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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01MD014853 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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The purpose of this study is to evaluate the dissemination and implementation of electronic health record-based clinical decision support tools for the management of pediatric overweight and obesity in primary care.
This study will evaluate iPOP-UP, a newly-optimized intervention to improve adherence to national guidelines for the management of childhood obesity, among 81 primary care practices, grouped into 71 clinic clusters, affiliated with three health systems serving children with racial and ethnic, socio-economic, rural-urban, and geographic diversity.
This multi-site, parallel 2-arm cluster randomized controlled "Hybrid Type 2" effectiveness-implementation trial will use mixed methods (electronic health record (EHR) data analysis, surveys, interviews, and focus groups) to simultaneously evaluate (1) the effectiveness of the iPOP-UP implementation package in improving clinical care and children's Body Mass Index (BMI) outcomes in pediatric primary care setting and (2) the impact of the implementation strategy on the reach, adoption, fidelity, cost, and maintenance of the intervention.
The unit of randomization in this study is pediatric primary care practice clusters. Within the participating 71 clusters, pediatric primary care clinicians working at the implementation sites will be invited to participate in pre- and post-intervention surveys assessing their practice behaviors, obesity-related attitudes, beliefs, and self-efficacy, EHR usage and attitudes, and training preferences. In addition, a limited data set of EHR from patients visits will be queried and analyzed to evaluate clinical care outcomes and children's BMI outcomes. Limited data (to include dates and geographic information but no facial identifiers) will be queried and analyzed for all children 1) age 2.0 to ≤18 years-old at baseline, 2) with a well-child visit, during which height and weight are measured, at one of the participating practices during the study period, and 3) with a BMI ≥85th percentile for age/sex (CDC criteria for overweight/obesity).
Outcomes include: (a) change in BMI, measured as the yearly change in BMI expressed as a percentage of the 95th percentile (%BMIp95); (b) Change in clinicians' objective practice around managing elevated BMI in primary care using EHR data; (c) Change in clinicians' self-reported knowledge, attitudes, and practice around managing elevated BMI in primary care; and (d) Utilization of Clinical Decision Support (CDS) tools. The investigators will also describe implementation outcomes (reach, adoption, fidelity/adaptation, and cost) through qualitative and quantitative data collection from members of the study team throughout the process of implementation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinical Decision Support Tool | Experimental | Practices assigned to iPOP-UP intervention which involves EHR-based CDS tools refined through a formative evaluation and user-centered design. |
|
| Control | No Intervention | Practices assigned to usual care that will not have access to the iPOP-UP CDS tool but will have access to many opportunities available to all pediatric clinicians nationally around the release of the new American Academy of Pediatrics guidelines for obesity management. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Improving Pediatric Obesity Practice Using Prompts (iPOP-UP) | Behavioral | EHR-based CDS tools refined through a formative evaluation and user-centered design process that immediately preceded this study. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in BMI as Percentage of 95th Percentile | Calculated as a percentage of the participant's BMI (m/kg2) divided by the BMI (m/kg2) at the 95th percentile for the participant's age and sex based on CDC growth curves. A negative percentage indicates that the participant's BMI has decreased since trial launch. | Up to 15 months after first primary care visit following trial launch |
| Percent Adherence in Composite Measure of Clinician's Adherence to Clinical Guidelines, for Visits Completed Among Children 2-18 Years-old With BMI ≥85th Percentile. | Percent change in composite measure of adherence to clinical guidelines, calculated from practice behaviors queried from the EHR. A dichotomous variable, adherence is defined as whether or not, for each relevant visit, the clinician followed all evidence of recommended obesity-related care during the study period:
A score of 1 indicates that a clinician followed all evidence of recommended obesity-related care; a score of 0 indicates that a clinician did not follow at least one recommendation for obesity-related care. | 6 months after trial launch |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Adherent Visits in Composite Measure of Clinician's Adherence to Clinical Guidelines | Percent adherent visits at 12 and 18 months in composite measure of adherence to clinical guidelines, calculated from practice behaviors queried from the EHR. A dichotomous variable, adherence is defined as whether or not, for each relevant visit, the clinician followed all evidence of recommended obesity-related care during the study period:
