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| Name | Class |
|---|---|
| Stanford University | OTHER |
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This study evaluates the value of routine follow-up with a child's pediatrician after hospitalization for bronchiolitis. Parents of half of participants will be instructed to follow-up with the child's pediatrician regardless of symptom resolution, while the other half will be instructed to follow-up on an as-needed basis (only if the child worsens, doesn't improve, or other concerns develop).
Bronchiolitis is highly prevalent and burdensome among children less than 2 years of age. For this reason, many therapies have been tried by providers and studied by researchers. Unfortunately, interventions have largely been shown to be ineffective, prompting campaigns to reduce use of ineffective therapies. One commonly prescribed but thus far unstudied intervention often provided to children discharged after hospitalization for bronchiolitis is routine follow up with their pediatrician. Whether the costs and time spent for these visits are worthwhile depends on the extent to which the child and the child's parents benefit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Scheduled PCP follow-up | Active Comparator | Parents of children randomized to scheduled follow up will be instructed to follow up with their primary care physician (PCP) within 4 days of discharge regardless of improvement and/or symptom resolution. Research coordinators will verify that the child has a scheduled follow up appointment prior to discharge. |
|
| As needed PCP follow-up | Experimental | At the time of hospital discharge, parents will be instructed that the child does not need to automatically follow up with his/her primary care physician (PCP). Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scheduled PCP follow-up | Behavioral | Parents of children randomized to scheduled follow up will be instructed to follow up with their primary care physician within 4 days of discharge regardless of improvement and/or symptom resolution. Research coordinators will verify that the child has a scheduled follow up appointment prior to discharge. |
| Measure | Description | Time Frame |
|---|---|---|
| Parental Anxiety | Parental anxiety, as measured by the anxiety portion of the Hospital Anxiety and Depression Scale (HADS), a 0-28 point scale, with higher values representing higher anxiety. | Measured at the first data collection phone call (5-9 days following discharge). |
| Measure | Description | Time Frame |
|---|---|---|
| Time From Hospital Discharge to Cough Resolution | Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first. | |
| Time From Hospital Discharge to Child Reported Back to Normal |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Coon, MD, MS | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Packard El Camino Hospital | Mountain View | California | 94040 | United States | ||
| Lucile Packard Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 6880820 | Background | Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x. | |
| 22084265 | Background | Ridd MJ, Lewis G, Peters TJ, Salisbury C. Patient-doctor depth-of-relationship scale: development and validation. Ann Fam Med. 2011 Nov-Dec;9(6):538-45. doi: 10.1370/afm.1322. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Scheduled PCP Follow-up | Parents of children randomized to scheduled follow up will be instructed to follow up with their primary care physician (PCP) within 4 days of discharge regardless of improvement and/or symptom resolution. Research coordinators will verify that the child has a scheduled follow up appointment prior to discharge. Scheduled PCP follow-up: Parents of children randomized to scheduled follow up will be instructed to follow up with their primary care physician within 4 days of discharge regardless of improvement and/or symptom resolution. Research coordinators will verify that the child has a scheduled follow up appointment prior to discharge. |
| FG001 | As Needed PCP Follow-up | At the time of hospital discharge, parents will be instructed that the child does not need to automatically follow up with his/her primary care physician (PCP). Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise. As needed PCP follow-up: At the time of hospital discharge, parents will be instructed that the child does not need to automatically follow up with his/her primary care physician. Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Scheduled PCP Follow-up | Parents of children randomized to scheduled follow up will be instructed to follow up with their primary care physician (PCP) within 4 days of discharge regardless of improvement and/or symptom resolution. Research coordinators will verify that the child has a scheduled follow up appointment prior to discharge. Scheduled PCP follow-up: Parents of children randomized to scheduled follow up will be instructed to follow up with their primary care physician within 4 days of discharge regardless of improvement and/or symptom resolution. Research coordinators will verify that the child has a scheduled follow up appointment prior to discharge. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Parental Anxiety | Parental anxiety, as measured by the anxiety portion of the Hospital Anxiety and Depression Scale (HADS), a 0-28 point scale, with higher values representing higher anxiety. | Posted | Mean | Standard Deviation | points on a scale | Measured at the first data collection phone call (5-9 days following discharge). |
