Automatic vs. As-Needed Follow-Up for Infections
(FAAN-C Trial)
Recruiting in Palo Alto (17 mi)
+12 other locations
Overseen byEric Coon, MD
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Utah
Disqualifiers: Chronic complex disease, Immunodeficiency, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Compare the effectiveness of automatic vs as-needed (PRN) post-hospitalization follow-up for children who are hospitalized for common infections.
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 data supports the effectiveness of the treatment As-needed follow-up for infections?
Research on routine follow-up after breast cancer surgery suggests that while routine follow-ups may not always be clinically beneficial, a more tailored approach, like as-needed follow-up, can reduce patient anxiety and unnecessary hospital visits, while maintaining care standards and providing effective support.
12345Is automatic or as-needed follow-up for infections generally safe for humans?
The research does not provide specific safety data for automatic or as-needed follow-up for infections, but it discusses the use of automated systems for infection surveillance, which can improve data accuracy and reduce resource use. This suggests that automated methods are considered safe and beneficial for monitoring infections.
678910How does the 'As-needed follow-up' treatment differ from other treatments for infections?
The 'As-needed follow-up' treatment is unique because it allows for follow-up care only when necessary, rather than scheduling routine visits for all patients. This approach can save time and resources by focusing on patients who actually need further care, unlike traditional methods that require all patients to return for follow-up regardless of their condition.
1112131415Eligibility Criteria
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.
I, as a parent, can communicate in English or Spanish.
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.
+9 more
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: As-needed (PRN) post-hospitalization follow-upExperimental Treatment1 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-upActive Control1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Lucile Packard Children's HospitalPalo Alto, CA
Phoenix Children's HospitalPhoenix, AZ
Primary Children's HospitalSalt Lake City, UT
St. Louis Children's HospitalSaint Louis, MO
More Trial Locations
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Who Is Running the Clinical Trial?
University of UtahLead Sponsor
Patient-Centered Outcomes Research InstituteCollaborator
References
Supportive care after breast cancer surgery. [2016]Routine follow-up after treatment for breast cancer aims to monitor for recurrence, manage late effects of treatment and give patients information, support and reassurance. However, most symptoms of local recurrence are first identified by patients so time spent following up women who are essentially well may not be clinically beneficial or cost effective. To better use its resources, Calderdale and Huddersfield Foundation Trust developed a follow-up education programme for patients at low-to-moderate risk; after two years an audit showed it reduced overall patient anxiety and routine hospital appointments, maintained standards of care and provided patient with an effective support network.
Examination of Post-discharge Follow-up Appointment Status and 30-Day Readmission. [2022]Post-hospital discharge follow-up appointments are intended to evaluate patients' recovery following a hospitalization, but it is unclear how appointment statuses are associated with readmissions.
Patient Perceptions on Facilitating Follow-Up After Heart Failure Hospitalization. [2018]Timely follow-up after hospitalization for heart failure (HF) is recommended. However, follow-up is suboptimal, especially in lower socioeconomic groups. Patient-centered solutions for facilitating follow-up post-HF hospitalization have not been extensively evaluated.
Patient's needs and preferences in routine follow-up after treatment for breast cancer. [2022]The purpose of the study was to analyse the needs of women who participated in a routine follow-up programme after treatment for primary breast cancer. A cross-sectional survey was conducted using a postal questionnaire among women without any sign of relapse during the routine follow-up period. The questionnaire was sent 2-4 years after primary surgical treatment. Most important to patients was information on long-term effects of treatment and prognosis, discussion of prevention of breast cancer and hereditary factors and changes in the untreated breast. Patients preferred additional investigations (such as X-ray and blood tests) to be part of routine follow-up visits. Less satisfaction with interpersonal aspects and higher scores on the Hospital Anxiety and Depression Scale (HADS) scale were related to stronger preferences for additional investigation. Receiving adjuvant hormonal or radiotherapy was related to a preference for a more intensive follow-up schedule. There were no significant differences between patients treated with mastectomy compared to treated with breast-conserving therapy. During routine follow-up after a diagnosis of breast cancer, not all patients needed all types of information. When introducing alternative follow-up schedules, individual patients' information needs and preferences should be identified early and incorporated into the follow-up routine care, to target resources and maximise the likelihood that positive patient outcomes will result.
Evaluation of routine follow-up after surgery for breast carcinoma. [2004]Evaluation of routine follow-up after radical operation for breast carcinoma was focused on 81 women with recurrence. They were grouped according to whether the recurrence was detected at planned control examination (routine group), at examination between planned control dates (non-routine group) or in patients without routine control (non-follow-up group). Most of the recurrences were diagnosed at non-routine visits. The disease-free interval showed no significant difference between these three groups. The routine follow-up seemed to have no effect on survival. The interval from operation to detection of recurrence was less than three years in 75% of the cases. The average number of routine hospital visits preceding a diagnosis of recurrence was 118. Cancer of the second breast was found in four patients. The routine follow-up programme thus did not seem to favour early detection of recurrence or to prolong survival. The influence of regular follow-up on the quality of life is discussed.
PRAISE: providing a roadmap for automated infection surveillance in Europe. [2021]Healthcare-associated infections (HAI) are among the most common adverse events of medical care. Surveillance of HAI is a key component of successful infection prevention programmes. Conventional surveillance - manual chart review - is resource intensive and limited by concerns regarding interrater reliability. This has led to the development and use of automated surveillance (AS). Many AS systems are the product of in-house development efforts and heterogeneous in their design and methods. With this roadmap, the PRAISE network aims to provide guidance on how to move AS from the research setting to large-scale implementation, and how to ensure the delivery of surveillance data that are uniform and useful for improvement of quality of care.
