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Improving Medical Care With Electronic Interventions Based on Automated Text and Phone Messages

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03002311
First Posted: December 23, 2016
Last Update Posted: September 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Epharmix, Inc
Information provided by (Responsible Party):
Will R Ross, Washington University School of Medicine
  Purpose
This study's purpose is to test the effects of an electronic health intervention platform developed by Epharmix, which features two-way SMS text messages and phone calls intended to improve clinical outcomes compared to the standard of care. The investigators hypothesize that this system can improve frequency and quality of data gathering across various specialties, leading to expedited provider intervention and improved health outcomes.

Condition Intervention Phase
General Medicine Maternal Health Pediatric Health Neurology Psychiatry Emergency Medicine Internal Medicine Nephrology Wellness Mobile Health Surgery Mental Health Chronic Obstructive Pulmonary Disease Diabetes Mellitus CHF Depression Breast Feeding PostPartum Depression Perinatal Mood and Anxiety Disorder Other: Epharmix Other: Standard of care Other: Placebo Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Improving Medical Care With Electronic Interventions Based on Automated Text and Phone Messages

Further study details as provided by Will R Ross, Washington University School of Medicine:

Primary Outcome Measures:
  • Adherence [ Time Frame: Up to 5 years ]

    To determine if Epharmix automated text and phone reminders improve adherence to physician prescribed activities, such as appointments, medications, or actions.

    Primary outcome will be the percent increase in adherence to physician prescribed actions (defined as number of completed events of interest divided by number of clinically prescribed events) compared to standard of care and/or placebo.



Secondary Outcome Measures:
  • Patient engagement [ Time Frame: Up to 5 years ]
    To measure patient engagement rate with an automated text message and phone call system (number of messages responded to by patient divided by the number of messages sent to the patient as prescribed by care provider x100%)

  • Time to COPD specific hospitalization(s) [ Time Frame: Up to 5 years ]
    To determine if an automated text message and phone call system can be used to obtain more timely and comprehensive clinical data for ongoing physician review, than by traditional methods, to decrease disease specific hospitalizations (days, weeks, months, years).

  • Change in HbA1c from baseline [ Time Frame: Up to 5 years ]
    To determine if an automated text message and phone call system can be used to obtain more timely and comprehensive clinical data for ongoing physician review, than by traditional methods, to lower HbA1c values for patients with a baseline HbA1c > 7.0%

  • Follow-up appointment adherence [ Time Frame: Up to 5 years (Up to 6 months after ED discharge per individual patient) ]
    To determine if an automated text message and phone call system can be used to increase follow-up appointment adherence/attendance for patients seen in the emergency department and instructed to arrange and attend one or more outpatient appointments post-discharge.

  • Breastfeeding duration [ Time Frame: Up to 6 months postpartum ]
    Determine if exclusive breastfeeding duration can be improved by using an automated bidirectional communication tool compared to standard of care through six months postpartum.


Estimated Enrollment: 5000
Study Start Date: January 2016
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Control
Receiving current standard of care as designated by clinical provider or clinic's standard operating practice. Depending on the specific disease/condition studied, in addition to standard of care, participants may receive placebo version of eHealth intervention.
Other: Standard of care
Current standard of care as designated by clinical provider or clinic's standard operating practice.
Other: Placebo
Depending on the specific disease/condition studied, in addition to standard of care, participants in the control arm may receive text or phone calls requesting clinical data (e.g. mood, weight, blood glucose level, or disease specific events) that a patient can provide on their own. Depending on the disease condition, these answers may trigger a prompt for the patient to call in to the provider, although no alert will be sent to the provider prompting a call to the patient. Patients are able to contact their provider at any time as per standard of care, but are not proactively prompted by the Epharmix system to contact their provider based on responses/values provided for data collection.
Experimental: Epx eHealth Intervention
After providing consent, any patient who opted in will begin receiving text or phone calls regarding reminders for physician prescribed actions, or will begin receiving text or phone calls requesting clinical data (e.g. mood, weight, blood glucose level, or disease specific events) that a patient can provide on their own. The repetition rate and frequency will be differed based on disease and physician preference. The patient can then respond to these messages via numerical or binary answers (Y/N). Depending on the disease condition, these answers may trigger a prompt for the patient to call in to the provider, or where possible, an alert to the provider (delivered via page, phone call, or E-Mail) to proactively call the patient to manage their health condition.
Other: Epharmix
An electronic intervention platform uses SMS text messaging or pre-recorded phone messages for various adherence tracking and data collection applications, in order to supplement clinical care. Specific messages include proactively asking patients or a designated patient advocate if the patient has experienced a medical event recently; requesting specific care-related information, such as glucose values, current mood, or medication adherence; and providing health care education, i.e. what to do if they are experiencing physical symptoms. Patients receiving the messages are also provided with key contact information for their designated health care provider to promote patient engagement, as well as prompt and appropriate medical intervention.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   5 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All potential subjects are BJC Health Care/Washington University patients who have medical records, including a known phone number, at which they can either receive SMS text messages and/or phone calls.
  • All potential subjects are patients who have records of a phone number known.

Exclusion Criteria:

  • Persons unable to be contacted by phone call or SMS text message, or choose to opt-out of the study.
  • Persons with severe neurological or cognitive disorders, limiting their ability to provide informed consent.
  • Persons no longer receiving medical care at Barnes Jewish hospital or Washington University.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03002311


Locations
United States, Missouri
St. Louis Children's Hospital
Saint Louis, Missouri, United States, 63110
Washington University School of Medicine - Barnes Jewish Hospital
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Epharmix, Inc
Investigators
Principal Investigator: Will R Ross, MD, MPH Washington University School of Medicine
  More Information

Publications:

Responsible Party: Will R Ross, Associate Dean for Diversity; Professor of Medicine, Nephrology/Internal Medicine, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03002311     History of Changes
Other Study ID Numbers: 201504079
First Submitted: November 23, 2016
First Posted: December 23, 2016
Last Update Posted: September 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Will R Ross, Washington University School of Medicine:
Bioinformatics
Electronic pharmacology
Mobile health
Electronic health
Adherence
Digital health
Health information technology
mHealth
eHealth

Additional relevant MeSH terms:
Diabetes Mellitus
Depression
Depressive Disorder
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Emergencies
Anxiety Disorders
Depression, Postpartum
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Puerperal Disorders
Pregnancy Complications