Automatic vs. As-Needed Follow-Up for Infections

(FAAN-C Trial)

Recruiting at 13 trial locations

Overseen By Sara T McCormick, MPA

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Chronic complex disease, Immunodeficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 14 days

2674 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best follow-up methods for children discharged from the hospital after common infections, such as pneumonia or urinary tract infections. It compares two approaches: one where parents decide if a follow-up is needed based on their child's symptoms (as-needed follow-up) and another where a follow-up is automatically scheduled (automatic follow-up). The goal is to determine which method aids better recovery. Children hospitalized for these infections, whose parents speak English or Spanish, may be suitable participants, provided they do not have other complex health issues. As an unphased trial, this study offers a unique opportunity to improve post-hospital care for children.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these follow-up methods are safe for children?

Research has shown that families can safely decide if their child needs a follow-up visit after hospitalization for common infections. Studies found that this approach does not increase the likelihood of the child returning to the hospital. Allowing families to choose when to have a follow-up visit proves effective and does not lead to more complications compared to automatically scheduling these visits. Overall, evidence supports that this flexible follow-up can safely care for children after they leave the hospital. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial exploring follow-up methods for infections because it aims to optimize post-hospital care. Unlike the traditional approach where everyone schedules a follow-up regardless of symptoms, this trial investigates whether as-needed follow-ups can be just as effective. This could empower patients to make informed decisions about their own care, potentially reducing unnecessary medical visits and resource use. The trial's focus on patient-driven follow-up represents a shift towards more personalized healthcare, which could improve patient satisfaction and outcomes.

What evidence suggests that this trial's follow-up methods could be effective for infections?

This trial will compare two follow-up strategies after hospitalization for infections: as-needed follow-up and automatic follow-up. Research has shown that allowing parents to decide when to follow up after their child is hospitalized for common infections can be effective and safe. Specifically, studies found that this approach results in 62% fewer follow-up visits while still easing parents' worries as effectively as automatic follow-ups. It enables families to monitor their child's symptoms and decide if a visit is necessary, offering more convenience and less stress. Conversely, automatic follow-up involves a scheduled check-up regardless of symptom changes, which some parents might find reassuring. Both methods have their advantages, with as-needed follow-up showing promise in reducing unnecessary visits. ^{1 3 4 6 7}

Who Is on the Research Team?

Eric Coon, MD

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

Children under 18 hospitalized for pneumonia, skin infections, gastroenteritis, or urinary tract infection can join. They must speak English or Spanish. Kids with chronic diseases, needing surgery beyond minor procedures, with immune issues, or scheduled follow-ups within a week of discharge cannot participate.

Inclusion Criteria

I was hospitalized for pneumonia, skin infection, stomach flu, or a UTI.

I am under 18 years old.

Exclusion Criteria

I have pneumonia and am receiving treatment with a chest tube.

I have a weakened immune system.

I have a long-term, complex health condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either automatic or as-needed (PRN) post-hospitalization follow-up recommendations

14 days

1 visit (in-person or virtual) as needed

Follow-up

Participants are monitored for hospital readmissions and other outcomes after discharge

6 months

Multiple visits (in-person or virtual) as needed

What Are the Treatments Tested in This Trial?

Interventions

• As-needed follow up
• Automatic follow-up

Trial Overview The trial is testing if automatic follow-up appointments after hospitalization are better than scheduling them only as needed for children recovering from common infections like pneumonia and UTIs.

How Is the Trial Designed?

Group I: As-needed (PRN) post-hospitalization follow-up Experimental Treatment 1 Intervention

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.

Group II: Automatic post-hospitalization follow-up Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

In a study of 226 pediatric surgery patients, only 13.27% required clinical intervention during routine postoperative follow-up, suggesting that not all patients need mandatory in-person visits after surgery.

Patients who underwent simpler procedures, like inguinal hernia repairs, had fewer complications and could benefit from telephonic follow-ups, while those with more complex surgeries, such as laparotomies, were more likely to need physical visits due to higher complication rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determining the Clinical Value of Routine Post Operative follow up in Common Paediatric Surgical Conditions: A Prospective Observational Study. Menon, R., Pathak, M., Nayak, S., et al.[2023]

Routine follow-up after primary breast cancer treatment is essential for early detection of recurrences or new cancers, primarily using methods like self-examination, physical exams, and mammography.

