Pediatric ObesityiPOP-UPNCT03648242
Improving Pediatric Obesity Practice Using Prompts
A study testing Interruptive Clinical Decision Support in people with Pediatric Obesity, run by Yale University at 1 site in United States.
Trial summary
This study compares the effectiveness of electronic health record (EHR)-based tools to support the management of pediatric obesity in primary care. All clinicians will receive an interruptive "pop-up" alert We will examine the impact -- the added value versus unintended consequences -- of the interruptive alert on the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- Interruptive Clinical Decision Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
All pediatric primary care providers providing well child care for patients ages 2-17 years-old in the Boston Children's Hospital primary care practices will be eligible for the study. There are no exclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Improving Pediatric Obesity Practice Using Prompts (iPOP-UP): Using Electronic Health Records to Support Decision-Making in Pediatric Obesity Care
This study compares the effectiveness of electronic health record (EHR)-based tools to support the management of pediatric obesity in primary care. All clinicians will receive an interruptive "pop-up" alert We will examine the impact -- the added value versus unintended consequences -- of the interruptive alert on the quality of obesity management in pediatric primary care.
Read the detailed description
The primary specific aims of this study are to:
- To assess the impact of EHR-based tools for pediatric obesity in primary care. Hypotheses: EHR-based clinical decision support tools that interrupt but support clinical workflow will (1) improve measures of pediatric obesity care quality delivered by clinicians (e.g., addition of obesity to the problem list, recommended screening for comorbidities, and follow-up/referral plans) and (2) result in a reduced rate of BMI increase over one year among children with obesity.
- To utilize a mixed methods approach with surveys and semi-structured qualitative interviews with clinicians to (1) examine the extent to which the EHR tools positively impact clinicians' awareness, knowledge and adherence to expert guidelines for pediatric obesity management, and (2) to explore the barriers to and facilitators of clinicians' use of the EHR tools and factors that influence adoption.
- Conditions
- Pediatric Obesity
- Being tested
- Interruptive Clinical Decision Support
- Keywords
- pediatric obesity, electronic health record, clinical decision support
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interruptive Clinical Decision SupportBehavioural
An interruptive, "soft-stop" alert will pop up when a pediatric primary care provider open a child's electronic health record (i.e., a new window in the forefront of the screen interrupting workflow and requiring the clinician to take an action) alerting them that the child meets criteria for obesity based on their age/sex-specific BMI percentile. The pop-up alert includes:
- One-click addition of elevated BMI to problem list
- Reminder to utilize Suggested PowerPlan
- One-click access to a patient handout on evidence-based behavior change goals (screen time, sugary drinks, physical activity, sleep) and link to additional handouts and resources
- Tables displaying trends in growth measures, blood pressure and relevant laboratory tests
- Links to existing, evidence-based childhood obesity screening and management guidelines
| Study group | Role | What they receive |
|---|---|---|
| Interruptive Clinical Decision Support | Experimental | Not described Receives: Behavioral: Interruptive Clinical Decision Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body mass index (BMI)
change in BMI, calculated from height and weight measured as part of routine clinical practice during primary care clinic visits and documented in the EHR
Measured: 1 year pre-intervention, baseline, and 1 year post-intervention
Change in percent BMI above the 95th percentile (%BMIp95)
Change in percentage of age/sex-adjusted BMI above the 95th percentile (%BMIp95), calculated from height and weight measured as part of routine clinical practice during primary care clinic visits and documented in the EHR
Measured: 1 year pre-intervention, baseline, and 1 year post-intervention
Change in documentation of elevated BMI diagnosis
Change in proportion of patients with obesity who have elevated BMI documented in the EHR
Measured: 1-year pre-implementation compared to 1-year post-implementation
Change in proportion of patients with obesity
Change in proportion of patients with obesity who receive age-appropriate screening for comorbidities (blood measure measurement and age-appropriate laboratory screening)
Measured: 1-year pre-implementation compared to 1-year post-implementation
Change in proportion of patients with obesity who have counseling for obesity-related behavior change documented in the EHR
Measured: 1-year pre-implementation compared to 1-year post-implementation
Change in proportion of patients with obesity with follow-up or referral orders
Measured: 1-year pre-implementation compared to 1-year post-implementation
Secondary outcomes (2)
Change in provider knowledge, attitudes and practice around obesity management in primary care assessed via an electronic surveys and qualitative interviews of clinicians
Measured: baseline compared to 6 months post-implementation
System usability scale (SUS) score
the system usability scale is a validated 10-item measure of system usability
Measured: 6 months post-implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start1 Sep 2018
- Primary completion30 Sep 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Corinna Rea, MD, MPH, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03648242
- Sponsor's protocol ID
- 2000026382
- Other IDs
- 1K08HS024332-01A1
- Acronym
- iPOP-UP
- Status last verified
- May 2021
- First submitted
- 21 Aug 2018
- Last updated
- 17 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Pediatric Obesity Practice Using Prompts (iPOP-UP): Using Electronic Health Records to Support Decision-Making in Pediatric Obesity Care
- ClinicalTrials.gov ID
- NCT03648242
- Acronym / sponsor ID
- iPOP-UP / 2000026382
- Conditions
- Pediatric Obesity
- Keywords
- pediatric obesity, electronic health record, clinical decision support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Boston Children's Hospital
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 27 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares the effectiveness of electronic health record (EHR)-based tools to support the management of pediatric obesity in primary care. All clinicians will receive an interruptive "pop-up" alert We will examine the impact -- the added value versus unintended consequences -- of the interruptive alert on the quality of obesity management in pediatric primary care.
