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

Sponsor

University of Utah (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05471908

Collaborator

Patient-Centered Outcomes Research Institute (Other)

2,674

Enrollment

Locations

Arms

65.4

Anticipated Duration (Months)

267.4

Patients Per Site

4.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pneumonia Urinary Tract Infections Soft Tissue Infections Gastroenteritis	Behavioral: As-needed follow up Behavioral: Automatic follow-up	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

2674 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (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.

Primary Purpose:

Health Services Research

Official Title:

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

Anticipated Study Start Date :

Sep 15, 2022

Anticipated Primary Completion Date :

Feb 1, 2027

Anticipated Study Completion Date :

Feb 28, 2028

Arms and Interventions

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.

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Medical interventions [Within 14 days of hospital discharge]
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 [7 days after hospital discharge]
Mean health-related quality of life score 7 days after hospital discharge, measured by the Impact on Activities and Routines instrument.

Other Outcome Measures

Cost burden [Within 14 days of hospital discharge]
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.
Child time [Within 14 days of hospital discharge]
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
Parent time [Within 14 days of hospital discharge]
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
Symptom duration [Within 7 days of hospital discharge]
Proportion of participants who have completely recovered from their infection at 7 days after hospital discharge
Total additional ambulatory visits [Within 30 days of hospital discharge]
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.
Non-primary care ambulatory visits [Within 30 days of hospital discharge]
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.
Parent self-efficacy [7 days after hospital discharge]
Mean self-efficacy score 7 days after hospital discharge, measured by the PROMIS self-efficacy short form.
Parent anxiety [7 days after hospital discharge]
Mean anxiety score 7 days after hospital discharge, measured by the PROMIS anxiety short form.
Satisfaction with care [7 days after hospital discharge]
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
Telephone and electronic communications with medical providers [Within 14 days of hospital discharge]
Mean number of telephone and electronic (excluding telehealth visits) communications with a medical provider within 14 days of hospital discharge
Well-child visits [Within 6 months of hospital discharge]
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
Immunizations [Within 6 months of hospital discharge]
Proportion of participants who receive an immunization within 6 months of hospital discharge
Usual place of medical care [Within 6 months of hospital discharge]
Proportion of participants who report having a usual place of medical care 6 months after hospital discharge
Medical interventions related to the index infection [Within 14 days of hospital discharge]
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
Medical errors [Within 14 days of hospital discharge]
Proportion of parents who report that their child experienced a medical error within 14 days of hospital discharge, measured by the Family Safety Interview
Hospital readmissions related to the index infection [Within 14 days of hospital discharge]
Proportion of participants who experience a hospital readmission related to the index infection within 14 days of hospital discharge

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 18 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Packard at El Camino Hospital	Mountain View	California	United States	94040
2	Lucile Packard Children's Hospital	Palo Alto	California	United States	94304
3	Penn Medicine Princeton Medical Center	Plainsboro	New Jersey	United States	08536
4	Cincinnati Children's Hospital Medical Center - Main Campus	Cincinnati	Ohio	United States	45229
5	Cincinnati Children's Hospital Medical Center - Liberty Campus	Liberty Township	Ohio	United States	45044
6	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104
7	Texas Children's Main	Houston	Texas	United States	77030
8	Texas Children's West	Houston	Texas	United States	77094
9	Riverton Hospital	Riverton	Utah	United States	84065
10	Primary Children's Hospital	Salt Lake City	Utah	United States	84113