescribed medications identified as one of the four targeted PIPs recommended by Choosing Wisely Canada and the Canadian DePrescribing Network (CaDeN).	12 months
Secondary	Patient perception of SPIDER	Qualitative methods (survey and interview) will be used to measure patients' perception of SPIDER. Patients' attitude toward polypharmacy and deprescribing will be measured using a survey adopted from Veterans Affairs Multi-dimensional Survey. Patients' experience with the process, symptoms, relationship with the care provider, empowerment and care coordination dimension will be measured using an interview.	12 months
Secondary	Care provider perception of SPIDER	Qualitative methods (survey and focus group) will be used to measure care providers' perception of SPIDER, including the dimensions of acceptability, implementation, adaptation, integration, practicality and efficacy.	12 months
Secondary	Cost-utility of SPIDER	The cost-utility of SPIDER will be measured as the incremental gain in quality of life (measured by EuroQol-5D) between the two arms in relation to intervention costs and by comparing the differences in investments and healthcare costs captured through EMR data and emergency room use and hospitalization.	12 months