Detailed description
The primary specific aims of this study are to:
- To assess the impact of EHR-based tools for pediatric obesity in primary care. Hypotheses: EHR-based clinical decision support tools that interrupt but support clinical workflow will (1) improve measures of pediatric obesity care quality delivered by clinicians (e.g., addition of obesity to the problem list, recommended screening for comorbidities, and follow-up/referral plans) and (2) result in a reduced rate of BMI increase over one year among children with obesity.
- To utilize a mixed methods approach with surveys and semi-structured qualitative interviews with clinicians to (1) examine the extent to which the EHR tools positively impact clinicians' awareness, knowledge and adherence to expert guidelines for pediatric obesity management, and (2) to explore the barriers to and facilitators of clinicians' use of the EHR tools and factors that influence adoption.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interruptive Clinical Decision Support | Experimental | Behavioral: Interruptive Clinical Decision Support |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interruptive Clinical Decision SupportAn interruptive, "soft-stop" alert will pop up when a pediatric primary care provider open a child's electronic health record (i.e., a new window in the forefront of the screen interrupting workflow and requiring the clinician to take an action) alerting them that the child meets criteria for obesity based on their age/sex-specific BMI percentile. The pop-up alert includes: * One-click addition of elevated BMI to problem list * Reminder to utilize Suggested PowerPlan * One-click access to a patient handout on evidence-based behavior change goals (screen time, sugary drinks, physical activity, sleep) and link to additional handouts and resources * Tables displaying trends in growth measures, blood pressure and relevant laboratory tests * Links to existing, evidence-based childhood obesity screening and management guidelines | Behavioural | Interruptive Clinical Decision Support |
Primary outcome
Change in body mass index (BMI)
Time frame: 1 year pre-intervention, baseline, and 1 year post-intervention
change in BMI, calculated from height and weight measured as part of routine clinical practice during primary care clinic visits and documented in the EHR
Change in percent BMI above the 95th percentile (%BMIp95)
Time frame: 1 year pre-intervention, baseline, and 1 year post-intervention
Change in percentage of age/sex-adjusted BMI above the 95th percentile (%BMIp95), calculated from height and weight measured as part of routine clinical practice during primary care clinic visits and documented in the EHR
Change in documentation of elevated BMI diagnosis
Time frame: 1-year pre-implementation compared to 1-year post-implementation
Change in proportion of patients with obesity who have elevated BMI documented in the EHR
Change in proportion of patients with obesity
Time frame: 1-year pre-implementation compared to 1-year post-implementation
Change in proportion of patients with obesity who receive age-appropriate screening for comorbidities (blood measure measurement and age-appropriate laboratory screening)
Change in proportion of patients with obesity who have counseling for obesity-related behavior change documented in the EHR
Time frame: 1-year pre-implementation compared to 1-year post-implementation
Change in proportion of patients with obesity with follow-up or referral orders
Time frame: 1-year pre-implementation compared to 1-year post-implementation
2 secondary outcomes
Change in provider knowledge, attitudes and practice around obesity management in primary care assessed via an electronic surveys and qualitative interviews of clinicians
Time frame: baseline compared to 6 months post-implementation
System usability scale (SUS) score
Time frame: 6 months post-implementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corinna Rea, MD, MPH principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interruptive Clinical Decision Support in people with Pediatric Obesity, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body mass index (BMI) (time frame: 1 year pre-intervention, baseline, and 1 year post-intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2021.