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| ID | Type | Description | Link |
|---|---|---|---|
| ACP-231928-N | Other Grant/Funding Number | American Lung Association |
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Funding complete
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| Name | Class |
|---|---|
| American Lung Association | OTHER |
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Many children have asthma and this causes problems with their health. A lot of children with uncontrolled asthma use emergency departments for asthma care, and so this is an ideal place for an intervention for these children. One intervention is prescribing inhaled steroids to children with uncontrolled asthma, but currently this is rarely done in the emergency department. Inhaled steroids have been shown to be good at making children better long-term when they have uncontrolled asthma.
This study identifies children in the emergency department with uncontrolled asthma using a tool called the Pediatric Asthma Control and Communication Instrument (PACCI). If children meet criteria for uncontrolled asthma they will be randomly assigned to either: 1) routine asthma care which includes close follow up with their doctor or 2) prescribing of an inhaled corticosteroid from the emergency department. The investigators hypothesize that children who are prescribed inhaled steroids for uncontrolled asthma from the emergency department will have better 6 month asthma control than children who receive routine asthma care.
Specific aim 1 - An ED-based RCT to determine if ICS prescription in children identified using the PACCI as having uncontrolled asthma results in less asthma morbidity compared to routine asthma care. We hypothesize that children receiving ICS prescriptions will have fewer unscheduled health care use for asthma exacerbations (doctor's office visits, ED visits, or hospitalizations), and greater quality of life.
Specific aim 2 - Thematic analysis of interviews with parents who are adherent versus non-adherent with ICS prescription filling and use to determine the factors associated with adherence. We hypothesize that factors will include: 1) Parent beliefs about the chronic versus episodic nature of asthma, 2) Parent's knowledge of benefits and risks of ICS, and 3) Provision and use of an asthma action plan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inhaled corticosteroid (fluticasone) | Experimental | Child receives: 1) standardized asthma discharge instructions, and the intervention which is 2) inhaled corticosteroid prescription with accompanying instructions. |
|
| Routine Asthma Care | Placebo Comparator | Child receives: 1) Standard Asthma Discharge Instructions. No intervention in this arm (placebo controlled) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluticasone | Drug | During discharge, the study MD/nurse informs the family that the child has been randomized to the inhaled corticosteroid (ICS) group, and will be prescribed fluticasone to help control the asthma. The families preferred pharmacy is determined and a prescription for a fluticasone multi-dose inhaler (MDI) provided. Dosing follows the NHLBI asthma guidelines for low dose ICS in this age group (88 mcg administered twice per day, dispense one inhaler, 3 refills). In addition to standard asthma discharge instructions, the family receives specific instructions for ICS administration, possible side effects of medication use, and distinction between controller and quick-relief rescue medications. Parents are instructed to discuss with their primary care provider the length of ICS use. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality-of-life Using the Integrated Therapeutics Group Child Asthma Short Form | The Integrated Therapeutics Group Child Asthma Short Form (ITG-CASF) has been validated in the ED setting for children 2 to 17 years old, is reliable (Cronbach's α =0.70), and can be administered by telephone. Each item is rated on a 5-point scale. Each response is scaled as a percentage of the maximum response, and the total score is the maximum percentage based on the number of questions answered. The scores range from 0 (minimum) - 100 (maximum), with higher scores reflecting better quality of life. The change in ITG-CASF scores for children with improved overall clinical status are 10 points higher than when children have not improved. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| ED Visits for Asthma | Emergency department visits for asthma over a 6 month period by parent report. | 6 months |
| Primary Care Visits for Well Checks | Primary care visits well checks over a 6 month period by parent report. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aris C Garro, MD, MPH | Brown University and Rhode Island Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rhode Island Hospital / Hasbro Children's Hospital | Providence | Rhode Island | 02906 | United States |
Availability on request
Data currently available on request
Requests will be reviewed by the study investigators for appropriateness
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| ID | Title | Description |
|---|---|---|
| FG000 | Inhaled Corticosteroid (ICS) | Child receives: 1) asthma discharge instructions, and 2) ICS prescription. Asthma Discharge Instructions include 1) describing asthma symptoms, 2) signs of respiratory distress, 3) instructions to visit the primary care provider within a week, 4) provision/review of asthma action plan, 5) providing an aerochamber device (if necessary) and 6) smoking cessation advice if indicated. The family is also told that the child has been randomized to be prescribed an ICS to help control the asthma. Prescribing follows the NHLBI asthma guidelines for low dose ICS in this age group with 3 refills provided. In addition to standard asthma discharge instructions, the family receives specific instructions for ICS administration, possible side effects of ICS use, and teaching about controller and quick-relief rescue medications. Parents are instructed to discuss with their primary care provider the length of ICS use. |
