Remote Electronic Patient Monitoring in Gastrointestinal Cancer
- Conditions
- Gastrointestinal Cancer
- Interventions
- Device: Remote Electronic Patient Monitoring
- Registration Number
- NCT04030624
- Lead Sponsor
- Massachusetts General Hospital
- Brief Summary
The goal of this research study is to evaluate a program that involves remote electronic monitoring of vital signs and symptoms of patients with gastrointestinal cancer who were recently hospitalized at Massachusetts General Hospital or presented to the oncology clinic for an unplanned, urgent visit.
- Detailed Description
Patients with gastrointestinal cancer often experience troublesome symptoms and side effects related to the cancer and its treatment. Unfortunately, patients commonly require hospital admission or urgent clinic visits to help manage uncontrolled symptoms. For this study, the investigators seek to determine if a program that entails remote electronic monitoring may improve the overall care experience of patients with gastrointestinal cancer who have urgent care needs.
The investigators are asking the participants to take part in this research study because the participants are currently hospitalized at Massachusetts General Hospital or recently presented to the oncology clinic for an urgent visit, and are receiving treatment at the Cancer Center. The goal of this study is to test a program that involves remote electronic monitoring of vital signs and patient-reported health outcomes. This study is a pilot study, and the investigators are evaluating the feasibility of delivering the program, the acceptability and satisfaction with the program, changes in the quality of life and symptoms of patients who receive the program, as well as the frequency of urgent hospital visits while the patient is in the program.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Age 18 or older
- Diagnosed with gastrointestinal cancer
- Hospitalized at Massachusetts General Hospital (MGH) or presenting to the ambulatory MGH oncology clinic for an unplanned, urgent visit
- Planning to receive outpatient care at the MGH Cancer Center
- Ability to read and respond to questions in English
- Uncontrolled psychiatric illness or impaired cognition that would interfere with completing study procedures
- Enrolled in hospice
- Planning to be discharged to any location other than their home
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Remote Electronic Patient Monitoring Remote Electronic Patient Monitoring * The Remote Electronic Patient Monitoring intervention will entail monitoring of vital sign data and patient reported assessments to address and manage any concerning issues identified. * The Remote Patient Monitoring system uses algorithms that can indicate when patient vitals and patient-reported outcomes have changed. * Automatic patient surveys are sent to the patient with results displayed on the clinician user interface (i.e., dashboard) on a computer located in the clinical area. * Qualitative interviews with patient participants and their oncology clinicians using a semi-structured interview guide will be conducted.
- Primary Outcome Measures
Name Time Method The Feasibility of Remote Electronic Patient Monitoring Intervention 4 weeks The intervention will be deemed feasible if at least 50% (95% confidence interval +/- 13%) of patients agree to participate in the study and sign informed consent, and if participants wear the Remote Electronic Patient Monitoring device ≥ 50% (95% confidence interval +/- 13%) of the time within the two weeks following the baseline time point.
- Secondary Outcome Measures
Name Time Method Proportion of participants completing self-reported symptom monitoring through the remote electronic monitoring device during study period 4 weeks Proportion of intervention-triggered events that are not clinically acted upon (i.e., no change in patient care based on an intervention trigger) during study period 4 weeks Patient-Reported Symptoms 2 weeks and 4 weeks Change in patient-reported symptoms from baseline to 2 and 4 weeks per the Edmonton Symptom Assessment System-revised
Number of intervention-triggered phone calls from clinicians required per patient as well as average duration of these calls during study period 4 weeks Number of intervention-triggered emails generated to the primary oncology team during study period 4 weeks Acceptability of Remote Electronic Patient Monitoring Intervention 4 weeks Participant report of perceptions of the usefulness, effectiveness, and relevance of the intervention per acceptability ratings and qualitative interviews with patient participants and their clinicians.
Number of concerning issues identified per patient during study period 4 weeks Proportion of participants completing vital sign monitoring through the remote electronic monitoring device during study period 4 weeks Health Care Utilization 4 weeks Number of urgent clinic visits, emergency department visits, and hospital admissions during study period
Patient-Reported Quality of Life 2 weeks and 4 weeks Change in patient-reported quality of life from baseline to 2 and 4 weeks per the Functional Assessment of Cancer Therapy-General
Patient-Reported Depression and Anxiety Symptoms 2 weeks and 4 weeks Change in patient-reported depression and anxiety symptoms from baseline to 2 and 4 weeks per the Patient Health Questionnaire-4