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临床试验/NCT06168435
NCT06168435Enrolling By Invitation不适用

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)

St. Mary's Research Center, Canada1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2020年11月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
500
试验地点
1
主要终点
Patient activation

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Receiving cancer care at designated center

排除标准

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

研究组 & 干预措施

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

干预措施: eIMPAQc (Other)

结局指标

主要结局

Patient activation

时间窗: Baseline, 4 months

13 items Patient Activation Measure provides an overall score

Quality of life

时间窗: Bsaseline,4 months

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.

Acceptability of using the eIMPAQc ePRO system in cancer care centres

时间窗: Throughout the implementation period, over the course of each participants' 4-6 month follow-up period

Acceptability of the components of the eIMPAQc program will be assessed through a 40 item eIMPAQc acceptability questionnaire

Patient perception of communication with health care team

时间窗: Baseline, 4 months

6 item Clinician-patient communication subscale of the Primary Care Assessment Survey (PCAS), provides an overall score

Survival

时间窗: In the 18 months following consent

Incidence of mortality

Satisfaction

时间窗: 4 months

Measured using the 8 item Client Satisfaction Questionnaire (CSQ-8)

Symptom severity

时间窗: Baseline, 4 months

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.

Feasibility of using the eIMPAQc ePRO system in cancer care centres

时间窗: Throughout the implementation period, over the course of each participants' 4-6 month follow-up period

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

Emergency room visits

时间窗: In the 18 months following consent

Using hospital administrative data, we will report on the number of individual visits to the emergency room

次要结局

未报告次要终点

研究者

发起方
St. Mary's Research Center, Canada
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sylvie Lambert

Principal Scientist

St. Mary's Research Center, Canada

研究点 (1)

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