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

• ClinicalTrials.gov Identifier: NCT04709939
• Recruitment Status: Recruiting
• First Posted: January 14, 2021
• Last Update Posted: September 9, 2021
• Sponsor: University of Iowa
• Collaborator: National Institutes of Health (NIH)
• Information provided by (Responsible Party): Philip Polgreen, University of Iowa

Study Description

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.

Condition or disease	Intervention/treatment
Outpatient Parenteral Antibiotic Therapy	Other: OPAT; Other: Focus Group

Detailed 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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 120 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Determining the Acceptability and Feasibility of Mobile-health Approaches to Gather Clinical Information From Patients at Home Following Hospital Discharge
• Actual Study Start Date: August 27, 2021
• Estimated Primary Completion Date: December 2021
• Estimated Study Completion Date: December 2021

Groups and Cohorts

Group/Cohort	Intervention/treatment
Patient Participants; Adults patients who are discharged from the hospital on outpatient parenteral antibiotic therapy.	Other: OPAT; 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.	Other: Focus Group; Focus group with infectious disease physicians who prescribe OPAT to patients but were not involved in the study.

Outcome Measures

Primary Outcome Measures :

1. Number of Days with a Temperature Reading [ Time Frame: 30 days ]
   The number of days that participants submit a temperature reading during the course of the study.
2. Number of Completed Surveys [ Time Frame: 30 days ]
   The number of completed surveys that the participant submits over the course of the study.
3. Number of Photos Sent [ Time Frame: 30 days ]
   The number of photos that the participant submits over the course of the study.
4. Sample Size Estimation for Future Study [ Time Frame: 30 days ]
   The sample size required to conduct a powered study in the future.

Secondary Outcome Measures :

1. Suggestions for Future Use survey [ Time Frame: 30 days ]
   Feedback from focus group participants for future applications of the methods.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 100 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients being discharged from hospital on OPAT.

Criteria

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

Contacts and Locations

Contacts

Contact: Philip M Polgreen, MD, MPH; (319) 384-6194; philip-polgreen@uiowa.edu

Contact: Shelby L Francis, PhD; (319) 678-8037; shelby-francis@uiowa.edu

Locations

United States, Iowa

University of Iowa Hospitals & Clinics; Recruiting

Iowa City, Iowa, United States, 52242

Contact: Shelby L Francis, PhD 319-775-0689 shelby-francis@uiowa.edu

Sponsors and Collaborators

University of Iowa

National Institutes of Health (NIH)

Investigators

• Principal Investigator: Philip M Polgreen, MD, MPH; University of Iowa

More Information

• Responsible Party: Philip Polgreen, Professor, Internal Medicine, University of Iowa
• ClinicalTrials.gov Identifier: NCT04709939
• Other Study ID Numbers: 202010084; R21TR003410 ( U.S. NIH Grant/Contract )
• First Posted: January 14, 2021
• Last Update Posted: September 9, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No