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

Outpatient Parenteral Antibiotic Therapy Clinical Trial

Official title:

Determining the Acceptability and Feasibility of Mobile-health Approaches to Gather Clinical Information From Patients at Home Following Hospital Discharge

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04709939
• Other study ID #: 202010084
• Secondary ID: R21TR003410
• Status: Completed
• Start date: August 27, 2021
• Est. completion date: November 19, 2022

Study information

• Verified date: November 2023
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: November 19, 2022
• Est. primary completion date: November 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Patient 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

Patient Exclusion Criteria:

• Prisoner status

• Unable to provide own written, informed consent

Physician Inclusion Criteria:

• Infectious disease physician who prescribes OPAT

Physician Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Outpatient Parenteral Antibiotic Therapy

Intervention

Other:
• OPAT
Observation of patients who are discharged from the hospital on OPAT.
• Focus Group
Focus group with infectious disease physicians who prescribe OPAT to patients but were not involved in the study.

Locations

Country	Name	City	State
United States	University of Iowa Hospitals & Clinics	Iowa City	Iowa

Sponsors (3)

Lead Sponsor	Collaborator
University of Iowa	National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Days with a Temperature Reading	The number of days that participants submit a temperature reading during the course of the study.	30 days
Primary	Number of Completed Surveys	The number of completed surveys that the participant submits over the course of the study.	30 days
Primary	Number of Photos Sent	The number of photos that the participant submits over the course of the study.	30 days
Primary	Sample Size Estimation for Future Study	The sample size required to conduct a powered study in the future.	30 days
Secondary	Suggestions for Future Use survey	Feedback from focus group participants for future applications of the methods.	30 days