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

NCT06168435 | Unknown

• 1 other identifier: SMHC 18-24
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer

Keywords

ePRO

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (2)

Pre-implementation

NO INTERVENTION

Outcomes collected in patient populations prior to roll-out of the eIMPAQc

Post-implementation

EXPERIMENTAL

Outcomes collected in patient populations after roll-out of eIMPAQc

Other: eIMPAQc

Interventions

eIMPAQc OTHER

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.

Post-implementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Receiving cancer care at designated center

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

St. Mary's Research Centre

Montreal, Quebec, H3T1M5, Canada

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Scientist

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: December 13, 2023
• Study Start: November 3, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 13, 2023

Record last verified: 2023-12

Locations

CA (1)