Symptom Management Implementation of Patient Reported Outcomes in Oncology

Not Applicable

Active, not recruiting

Conditions: Gynecologic Cancer
Gastrointestinal Cancer
Other Cancer
Thoracic Cancer

Interventions: Other: eSyM App Usage
Other: SASS Questionnaire

Registration Number: NCT03850912

Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary: 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: 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

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: All

Target Recruitment: 25000

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.

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Activity 4: eSyM+ Participants	SASS Questionnaire	* 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 (Self-Efficacy, Attainment of informational needs, Symptom Burden, and Satisfaction with care) Questionnaire (eSyM+ version or eSyM-Non-Responder version)" * A medical record abstraction will be completed for all eSyM+ patients
Activity 4: eSyM- Participants	SASS Questionnaire	* 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
Activity 3: Pilot Test eSyM App	eSyM App Usage	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)
Activity 4: eSyM+ Participants	eSyM App Usage	* 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 (Self-Efficacy, Attainment of informational needs, Symptom Burden, and Satisfaction with care) Questionnaire (eSyM+ version or eSyM-Non-Responder version)" * A medical record abstraction will be completed for all eSyM+ patients

Primary Outcome Measures

Name	Time	Method
'Emergency Department - Treat and Release' (EDTR) Rate at 30-days	30 days	The primary study outcome of the stepped wedge cluster RCT (randomized controlled trial) 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 (Healthcare Cost and Utilization Project) 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.

Secondary Outcome Measures

Name	Time	Method
eSyM sustainability at the patient, clinic and health system level	1-year medical record abstraction	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 (Intervention Appropriateness Measure) and AIM (Acceptability of Intervention Measure) 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
Patients' satisfaction with their cancer care at 30-days post-chemo start or post-surgery: AHRQ's (Agency for Healthcare Research and Quality) CAHPS (Consumer Assessment of Healthcare Providers & Systems) Analysis Program	One time survey (30-60 days after surgery or first dose of chemo)	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.
Impact on initiation of adjuvant chemotherapy and chemotherapy duration assessed at 1 year	1-year medical record abstraction	The investigators will be using the EHR 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.
Patients' outcomes, indicated by levels of self-efficacy and symptom burden, at day 30 of eSyM usage	One time survey (30-60 days after surgery or first dose of chemo)	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 (Patient-Reported Outcomes Measurement Information System) domains including fatigue, pain, depression, anxiety, and physical functioning217, 130 Cella recommends using 0.5 SD (Standard Deviation) as the MID for PROMIS scales218,219.
Sustainability of ePRO symptom management within a health system	1-year medical record abstraction	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.

Trial Locations

Locations (6): Baptist Memoiral HealthCare
🇺🇸
Memphis, Tennessee, United States
Lifespan
🇺🇸
Providence, Rhode Island, United States
Maine Medical Center
🇺🇸
Portland, Maine, United States
Dana Farber Cancer Institute
🇺🇸
Boston, Massachusetts, United States
West Virginia University Medical Center
🇺🇸
Morgantown, West Virginia, United States
Dartmouth-Hitchcock Medical Center
🇺🇸
Lebanon, New Hampshire, United States