NCT03689049

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
11mo left

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

9 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Mar 2018Mar 2027

Study Start

First participant enrolled

March 26, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2018

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

9 years

First QC Date

September 26, 2018

Last Update Submit

April 29, 2026

Conditions

PolypharmacyInappropriate PrescribingAgedPrimary Health CareQuality ImprovementElectronic Health Records

Keywords

PolypharmacyDeprescribingAged AdultElderly PatientPrimary Health CareQuality ImprovementPractice FacilitationLearning CollaborativeElectronic Medical Records (EMR)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Patient perception of SPIDER

    12 months

  • Care provider perception of SPIDER

    12 months

  • Cost-utility of SPIDER

    12 months

Study Arms (2)

SPIDER

EXPERIMENTAL

QI Learning Collaboratives.

Procedure: SPIDERProcedure: Usual Care

Usual Care

PLACEBO COMPARATOR

Standard primary care.

Procedure: Usual Care

Interventions

SPIDERPROCEDURE

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.

SPIDER
Usual CarePROCEDURE

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.

SPIDERUsual Care

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.
  • 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.
  • 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.

You may not qualify if:

  • 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.
  • 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.
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Southern Alberta Primary Care Research Network (SAPCReN)

Calgary, Alberta, T2N 4N1, Canada

Location

Northern Alberta Primary Care Research Network (NAPCReN)

Edmonton, Alberta, T6G 2T4, Canada

Location

British Columbia node of the pan-Canadian CPCSSN (BC-CPCSSN)

Vancouver, British Columbia, V6T 2B5, Canada

Location

Manitoba Primary Care Research Network (MaPCReN)

Winnipeg, Manitoba, R3E 0T6, Canada

Location

Atlantic Practice Based Research Network (APBRN)

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

Maritime Family Practice Research Network (MaRNet-FP)

Halifax, Nova Scotia, B3H 2E2, Canada

Location

Ottawa Practice Enhancement Network (OPEN )

Ottawa, Ontario, K1R 7G5, Canada

Location

University of Toronto Practice Based Research Network

Toronto, Ontario, M5G 1V7, Canada

Location

Réseau de recherche en soins primaires de l'Université de Montréal (RRSPUM)

Laval, Quebec, H7M 3L9, Canada

Location

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Study Officials

  • Michelle Greiver, MD

    North York General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Blinding of participants cannot be achieved in pragmatic trials of QI interventions in primary care.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2018

First Posted

September 28, 2018

Study Start

March 26, 2018

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data will be available within 12 months of study completion
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.

Locations

CA(9)