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

November 27, 2023 updated by: University of Toronto Practice Based Research Network

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
        • Southern Alberta Primary Care Research Network (SAPCReN)
      • Edmonton, Alberta, Canada, T6G 2T4
        • Northern Alberta Primary Care Research Network (NAPCReN)
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 2B5
        • British Columbia node of the pan-Canadian CPCSSN (BC-CPCSSN)
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0T6
        • Manitoba Primary Care Research Network (MaPCReN)
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Atlantic Practice Based Research Network (APBRN)
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2E2
        • Maritime Family Practice Research Network (MaRNet-FP)
    • Ontario
      • Ottawa, Ontario, Canada, K1R 7G5
        • Ottawa Practice Enhancement Network (OPEN )
      • Toronto, Ontario, Canada, M5G 1V7
        • University of Toronto Practice Based Research Network
    • Quebec
      • Laval, Quebec, Canada, H7M 3L9
        • Réseau de recherche en soins primaires de l'Université de Montréal (RRSPUM)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SPIDER
QI Learning Collaboratives.
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.
Procedure: 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.
Placebo Comparator: Usual Care
Standard primary care.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Potentially Inappropriate Prescriptions (PIPs).
Time Frame: 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient perception of SPIDER
Time Frame: 12 months
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
Care provider perception of SPIDER
Time Frame: 12 months
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
Cost-utility of SPIDER
Time Frame: 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Toronto Practice Based Research Network

Collaborators

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

Investigators

  • Principal Investigator: Michelle Greiver, MD, North York General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2018

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

September 26, 2018

First Submitted That Met QC Criteria

September 27, 2018

First Posted (Actual)

September 28, 2018

Study Record Updates

Last Update Posted (Estimated)

December 1, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KPG-156886

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

This study uses some data from the Canadian Primary Care Sentinel Surveillance Network (CPCSSN) for outcome measurement. A data dictionary is available from CPCSSN. While data sharing agreements prohibit CPCSSN from making the data publicly available, access may be granted to those who meet pre-specified criteria for confidential access, available at http://cpcssn.ca/research-resources/cpcssn-data-for-research/; researchers with additional questions can contact CPCSSN by using the link. Outcome data collected for this project can be made available to researchers upon request; a SPIDER study member will need to be part of the new work to ensure adequate interpretation of the data. The study protocol including statistical analysis plan and informed consent form will be publicly available.

IPD Sharing Time Frame

Data will be available within 12 months of study completion

IPD Sharing Access Criteria

Outcome data collected for this project can be made available to researchers upon request; a SPIDER study member will need to be part of the new work to ensure adequate interpretation of the data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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