2674 Participants Needed

Automatic vs. As-Needed Follow-Up for Infections

(FAAN-C Trial)

Recruiting at 12 trial locations
EC
ST
Overseen BySara T McCormick, MPA
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Utah
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

Compare the effectiveness of automatic vs as-needed (PRN) post-hospitalization follow-up for children who are hospitalized for common infections.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment As-needed follow-up for infections?

Research on routine follow-up after breast cancer surgery suggests that while routine follow-ups may not always be clinically beneficial, a more tailored approach, like as-needed follow-up, can reduce patient anxiety and unnecessary hospital visits, while maintaining care standards and providing effective support.12345

Is automatic or as-needed follow-up for infections generally safe for humans?

The research does not provide specific safety data for automatic or as-needed follow-up for infections, but it discusses the use of automated systems for infection surveillance, which can improve data accuracy and reduce resource use. This suggests that automated methods are considered safe and beneficial for monitoring infections.678910

How does the 'As-needed follow-up' treatment differ from other treatments for infections?

The 'As-needed follow-up' treatment is unique because it allows for follow-up care only when necessary, rather than scheduling routine visits for all patients. This approach can save time and resources by focusing on patients who actually need further care, unlike traditional methods that require all patients to return for follow-up regardless of their condition.1112131415

Research Team

EC

Eric Coon, MD

Principal Investigator

University of Utah

Eligibility Criteria

Children under 18 hospitalized for pneumonia, skin infections, gastroenteritis, or urinary tract infection can join. They must speak English or Spanish. Kids with chronic diseases, needing surgery beyond minor procedures, with immune issues, or scheduled follow-ups within a week of discharge cannot participate.

Inclusion Criteria

I was hospitalized for pneumonia, skin infection, stomach flu, or a UTI.
I am under 18 years old.
I, as a parent, can communicate in English or Spanish.

Exclusion Criteria

I have pneumonia and am receiving treatment with a chest tube.
I have a weakened immune system.
I have a long-term, complex health condition.
See 9 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either automatic or as-needed (PRN) post-hospitalization follow-up recommendations

14 days
1 visit (in-person or virtual) as needed

Follow-up

Participants are monitored for hospital readmissions and other outcomes after discharge

6 months
Multiple visits (in-person or virtual) as needed

Treatment Details

Interventions

  • As-needed follow up
  • Automatic follow-up
Trial OverviewThe trial is testing if automatic follow-up appointments after hospitalization are better than scheduling them only as needed for children recovering from common infections like pneumonia and UTIs.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: As-needed (PRN) post-hospitalization follow-upExperimental Treatment1 Intervention
At hospital discharge, participant receives a recommendation for PRN follow-up. Recommendation informs participant that scheduling a follow-up visit is not needed at discharge and suggests that participant follow symptoms after discharge to decide if a visit is ultimately needed or not.
Group II: Automatic post-hospitalization follow-upActive Control1 Intervention
At hospital discharge, participant receives a recommendation for automatic follow-up. Recommendation instructs participant to schedule a follow-up visit and attend the visit even if symptoms get better.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials
1,169
Recruited
1,623,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials
592
Recruited
27,110,000+

Findings from Research

A follow-up education program for breast cancer patients at low-to-moderate risk effectively reduced overall patient anxiety and the number of routine hospital appointments after two years.
The program maintained high standards of care while providing patients with a supportive network, suggesting a more efficient use of healthcare resources for this group.
Supportive care after breast cancer surgery.Allinson, VM., Dent, J.[2016]
Patients who attended their post-discharge follow-up appointments within the first week had a significantly lower risk of being readmitted within 30 days compared to those who had no follow-up scheduled, with adjusted hazard ratios of 0.57 for medical and 0.58 for surgical patients.
Missing follow-up appointments or not having any scheduled follow-up was associated with higher readmission rates, particularly highlighting the importance of timely post-discharge care in preventing readmissions.
Examination of Post-discharge Follow-up Appointment Status and 30-Day Readmission.Coppa, K., Kim, EJ., Oppenheim, MI., et al.[2022]
In a study of 83 racially diverse heart failure patients from a low-income area, the most desired follow-up intervention was having appointments close to home, with 77% of participants expressing this preference.
Reminder messages were also highly favored, with 73% of patients indicating they would find this helpful, highlighting the importance of accessible and supportive follow-up care for improving post-hospitalization outcomes.
Patient Perceptions on Facilitating Follow-Up After Heart Failure Hospitalization.Breathett, K., D'Amico, R., Adesanya, TMA., et al.[2018]

References

Supportive care after breast cancer surgery. [2016]
Examination of Post-discharge Follow-up Appointment Status and 30-Day Readmission. [2022]
Patient Perceptions on Facilitating Follow-Up After Heart Failure Hospitalization. [2018]
Patient's needs and preferences in routine follow-up after treatment for breast cancer. [2022]
Evaluation of routine follow-up after surgery for breast carcinoma. [2004]
PRAISE: providing a roadmap for automated infection surveillance in Europe. [2021]
Incidence rates of hospital-acquired urinary tract and bloodstream infections generated by automated compilation of electronically available healthcare data. [2019]
Statistical approaches to group sequential monitoring of postmarket safety surveillance data: current state of the art for use in the Mini-Sentinel pilot. [2022]
The rationale for a post-marketing surveillance. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Automated methods for surveillance of surgical site infections. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Development and validation of models for detection of postoperative infections using structured electronic health records data and machine learning. [2023]
Literature review of evidence-based follow-up strategies of cancer patients [2022]
Determining the Clinical Value of Routine Post Operative follow up in Common Paediatric Surgical Conditions: A Prospective Observational Study. [2023]
Follow-up after primary treatment for breast cancer. [2019]
Follow-up of outpatient test results: a survey of house-staff practices and perceptions. [2015]