Symptom Management Implementation of Patient Reported Outcomes in Oncology (SIMPRO)

Dana-Farber Cancer Institute

Status: Completed

Conditions: Gastrointestinal Cancer; Gynecologic Cancer; Other Cancer; Thoracic Cancer

Treatments: Other: Stakeholder Survey (Intervention Period); Other: Stakeholder Survey (Control Period); Other: SASS Questionnaire; Other: eSyM; Other: Qualitative Interview

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03850912

18-734

1UM1CA233080-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Deficits in the management of common symptoms cause substantial morbidity for cancer patients.Because the health care delivery system is structured to be reactive and not proactive, there are missed opportunities to optimize symptom control. Growth in Internet access and proliferation of smartphones has created an opportunity to re-engineer cancer care delivery. Electronic symptom tracking and feedback is a promising strategy to improve symptom control. Electronic patient reported outcome (ePRO) monitoring of cancer symptoms has been shown to decrease symptom burden, improve quality of life, reduce acute care and even extend survival. SIMPRO will use functioning ePRO prototypes to create and refine the electronic symptom management system eSyM

Full description

A multi-disciplinary team of investigators from 6 health systems have formed the Symptom Management IMplementation of Patient Reported Outcomes in Oncology (SIMPRO) Research Center. SIMPRO will use functioning ePRO prototypes to create and refine the electronic symptom management system eSyM. eSyM is the name of the platform the team will refine, integrate, implement and evaluate. eSyM addresses each of the 4 evidence gaps by:

• Implementing eSyM in cancer centers in small, rural or community-based systems.
• Integrating eSyM into the EHR (electronic health record) of the predominant vendor used nationwide.
• Leveraging evidence-based tools, patient engagement, and population management.
• Executing this work using the Consolidated Framework for Implementation Research across all phases to maximize the chances that eSyM and similar systems achieve their intended goals and decrease the morbidity of cancer treatment at a population level.

This project contains 5 activities:

1. Obtain stakeholder feedback
2. Build and deploy eSyM
3. Pilot test eSyM
4. Pragmatic stepped-wedge cluster randomized trial
5. Integration of eSyM data to develop algorithms to estimate the risk of experiencing an outcome, including, but not limited to, ED usage and hospitalization among cancer patients

Enrollment: 42,808 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Stakeholder Feedback and Stakeholder Qualitative Interviews Population:

• Age ≥ 18 years
• The potential stakeholders are: patient advisory council members, health system leaders, clinicians, clinic support staff/administration, IT/Informatics staff

Cluster Randomized Trial, Patient QualitativeInterviews, Pilot Testing & SASS Questionnaire Population:

• Age ≥ 18 years

• Priority population will be patients who meet one of the following:

  • Suspected thoracic cancer [lung or bronchus] AND is inpatient following thoracic surgery.
  • Suspected gastrointestinal cancer [colorectal, pancreas, liver/biliary, esophagus,or gastric] AND is inpatient following gastrointestinal surgery.
  • Suspected gynecologic cancer [ovary, uterus, or cervix] AND is inpatient following gynecologic surgery.
  • Diagnosis of thoracic cancer [lung or bronchus] AND scheduled to start a new treatment plan for thoracic cancer.
  • Diagnosis of gastrointestinal cancer [colorectal, pancreas, liver/biliary, esophagus,or gastric] AND scheduled to start a new treatment plan for gastrointestinal cancer.
  • Diagnosis of gynecologic cancer [ovary, uterus, or cervix] AND scheduled to start a new treatment plan for gynecologic cancer.

• Total population allowed to use eSyM:

  • Any patient at any participating site.

Exclusion criteria

- Participants not meeting the inclusion critera above.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42,808 participants in 9 patient groups

Stakeholder Feedback (Control Period)

Other group

Description:

Eligible stakeholders at each SIMPRO site were invited to provide feedback through focus groups, team meetings, and surveys before the trial rollout of eSyM to inform development and implementation. Stakeholders included: * patient advisory councils * health system leaders * clinicians * clinic support staff/administration * IT/Informatics

Treatment:

Other: Stakeholder Survey (Control Period)

Stakeholder Feedback (Intervention Period)

Other group

Description:

Eligible stakeholders at each SIMPRO site were invited to provide feedback through surveys after the trial rollout of eSyM to inform intervention normalization and sustainability. Stakeholders included: * health system leaders * clinicians * clinic support staff/administration * IT/Informatics

Treatment:

Other: Stakeholder Survey (Intervention Period)

SASS Questionnaire Participants (Control Period)

Other group

Description:

A subset of trial control patients were asked to complete a research questionnaire called the SASS Questionnaire before the roll-out of eSyM to assess patient outcomes including self-efficacy, attainment of informational needs, symptom burden, and satisfaction with care.

Treatment:

Other: SASS Questionnaire

SASS Questionnaire Participants (Intervention Period)

Other group

Description:

A subset of trial intervention patients were asked to complete a research questionnaire called the SASS Questionnaire after the roll-out of eSyM to assess patient outcomes including self-efficacy, attainment of informational needs, symptom burden, and satisfaction with care.

Treatment:

Other: SASS Questionnaire

Patient Qualitative Interviews

Other group

Description:

A subset of trial intervention patients were asked to participate in a one-time patient interview to provide feedback on facilitators and barriers to eSyM implementation and adoption after the roll-out of eSyM.

Treatment:

Other: Qualitative Interview

Stakeholder Qualitative Interviews

Other group

Description:

A subset of eligible stakeholders at each site were asked to participate in a one-time interview to provide feedback on facilitators and barriers to eSyM implementation and adoption after the roll-out of eSyM.

Treatment:

Other: Qualitative Interview

Pilot Testing

Other group

Description:

A subset of control patients at each site were selected to pilot test the eSyM intervention prior to trial start.

Treatment:

Other: eSyM

Cluster Randomized Trial (Control Patients)

No Intervention group

Description:

These patients (and/or proxy) were seen at a participating site prior to the trial rollout of eSyM and were not exposed to the eSyM intervention.

Cluster Randomized Trial (Intervention Patients)

Experimental group

Description:

These patients (and/or proxy) were seen at a participating site after the trial rollout of eSyM and were exposed to the eSyM intervention.

Treatment:

Other: eSyM