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

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ClinicalTrials.gov Identifier: NCT03850912
Recruitment Status : Recruiting
First Posted : February 22, 2019
Last Update Posted : September 16, 2020
Sponsor:
Collaborators:
National Cancer Institute (NCI)
RTI International
Baptist Memorial Health Care Corporation
Dartmouth-Hitchcock Medical Center
Maine Medical Center
West Virginia University
Lifespan
Information provided by (Responsible Party):
Deborah Schrag, MD, Dana-Farber Cancer Institute

Tracking Information
First Submitted Date  ICMJE February 20, 2019
First Posted Date  ICMJE February 22, 2019
Last Update Posted Date September 16, 2020
Actual Study Start Date  ICMJE July 25, 2019
Estimated Primary Completion Date May 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 22, 2019)
'Emergency Department - Treat and Release' (EDTR) Rate at 30-days [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 21, 2019)
'Emergency Department - Treat and Release' (EDTR) Rate at 30-days [ Time Frame: 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). We 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. We 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2019)
  • Patients' outcomes, indicated by levels of self-efficacy and symptom burden, at day 30 of eSyM usage [ Time Frame: 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 domains including fatigue, pain, depression, anxiety, and physical functioning217, 130 Cella recommends using 0.5 SD as the MID for PROMIS scales218,219.
  • Patients' satisfaction with their cancer care at 30-days post-chemo start or post-surgery: AHRQ's CAHPS Analysis Program [ Time Frame: 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.
  • eSyM sustainability at the patient, clinic and health system level [ Time Frame: 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 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
  • Impact on initiation of adjuvant chemotherapy and chemotherapy duration assessed at 1 year [ Time Frame: 1-year medical record abstraction ]
    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.
  • Sustainability of ePRO symptom management within a health system [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2019)
  • Patients' outcomes, indicated by levels of self-efficacy and symptom burden, at day 30 of eSyM usage [ Time Frame: 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, we 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.
  • Patients' satisfaction with their cancer care at 30-days post-chemo start or post-surgery: AHRQ's CAHPS Analysis Program [ Time Frame: One time survey (30-60 days after surgery or first dose of chemo) ]
    We 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 we can detect with 80% power. For example, with 360 patients (e.g., those who have GI surgery) we have >80% power to detect effect size >0.44, a meaningful difference in CAHPS scores.
  • eSyM sustainability at the patient, clinic and health system level [ Time Frame: 1-year medical record abstraction ]
    We 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
  • Impact on initiation of adjuvant chemotherapy and chemotherapy duration assessed at 1 year [ Time Frame: 1-year medical record abstraction ]
    We will be using the EMR to evaluate the timing of first dose to the last dose of a specific chemotherapy regimen. We 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. We will censor follow-up at 1 year. We 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.
  • Sustainability of ePRO symptom management within a health system [ Time Frame: 1-year medical record abstraction ]
    We will evaluate sustainability at the patient, clinic and health system level using simple rates and proportions. To evaluate sustainability, we will examine the consequences of withdrawing grant-funded nursing support for symptom management in the post-implementation period. We 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, we will perform difference in difference analysis.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Symptom Management Implementation of Patient Reported Outcomes in Oncology
Official Title  ICMJE SIMPRO Research Center: Integration and Implementation of PROs for Symptom Management in Oncology Practice
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 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:

  1. Obtain stakeholder feedback
  2. Build and deploy eSyM
  3. Pilot test eSyM
  4. Pragmatic stepped-wedge cluster randomized trial
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Other Cancer
  • Gastrointestinal Cancer
  • Thoracic Cancer
  • Gynecologic Cancer
Intervention  ICMJE
  • Other: eSyM App Usage
    Patients (and/or proxy) will report their cancer-related symptoms and receive tailored feedback via eSyM
  • Other: SASS Questionnaire
    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.
Study Arms  ICMJE
  • No Intervention: Activity 1: Stakeholder Feedback

    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
    • Build and deploy eSyM
    • Finalize training materials based on findings from stakeholder engagement
  • Experimental: Activity 3: Pilot Test eSyM App

    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)
    Intervention: Other: eSyM App Usage
  • Experimental: Activity 4: eSyM+ Participants
    • 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)"
    • A medical record abstraction will be completed for ALL eSyM+ patients
    Interventions:
    • Other: eSyM App Usage
    • Other: SASS Questionnaire
  • Experimental: Activity 4: eSyM- Participants
    • 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
    Intervention: Other: SASS Questionnaire
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 21, 2019)
18000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2023
Estimated Primary Completion Date May 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Deborah Schrag, MD, MPH 617-582-8301 deb_schrag@dfci.harvard.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03850912
Other Study ID Numbers  ICMJE 18-734
1UM1CA233080-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research data set used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Data can be shared no earlier than 1 year following the date of publication
Access Criteria: DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
Responsible Party Deborah Schrag, MD, Dana-Farber Cancer Institute
Study Sponsor  ICMJE Dana-Farber Cancer Institute
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • RTI International
  • Baptist Memorial Health Care Corporation
  • Dartmouth-Hitchcock Medical Center
  • Maine Medical Center
  • West Virginia University
  • Lifespan
Investigators  ICMJE
Principal Investigator: Deborah Schrag, MD, MPH Dana-Farber Cancer Institute
PRS Account Dana-Farber Cancer Institute
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP