Mobile-health Approach to Gather Clinical Information From Patients Following Hospital Discharge

NCT ID: NCT04709939

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

97 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-27

Study Completion Date

2022-11-19

Brief Summary

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The purpose of this study is to assess the feasibility of using a mobile-health approach to gather clinical data from patients following discharge from the hospital on outpatient parenteral antibiotic therapy (OPAT). The study population will consist of adult participants who have a smartphone that is capable of both text messaging and pairing with a Bluetooth thermometer that will be provided. Following discharge, patients will be asked to respond to two daily text messages. They will also be reminded to take and send in photos of any skin rashes that may develop as well as their PICC-line site during dressing changes. Text messages will be sent for up to 30 days, but will be stopped sooner if the patient is readmitted to the hospital or if OPAT is discontinued. At the end of the 30 days, all patients will be sent a text message survey about usability, the time it took to complete the study tasks, suggestions for future improvements, and whether they would be willing to be interviewed via phone. A subset of the participants will be interviewed via phone to obtain more detailed feasibility data. Information from the patient's medical record will be collected at the time of hospital discharge as well as at the end of the study period.

Additionally, a focus group (via conference call) will be conducted with all research team members and infectious disease physicians involved in OPAT who did not use the system to gauge their needs and to get ideas for future applications of our tools.

Detailed Description

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Following hospital discharge on OPAT, patients will be asked to respond to two daily text messages, one in the morning and one in the evening. The message will 1) ask them to take their temperature using the provided thermometer, 2) will provide a link to a web-based survey that will ask about any symptoms as well as provide a free text response field, and 3) remind them to take and send in any photos of any skin rashes that may develop as well as their PICC-line site during dressing changes. Text messages will be sent for up to 30 days, but will be stopped sooner if the patient is readmitted to the hospital or if OPAT is discontinued. At the end of the 30 days, all patients will be sent a text message survey about usability, the time it took to complete the study tasks, suggestions for future improvements, and whether they would be willing to be interviewed via phone. A subset of the participants will be interviewed via phone to obtain more detailed feasibility data.

Additional information will also be collected from the patient and their medical record at the time of hospital discharge (patient caregiver situation, pronouns to address them, artificial material in joints or bones, biological sex, race, ethnicity, height, weight, BMI, zip code, insurance, reason for OPAT, organisms in cultures, where patient is receiving discharge medication, discharge medications, and any other diagnoses/co-morbidities) as well as 2 months after enrollment (any readmission dates and reasons, emergency room visit dates and reasons, clinic visit dates and reasons, and medication changes within 30 days of starting OPAT). These data will be collected 2 months after enrollment to ensure that all readmissions, visits, and medication changes are captured in the medical record.

The software will save time-stamped responses to all web-based surveys, photos sent in, and temperatures taken by the thermometer.

Additionally, a focus group will be conducted (via conference call) with all research team members and infectious disease physicians involved in OPAT who did not use the system to gauge their needs and to get ideas for future applications of our tools. This conference call will be video and audio recorded.

There will not be any long-term follow up for the study.

Conditions

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Outpatient Parenteral Antibiotic Therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient Participants

Adults patients who are discharged from the hospital on outpatient parenteral antibiotic therapy.

OPAT

Intervention Type OTHER

Observation of patients who are discharged from the hospital on OPAT.

Physician Participants

Infectious disease physicians who prescribe OPAT to their patients but were not involved in the study.

Focus Group

Intervention Type OTHER

Focus group with infectious disease physicians who prescribe OPAT to patients but were not involved in the study.

Interventions

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OPAT

Observation of patients who are discharged from the hospital on OPAT.

Intervention Type OTHER

Focus Group

Focus group with infectious disease physicians who prescribe OPAT to patients but were not involved in the study.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age 18 to 100
* Being discharged from hospital on OPAT
* Owns a smartphone capable of text messaging and being paired to Bluetooth thermometer
* Able to send SMS and MMS messages via phone


* Infectious disease physician who prescribes OPAT

Exclusion Criteria

* Prisoner status
* Unable to provide own written, informed consent


* None
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role collaborator

University of Iowa

OTHER

Sponsor Role lead

Responsible Party

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Philip Polgreen

Professor, Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Philip M Polgreen, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

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University of Iowa Hospitals & Clinics

Iowa City, Iowa, United States

Site Status

Countries

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United States

Other Identifiers

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R21TR003410

Identifier Type: NIH

Identifier Source: secondary_id

View Link

202010084

Identifier Type: -

Identifier Source: org_study_id

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