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Remote Electronic Patient Monitoring in Gastrointestinal Cancer

10 november 2020 uppdaterad av: Joseph A. Greer, Ph.D., Massachusetts General Hospital
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.

Studieöversikt

Status

Indragen

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Fas

  • Inte tillämpbar

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Enhet: Remote Electronic Patient Monitoring
The Remote Patient Monitoring intervention is a remote monitoring system intended for use by healthcare professionals for the collection of physiological data in home and healthcare settings. Patient information is displayed on a computer located at the medical institution. Throughout the day, patient data from the remote monitoring system are presented on the clinician user interface (e.g., temperature, blood pressure, heart rate, respiration rate). Data are transmitted from sensors to the patient's smart phone.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
The Feasibility of Remote Electronic Patient Monitoring Intervention
Tidsram: 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.
4 weeks

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Proportion of participants completing self-reported symptom monitoring through the remote electronic monitoring device during study period
Tidsram: 4 weeks
4 weeks
Proportion of participants completing vital sign monitoring through the remote electronic monitoring device during study period
Tidsram: 4 weeks
4 weeks
Number of concerning issues identified per patient during study period
Tidsram: 4 weeks
4 weeks
Number of intervention-triggered phone calls from clinicians required per patient as well as average duration of these calls during study period
Tidsram: 4 weeks
4 weeks
Number of intervention-triggered emails generated to the primary oncology team during study period
Tidsram: 4 weeks
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
Tidsram: 4 weeks
4 weeks
Acceptability of Remote Electronic Patient Monitoring Intervention
Tidsram: 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.
4 weeks
Patient-Reported Quality of Life
Tidsram: 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
2 weeks and 4 weeks
Patient-Reported Symptoms
Tidsram: 2 weeks and 4 weeks
Change in patient-reported symptoms from baseline to 2 and 4 weeks per the Edmonton Symptom Assessment System-revised
2 weeks and 4 weeks
Patient-Reported Depression and Anxiety Symptoms
Tidsram: 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
2 weeks and 4 weeks
Health Care Utilization
Tidsram: 4 weeks
Number of urgent clinic visits, emergency department visits, and hospital admissions during study period
4 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Massachusetts General Hospital

Utredare

  • Huvudutredare: Joseph Greer, MD, Massachusetts General Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Förväntat)

1 september 2020

Primärt slutförande (Faktisk)

9 september 2020

Avslutad studie (Faktisk)

9 september 2020

Studieregistreringsdatum

Först inskickad

22 juli 2019

Först inskickad som uppfyllde QC-kriterierna

22 juli 2019

Första postat (Faktisk)

24 juli 2019

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

13 november 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

10 november 2020

Senast verifierad

1 november 2020

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 19-329

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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 dataset 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.

Tidsram för IPD-delning

Data can be shared no earlier than 1 year following the date of publication

Kriterier för IPD Sharing Access

BCH - Contact the Technology & Innovation Development Office at www.childrensinnovations.org or email TIDO@childrens.harvard.edu BIDMC - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu MGH - Contact the Partners Innovations team at http://www.partners.org/innovation

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • ICF

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Ja

produkt tillverkad i och exporterad från U.S.A.

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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