PCORI funds implementation projects to promote the use of findings from PCORI-funded studies. This project focuses on implementing findings from the completed PCORI-funded research project: "Comparing the Effectiveness of Electronic Symptom Monitoring versus Usual Care in Improving Survival among Patients with Metastatic Cancer -- The PRO-TECT Trial
1. What were the results from the original PCORI-funded research study?
The prior PCORI-funded PRO-TECT national randomized trial showed that monitoring patients’ symptoms during cancer treatment using weekly online surveys (called patient-reported outcomes or ePROs) significantly improves clinically meaningful outcomes including health-related quality of life, symptom burden and physical function; reduces emergency department visits and hospitalizations; and is highly valued by patients, nurses and doctors as a tool to improve communication and quality of care. No impact was seen on survival. Benefits were seen across all cancer types and treatments. Patient participation was high (more than 90 percent). Dissemination has been considerable, with a high-impact publication in the Journal of the American Medical Association, a high-profile presentation in the plenary series of the American Society of Clinical Oncology, results supporting a major international guideline (from the European Society for Medical Oncology), and findings informing value-based care models from Medicare and private payers. The project will take the effective approach to ePROs from PRO-TECT and implement it widely in cancer care practices and networks.
2. Why is this research finding important?
The findings of PRO-TECT are potentially practice-changing, but are limited by conduct in a research setting without evidence of real-world implementation and effectiveness. Based on PRO-TECT and prior research by the investigators, remote symptom monitoring with ePROs is increasingly included in value-based payment models in oncology – including in the national and voluntary “Enhancing Oncology Model (EOM)” from the Centers for Medicare & Medicaid Services (CMS). EOM requires the gradual implementation of ePROs in participating practices, with a pre-implementation period from July 2023-July 2025 and required implementation beginning July 2025. Hence, there is critical need for evidence of successful real-world ePRO implementation and effectiveness, standard operating procedures, and dissemination in order to foster wide uptake and bring the findings of PRO-TECT to fruition.
3. What is the goal of this project?
This project, the OncoPRO Initiative, aims to:
- Generate evidence of equitable real-world ePRO implementation and effectiveness
- Provide standard operating procedures for future practices to implement ePROs;
- Foster dissemination toward national uptake
OncoPRO will be conducted by the PRO-TECT investigators, with leadership by ePRO implementation experts, value-based care leaders, patient and clinician partners, and ePRO methodologists. Moreover, this project is carried out in partnership with the American Society of Clinical Oncology (ASCO; the largest oncology professional society in the United States), the American Cancer Society, two national patient organizations (Research Advocacy Network; Patients & Partners), the four major electronic medical record (EMR) software vendors serving oncology (Epic, Cerner, iKnowMed, OncoEMR), and two major ePRO software vendors (Navigating Cancer and Carevive), and two major oncology practice networks (US Oncology and Flatiron). There will be observation by the Centers for Medicare & Medicaid Services to inform the approach to ePROs in the CMS Enhancing Oncology Model.
4. What is the project team doing?
The OncoPRO Initiative is proposed as a two-phase project. In Phase I (years 1-3), a limited number of practices with diverse patient populations and locations have agreed to implement ePROs using implementation tenets developed in the PRO-TECT trial (two practices for each of the four partner EMR systems). A central ePRO Implementation Registry and dashboard will be developed by the Project Team with ASCO and be housed/maintained at ASCO as part of their well-established national Oncology Medical Home program for Patient-Centered Cancer Care Certification. The partner EMR and ePRO vendors will support practices with technical builds and data feeds to the ASCO registry. The registry will generate monthly reports for monitoring implementation and program evaluation. ASCO will organize practice representatives into an ePRO Learning Collaborative where feedback from the registry and exchange between practices will facilitate implementation efforts.
In Phase II (years 3-6), substantially more practices will participate and be brought into the ASCO registry and learning collaborative. The American Cancer Society will develop a patient toolkit, convene stakeholders, and disseminate results. The patient organizations will disseminate findings in webinars and listservs. The project team will oversee and facilitate all aspects of the project, with gradual transitions to independence of the partner organizations over time to enable continued scaling and broad uptake of ePROs nationally.
5. How is the team evaluating this project?
The project team will evaluate real-world ePRO implementation and effectiveness using the established RE-AIM 3.0 framework which has previously been adapted for ePROs. This framework includes evaluation of reach, equity, effectiveness, adoption, implementation, and maintenance. For each of these, the team has developed specific metrics and goal criteria to determine programmatic success and to identify areas warranting attention. These metrics will leverage multiple data sources including practice information systems, administrative databases, and interviews of clinical staff and patients.
6. How is the team involving patients and others in making sure the findings reach people who can use them?
The OncoPRO Initiative’s project team includes four patient partners in the key personnel, all who were co-investigators on the PRO-TECT trial, and will enlist patient organizations and advocates nationally to disseminate results as they did for PRO-TECT. This project will be conducted in partnership with two oncology patient organizations, the Research Advocacy Network and Patients & Partners. These organizations previously partnered in the PRO-TECT trial and contributed substantially to dissemination through multiple online webinars, newsletter feeds, social media posts, and conference presentations and will play a similar role for this project. The American Cancer Society, which also partnered on PRO-TECT, will disseminate findings through online informational channels and newsletters.
7. How will this project help ensure future uptake and use of findings from patient-centered outcomes research?
The OncoPRO Initiative will generate the necessary enduring infrastructure – and engage the key national organizations, software vendors, and practice networks – to initiate momentum and a cascade effect towards broad national uptake of ePRO symptom monitoring. The project team will create sustainable approaches through ASCO, practice networks, and EMR vendors. They will show the feasibility and effectiveness of implementation through exemplar practices and disseminate standard procedures that future practices can follow towards successful uptake, including in value-based models like EOM.
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.