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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL133789 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The overall goal of this research study is to test the effectiveness of a multifaceted and multi-level prompting intervention in a real world urban primary care office setting on improving provider-delivered guideline-based asthma care and reducing asthma morbidity among urban children with persistent or uncontrolled asthma.
Investigators will conduct a cluster randomized trial comparing the intervention to enhanced usual care (eUC) in 20 Bronx practices serving over 5,000 children ages 2-12 years with persistent or uncontrolled asthma. Eleven eUC practices will receive guideline information and assess children's asthma severity and control, but active intervention components will not be provided. Practices will join the study in 4 waves over 4 years (4-6 practices per year). Provider adoption of guidelines and utilization of care in all patients (~5,000) ages 2-12 years with persistent or uncontrolled asthma from intervention and eUC practices will be evaluated using Electronic Health Records (EHR) data and practice-based screening for asthma severity and control. Investigators will also enroll a random subset of 512 caregivers of children with persistent/uncontrolled asthma from both study arms to systematically evaluate caregiver-reported child morbidity outcomes and obtain measures not available in EHR.
Intervention consists of academic detailing in the EHR that follow national asthma guidelines and outreach worker care coordination for patients with persistent or uncontrolled asthma.
Comment: While caregivers reported on child outcomes, caregivers were not subjects of the study. See "Pre-Assignment Details" section within the Participant Flow module for more details.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced Multifaceted Prompting Intervention (eMPI) | Experimental | The enhanced MPI program (eMPI) consists of innovative multi-level and team-based strategies to enable providers to effectively and efficiently adopt asthma care guidelines. eMPI uses guideline-based prompts at the time of an office visit to support providers' decision-making, increasing the likelihood that they will recommend corrective actions (i.e., preventive medication prescription) to improve asthma management. |
|
| Enhanced Usual Care (eUC) Practices | No Intervention | Participants will receive a review packet of the National Asthma Education and Prevention Program (NAEPP) guidelines and educational resources for families. Children will be assessed for asthma severity and level of control at each visit as part of best-practice care, but active intervention components will not be provided. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eMPI | Behavioral | The core elements of the multilevel strategy for implementation include: Direct Support for Providers' Delivery of Guideline-Based Care in Practice; Enhancements to Increase the Feasibility and Sustainability of eMPI; Involving Clinic Staff in Promoting and Supporting Use of Guidelines; Building Accountability and Commitment to Guideline-Based Care; Promoting Providers' Understanding, Acceptance, and Use of Guidelines |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With 1 or More Guideline-based Corrective Actions Taken | The percentage of participants with 1 or more guideline-based corrective actions taken (i.e., controller medication prescription or adjustment, trigger evaluation), as recorded in the electronic health record (EHR) is reported. Results are summarized in number/percentage of participants with 1 or more guideline-based corrective actions taken by study arm. | Immediately post-intervention, up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom Free Days (SFDs) | The number of days without symptoms during the past 14 days is summarized by study arm at baseline and every 3 months up through the 12 month follow up evaluation. | Baseline, and 3 month, 6 month, 9 month, and 12 month follow-up evaluations |
| Measure | Description | Time Frame |
|---|---|---|
| Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) | caregiver asthma related quality of life | every 3 months up to 12 months |
| Health Care Utilization: Number of ED Visits for Asthma | number of ED visits for asthma |
Inclusion Criteria:
The criteria listed below will apply to ~5,000 children from eMPI and eUC practices:
Additional inclusion criteria will apply to a subset of 512 of children whose caregivers will be interviewed to obtain caregiver-reported morbidity outcomes:
Exclusion Criteria:
Additional exclusion criteria will apply to a subset of 512 children/caregivers as described above:
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| Name | Affiliation | Role |
|---|---|---|
| Marina Reznik, MD, MS | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital at Montefiore, Albert Einstein College of Medicine | The Bronx | New York | 10467 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24784481 | Background | Bloom B, Jones LI, Freeman G. Summary health statistics for U.S. children: National Health Interview Survey, 2012. Vital Health Stat 10. 2013 Dec;(258):1-81. | |
| 19484676 | Background | Flores G, Snowden-Bridon C, Torres S, Perez R, Walter T, Brotanek J, Lin H, Tomany-Korman S. Urban minority children with asthma: substantial morbidity, compromised quality and access to specialists, and the importance of poverty and specialty care. J Asthma. 2009 May;46(4):392-8. doi: 10.1080/02770900802712971. |
| Label | URL |
|---|---|
| National Heart Lung and Blood Institute. National Asthma Education and Prevention Program. Expert panel report 3: guidelines for the diagnosis and management of asthma. NIH Publication Number 08 5846. Bethesda, MD: 2007. | View source |
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IPD will not be shared for this study. This study predated the 2023 Data Management and Sharing Policy and was subject to the 2003 NIH Data Sharing Policy. Based on this policy it did not meet the requirements for the sharing of research, and therefore IPD, data.