A score of 1 indicates that a clinician followed all evidence of recommended obesity-.related care; a score of 0 indicates that a clinician did not follow at least one recommendation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mahnoosh (Mona) Sharifi, MD, MPH | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eskenazi Health | Indianapolis | Indiana | 46202 | United States | ||
| Duke University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38771622 | Derived | Ray J, Finn EB, Tyrrell H, Aloe CF, Perrin EM, Wood CT, Miner DS, Grout R, Michel JJ, Damschroder LJ, Sharifi M. User-Centered Framework for Implementation of Technology (UFIT): Development of an Integrated Framework for Designing Clinical Decision Support Tools Packaged With Tailored Implementation Strategies. J Med Internet Res. 2024 May 21;26:e51952. doi: 10.2196/51952. | |
| 38700557 | Derived | Nugent JT, Maciejewski KR, Finn EB, Grout RW, Wood CT, Esserman D, Michel JJ, Lu Y, Sharifi M. High Blood Pressure in Children Aged 3 to 12 Years Old With Overweight or Obesity. Child Obes. 2024 Dec;20(8):581-589. doi: 10.1089/chi.2023.0143. Epub 2024 May 3. |
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Only clinics were enrolled and randomized; no individual participants were directly consented/randomized. Of 92 clinics invited to participate in the trial, 81 clinics agreed/enrolled and were grouped into 71 clinic clusters and cluster-randomized to iPOP-UP vs usual care using covariate constrained randomization based on site, % patients publicly insured, % non-Hispanic White, geographic location (urban vs not), practice size, practice volume, and academic vs non-academic.
Participating primary care practices (n=81) were recruited and enrolled prior to the study start and grouped into a total of 71 clusters to account for clinician crossover between some participating practices. During an 18-month observation period (February 2023 through December 2024), clinicians and children were observed for any completed visit in participating practices among children aged 2-18 years old with BMI ≥85th percentile via the electronic health record.
| ID | Title | Description |
|---|---|---|
| FG000 | IPOP-UP Implementation Strategy | Practices assigned to the Improving Pediatric Obesity Practice Using Prompts (iPOP-UP), which involved electronic health record-based clinical decision support (CDS) tools and other implementation strategies to support adherence to the 2023 AAP clinical practice guidelines (CPG) for childhood obesity. iPOP-UP CDS tool: Pediatric clinicians in the intervention arm had: (1) the iPOP-UP CDS tools integrated into the EHR for use during a well-child visit; (2) have access to educational materials and learning collaboratives regarding the iPOP-UP CDS tools and AAP CPG. |
| FG001 | Usual Care | No study procedures will be implemented in the control practices. Practices assigned to usual care and will not have access to the iPOP-UP CDS tools and implementation strategies. Practices will have access to opportunities available to all pediatric clinicians nationally around the release of the new American Academy of Pediatrics guidelines for obesity management. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not collected for clinicians.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | IPOP-UP Implementation Strategy | Practices assigned to the Improving Pediatric Obesity Practice Using Prompts (iPOP-UP), which involved electronic health record-based clinical decision support (CDS) tools and other implementation strategies to support adherence to the 2023 AAP clinical practice guidelines (CPG) for childhood obesity. iPOP-UP CDS tool: Pediatric clinicians in the intervention arm had: (1) the iPOP-UP CDS tools integrated into the EHR for use during a well-child visit; (2) have access to educational materials and learning collaboratives regarding the iPOP-UP CDS tools and AAP CPG. |
| 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 | Mean Change in BMI as Percentage of 95th Percentile | Calculated as a percentage of the participant's BMI (m/kg2) divided by the BMI (m/kg2) at the 95th percentile for the participant's age and sex based on CDC growth curves. A negative percentage indicates that the participant's BMI has decreased since trial launch. | Posted | Mean | 97.5% Confidence Interval | percentage | Up to 15 months after first primary care visit following trial launch |
|
Not collected
No adverse events (AEs) among participants (children and pediatric clinicians at enrolled practices) were expected or monitored because this trial aimed to evaluate an implementation strategy to improve adherence to standard of care practices for childhood obesity management per American Academy of Pediatrics' clinical practice guidelines. The intervention included clinical decision support tools, a learning collaborative, quality improvement cycles, and multi-modal training.
