e-IMPAQc Systematic Assessment of Patient Reported Outcomes in Cancer Care (eIMPAQc)

e-IMPAQc Implementation and Evaluation of a Mobile Application for the Systematic Assessment of Patient and Caregiver Reported Outcomes in Quebec Across the Cancer Continuum (eIMPAQc)

Purpose: The Electronic Implementation of Patient and Caregiver Reported Outcomes across cancer centres in Quebec project, or e-IMPAQc, was launched in 2017. e-IMPAQc's goal is to actively engage patients, their caregivers, healthcare professionals (HCPs), managers, policy makers, researchers and IT personnel to co-develop, implement, and evaluate an evidence-informed electronic patient-reported outcomes (e-PRO) screening and management program across Quebec.

Methods: e-IMPAQc built on the Improving Patient Experience and Health Outcomes Collaborative (iPEHOC) project, the first initiative in the province to implement e-PRO screening and was rolled out in three phases. e-IMPAQc has five main components: 1) primary and secondary standardized e-PRO questionnaires and algorithm; 2) summary report for clinicians with alert system; 3) summary report for patients, with tailored notifications regarding symptom severity; 4) self-management fact sheets library; and 5) clinical dashboard. Phase 1 included initiating change management and the co-development of the e-PRO algorithm with patients, their caregivers, HCPs, managers, policy makers, researchers and IT personnel (herein collectively referred as stakeholders) across seven cancer centres. The iPEHOC algorithm was used as a starting point given its successful implementation in one of the participating cancer centres for several years. Phase 1 also included feasibility work to establish a caregiver-reported outcomes (CROs) algorithm as well as the identification and configuration of appropriate electronic platforms on which to house e-IMPAQc. In Phase 2 the focus was on preparing for imminent implementation through workflow mapping and putting in place implementation support (e.g., site coordinators). A pilot of e-IMPAQc (excluding CROs) was also undertaken at one of the participating centres. In Phase 3, e-IMPAQc is being sequentially rolled out to as many cancer centres as possible and then evaluated. Qualitative and quantitative methods are used to document the process of implementation, patient and caregiver, and knowledge transfer (KT) outcomes.

Study Overview

• Status: Enrolling by invitation
• Conditions: Cancer
• Intervention / Treatment: Other: eIMPAQc

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3T1M5
      • St. Mary's Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Receiving cancer care at designated center

Exclusion Criteria:

• Unable to speak English or French
• Unable to use email and internet

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Pre-implementation; Outcomes collected in patient populations prior to roll-out of the eIMPAQc
Experimental: Post-implementation; Outcomes collected in patient populations after roll-out of eIMPAQc	Other: eIMPAQc; e-IMPAQc has five main components: 1) primary and secondary standardized e-PRO questionnaires and algorithm; 2) summary report for clinicians with alert system; 3) summary report for patients, with tailored notifications regarding symptom severity; 4) self-management fact sheets library; and 5) clinical dashboard.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom severity	Symptom severity as measured by the population-specific eIMPAQc symptom screening algorithm, including the Edmonton Symptom Assessment System Revised (ESAS-r) screening measures. Severity is measured on a scale of 0-10.	Baseline, 4 months
Patient perception of communication with health care team	6 item Clinician-patient communication subscale of the Primary Care Assessment Survey (PCAS), provides an overall score	Baseline, 4 months
Patient activation	13 items Patient Activation Measure provides an overall score	Baseline, 4 months
Quality of life	The EQ-5D-5L is used to measure health related, quality of life. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each level is rated on scale that describes the degree of problems in that area.	Bsaseline,4 months
Emergency room visits	Using hospital administrative data, we will report on the number of individual visits to the emergency room	In the 18 months following consent
Survival	Incidence of mortality	In the 18 months following consent
Feasibility of using the eIMPAQc ePRO system in cancer care centres	Feasibility of using the eIMPAQc symptom screening and management program will be measured using the following metrics: Rates of consent to use eIMPAQc among eligible patients referred/invited to patriciate; Rates of administration and completion of the eIMPAQc ePRO screening processes; Number and timing of withdrawals; Number of eIMPAQc ePRO screenings that generate an alert and/or clinical action Metrics will be combined with qualitative data from semi-structured interviews with participants to provide an overall assessment of feasibility	Throughout the implementation period, over the course of each participants' 4-6 month follow-up period
Acceptability of using the eIMPAQc ePRO system in cancer care centres	Acceptability of the components of the eIMPAQc program will be assessed through a 40 item eIMPAQc acceptability questionnaire	Throughout the implementation period, over the course of each participants' 4-6 month follow-up period
Satisfaction	Measured using the 8 item Client Satisfaction Questionnaire (CSQ-8)	4 months

Collaborators and Investigators

• Sponsor: St. Mary's Research Center, Canada

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2020
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: August 14, 2023
• First Submitted That Met QC Criteria: December 4, 2023
• First Posted (Actual): December 13, 2023

Study Record Updates

• Last Update Posted (Actual): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: ePRO
• Other Study ID Numbers: SMHC 18-24

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No