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

NCT04709939 | Completed

• 2 other identifiers: 202010084R21TR003410
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Outpatient Parenteral Antibiotic Therapy

Outcome Measures

Primary Outcomes (4)

• 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

• Number of Completed Surveys

  The number of completed surveys that the participant submits over the course of the study.

  30 days

• Number of Photos Sent

  The number of photos that the participant submits over the course of the study.

  30 days

• Sample Size Estimation for Future Study

  The sample size required to conduct a powered study in the future.

  30 days

Secondary Outcomes (1)

• Suggestions for Future Use survey

  30 days

Study Arms (2)

Patient Participants

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

Other: OPAT

Physician Participants

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

Other: Focus Group

Interventions

OPAT OTHER

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

Patient Participants

Focus Group OTHER

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

Physician Participants

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients being discharged from hospital on OPAT.

You may qualify if:

• 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

You may not qualify if:

• Prisoner status
• Unable to provide own written, informed consent
• Infectious disease physician who prescribes OPAT
• None

Sponsors & Collaborators

• University of Iowa: lead
• National Institutes of Health (NIH): collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Interventions

Focus Groups

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Philip M Polgreen, MD, MPH

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Internal Medicine

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: January 14, 2021
• Study Start: August 27, 2021
• Primary Completion: November 19, 2022
• Study Completion: November 19, 2022
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)