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

Cancer Clinical Trial

— eIMPAQc  

Official title:

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)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06168435
• Other study ID #: SMHC 18-24
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 3, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: St. Mary's Research Center, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Receiving cancer care at designated center

Exclusion Criteria:

• Unable to speak English or French

• Unable to use email and internet

Related Conditions & MeSH terms

• Cancer

Intervention

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.

Locations

Country	Name	City	State
Canada	St. Mary's Research Centre	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
St. Mary's Research Center, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Patient activation	13 items Patient Activation Measure provides an overall score	Baseline, 4 months
Primary	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
Primary	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
Primary	Survival	Incidence of mortality	In the 18 months following consent
Primary	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
Primary	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
Primary	Satisfaction	Measured using the 8 item Client Satisfaction Questionnaire (CSQ-8)	4 months