Follow-up Automatically vs. As-Needed Comparison (FAAN-C) Trial

Pneumonia Clinical Trial

— FAAN-C  

Official title:

The Follow-up Automatically vs. As-Needed Comparison Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05471908
• Other study ID #: IHS-2021C1-22388
• Status: Recruiting
• Phase: N/A
• Start date: August 22, 2022
• Est. completion date: February 28, 2028

Study information

• Verified date: April 2024
• Source: University of Utah
• Contact: Eric Coon, MD, MS
• Phone: 801-587-2160
• Email: Eric.Coon[@]hsc.utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

BACKGROUND:

Automatic post-hospitalization follow-up visits are commonly recommended by hospital-based pediatricians. The intuitive appeal of automatic follow-up visits is that they might decrease hospital readmissions and promote continuity of care. However, automatic follow-up visits result in missed work for parents, missed school for children, and expenses like co-pays and transportation costs. The principal alternative strategy to automatic follow-up is PRN (pro re nata, "as-needed") follow-up, a patient and family-centered approach that empowers parents to monitor their child's symptoms and decide if a follow-up visit is necessary.

OBJECTIVE:

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

DESIGN:

The Follow-up Automatically vs As-Needed Comparison (FAAN-C, or "fancy") trial is a multicenter randomized controlled trial

POPULATION:

Children hospitalized for pneumonia, skin and soft tissue infection, acute gastroenteritis, or urinary tract infection will be eligible for enrollment.

EXPERIMENTAL INTERVENTION:

Randomization to a recommendation for PRN post-hospitalization follow-up

CONTROL INTERVENTION:

Randomization to a recommendation for automatic post-hospitalization follow-up

OUTCOMES:

The primary outcome is hospital readmission within 14 days of discharge. Secondary outcomes are medical interventions and child health-related quality of life. Exploratory outcomes are cost burden, child time, parent time, symptom duration, total additional ambulatory visits, non-primary care ambulatory visits, parent self-efficacy, parent anxiety, satisfaction with care, telephone and electronic communications with medical providers, well-child visits, immunizations, usual place of medical care, and medical interventions related to the index infection. Safety outcomes are medical errors and hospital readmissions related to the index infection.

TRIAL SIZE:

A total of 2,674 patients (1,337 patients in each group) will be randomized, providing 90% power to demonstrate non-inferiority of a recommendation for PRN follow-up compared to a recommendation for automatic follow-up.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2674
• Est. completion date: February 28, 2028
• Est. primary completion date: February 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Age <18 years at the time of randomization

• Hospitalization due to a primary diagnosis of pneumonia, skin and soft tissue infection, acute gastroenteritis, or urinary tract infection.

• Parent speaks English or Spanish.

Exclusion Criteria:

• Presence of a comorbid disease that is both chronic and complex

• Principal disease required surgical intervention (beyond superficial incision and drainage)

• Immunodeficiency

• A well-child check-up or post-hospitalization follow-up visit is already scheduled within 7 days of hospital discharge

• Parent or participant strongly prefers PRN or automatic follow-up

• A medical provider feels strongly that a post-hospitalization follow-up visit is needed within 7 days of hospital discharge

• Sibling concurrently hospitalized

• Unable to identify a clinic where the participant would receive any needed post-hospitalization follow-up

• Diagnosis of pneumonia complicated by:

o Receiving a chest tube

• Diagnosis of urinary tract infection complicated by:

• History of neurogenic bladder or urologic surgery

• Renal imaging anticipated within 7 days of hospital discharge

• Renal abscess

• Diagnosis of skin and soft tissue infection complicated by:

• Chronic wound

• Postoperative infection

• Predisposition to poor wound healing

• Discharging with a drain in place

• Complicated by necrotizing fasciitis or toxic shock syndrome

• Diagnosis of gastroenteritis complicated by:

• Hemolytic uremic syndrome

Related Conditions & MeSH terms

• Communicable Diseases
• Gastroenteritis
• Infections
• Pneumonia
• Soft Tissue Infections
• Urinary Tract Infections

