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

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

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

Study Overview

• Status: Recruiting
• Conditions: Pneumonia; Gastroenteritis; Urinary Tract Infections; Soft Tissue Infections
• Intervention / Treatment: Behavioral: As-needed follow up; Behavioral: Automatic follow-up

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 2674
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eric Coon, MD, MS; Phone Number: 801-587-2160; Email: eric.coon@hsc.utah.edu
• Study Contact Backup: Name: Sara T McCormick, MPA; Phone Number: 801-209-0841; Email: sara.mccormick@hsc.utah.edu

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Recruiting
      • Phoenix Children's Hospital
      • Contact: Brittany Wold, MD
  • California
    • Mountain View, California, United States, 94040
      • Recruiting
      • Packard at El Camino Hospital
      • Contact: Lauren Destino, MD
    • Palo Alto, California, United States, 94304
      • Recruiting
      • Lucile Packard Children's Hospital
      • Contact: Alan Schroeder, MD
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • St. Louis Children's Hospital
      • Contact: Sarah Bram, MD
  • New Jersey
    • Plainsboro, New Jersey, United States, 08536
      • Recruiting
      • Penn Medicine Princeton Medical Center
      • Contact: Julianne Prasto, MD
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Recruiting
      • Cincinnati Children's Hospital Medical Center - Main Campus
      • Contact: Patrick Brady, MD
    • Liberty Township, Ohio, United States, 45044
      • Recruiting
      • Cincinnati Children's Hospital Medical Center - Liberty Campus
      • Contact: Patrick Brady, MD
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Children's Hospital of Philadelphia
      • Contact: Chris Bonafide, MD
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Texas Children's Main
      • Contact: Sowdhamini Wallace, MD; Email: sswallac@texaschildrens.org
    • Houston, Texas, United States, 77094
      • Recruiting
      • Texas Children's West
      • Contact: Katie Ban, MD
  • Utah
    • Lehi, Utah, United States, 84043
      • Recruiting
      • Intermountain Primary Children's Hospital Larry H. and Gail Miller Family Campus
      • Contact: Kristina McKinley, MD
    • Riverton, Utah, United States, 84065
      • Completed
      • Riverton Hospital
    • Salt Lake City, Utah, United States, 84113
      • Recruiting
      • Primary Children's Hospital
      • Contact: Eric Coon, MD, MS; Phone Number: 801-587-2160; Email: eric.coon@hsc.utah.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: As-needed (PRN) post-hospitalization 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.	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.; Other Names: PRN (pro re nata)
Active Comparator: Automatic post-hospitalization 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Symptom duration	Proportion of participants who have completely recovered from their infection at 7 days after hospital discharge	Within 7 days of hospital discharge
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
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
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
Parent anxiety	Mean anxiety score 7 days after hospital discharge, measured by the PROMIS anxiety short form.	7 days after hospital discharge
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
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
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
Immunizations	Proportion of participants who receive an immunization within 6 months of hospital discharge	Within 6 months of hospital discharge
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: Eric Coon, MD, University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2022
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 28, 2028

Study Registration Dates

• First Submitted: July 21, 2022
• First Submitted That Met QC Criteria: July 21, 2022
• First Posted (Actual): July 25, 2022

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: randomized control trial; follow-up care; post-hospitalization; patient centered care
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Urologic Diseases; Disease Attributes; Gastrointestinal Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections; Communicable Diseases; Urinary Tract Infections; Gastroenteritis; Soft Tissue Infections
• Other Study ID Numbers: IHS-2021C1-22388

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No