Intensive diagnostic evaluations, such as CT scans and MRIs, are no longer deemed cost-effective, leading to a shift towards more flexible, individualized follow-up care, including non-specialist models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Follow-up after primary treatment for breast cancer. Sakorafas, GH., Tsiotou, AG., Pavlakis, G.[2019]

In a study of 81 women with breast cancer recurrence, most recurrences were detected during non-routine visits rather than through planned follow-up examinations, suggesting that routine follow-up may not be effective for early detection.

The routine follow-up did not significantly impact survival rates, as 75% of recurrences were identified within three years post-operation, indicating that regular check-ups may not improve outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of routine follow-up after surgery for breast carcinoma. Brøyn, T., Frøyen, J.[2004]

In a study of 30,639 surgeries across 5 hospitals, automated surveillance models using electronic health records data accurately identified postoperative infections, achieving over 91% accuracy and high sensitivity and specificity.

The models, which used only 4 to 8 key variables, demonstrated that automated tracking of infections could replace manual chart reviews, potentially improving the monitoring of complications for all surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and validation of models for detection of postoperative infections using structured electronic health records data and machine learning. Colborn, KL., Zhuang, Y., Dyas, AR., et al.[2023]

Automated data from pharmacy and administrative claims can enhance the monitoring of surgical site infections in the U.S. population, improving both inpatient and postdischarge surveillance.

Using these data sources can lead to more accurate infection rate estimates and better adjustments for patients' existing health conditions, while also reducing the resources needed for surveillance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated methods for surveillance of surgical site infections. Platt, R., Yokoe, DS., Sands, KE.[2019]

The PRAISE network has developed a comprehensive roadmap for the large-scale implementation of automated surveillance (AS) systems to monitor healthcare-associated infections (HAI), addressing the need for uniform and useful data to improve quality of care.

This roadmap emphasizes the importance of stakeholder engagement, resource investment, and the redevelopment of surveillance methods to ensure effective AS systems are established across healthcare networks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PRAISE: providing a roadmap for automated infection surveillance in Europe. van Mourik, MSM., van Rooden, SM., Abbas, M., et al.[2021]

The manuscript outlines advanced statistical methods for actively monitoring the safety of medical products post-approval, using the FDA's Mini-Sentinel Pilot as a case study, which emphasizes the importance of ongoing safety evaluations.

Four distinct statistical approaches are detailed for analyzing safety outcomes, each with its own strengths and limitations, providing a framework for robust postmarket surveillance using existing electronic healthcare data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Statistical approaches to group sequential monitoring of postmarket safety surveillance data: current state of the art for use in the Mini-Sentinel pilot. Cook, AJ., Tiwari, RC., Wellman, RD., et al.[2022]

Post-marketing surveillance is crucial for identifying and mitigating risks associated with medications after they are on the market, as complete safety assessments cannot be done before approval.

Various methods exist for post-marketing surveillance, each with its pros and cons: spontaneous reporting is quick but often underreported, intensive monitoring provides high-quality data at a higher cost, and prospective studies yield informative results but require more time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The rationale for a post-marketing surveillance. Westerholm, B.[2022]

Modern curative treatments have led to a growing number of cancer patients remaining tumor-free after primary care, but many experience a decline in life expectancy and quality of life upon relapse, highlighting the need for effective follow-up strategies.

Follow-up protocols for cancer patients should be tailored based on tumor characteristics and recurrence patterns, and incorporating family doctors or nurses into routine care may alleviate specialist workload while maintaining patient care quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Literature review of evidence-based follow-up strategies of cancer patients Karádi, O., Mangel, LC.[2022]

Automated monitoring of hospital-acquired infections (HAIs) demonstrated high sensitivity, detecting 88% of general UTIs, 78% of HA-UTIs, and 100% of bloodstream infections (BSIs), indicating its effectiveness compared to traditional point-prevalence surveys.

Over a five-year period, the incidence rates for HA-UTIs ranged from 4.14 to 6.61 per 1000 bed-days, while HA-BSIs ranged from 0.09 to 1.25 per 1000 bed-days, suggesting that automated monitoring can provide consistent and objective data for infection tracking in hospitals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence rates of hospital-acquired urinary tract and bloodstream infections generated by automated compilation of electronically available healthcare data. Redder, JD., Leth, RA., Møller, JK.[2019]

A survey of 75 internal medicine house-staff physicians revealed that 74% sometimes struggle to follow up on outpatient test results, raising concerns about patient safety.