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Because children with asthma (ages 2-12) were the subjects of the study, caregivers had to complete validated surveys/questionnaires in order to collect child-specific data and outcome measures about their child's asthma. The study was exclusively for children with asthma. Parents were not subjects in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Enhanced Multifaceted Prompting Intervention (eMPI) | The enhanced MPI program (eMPI) consists of innovative multi-level and team-based strategies to enable providers to effectively and efficiently adopt asthma care guidelines. eMPI uses guideline-based prompts at the time of an office visit to support providers' decision-making, increasing the likelihood that they will recommend corrective actions (i.e., preventive medication prescription) to improve asthma management. eMPI: The core elements of the multilevel strategy for implementation include: Direct Support for Providers' Delivery of Guideline-Based Care in Practice; Enhancements to Increase the Feasibility and Sustainability of eMPI; Involving Clinic Staff in Promoting and Supporting Use of Guidelines; Building Accountability and Commitment to Guideline-Based Care; Promoting Providers' Understanding, Acceptance, and Use of Guidelines |
| FG001 | Enhanced Usual Care (eUC) Practices | Participants will receive a review packet of the National Asthma Education and Prevention Program (NAEPP) guidelines and educational resources for families. Children will be assessed for asthma severity and level of control at each visit as part of best-practice care, but active intervention components will not be provided. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Enhanced Multifaceted Prompting Intervention (eMPI) | The enhanced MPI program (eMPI) consists of innovative multi-level and team-based strategies to enable providers to effectively and efficiently adopt asthma care guidelines. eMPI uses guideline-based prompts at the time of an office visit to support providers' decision-making, increasing the likelihood that they will recommend corrective actions (i.e., preventive medication prescription) to improve asthma management. eMPI: The core elements of the multilevel strategy for implementation include: Direct Support for Providers' Delivery of Guideline-Based Care in Practice; Enhancements to Increase the Feasibility and Sustainability of eMPI; Involving Clinic Staff in Promoting and Supporting Use of Guidelines; Building Accountability and Commitment to Guideline-Based Care; Promoting Providers' Understanding, Acceptance, and Use of Guidelines |
| 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 | Percentage of Participants With 1 or More Guideline-based Corrective Actions Taken | The percentage of participants with 1 or more guideline-based corrective actions taken (i.e., controller medication prescription or adjustment, trigger evaluation), as recorded in the electronic health record (EHR) is reported. Results are summarized in number/percentage of participants with 1 or more guideline-based corrective actions taken by study arm. | All randomized subjects were analyzed. | Posted | Count of Participants | Participants | Immediately post-intervention, up to 1 year |
|
Up to 1 year
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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 | Enhanced Multifaceted Prompting Intervention (eMPI) | The enhanced MPI program (eMPI) consists of innovative multi-level and team-based strategies to enable providers to effectively and efficiently adopt asthma care guidelines. eMPI uses guideline-based prompts at the time of an office visit to support providers' decision-making, increasing the likelihood that they will recommend corrective actions (i.e., preventive medication prescription) to improve asthma management. eMPI: The core elements of the multilevel strategy for implementation include: Direct Support for Providers' Delivery of Guideline-Based Care in Practice; Enhancements to Increase the Feasibility and Sustainability of eMPI; Involving Clinic Staff in Promoting and Supporting Use of Guidelines; Building Accountability and Commitment to Guideline-Based Care; Promoting Providers' Understanding, Acceptance, and Use of Guidelines |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marina Reznik, MD, MS | Montefiore Medical Center | 718-741-2494 | mreznik@montefiore.org |
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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 6, 2020 | Aug 19, 2025 | Prot_SAP_000.pdf |
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Cluster randomized design
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Follow up assessments will be collected by blinded interviewers
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|
| every 3 months up to 12 months |
| Health Care Utilization: Number Hospitalizations for Asthma | number hospitalizations for asthma | every 3 months up to 12 months |
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| 14555561 | Background | Jenkins HA, Cherniack R, Szefler SJ, Covar R, Gelfand EW, Spahn JD. A comparison of the clinical characteristics of children and adults with severe asthma. Chest. 2003 Oct;124(4):1318-24. doi: 10.1378/chest.124.4.1318. |
| 12359798 | Background | Sharek PJ, Mayer ML, Loewy L, Robinson TN, Shames RS, Umetsu DT, Bergman DA. Agreement among measures of asthma status: a prospective study of low-income children with moderate to severe asthma. Pediatrics. 2002 Oct;110(4):797-804. doi: 10.1542/peds.110.4.797. |
| Background | Bacharier LB MD, Lemanske RF, Schend V, Sorkness C, Strunk RC. Classifying asthma severity in children: is measuring lung function helpful? . J Allergy Clin Immunol. 2002. |