Incidence rates of hospital-acquired urinary tract and bloodstream infections generated by automated compilation of electronically available healthcare data. [2019]Monitoring of hospital-acquired infection (HAI) by automated compilation of registry data may address the disadvantages of laborious, costly and potentially subjective and often random sampling of data by manual surveillance.
Statistical approaches to group sequential monitoring of postmarket safety surveillance data: current state of the art for use in the Mini-Sentinel pilot. [2022]This manuscript describes the current statistical methodology available for active postmarket surveillance of pre-specified safety outcomes using a prospective incident user concurrent control cohort design with existing electronic healthcare data.
The rationale for a post-marketing surveillance. [2022]Post-marketing surveillance is essential in order to protect patients against avoidable risks from medication. Complete assessment of a drug cannot, for practical reasons, be made before marketing. There are several methods which can be used in post-marketing surveillance. Spontaneous reporting on adverse drug reactions is a quick method, but underreporting is a problem. Intensive monitoring gives high quality data but is expensive. Health registers can be used to trace cases for case-control studies but diagnoses are sometimes incorrect. Prospective studies is an informative way to obtain results but they take time. Data on drug utilization are also valuable because they give an estimate of the size of the population using a particular drug. They also reveal whether warnings about adverse drug reactions have had any effect on the prescribing pattern.
Automated methods for surveillance of surgical site infections. [2019]Automated data, especially from pharmacy and administrative claims, are available for much of the U.S. population and might substantially improve both inpatient and postdischarge surveillance for surgical site infections complicating selected procedures, while reducing the resources required. Potential improvements include better sensitivity, less susceptibility to interobserver variation, more uniform availability of data, more precise estimates of infection rates, and better adjustment for patients' coexisting illness.
Development and validation of models for detection of postoperative infections using structured electronic health records data and machine learning. [2023]Postoperative infections constitute more than half of all postoperative complications. Surveillance of these complications is primarily done through manual chart review, which is time consuming, expensive, and typically only covers 10% to 15% of all operations. Automated surveillance would permit the timely evaluation of and reporting of all operations.
Literature review of evidence-based follow-up strategies of cancer patients [2022]An increasing proportion of cancer patients remains permanently tumorfree after primary care due to modern curative treatments. However, the life expectancy and quality of life deteriorate significantly in most relapsed cases in spite of different palliative therapies. To detect the early relapse in asymptomatic stage, patients undergo a preplanned care process, targeting primarily their improved survival. Several studies and reviews have been conducted in recent decades to determine the optimal and rational frequency and methods of control examinations. The data of different followup strategies were analyzed from several perspectives. Recommended followup protocols differ significantly based on the origin, histological characteristics, stage, prognostic factors and typical sites of recurrences, such as local, “oligometastatic” or systemic relapse of tumors. In addition to the detection of recurrence, the importance of qual ity of life, monitoring of psychological status and psychosomatic complaints as well as the costeffectiveness of protocols also came to the focus. Involving family doctors or qualified nurses in routine oncology followup may function as an alternative option to reducing the workload of specialists. The COVID–19 pandemic resulted in the use of telemedicine methods in the evaluation of examinations and followup strategies coming to the fore, while at the same time this made the reevaluation of control care algorithms even more important. In this paper, we review the results of studies comparing the different followup strategies, highlighting which protocols help to optimize the use of health care capacity while preserving the survival chance of cancer patients in relapse.
Determining the Clinical Value of Routine Post Operative follow up in Common Paediatric Surgical Conditions: A Prospective Observational Study. [2023]The traditional postoperative visit consists of an in-person hospital visit at a predetermined date which requires the investment of time and resources. This implies a need to prioritize visits rather than mandating them, which can be assessed by the requirement of clinical intervention at the time of follow-up. The purpose of this study is to determine the clinical value of routine postoperative physical follow-up in common pediatric surgery conditions, to identify factors determining follow-up, and to estimate the cost of routine follow-up.
Follow-up after primary treatment for breast cancer. [2019]Follow-up after primary treatment for breast cancer is a routine practice aiming at early detection and management of local recurrences and/or distant metastases of the disease or of new primaries. Breast self-examination and periodic physical examination, mammography, and pelvic examination are the most important methods in following-up these patients. The, at one time, more popular intensive routine diagnostic evaluation (including head, chest, abdominal, and pelvic computerized tomography and/or magnetic resonance imaging, liver ultrasonography, bone scans, tumor markers, etc.) is not currently considered appropriate and cost-effective. However, flexibility, based on clinical judgement, is required on the part of medical staff involved in the follow-up in order appropriately to adapt the general guidelines and meet the specific needs of the individual patients. Non-specialist or non-physician models of follow-up care have been proposed as interesting and cost-effective alternatives in the follow-up of breast cancer patients.
Follow-up of outpatient test results: a survey of house-staff practices and perceptions. [2015]Failure to follow up outpatient test results is a potential patient safety concern; however, data about how house-staff physicians follow up on tests are sparse. The authors sought to assess internal medicine house-staff practices and perceptions regarding the follow-up of outpatient tests and identified barriers to timely follow-up. Seventy-five of 111 eligible house staff at a large urban teaching hospital (68%) completed the survey. Seventy-four percent reported they were sometimes unable to follow up on test results, 78% were at least somewhat worried about inadequate follow-up, and 46% stated that they have seen a patient's medical condition worsen due to a delay in test result follow-up at least a few times a year. Barriers to timely follow-up included lack of a reminder system (40%), difficulty accessing results (24%), too many competing demands on time (27%), and uncertainty about who should follow up on results (16%).