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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 | IPOP-UP Implementation Strategy | Practices assigned to the Improving Pediatric Obesity Practice Using Prompts (iPOP-UP), which involved electronic health record-based clinical decision support (CDS) tools and other implementation strategies to support adherence to the 2023 AAP clinical practice guidelines (CPG) for childhood obesity. iPOP-UP CDS tool: Pediatric clinicians in the intervention arm had: (1) the iPOP-UP CDS tools integrated into the EHR for use during a well-child visit; (2) have access to educational materials and learning collaboratives regarding the iPOP-UP CDS tools and AAP CPG. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mona Sharifi | Yale School of Medicine | 203-785-7821 | Mona.Sharifi@yale.edu |
Not provided
| 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 | Jan 21, 2026 | Feb 4, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 12, 2025 | Jan 13, 2026 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
Not provided
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This is a multi-site, parallel 2-arm cluster randomized controlled trial "Hybrid Type 2" effectiveness-implementation study to simultaneously evaluate (1) the effectiveness of iPOP-UP in improving clinical care and child weight outcomes in pediatric primary care setting and (2) the impact of the implementation strategy on the reach, adoption, fidelity, cost, and maintenance of the intervention.
Not provided
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| 12 and 18 months after trial launch |
| Percent Visits With Inclusion of Diagnosis Code Indicating High BMI in Problem List | Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of inclusion of diagnosis code indicating high BMI in problem list, queried from the electronic health record at baseline, 6, 12, and 18 months to see change at 6 months and how it's sustained at 12 and 18 months. A higher proportion of visits with relevant diagnosis code is consistent with recommended care. | 6, 12 and 18 months after trial launch |
| Percent Visits With Inclusion of Diagnosis Code Indicating High BMI in Visit Diagnosis | Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of inclusion of diagnosis code indicating high BMI queried from the electronic health record. A higher proportion of visits with relevant diagnosis code is consistent with recommended care. | 6, 12 and 18 months after trial launch |
| Percent Adherent Visits to Guideline Recommended Screening Lab Orders for Obesity Related Comorbidities, if Eligible | Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of screening lab orders for obesity-related comorbidities recommended by the American Academy of Pediatrics clinical practice guideline for obesity based on age and BMI percentile, queried from the electronic health record. A higher proportion of visits with recommended screening lab orders is consistent with recommended care. | 6, 12 and 18 months after trial launch |
| Percent Adherent Visits in Appropriate Blood Pressure Screening | Percent adherent visits completed among children 3-18 years with BMI ≥85th percentile during the study period with evidence of appropriate blood pressure screening queried from the electronic health record. A higher proportion of visits with blood pressure screening is consistent with recommended care. | 6, 12 and 18 months after trial launch |
| Percent Adherent Visits in Structured Documentation of Counseling | Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of counseling structured documentation queried from the electronic health record. A higher proportion of visits with counseling structured documentation is consistent with recommended care. | 6, 12 and 18 months after trial launch |
| Percent Visits With Follow-up Visit Requested | Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of follow-up visit requested, queried from the electronic health record. A higher proportion of visits with follow-up visit requested is consistent with recommended care. | 6, 12 and 18 months after trial launch |
| Percent Visits With Referral for Further Management of Obesity | Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of referral for further management of obesity queried from the electronic health record. A higher proportion of visits with follow-up or referral for further management of obesity is consistent with recommended care. | 6, 12 and 18 months after trial launch |
| Percent Visits With Weight Loss Medication Orders, if Eligible | Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of weight loss medication orders, if eligible, queried from the electronic health record. A higher proportion of visits with weight loss medication orders, when eligible, is consistent with recommended care. | 6, 12 and 18 months after trial post intervention launch |
| Percent Visits With Bariatric Surgery Program Referrals, if Eligible | Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of bariatric surgery program referrals, if eligible queried from the electronic health record. A higher proportion of referrals to bariatric surgery programs, when eligible, is consistent with recommended care. | 6, 12 and 18 months after trial launch |
| Percent Change in Potentially Unnecessary Insulin or Thyroid Laboratory Tests Ordered | Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of insulin or thyroid lab orders, not routinely recommended for evaluation of children with obesity, queried from the electronic health record. A lower proportion indicates better adherence to recommended care. | 6, 12 and 18 months after trial launch |
| Percent Visits With Clinicians' Utilization of the Clinical Decision Support Tools | Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of clinician use of the clinical decision support tools in the electronic health record developed for this trial, calculated from electronic health record query. Measure= % of visits at intervention sites at which the clinicians' uses clinical decision support tools through18 months A higher proportion indicates greater utilization of clinical decision support tools. | 6, 12 and 18 months following trial launch |
| Mean Change in Clinicians' Attitudes and Practice Around Managing Elevated BMI in Primary Care | Mean change in clinician's attitudes and practice around management of elevated BMI measured using survey questions. Five factors will be assessed: Practice, Treatment self-efficacy, Counseling self-efficacy, Expectations, and Technology. Possible responses range from 1 (strongly disagree) to 5 (strongly agree) for attitudes or 1 (never) to 5 (almost always). Negative values indicate higher disagreement. | baseline and 6 months post intervention launch |
| Total Cost and Cost-effectiveness of iPOP-UP | Total cost of design, build, implementation of the tools, and other implementation strategies of iPOP-UP incurred by the clinics. Using a healthcare sector perspective, a micro-costing approach was utilized to estimate costs associated with the design, build, and implementation of EHR-based CDS for the management of pediatric overweight/obesity in primary care. | From 6 months before trial launch and up to 15 months after first primary care visit following trial launch |
| Durham |
| North Carolina |
| 27708 |
| United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| BG001 | Usual Care | No study procedures will be implemented in the control practices. Practices assigned to usual care and will not have access to the iPOP-UP CDS tools and implementation strategies. Practices will have access to opportunities available to all pediatric clinicians nationally around the release of the new American Academy of Pediatrics guidelines for obesity management. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| Site | Number of participants per site | Count of Participants | Participants | No |
|
| BMI as percentage of 95th Percentile | Calculated as a percentage of the participant's BMI (m/kg2) divided by the BMI (m/kg2) at the 95th percentile for the participant's age and sex based on CDC growth curves | Mean | Standard Deviation | percentage points |
|
| BMI z-score | BMI z-score has a population mean of 0 with standard deviation of 1. Positive scores indicate and increase in BMI above the average. | Mean | Standard Deviation | z-score |
|
| Mean BMI | Mean | Standard Deviation | kg/m^2 |
|
| Mean BMI percentile | Mean BMI percentile | Mean | Standard Deviation | percentile |
|
| Weight class | Overweight = BMI is 25.0 to < 30.0; Class 1 = BMI of 30 to < 35; Class 2 = BMI of 35 to < 40; Class 3 = BMI of 40 or higher | Count of Participants | Participants |
|
| Primary language | Count of Participants | Participants |
|
| Financial class | Count of Participants | Participants |
|
| Practice Setting | Count of Participants | Participants |
|
| Number of participants seen in an academic setting | Count of Participants | Participants |
|
| Visits at clinics above Median Clinicians | Visits at clinics above Median Clinicians (high practitioner volume) | Number | visits |
|
| Visits at clinics above Median Patients | Visits at clinics above Median Patients (high patient volume) | Number | visits |
|
| Visits at clinics above Median Medicaid | Visits at clinics above Median Medicaid (high medicaid volume) | Number | visits |
|
| Visits at clinics above Median Non-Hispanic White (NHW) | Visits at clinics above Median NHW (high NHW volume) | Number | visits |
|
| OG001 | Usual Care | No study procedures will be implemented in the control practices. Practices assigned to usual care and will not have access to the iPOP-UP CDS tools and implementation strategies. Practices will have access to opportunities available to all pediatric clinicians nationally around the release of the new American Academy of Pediatrics guidelines for obesity management. |
|
|
|
| Primary | Percent Adherence in Composite Measure of Clinician's Adherence to Clinical Guidelines, for Visits Completed Among Children 2-18 Years-old With BMI ≥85th Percentile. | Percent change in composite measure of adherence to clinical guidelines, calculated from practice behaviors queried from the EHR. A dichotomous variable, adherence is defined as whether or not, for each relevant visit, the clinician followed all evidence of recommended obesity-related care during the study period:
A score of 1 indicates that a clinician followed all evidence of recommended obesity-related care; a score of 0 indicates that a clinician did not follow at least one recommendation for obesity-related care. | Assessed in clinicians | Posted | Mean | 97.5% Confidence Interval | percent adherence | 6 months after trial launch |
|
|
|
|
| Secondary | Percent Adherent Visits in Composite Measure of Clinician's Adherence to Clinical Guidelines | Percent adherent visits at 12 and 18 months in composite measure of adherence to clinical guidelines, calculated from practice behaviors queried from the EHR. A dichotomous variable, adherence is defined as whether or not, for each relevant visit, the clinician followed all evidence of recommended obesity-related care during the study period:
A score of 1 indicates that a clinician followed all evidence of recommended obesity-.related care; a score of 0 indicates that a clinician did not follow at least one recommendation. | Assessed in clinicians only | Posted | Mean | 97.5% Confidence Interval | Percent adherent visits | 12 and 18 months after trial launch |
|
|
|
|
| Secondary | Percent Visits With Inclusion of Diagnosis Code Indicating High BMI in Problem List | Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of inclusion of diagnosis code indicating high BMI in problem list, queried from the electronic health record at baseline, 6, 12, and 18 months to see change at 6 months and how it's sustained at 12 and 18 months. A higher proportion of visits with relevant diagnosis code is consistent with recommended care. | Assessed in clinicians | Posted | Mean | 97.5% Confidence Interval | percent visits | 6, 12 and 18 months after trial launch |
|
|
|
|
| Secondary | Percent Visits With Inclusion of Diagnosis Code Indicating High BMI in Visit Diagnosis | Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of inclusion of diagnosis code indicating high BMI queried from the electronic health record. A higher proportion of visits with relevant diagnosis code is consistent with recommended care. | Assessed in clinicians | Posted | Mean | 97.5% Confidence Interval | percent visits | 6, 12 and 18 months after trial launch |
|
|
|
|
| Secondary | Percent Adherent Visits to Guideline Recommended Screening Lab Orders for Obesity Related Comorbidities, if Eligible | Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of screening lab orders for obesity-related comorbidities recommended by the American Academy of Pediatrics clinical practice guideline for obesity based on age and BMI percentile, queried from the electronic health record. A higher proportion of visits with recommended screening lab orders is consistent with recommended care. | Assessed in clinicians | Posted | Mean | 97.5% Confidence Interval | percent adherent visits | 6, 12 and 18 months after trial launch |
|
|
|
|
| Secondary | Percent Adherent Visits in Appropriate Blood Pressure Screening | Percent adherent visits completed among children 3-18 years with BMI ≥85th percentile during the study period with evidence of appropriate blood pressure screening queried from the electronic health record. A higher proportion of visits with blood pressure screening is consistent with recommended care. | Assessed in clinicians | Posted | Mean | 97.5% Confidence Interval | percent adherent visits | 6, 12 and 18 months after trial launch |
|
|
|
|
| Secondary | Percent Adherent Visits in Structured Documentation of Counseling | Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of counseling structured documentation queried from the electronic health record. A higher proportion of visits with counseling structured documentation is consistent with recommended care. | Assessed in clinicians | Posted | Mean | 97.5% Confidence Interval | percent adherent visits | 6, 12 and 18 months after trial launch |
|
|
|
|
| Secondary | Percent Visits With Follow-up Visit Requested | Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of follow-up visit requested, queried from the electronic health record. A higher proportion of visits with follow-up visit requested is consistent with recommended care. | Assessed in clinicians | Posted | Mean | 97.5% Confidence Interval | percent visits | 6, 12 and 18 months after trial launch |
|
|
|
|
| Secondary | Percent Visits With Referral for Further Management of Obesity | Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of referral for further management of obesity queried from the electronic health record. A higher proportion of visits with follow-up or referral for further management of obesity is consistent with recommended care. | Assessed in clinicians | Posted | Mean | 97.5% Confidence Interval | percent visits | 6, 12 and 18 months after trial launch |
|
|
|
|
| Secondary | Percent Visits With Weight Loss Medication Orders, if Eligible | Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of weight loss medication orders, if eligible, queried from the electronic health record. A higher proportion of visits with weight loss medication orders, when eligible, is consistent with recommended care. | Assessed in clinicians | Posted | Mean | 97.5% Confidence Interval | percent visits | 6, 12 and 18 months after trial post intervention launch |
|
|
|
|
| Secondary | Percent Visits With Bariatric Surgery Program Referrals, if Eligible | Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of bariatric surgery program referrals, if eligible queried from the electronic health record. A higher proportion of referrals to bariatric surgery programs, when eligible, is consistent with recommended care. | Assessed in clinicians | Posted | Number | percent visits | 6, 12 and 18 months after trial launch |
|
|
|
| Secondary | Percent Change in Potentially Unnecessary Insulin or Thyroid Laboratory Tests Ordered | Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of insulin or thyroid lab orders, not routinely recommended for evaluation of children with obesity, queried from the electronic health record. A lower proportion indicates better adherence to recommended care. | Assessed in clinicians | Posted | Mean | 97.5% Confidence Interval | percent change | 6, 12 and 18 months after trial launch |
|
|
|
|
| Secondary | Percent Visits With Clinicians' Utilization of the Clinical Decision Support Tools | Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of clinician use of the clinical decision support tools in the electronic health record developed for this trial, calculated from electronic health record query. Measure= % of visits at intervention sites at which the clinicians' uses clinical decision support tools through18 months A higher proportion indicates greater utilization of clinical decision support tools. | Assessed in clinicians only. The clinical decision support tools were not available in usual care arm clinics, so usage of these tools was not possible. | Posted | Mean | 97.5% Confidence Interval | percent visits | 6, 12 and 18 months following trial launch |
|
|
|
| Secondary | Mean Change in Clinicians' Attitudes and Practice Around Managing Elevated BMI in Primary Care | Mean change in clinician's attitudes and practice around management of elevated BMI measured using survey questions. Five factors will be assessed: Practice, Treatment self-efficacy, Counseling self-efficacy, Expectations, and Technology. Possible responses range from 1 (strongly disagree) to 5 (strongly agree) for attitudes or 1 (never) to 5 (almost always). Negative values indicate higher disagreement. | Data presented here is from all participant that completed the assessment. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline and 6 months post intervention launch |
|
|
|
|
| Secondary | Total Cost and Cost-effectiveness of iPOP-UP | Total cost of design, build, implementation of the tools, and other implementation strategies of iPOP-UP incurred by the clinics. Using a healthcare sector perspective, a micro-costing approach was utilized to estimate costs associated with the design, build, and implementation of EHR-based CDS for the management of pediatric overweight/obesity in primary care. | This was only collected in the intervention group. The clinical decision support tools were not available in usual care arm clinics, so usage of these tools was not possible. This outcome was analyzed at the clinic level. | Posted | Number | US dollars | From 6 months before trial launch and up to 15 months after first primary care visit following trial launch | clinics | clinics |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Usual Care | No study procedures will be implemented in the control practices. Practices assigned to usual care and will not have access to the iPOP-UP CDS tools and implementation strategies. Practices will have access to opportunities available to all pediatric clinicians nationally around the release of the new American Academy of Pediatrics guidelines for obesity management. | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
