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

Primary Purpose

Pneumonia, Urinary Tract Infections, Soft Tissue Infections

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
As-needed follow up
Automatic follow-up
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pneumonia focused on measuring post-hospitalization, follow-up care, patient centered care, randomized control trial

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Phoenix Children's HospitalRecruiting
  • Packard at El Camino HospitalRecruiting
  • Lucile Packard Children's HospitalRecruiting
  • St. Louis Children's HospitalRecruiting
  • Penn Medicine Princeton Medical CenterRecruiting
  • Cincinnati Children's Hospital Medical Center - Main CampusRecruiting
  • Cincinnati Children's Hospital Medical Center - Liberty CampusRecruiting
  • Children's Hospital of PhiladelphiaRecruiting
  • Texas Children's MainRecruiting
  • Texas Children's WestRecruiting
  • Riverton HospitalRecruiting
  • Primary Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

As-needed (PRN) post-hospitalization follow-up

Automatic post-hospitalization follow-up

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Hospital readmission
The proportion of participants who experience a hospital readmission within 14 days of their index hospital discharge.

Secondary Outcome Measures

Medical interventions
The proportion of participants who receive either a laboratory test, imaging test, or a new medication 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.

Full Information

First Posted
July 21, 2022
Last Updated
August 9, 2023
Sponsor
University of Utah
Collaborators
Patient-Centered Outcomes Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05471908
Brief Title
Follow-up Automatically vs. As-Needed Comparison (FAAN-C) Trial
Acronym
FAAN-C
Official Title
The Follow-up Automatically vs. As-Needed Comparison Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 22, 2022 (Actual)
Primary Completion Date
February 2027 (Anticipated)
Study Completion Date
February 28, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
Collaborators
Patient-Centered Outcomes Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Urinary Tract Infections, Soft Tissue Infections, Gastroenteritis
Keywords
post-hospitalization, follow-up care, patient centered care, randomized control trial

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Owing to the nature of the comparators, blinding of participants and their medical providers is not possible. However, outcomes that require adjudication will be adjudicated by persons blinded to the subject's randomized group. Outcomes requiring adjudication in FAAN-C are the safety outcomes (hospital readmissions related to the index infection and medical errors). Specifically, a clinician will determine if the readmission was related to the index infection and a separate clinician will score parent-reported medical errors in terms of severity (as described in the Safety Reporting section of the protocol). The clinicians performing adjudication of these outcomes will be blinded to the subject's randomized group.
Allocation
Randomized
Enrollment
2674 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
As-needed (PRN) post-hospitalization follow-up
Arm Type
Experimental
Arm Description
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.
Arm Title
Automatic post-hospitalization follow-up
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
As-needed follow up
Other Intervention Name(s)
PRN (pro re nata)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Automatic follow-up
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hospital readmission
Description
The proportion of participants who experience a hospital readmission within 14 days of their index hospital discharge.
Time Frame
Within 14 days of hospital discharge
Secondary Outcome Measure Information:
Title
Medical interventions
Description
The proportion of participants who receive either a laboratory test, imaging test, or a new medication within 14 days of hospital discharge
Time Frame
Within 14 days of hospital discharge
Title
Child health-related quality of life
Description
Mean health-related quality of life score 7 days after hospital discharge, measured by the Impact on Activities and Routines instrument.
Time Frame
7 days after hospital discharge
Other Pre-specified Outcome Measures:
Title
Cost burden
Description
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.
Time Frame
Within 14 days of hospital discharge
Title
Child time
Description
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
Time Frame
Within 14 days of hospital discharge
Title
Parent time
Description
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
Time Frame
Within 14 days of hospital discharge
Title
Symptom duration
Description
Proportion of participants who have completely recovered from their infection at 7 days after hospital discharge
Time Frame
Within 7 days of hospital discharge
Title
Total additional ambulatory visits
Description
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.
Time Frame
Within 30 days of hospital discharge
Title
Non-primary care ambulatory visits
Description
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.
Time Frame
Within 30 days of hospital discharge
Title
Parent self-efficacy
Description
Mean self-efficacy score 7 days after hospital discharge, measured by the PROMIS self-efficacy short form.
Time Frame
7 days after hospital discharge
Title
Parent anxiety
Description
Mean anxiety score 7 days after hospital discharge, measured by the PROMIS anxiety short form.
Time Frame
7 days after hospital discharge
Title
Satisfaction with care
Description
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
Time Frame
7 days after hospital discharge
Title
Telephone and electronic communications with medical providers
Description
Mean number of telephone and electronic (excluding telehealth visits) communications with a medical provider within 14 days of hospital discharge
Time Frame
Within 14 days of hospital discharge
Title
Well-child visits
Description
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
Time Frame
Within 6 months of hospital discharge
Title
Immunizations
Description
Proportion of participants who receive an immunization within 6 months of hospital discharge
Time Frame
Within 6 months of hospital discharge
Title
Usual place of medical care
Description
Proportion of participants who report having a usual place of medical care 6 months after hospital discharge
Time Frame
Within 6 months of hospital discharge
Title
Medical interventions related to the index infection
Description
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
Time Frame
Within 14 days of hospital discharge
Title
Medical errors
Description
Proportion of parents who report that their child experienced a medical error within 14 days of hospital discharge, measured by the Family Safety Interview
Time Frame
Within 14 days of hospital discharge
Title
Hospital readmissions related to the index infection
Description
Proportion of participants who experience a hospital readmission related to the index infection within 14 days of hospital discharge
Time Frame
Within 14 days of hospital discharge

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Coon, MD, MS
Phone
801-587-2160
Email
Eric.Coon@hsc.utah.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sara T McCormick, MPA
Phone
801-209-0841
Email
sara.mccormick@hsc.utah.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Coon, MD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brittany Wold, MD
Facility Name
Packard at El Camino Hospital
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Destino, MD
Facility Name
Lucile Packard Children's Hospital
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alan Schroeder, MD
Facility Name
St. Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Bram, MD
Facility Name
Penn Medicine Princeton Medical Center
City
Plainsboro
State/Province
New Jersey
ZIP/Postal Code
08536
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julianne Prasto, MD
Facility Name
Cincinnati Children's Hospital Medical Center - Main Campus
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Brady, MD
Facility Name
Cincinnati Children's Hospital Medical Center - Liberty Campus
City
Liberty Township
State/Province
Ohio
ZIP/Postal Code
45044
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Brady, MD
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chris Bonafide, MD
Facility Name
Texas Children's Main
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sowdhamini Wallace, MD
Email
sswallac@texaschildrens.org
Facility Name
Texas Children's West
City
Houston
State/Province
Texas
ZIP/Postal Code
77094
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katie Ban, MD
Facility Name
Riverton Hospital
City
Riverton
State/Province
Utah
ZIP/Postal Code
84065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristina McKinley, MD
Facility Name
Primary Children's Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Coon, MD, MS
Phone
801-587-2160
Email
eric.coon@hsc.utah.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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