| FG001 | Routine Asthma Care | Child receives: 1) Standard Asthma Discharge Instructions. No intervention in this arm (placebo controlled) Asthma Discharge Instructions include 1) describing asthma symptoms, 2) signs of respiratory distress, 3) instructions to visit the primary care provider within a week, 4) provision/review of asthma action plan, 5) providing an aerochamber device (if necessary) and 6) smoking cessation advice if indicated. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Inhaled Corticosteroid (ICS) | Child receives: 1) asthma discharge instructions, and 2) ICS prescription. Asthma Discharge Instructions include 1) describing asthma symptoms, 2) signs of respiratory distress, 3) instructions to visit the primary care provider within a week, 4) provision/review of asthma action plan, 5) providing an aerochamber device (if necessary) and 6) smoking cessation advice if indicated. The family is also told that the child has been randomized to be prescribed an ICS to help control the asthma. Prescribing follows the NHLBI asthma guidelines for low dose ICS in this age group with 3 refills provided. In addition to standard asthma discharge instructions, the family receives specific instructions for ICS administration, possible side effects of ICS use, and teaching about controller and quick-relief rescue medications. Parents are instructed to discuss with their primary care provider the length of ICS use. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Quality-of-life Using the Integrated Therapeutics Group Child Asthma Short Form | The Integrated Therapeutics Group Child Asthma Short Form (ITG-CASF) has been validated in the ED setting for children 2 to 17 years old, is reliable (Cronbach's α =0.70), and can be administered by telephone. Each item is rated on a 5-point scale. Each response is scaled as a percentage of the maximum response, and the total score is the maximum percentage based on the number of questions answered. The scores range from 0 (minimum) - 100 (maximum), with higher scores reflecting better quality of life. The change in ITG-CASF scores for children with improved overall clinical status are 10 points higher than when children have not improved. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
6 months
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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 | Inhaled Corticosteroid (Fluticasone) | Child receives: 1) standardized asthma discharge instructions, and the intervention which is 2) inhaled corticosteroid prescription with accompanying instructions. fluticasone: The families preferred pharmacy is determined and a prescription for a fluticasone multi-dose inhaler (MDI) provided. Dosing follows the NHLBI asthma guidelines for low dose ICS in this age group (88 mcg administered twice per day, dispense one inhaler, 3 refills). Standard Asthma Discharge Instructions: 1) description of asthma manifestations related to current visit, 2) signs of respiratory distress family should be looking for, 3) instructions to follow up with the child's primary care provider within one week, 4) provision and review of an asthma action plan, 5) provision of a spacer device to be used with inhalers (if family does not already possess), and 6) smoking cessation advice. (if indicated) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Aris Garro | Rhode Island Hospital and Brown University | 401-480-8682 | arisgarro1@gmail.com |
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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 | Sep 28, 2018 | Mar 26, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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|
|
| Standard Asthma Discharge Instructions | Other | Study MD or nurse provides asthma discharge instructions using a standardized checklist. The topics covered include 1) description of asthma manifestations related to current visit, 2) signs of respiratory distress family should be looking for, 3) instructions to follow up with the child's primary care provider within one week, 4) provision and review of an asthma action plan, 5) provision of a spacer device to be used with inhalers (if family does not already possess), and 6) smoking cessation advice. (if indicated) |
|
| 6 months |
| Hospitalizations for Asthma | Hospitalizations for asthma over a 6 month period by parent report. | 6 months |
| Unscheduled Primary Care Visits | Unscheduled primary care visits for asthma over a 6 month period by parent report. | 6 months |
| Oral Steroid Courses | Oral steroid courses over a 6 month period by parent report. | 6 months |
| BG001 | Routine Asthma Care | Child receives: 1) Standard Asthma Discharge Instructions. No intervention in this arm (placebo controlled) Asthma Discharge Instructions include 1) describing asthma symptoms, 2) signs of respiratory distress, 3) instructions to visit the primary care provider within a week, 4) provision/review of asthma action plan, 5) providing an aerochamber device (if necessary) and 6) smoking cessation advice if indicated. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Routine Asthma Care | Child receives: 1) Standard Asthma Discharge Instructions. No intervention in this arm (placebo controlled) Standard Asthma Discharge Instructions: Study MD or nurse provides asthma discharge instructions using a standardized checklist. The topics covered include 1) description of asthma manifestations related to current visit, 2) signs of respiratory distress family should be looking for, 3) instructions to follow up with the child's primary care provider within one week, 4) provision and review of an asthma action plan, 5) provision of a spacer device to be used with inhalers (if family does not already possess), and 6) smoking cessation advice. (if indicated) |
|
|
| Secondary | ED Visits for Asthma | Emergency department visits for asthma over a 6 month period by parent report. | Posted | Mean | Standard Deviation | visits | 6 months |
|
|
|
| Secondary | Primary Care Visits for Well Checks | Primary care visits well checks over a 6 month period by parent report. | Posted | Mean | Standard Deviation | visits | 6 months |
|
|
|
| Secondary | Hospitalizations for Asthma | Hospitalizations for asthma over a 6 month period by parent report. | Posted | Mean | Standard Deviation | Hospitalizations | 6 months |
|
|
|
| Secondary | Unscheduled Primary Care Visits | Unscheduled primary care visits for asthma over a 6 month period by parent report. | Posted | Mean | Standard Deviation | visits | 6 months |
|
|
|
| Secondary | Oral Steroid Courses | Oral steroid courses over a 6 month period by parent report. | Posted | Mean | Standard Deviation | Courses | 6 months |
|
|
|
| 0 |
| 59 |
| 0 |
| 59 |
| 0 |
| 59 |
| EG001 | Routine Asthma Care | Child receives: 1) Standard Asthma Discharge Instructions. No intervention in this arm (placebo controlled) Standard Asthma Discharge Instructions: Study MD or nurse provides asthma discharge instructions using a standardized checklist. The topics covered include 1) description of asthma manifestations related to current visit, 2) signs of respiratory distress family should be looking for, 3) instructions to follow up with the child's primary care provider within one week, 4) provision and review of an asthma action plan, 5) provision of a spacer device to be used with inhalers (if family does not already possess), and 6) smoking cessation advice. (if indicated) | 0 | 59 | 0 | 59 | 0 | 59 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |