Symptom Management Implementation of Patient Reported Outcomes in Oncology

Study Overview
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Brief Summary
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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

Detailed Description
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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 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 4 activities: Obtain stakeholder feedback Build and deploy eSyM Pilot test eSyM Pragmatic stepped-wedge cluster randomized trial

Official Title
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SIMPRO Research Center: Integration and Implementation of PROs for Symptom Management in Oncology Practice

Conditions
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Other Cancer, Gastrointestinal Cancer, Thoracic Cancer, Gynecologic Cancer

Intervention / Treatment
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* Other: eSyM App Usage
* Other: SASS Questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Activity 1 Population: Age ≥ 18 years The potential stakeholders are: patient advisory council members, health system leaders, clinicians, clinic support staff/administration, IT/Informatics staff Activity 3 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. Activity 4 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Activity 1: Stakeholder Feedback<br>Obtain stakeholder feedback to inform eSyM finalization and implementation from: patient advisory councils health system leaders clinicians clinic support staff/administration IT/Informatics | |
| No Intervention: Activity 2: eSym Build<br>Build and deploy eSyM Finalize training materials based on findings from stakeholder engagement | |
| Experimental: Activity 3: Pilot Test eSyM App<br>Pilot testing of the eSyM app will include: Activity 3a (eSyM app usage by patients) Activity 3b (User acceptability testing) Activity 3c (Medical record abstraction) | Other: eSyM App Usage<br>* Patients (and/or proxy) will report their cancer-related symptoms and receive tailored feedback via eSyM<br>|
| Experimental: Activity 4: eSyM+ Participants<br>These patients (and/or proxy) will report their symptoms in eSyM A subset of these patients will be asked to complete a research questionnaire called the SASS Questionnaire (eSyM+ version or eSyM-Non-Responder version) A medical record abstraction will be completed for ALL eSyM+ patients | Other: eSyM App Usage<br>* Patients (and/or proxy) will report their cancer-related symptoms and receive tailored feedback via eSyM<br>Other: SASS Questionnaire<br>* A subset of eSyM+ and eSyM- patients will be asked to complete a research questionnaire called the SASS Questionnaire asking about their Self-efficacy, Attainment of information needs, Symptom burden, and Satisfaction with care (see PROMIS, CAHPS, IAM/AIM question banks - Appendices C through G). The questionnaire will stop being administered once 1800 total surveys have been received.<br>|
| Experimental: Activity 4: eSyM- Participants<br>These patients (and/or proxy) will NOT report their symptoms in eSyM A subset of these patients will be asked to complete a research questionnaire called the SASS Questionnaire (eSyM- version) A medical record abstraction will be completed for ALL eSyM- patients | Other: SASS Questionnaire<br>* A subset of eSyM+ and eSyM- patients will be asked to complete a research questionnaire called the SASS Questionnaire asking about their Self-efficacy, Attainment of information needs, Symptom burden, and Satisfaction with care (see PROMIS, CAHPS, IAM/AIM question banks - Appendices C through G). The questionnaire will stop being administered once 1800 total surveys have been received.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 'Emergency Department - Treat and Release' (EDTR) Rate at 30-days | The primary study outcome of the stepped wedge cluster RCT is the EDTR rate. This outcome will be defined in relation to the date of discharge from hospital (surgical oncology) or the initiation date of a new intravenous chemo regimen (medical oncology). The investigators will evaluate the # of EDTR visits for patients using the eSyM app. 30-day EDTR rates are estimated to vary between 8% to 15% for the control group. The investigators hypothesize that EDTR rates will be 3-4% lower in the eSyM+ group. Control group rates were estimated based on EDTR rates derived from HCUP data, institutional data and early phase analyses from CMMI's Oncology Care Model for Baptist Memorial, the only Oncology Care Model participant among our 6 sites. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' outcomes, indicated by levels of self-efficacy and symptom burden, at day 30 of eSyM usage | Patients (both Surg Onc and Med Onc) from each of the 6 sites will be surveyed in the period before and after rollout according to the stepped wedge design schema. Assuming a 75% response rate, the investigators expect to survey 400 patients per site (2400 total) to obtain 300 (1800 total) responses split evenly between eSyM+ and eSyM- subjects. Additional survey participants can readily be identified if the 75% response rate is not achieved. Yost and Cella have reported minimally important difference (MID) ranges for five PROMIS domains including fatigue, pain, depression, anxiety, and physical functioning217, 130 Cella recommends using 0.5 SD as the MID for PROMIS scales218,219. | One time survey (30-60 days after surgery or first dose of chemo) | 
| Patients' satisfaction with their cancer care at 30-days post-chemo start or post-surgery: AHRQ's CAHPS Analysis Program | The investigators will use the AHRQ's CAHPS Analysis Program to compare scores for eSyM+ and eSyM-, adjusting for case mix. Table Aim 2d (in the protocol) shows differences in satisfaction scores the investigators can detect with 80% power. For example, with 360 patients (e.g., those who have GI surgery) the investigators have >80% power to detect effect size >0.44, a meaningful difference in CAHPS scores. Patients will complete a subset of the CAHPS Cancer Care Survey. Items assessed will include: cancer care delivery, patient experience, and patient satisfaction. Responses will be assessed through the following options: a) (Never, Sometimes, Usually, Always) b) (Yes, definitely, Yes, somewhat, No) c) 0-10. | One time survey (30-60 days after surgery or first dose of chemo) | 
| eSyM sustainability at the patient, clinic and health system level | The investigators will be evaluating patient adoption rates and clinician usage rates by analyzing EHR data based on eSyM utilization patterns. Appropriateness and acceptability will be ascertained using Weiner's IAM and AIM surveys (8-items total, less than 3 minutes to complete) which will be administered along with CAHPS surveys. Appropriateness and acceptability ratings will be defined based on the % of respondents who agree or completely agree with the survey items compared to the % who are neutral, disagree, or completely disagree and characterized using descriptive statistics.81 | 1-year medical record abstraction | 
| Impact on initiation of adjuvant chemotherapy and chemotherapy duration assessed at 1 year | The investigators will be using the EMR to evaluate the timing of first dose to the last dose of a specific chemotherapy regimen. The investigators expect that patients exposed to eSyM may be able to: 1) initiate adjuvant therapy sooner; 2) remain on their chemotherapy regimens for longer duration. These time intervals are straightforward to measure from EHR encounter and date fields. For medical oncology patients, the outcome is time from the first dose to the last dose of a specific regimen. The investigators will censor follow-up at 1 year. The investigators will use generalized linear mixed-effect models to compare treatment duration for eSyM+ vs. eSyM- patients. For surgical oncology patients, the denominator population consists of patients who receive any adjuvant chemotherapy within 6 postoperative months. Tumor registry stage distribution at our 6 sites indicates that this will be 202 patients per site or 1212 in total. | 1-year medical record abstraction | 
| Sustainability of ePRO symptom management within a health system | The investigators will evaluate sustainability at the patient, clinic and health system level using simple rates and proportions. To evaluate sustainability, the investigators will examine the consequences of withdrawing grant-funded nursing support for symptom management in the post-implementation period. The investigators will compare outcomes from Period 6 (study month 45-50, all sites eSyM+) and the post-Implementation (Post-I; study months 51-56). Sites are trained and empowered to manage eSyM autonomously without research study staff. Then, during post-implementation, dedicated nursing support to monitor eSyM is tapered in half the sites (see Figure C2). To examine whether backing off on the study support attenuates the effect, the investigators will perform difference in difference analysis. | 1-year medical record abstraction | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Symptom management, Other Cancer, Digital health, Patient reported outcomes