|
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Scheduled PCP Follow-up | Parents of children randomized to scheduled follow up will be instructed to follow up with their primary care physician (PCP) within 4 days of discharge regardless of improvement and/or symptom resolution. Research coordinators will verify that the child has a scheduled follow up appointment prior to discharge. Scheduled PCP follow-up: Parents of children randomized to scheduled follow up will be instructed to follow up with their primary care physician within 4 days of discharge regardless of improvement and/or symptom resolution. Research coordinators will verify that the child has a scheduled follow up appointment prior to discharge. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric Coon | University of Utah | 801-662-3645 | Eric.Coon@hsc.utah.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 1, 2017 | Nov 15, 2017 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001988 | Bronchiolitis |
| ID | Term |
|---|---|
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
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|
| As needed PCP follow-up | Behavioral | At the time of hospital discharge, parents will be instructed that the child does not need to automatically follow up with his/her primary care physician. Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise. |
|
| Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first. |
| Number of Clinic Visits Prior to Symptom Resolution | Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first. |
| Any Hospital Re-admission Prior to Symptom Resolution | Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first. |
| Any ED Visit Prior to Symptom Resolution | Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first. |
| Number of Missed Work Days | Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first. |
| Missed Daycare | Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first. |
| Ambulatory Prescriptions (Albuterol, Antibiotics, Steroids) | Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first. |
| Ambulatory Testing (i.e. Pulse Oximetry, Chest X-ray) | Measured by parent report, at the first data collection phone call (5-9 days following discharge). |
| Relationship With PCP | Measured by the Patient-Doctor Depth-of-Relationship Scale, 0-32 points, with higher scores indicating a stronger relationship with PCP. | Measured by parent report via research coordinator phone call at 1 month from discharge. |
| Report That Care Was Perfect 1 Month After Discharge | Measured by a question from the Patient Satisfaction Questionnaire Short Form (PSQ-18), those who indicate agree or strongly agree | Measured by parent report via research coordinator phone call at 1 month from discharge. |
| Immunizations Received 1 Month After Discharge | Measured by parent report via research coordinator phone call at 1 month from discharge. |
| Palo Alto |
| California |
| 94304 |
| United States |
| Intermountain Riverton Hospital | Riverton | Utah | 84065 | United States |
| Primary Children's Hospital | Salt Lake City | Utah | 84113 | United States |
| 23883565 | Background | Thayaparan AJ, Mahdi E. The Patient Satisfaction Questionnaire Short Form (PSQ-18) as an adaptable, reliable, and validated tool for use in various settings. Med Educ Online. 2013 Jul 23;18:21747. doi: 10.3402/meo.v18i0.21747. No abstract available. |
| 37051799 | Derived | Willer RJ, Brady PW, Tyler AN, Treasure JD, Coon ER. The Current State of High-Flow Nasal Cannula Protocols at Children's Hospitals. Hosp Pediatr. 2023 May 1;13(5):e109-e113. doi: 10.1542/hpeds.2022-006969. |
| 35043194 | Derived | Coon ER, Schroeder AR, Lion KC, Ray KN. Disparities by Ethnicity in Enrollment of a Clinical Trial. Pediatrics. 2022 Feb 1;149(2):e2021052595. doi: 10.1542/peds.2021-052595. No abstract available. |
| 34928316 | Derived | Coon ER, Hester G, Ralston SL. Why Are So Many Children With Bronchiolitis Going to the Intensive Care Unit? JAMA Pediatr. 2022 Mar 1;176(3):231-233. doi: 10.1001/jamapediatrics.2021.5186. No abstract available. |
| 34234010 | Derived | Willer RJ, Johnson MD, Cipriano FA, Stone BL, Nkoy FL, Chaulk DC, Knochel ML, Kawai CK, Neiswender KL, Coon ER. Implementation of a Weight-Based High-Flow Nasal Cannula Protocol for Children With Bronchiolitis. Hosp Pediatr. 2021 Aug;11(8):891-895. doi: 10.1542/hpeds.2021-005814. Epub 2021 Jul 7. |