Intervention

Behavioral:
• As-needed follow up
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.
• Automatic follow-up
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.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center - Main Campus	Cincinnati	Ohio
United States	Texas Children's Main	Houston	Texas
United States	Texas Children's West	Houston	Texas
United States	Intermountain Primary Children's Hospital Larry H. and Gail Miller Family Campus	Lehi	Utah
United States	Cincinnati Children's Hospital Medical Center - Liberty Campus	Liberty Township	Ohio
United States	Packard at El Camino Hospital	Mountain View	California
United States	Lucile Packard Children's Hospital	Palo Alto	California
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Phoenix Children's Hospital	Phoenix	Arizona
United States	Penn Medicine Princeton Medical Center	Plainsboro	New Jersey
United States	Riverton Hospital	Riverton	Utah
United States	St. Louis Children's Hospital	Saint Louis	Missouri
United States	Primary Children's Hospital	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost burden	Mean total costs to parents (missed income and expenses) related to the participant's illness within 14 days of hospital discharge, measured by the cost burden survey.	Within 14 days of hospital discharge
Other	Child time	Mean number of hours of school or daycare missed by the participant within 14 days of hospital discharge as a result of their medical needs	Within 14 days of hospital discharge
Other	Parent time	Mean number of hours spent away from responsibilities (work or non-work related) by parents within 14 days of hospital discharge as a result of their child's medical needs	Within 14 days of hospital discharge
Other	Symptom duration	Proportion of participants who have completely recovered from their infection at 7 days after hospital discharge	Within 7 days of hospital discharge
Other	Total additional ambulatory visits	Mean number of ambulatory visits (in-person or via telehealth) that a participant attends, apart from the post-hospitalization follow-up visit, within 30 days of hospital discharge; Ambulatory visits include clinic, urgent care, and emergency department (not resulting in hospital admission) visits.	Within 30 days of hospital discharge
Other	Non-primary care ambulatory visits	Mean number of ambulatory visits (in-person or via telehealth) to non-primary care providers, within 30 days of hospital discharge; Non-primary care providers will include all providers outside of the clinic that families identify as their primary care clinic.	Within 30 days of hospital discharge
Other	Parent self-efficacy	Mean self-efficacy score 7 days after hospital discharge, measured by the PROMIS self-efficacy short form.	7 days after hospital discharge
Other	Parent anxiety	Mean anxiety score 7 days after hospital discharge, measured by the PROMIS anxiety short form.	7 days after hospital discharge
Other	Satisfaction with care	Proportion of participants who report agreeing or strongly agreeing with the statement, "I am satisfied with the medical care my child has received since hospital discharge," 7 days after hospital discharge	7 days after hospital discharge
Other	Telephone and electronic communications with medical providers	Mean number of telephone and electronic (excluding telehealth visits) communications with a medical provider within 14 days of hospital discharge	Within 14 days of hospital discharge
Other	Well-child visits	Proportion of participants who attend a well-child visit within Proportion of participants who attend a well-child visit within 6 months of hospital discharge	Within 6 months of hospital discharge
Other	Immunizations	Proportion of participants who receive an immunization within 6 months of hospital discharge	Within 6 months of hospital discharge
Other	Usual place of medical care	Proportion of participants who report having a usual place of medical care 6 months after hospital discharge	Within 6 months of hospital discharge
Other	Medical interventions related to the index infection	Proportion of participants who receive either a laboratory test, imaging test, or a new medication related to the index infection within 14 days of hospital discharge	Within 14 days of hospital discharge
Other	Medical errors	Proportion of parents who report that their child experienced a medical error within 14 days of hospital discharge, measured by the Family Safety Interview	Within 14 days of hospital discharge
Other	Hospital readmissions related to the index infection	Proportion of participants who experience a hospital readmission related to the index infection within 14 days of hospital discharge	Within 14 days of hospital discharge
Primary	Hospital readmission	The proportion of participants who experience a hospital readmission within 14 days of their index hospital discharge.	Within 14 days of hospital discharge
Secondary	Medical interventions	The proportion of participants who receive either a laboratory test, imaging test, or a new medication within 14 days of hospital discharge	Within 14 days of hospital discharge
Secondary	Child health-related quality of life	Mean health-related quality of life score 7 days after hospital discharge, measured by the Impact on Activities and Routines instrument.	7 days after hospital discharge