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| 39726143 | Result | Reznik M, Ball-Jones R, Ibarra J. The COVID-19 pandemic and asthma management: a family caregiver perspective. J Asthma. 2025 May;62(5):817-823. doi: 10.1080/02770903.2024.2447285. Epub 2025 Jan 8. |
| 36858248 | Result | Telzak A, Fiori KP, Chambers EC, Haughton J, Levano S, Reznik M. Unmet Social Needs and Pediatric Asthma Severity in an Urban Primary Care Setting. Acad Pediatr. 2023 Sep-Oct;23(7):1361-1367. doi: 10.1016/j.acap.2023.02.009. Epub 2023 Feb 27. |
| Patient-Centered Medical Home Recognition. | View source |
| BG001 | Enhanced Usual Care (eUC) Practices | Participants will receive a review packet of the National Asthma Education and Prevention Program (NAEPP) guidelines and educational resources for families. Children will be assessed for asthma severity and level of control at each visit as part of best-practice care, but active intervention components will not be provided. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Enhanced Usual Care (eUC) Practices | Participants will receive a review packet of the National Asthma Education and Prevention Program (NAEPP) guidelines and educational resources for families. Children will be assessed for asthma severity and level of control at each visit as part of best-practice care, but active intervention components will not be provided. |
|
|
|
| Secondary | Symptom Free Days (SFDs) | The number of days without symptoms during the past 14 days is summarized by study arm at baseline and every 3 months up through the 12 month follow up evaluation. | The number of participants analyzed at each timepoint for both arms is depicted in the table below. | Posted | Mean | Standard Deviation | number of symptom free days | Baseline, and 3 month, 6 month, 9 month, and 12 month follow-up evaluations |
|
|
|
|
| Other Pre-specified | Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) | caregiver asthma related quality of life | Not Posted | every 3 months up to 12 months | Participants |
| Other Pre-specified | Health Care Utilization: Number of ED Visits for Asthma | number of ED visits for asthma | Not Posted | every 3 months up to 12 months | Participants |
| Other Pre-specified | Health Care Utilization: Number Hospitalizations for Asthma | number hospitalizations for asthma | Not Posted | every 3 months up to 12 months | Participants |
| 0 |
| 265 |
| 0 |
| 265 |
| 0 |
| 265 |
| EG001 | Enhanced Usual Care (eUC) Practices | Participants will receive a review packet of the National Asthma Education and Prevention Program (NAEPP) guidelines and educational resources for families. Children will be assessed for asthma severity and level of control at each visit as part of best-practice care, but active intervention components will not be provided. | 0 | 265 | 0 | 265 | 0 | 265 |
Not provided
Not provided
| 3 month |
|
|
| 6 month |
|
|
| 9 month |
|
|
| 12 month |
|
|
| 6 month follow up | GLM with GEE | 0.741 | Ratio of Rate Ratios | 1.04 | 2-Sided | 95 | 0.85 | 1.27 | Superiority | A generalized linear model (GLM) with generalized estimating equations (GEE) was used to compare changes over time between the two groups in symptom-free days (SFDs) during the past two weeks, accounting for within-subject correlation. The null hypothesis at each time point was that there is no difference between groups in the change in SFDs. With 530 participants at baseline, ≤10% attrition at 12 months, the study has 80% power to detect a standardized effect size >0.29. |
| 9 month follow up | GLM with GEE | 0.724 | Ratio of Rate Ratios | 1.03 | 2-Sided | 95 | 0.85 | 1.25 | Superiority | A generalized linear model (GLM) with generalized estimating equations (GEE) was used to compare changes over time between the two groups in symptom-free days (SFDs) during the past two weeks, accounting for within-subject correlation. The null hypothesis at each time point was that there is no difference between groups in the change in SFDs. With 530 participants at baseline, ≤10% attrition at 12 months, the study has 80% power to detect a standardized effect size >0.29. |
| 12 month follow up | GLM with GEE | 0.229 | Ratio of Rate Ratios | 1.12 | 2-Sided | 95 | 0.93 | 1.34 | Superiority | A generalized linear model (GLM) with generalized estimating equations (GEE) was used to compare changes over time between the two groups in symptom-free days (SFDs) during the past two weeks, accounting for within-subject correlation. The null hypothesis at each time point was that there is no difference between groups in the change in SFDs. With 530 participants at baseline, ≤10% attrition at 12 months, the study has 80% power to detect a standardized effect size >0.29. |
| 3 month follow up | GLM with GEE | 0.186 | Ratio of Rate Ratios | 1.13 | 2-Sided | 95 | 0.94 | 1.34 | Superiority | This analysis is similar to Analysis 1, with adjustment for baseline outcome (symptom-free days) and seasonality. |
| 6 month follow up | GLM with GEE | 0.744 | Ratio of Rate Ratios | 1.04 | 2-Sided | 95 | 0.84 | 1.27 | Superiority | This analysis is similar to Analysis 2, with adjustment for baseline outcome (symptom-free days) and seasonality. |
| 9 month follow up | GLM with GEE | 0.765 | Ratio of Rate Ratios | 1.03 | 2-Sided | 95 | 0.85 | 1.25 | Superiority | This analysis is similar to Analysis 3, with adjustment for baseline outcome (symptom-free days) and seasonality. |
| 12 month follow up | GLM with GEE | 0.241 | Ratio of Rate Ratios | 1.11 | 2-Sided | 95 | 0.93 | 1.33 | Superiority | This analysis is similar to Analysis 4, with adjustment for baseline outcome (symptom-free days) and seasonality. |