Significant barriers to timely follow-up were identified, including a lack of reminder systems (40%) and competing time demands (27%), with nearly half of the respondents noting that delays in follow-up have led to worsened patient conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Follow-up of outpatient test results: a survey of house-staff practices and perceptions. Lin, JJ., Dunn, A., Moore, C.[2015]

A follow-up education program for breast cancer patients at low-to-moderate risk effectively reduced overall patient anxiety and the number of routine hospital appointments after two years.

The program maintained high standards of care while providing patients with a supportive network, suggesting a more efficient use of healthcare resources for this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supportive care after breast cancer surgery. Allinson, VM., Dent, J.[2016]

Patients who attended their post-discharge follow-up appointments within the first week had a significantly lower risk of being readmitted within 30 days compared to those who had no follow-up scheduled, with adjusted hazard ratios of 0.57 for medical and 0.58 for surgical patients.

Missing follow-up appointments or not having any scheduled follow-up was associated with higher readmission rates, particularly highlighting the importance of timely post-discharge care in preventing readmissions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examination of Post-discharge Follow-up Appointment Status and 30-Day Readmission. Coppa, K., Kim, EJ., Oppenheim, MI., et al.[2022]

In a study of 83 racially diverse heart failure patients from a low-income area, the most desired follow-up intervention was having appointments close to home, with 77% of participants expressing this preference.

Reminder messages were also highly favored, with 73% of patients indicating they would find this helpful, highlighting the importance of accessible and supportive follow-up care for improving post-hospitalization outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Perceptions on Facilitating Follow-Up After Heart Failure Hospitalization. Breathett, K., D'Amico, R., Adesanya, TMA., et al.[2018]

A survey of women 2-4 years post-treatment for primary breast cancer revealed that they prioritized information on long-term treatment effects, cancer prevention, and changes in the untreated breast during follow-up visits.

Patients expressed a desire for more intensive follow-up, including additional tests, especially if they had received adjuvant therapies, highlighting the need for personalized follow-up care that addresses individual information needs and preferences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient's needs and preferences in routine follow-up after treatment for breast cancer. de Bock, GH., Bonnema, J., Zwaan, RE., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05471908

Study Details | NCT05471908 | Follow-up Automatically vs. ... OBJECTIVE: Compare the effectiveness of automatic vs as-needed (PRN) post-hospitalization follow-up for children who are hospitalized for common infections.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38840329/

A multicenter randomized trial to compare automatic versus ... Participants are randomized to an as-needed versus automatic posthospitalization follow-up recommendation. The sample size estimate is 2674 ...

3. shmpublications.onlinelibrary.wiley.com shmpublications.onlinelibrary.wiley.com/doi/abs/10.1002/jhm.13425

A multicenter randomized trial to compare automatic versus as ... As-needed follow-up has been shown to be safe and effective ... Comparison of as-needed and scheduled posthospitalization follow-up for children ...

4. jamanetwork.com jamanetwork.com/journals/jamapediatrics/fullarticle/2767791

Comparison of As-Needed and Scheduled ... An as-needed follow-up visit led to 62% fewer follow-up visits and was noninferior to a scheduled follow-up visit with respect to reducing parental anxiety.

5. clinicalfutures.research.chop.edu clinicalfutures.research.chop.edu/transforming-pediatric-care-through-nearly-7-million-award-i-decide-trial-family-centered

Research In Practice Blog - Clinical Futures I-DECIDE has the potential to increase the practice of as-needed post-hospitalization follow-up for children with bronchiolitis. As-needed follow-up in this ...

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/08/NCT05471908/Prot_001.pdf

The Follow-up Automatically vs. As-Needed Comparison ( ... In addition to the primary outcome of all-cause hospital readmission, an additional safety outcome will be hospital readmissions related to the index infection.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39329025

Ideal Postdischarge Follow-Up After Severe Pneumonia or ... Our findings suggest that at least seven core elements are common in follow-up care after severe pneumonia or acute respiratory failure.