| 32675334 | Derived | Chi KW, Coon ER, Destino L, Schroeder AR. Parental Perspectives on Continuous Pulse Oximetry Use in Bronchiolitis Hospitalizations. Pediatrics. 2020 Aug;146(2):e20200130. doi: 10.1542/peds.2020-0130. Epub 2020 Jul 16. |
| 32628250 | Derived | Coon ER, Destino LA, Greene TH, Vukin E, Stoddard G, Schroeder AR. Comparison of As-Needed and Scheduled Posthospitalization Follow-up for Children Hospitalized for Bronchiolitis: The Bronchiolitis Follow-up Intervention Trial (BeneFIT) Randomized Clinical Trial. JAMA Pediatr. 2020 Sep 1;174(9):e201937. doi: 10.1001/jamapediatrics.2020.1937. Epub 2020 Sep 8. |
| BG001 | As Needed PCP Follow-up | At the time of hospital discharge, parents will be instructed that the child does not need to automatically follow up with his/her primary care physician (PCP). Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise. As needed PCP follow-up: At the time of hospital discharge, parents will be instructed that the child does not need to automatically follow up with his/her primary care physician. Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | As Needed PCP Follow-up | At the time of hospital discharge, parents will be instructed that the child does not need to automatically follow up with his/her primary care physician (PCP). Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise. As needed PCP follow-up: At the time of hospital discharge, parents will be instructed that the child does not need to automatically follow up with his/her primary care physician. Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise. |
|
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| Secondary | Time From Hospital Discharge to Cough Resolution | Posted | Mean | Standard Deviation | days | Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first. |
|
|
|
| Secondary | Time From Hospital Discharge to Child Reported Back to Normal | Posted | Mean | Standard Deviation | days | Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first. |
|
|
|
| Secondary | Number of Clinic Visits Prior to Symptom Resolution | Posted | Mean | Standard Deviation | visits | Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first. |
|
|
|
| Secondary | Any Hospital Re-admission Prior to Symptom Resolution | Posted | Mean | Standard Deviation | percent | Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first. |
|
|
|
| Secondary | Any ED Visit Prior to Symptom Resolution | Posted | Mean | Standard Deviation | percent | Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first. |
|
|
|
| Secondary | Number of Missed Work Days | Posted | Mean | Standard Deviation | days | Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first. |
|
|
|
| Secondary | Missed Daycare | Posted | Mean | Standard Deviation | days | Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first. |
|
|
|
| Secondary | Ambulatory Prescriptions (Albuterol, Antibiotics, Steroids) | Posted | Mean | Standard Deviation | percent | Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first. |
|
|
|
| Secondary | Ambulatory Testing (i.e. Pulse Oximetry, Chest X-ray) | Posted | Mean | Standard Deviation | percent | Measured by parent report, at the first data collection phone call (5-9 days following discharge). |
|
|
|
| Secondary | Relationship With PCP | Measured by the Patient-Doctor Depth-of-Relationship Scale, 0-32 points, with higher scores indicating a stronger relationship with PCP. | Posted | Mean | Standard Deviation | points on a scale | Measured by parent report via research coordinator phone call at 1 month from discharge. |
|
|
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| Secondary | Report That Care Was Perfect 1 Month After Discharge | Measured by a question from the Patient Satisfaction Questionnaire Short Form (PSQ-18), those who indicate agree or strongly agree | Posted | Mean | Standard Deviation | percent | Measured by parent report via research coordinator phone call at 1 month from discharge. |
|
|
|
| Secondary | Immunizations Received 1 Month After Discharge | Posted | Mean | Standard Deviation | percent | Measured by parent report via research coordinator phone call at 1 month from discharge. |
|
|
|
| 0 |
| 151 |
| 0 |
| 151 |
| 0 |
| 151 |
| EG001 | As Needed PCP Follow-up | At the time of hospital discharge, parents will be instructed that the child does not need to automatically follow up with his/her primary care physician (PCP). Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise. As needed PCP follow-up: At the time of hospital discharge, parents will be instructed that the child does not need to automatically follow up with his/her primary care physician. Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise. | 0 | 153 | 0 | 153 | 0 | 153 |
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| D012140 |
| Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |