PneumoniaFAAN-CNCT05471908
Follow-up Automatically vs. As-Needed Comparison (FAAN-C) Trial
A study testing As-needed follow up and Automatic follow-up in people with Pneumonia and Urinary Tract Infections, run by University of Utah at 14 sites in United States.
Trial summary
Compare the effectiveness of automatic vs as-needed (PRN) post-hospitalization follow-up for children who are hospitalized for common infections. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Pneumonia, Urinary Tract Infections, Soft Tissue Infections
- What is being tested?
- As-needed follow up and Automatic follow-up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,674 participants
- Where
- 14 sitesUnited States
- Study dates
- 22 Aug 2022to 28 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Liz Rodriquez contact
14 sites in 1 country
United States14 sites, 13 recruiting
- Recruiting
Cincinnati Children's Hospital Medical Center - Main Campus
Cincinnati, Ohio, 45229
Patrick Brady, MD
- Recruiting
Texas Children's Main
Houston, Texas, 77030
Sowdhamini Wallace, MD
- Recruiting
Texas Children's West
Houston, Texas, 77094
Katie Ban, MD
- Recruiting
Intermountain Primary Children's Hospital Larry H. and Gail Miller Family Campus
Lehi, Utah, 84043
Kristina McKinley, MD
- Recruiting
Cincinnati Children's Hospital Medical Center - Liberty Campus
Liberty Township, Ohio, 45044
Patrick Brady, MD
- Recruiting
Packard at El Camino Hospital
Mountain View, California, 94040
Lauren Destino, MD
- Recruiting
Lucile Packard Children's Hospital
Palo Alto, California, 94304
Alan Schroeder, MD
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Chris Bonafide, MD
- Recruiting
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Brittany Wold, MD
- Recruiting
Penn Medicine Princeton Medical Center
Plainsboro, New Jersey, 08536
Julianne Prasto, MD
- Completed
Riverton Hospital
Riverton, Utah, 84065
- Recruiting
Primary Children's Hospital
Salt Lake City, Utah, 84113
Kristina McKinley
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Eric Coon, MD, MS
- Recruiting
St. Louis Children's Hospital
St Louis, Missouri, 63110
Sarah Bram, MD
About this study
Official title: 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.
Read the 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.
- Being tested
- As-needed follow up, Automatic follow-up
- Keywords
- post-hospitalization, follow-up care, patient centered care, randomized control trial
- Medical subject headings
- Pneumonia, Urinary Tract Infections, Soft Tissue Infections, Gastroenteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
As-needed follow upBehavioural
Also called PRN (pro re nata)
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-upBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| As-needed (PRN) post-hospitalization follow-up | Experimental | 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. Receives: Behavioral: As-needed follow up |
| Automatic post-hospitalization follow-up | Active comparator | 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. Receives: Behavioral: Automatic follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital readmission
The proportion of participants who experience a hospital readmission within 14 days of their index hospital discharge.
Measured: Within 14 days of hospital discharge
Secondary outcomes (2)
Medical interventions
The proportion of participants who receive either a laboratory test, imaging test, or a new medication within 14 days of hospital discharge
Measured: 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.
Measured: 7 days after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start22 Aug 2022
- Primary completionFeb 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,674 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Eric Coon, Seattle Children's Hospital
- Investigators
- Eric Coon, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05471908
- Sponsor's protocol ID
- IHS-2021C1-22388
- Acronym
- FAAN-C
- Status last verified
- Dec 2025
- First submitted
- 21 Jul 2022
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Follow-up Automatically vs. As-Needed Comparison Trial
- ClinicalTrials.gov ID
- NCT05471908
- Acronym / sponsor ID
- FAAN-C / IHS-2021C1-22388
- Keywords
- post-hospitalization, follow-up care, patient centered care, randomized control trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,674 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 25 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| As-needed (PRN) post-hospitalization follow-up | Experimental | Behavioral: As-needed follow upAt 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 post-hospitalization follow-up | Active comparator | Behavioral: Automatic follow-upAt 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. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| As-needed follow upAlso: PRN (pro re nata)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. | Behavioural | As-needed (PRN) post-hospitalization follow-up |
| Automatic follow-upAt 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. | Behavioural | Automatic post-hospitalization follow-up |
Primary outcome
Hospital readmission
Time frame: Within 14 days of hospital discharge
The proportion of participants who experience a hospital readmission within 14 days of their index hospital discharge.
2 secondary outcomes
Medical interventions
Time frame: Within 14 days of hospital discharge
Child health-related quality of life
Time frame: 7 days after hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Liz Rodriquez contact
Eric Coon, MD principal investigator
University of Utah
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing As-needed follow up and Automatic follow-up in people with Pneumonia and Urinary Tract Infections, run by University of Utah at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eric Coon, MD, MS (801-587-2160, Eric.Coon@hsc.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital readmission (time frame: Within 14 days of hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.