Not provided
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 0.13 |
| Rate ratio |
| 1.36 |
| 2-Sided |
| 97.5 |
| 0.86 |
| 2.16 |
| Superiority |
| 12 months |
|
|
| 18 months |
|
|
| <.0001 |
| Rate ratio |
| 1.38 |
| 2-Sided |
| 97.5 |
| 1.25 |
| 1.52 |
| Superiority |
| 18 months | Generalized estimating equations | <.0001 | Rate ratio | 1.48 | 2-Sided | 97.5 | 1.33 | 1.64 | Superiority |
| 18 months |
|
| 0.23 |
| Rate ratio |
| 1.05 |
| 2-Sided |
| 97.5 |
| 0.96 |
| 1.15 |
| Superiority |
| 18 months | Generalized estimating equations | 0.061 | Rate ratio | 1.07 | 2-Sided | 97.5 | 0.99 | 1.16 | Superiority |
| 18 months |
|
| 0.0004 |
| Rate ratio |
| 1.19 |
| 2-Sided |
| 97.5 |
| 1.07 |
| 1.33 |
| Superiority |
| 18 months | Generalized estimating equations | <.0001 | Rate ratio | 1.27 | 2-Sided | 97.5 | 1.13 | 1.41 | Superiority |
| 18 months |
|
Poisson |
| 0.31 |
| Rate ratio |
| 1.01 |
| 2-Sided |
| 97.5 |
| 0.99 |
| 1.04 |
| Superiority |
| 18 months | Generalized estimating equations | Poisson | 0.2 | Rate ratio | 1.01 | 2-Sided | 97.5 | 0.99 | 1.03 | Superiority |
| 18 months |
|
| 0.015 |
| Rate ratio |
| 1.17 |
| 2-Sided |
| 97.5 |
| 1.01 |
| 1.35 |
| Superiority |
| 18 months | Generalized estimating equations | 0.0008 | Rate ratio | 1.26 | 2-Sided | 97.5 | 1.08 | 1.47 | Superiority |
| 18 months |
|
| 0.17 |
| Rate ratio |
| 0.87 |
| 2-Sided |
| 97.5 |
| 0.69 |
| 1.10 |
| Superiority |
| 18 months | Generalized estimating equations | 0.52 | Rate ratio | 0.93 | 2-Sided | 97.5 | 0.73 | 1.19 | Superiority |
| 18 months |
|
| 0.0008 |
| Rate ratio |
| 1.31 |
| 2-Sided |
| 97.5 |
| 1.09 |
| 1.58 |
| Superiority |
| 18 months | Generalized estimating equations | 0.052 | Rate ratio | 1.17 | 2-Sided | 97.5 | 0.98 | 1.41 | Superiority |
| 18 months |
|
| 0.84 |
| Rate ratio |
| 0.97 |
| 2-Sided |
| 97.5 |
| 0.69 |
| 1.36 |
| Superiority |
| 18 months | Generalized estimating equations | 0.06 | Rate ratio | 0.75 | 2-Sided | 97.5 | 0.53 | 1.06 | Superiority |
| 18 months |
|
| 18 months |
|
| 0.75 |
| Rate ratio |
| 1.02 |
| 2-Sided |
| 97.5 |
| 0.89 |
| 1.17 |
| Superiority |
| 18 months | Generalized estimating equations | 0.35 | Rate ratio | 1.06 | 2-Sided | 97.5 | 0.92 | 1.22 | Superiority |
| Title | Measurements |
|---|---|
|
| Counseling self-efficacy |
|
| Expectations |
|
| Technology |
|
| Superiority |
| Practice, Pre-intervention, between group comparison | Mixed Models Analysis | 0.4363 | Superiority |
| Practice, Post-intervention, between group comparison | Mixed Models Analysis | 0.3619 | Superiority |
| Practice, arm by time interaction | Mixed Models Analysis | 0.8818 | Superiority |
| Treatment | Mixed Models Analysis | 0.9026 | Superiority |
| Treatment | Mixed Models Analysis | 0.1850 | Superiority |
| Treatment, Pre-intervention, between group comparison | Mixed Models Analysis | 0.5624 | Superiority |
| Treatment, Post-intervention, between group comparison | Mixed Models Analysis | 0.5187 | Superiority |
| Treatment, arm by time interaction | Mixed Models Analysis | 0.3050 | Superiority |
| Counseling | Mixed Models Analysis | 0.3923 | Superiority |
| Counseling | Mixed Models Analysis | 0.7379 | Superiority |
| Counseling, Pre-intervention, between group comparison | Mixed Models Analysis | 0.0570 | Superiority |
| Counseling, Post-intervention, between group comparison | Mixed Models Analysis | 0.3922 | Superiority |
| Counseling, arm by time interaction | Mixed Models Analysis | 0.3914 | Superiority |
| Expectations | Mixed Models Analysis | 0.6703 | Superiority |
| Expectations | Mixed Models Analysis | 0.6001 | Superiority |
| Expectations, Pre-intervention, between group comparison | Mixed Models Analysis | 0.1778 | Superiority |
| Expectations, Post-intervention, between group comparison | Mixed Models Analysis | 0.1725 | Superiority |
| Expectations, arm by time interaction | Mixed Models Analysis | 0.9516 | Superiority |
| Technology | Mixed Models Analysis | 0.1425 | Superiority |
| Technology | Mixed Models Analysis | 0.7407 | Superiority |
| Technology, Pre-intervention, between group comparison | Mixed Models Analysis | 0.2668 | Superiority |
| Technology, Post-intervention, between group comparison | Mixed Models Analysis | 0.5753 | Superiority |
| Technology, arm by time interaction | Mixed Models Analysis | 0.1937 | Superiority |