Pediatric HypertensionBP-CATCHNCT03783650
Boosting Primary Care Awareness and Treatment of Childhood Hypertension
A study testing QIC with PCP and without subspecialist, QIC with Subspecialist and Hub and Spoke co-management in people with Pediatric Hypertension, run by Montefiore Medical Center at 1 site in United States.
Trial summary
The proposed research, building on an ongoing AHRQ-funded research project to prevent pediatric diagnostic errors in primary care (R01HS023608) and using a prospective, cluster-randomized, stepped wedge design, will investigate whether 1) a quality improvement collaborative (QIC) intervention without subspecialist… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pediatric Hypertension
- What is being tested?
- QIC with PCP and without subspecialist, QIC with Subspecialist and Hub and Spoke co-management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 14 Jul 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primary care pediatric practices who see children ages 3-22 years old.
- Practice must be able to field a 3-person core improvement team who can participate in the quality improvement collaborative.
Who cannot join
- Non-pediatric practices
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein College of Medicine
The Bronx, New York, 10461
About this study
Official title: BP-CATCH: Boosting Primary Care Awareness and Treatment of Childhood Hypertension
The proposed research, building on an ongoing AHRQ-funded research project to prevent pediatric diagnostic errors in primary care (R01HS023608) and using a prospective, cluster-randomized, stepped wedge design, will investigate whether 1) a quality improvement collaborative (QIC) intervention without subspecialist involvement, 2) a QIC with subspecialists and primary care physicians (PCPs) mutually engaged, and/or 3) a hub and spoke co-diagnosis, co-management model where PCPs diagnose and manage pediatric hypertension (HTN) with a supporting subspecialist advisor, reduce errors in pediatric HTN diagnosis and management compared to each other and usual care.
Read the detailed description
Pediatric HTN causes appreciable morbidity in pediatric patients and errors in diagnosis and management are frequent and understudied, jeopardizing pediatric safety in ambulatory settings. Additionally, the gap between the number of pediatric subspecialist providers and the number needed for patient care continues to widen, and it is unclear how to best reduce burden on subspecialists, improve PCP and subspecialist communication, and improve patient outcomes. This research team, with significant experience researching ambulatory pediatric safety, conducting QICs and HTN interventions, identified six large pediatric practice groups in rural, suburban and urban locations that are committed to reducing preventable HTN patient harm, to testing the effectiveness of a QIC to improve PCP HTN diagnosis and management, and to a hub and spoke HTN co-diagnosis and co-management model. The effect demonstrated by this project using a rigorous research design and the new 2017 pediatric HTN guidelines, will motivate pediatric clinics across the country to adopt these newly-identified best practices to improve pediatric HTN care. Primary care pediatricians have an imperative to diagnose and manage HTN and elevated BP (EBP) more accurately and earlier, and to improve interactions with subspecialists to reduce the lifelong preventable harm that results from these chronic conditions. This proposal, will identify a clear implementation strategy for rigorous, evidenced-based pediatric HTN diagnosis and management, and highlight a model to increase primary and subspecialty care integration that can be reproduced across other chronic conditions.
The primary human subjects of this work are the physicians and staff within the primary care pediatric practices and their associated pediatric hypertension subspecialists whose behavior the QIC is attempting to change. In order to know if these practices and subspecialists have changed their behaviors, we will look at patient data. To be included in the data cohort, patients must have a blood pressure (BP) measurement that is elevated (>= 90th percentile for patient's sex, age, and height, or >=120/80 (regardless of sex/age/ height) at a healthcare maintenance visit or non-acute care visit (e.g. chronic disease follow-up visit). The following patients would be excluded from the data cohort:
- Prior hypertension or elevated BP diagnosis. Patient can have prior elevated BP measurements as long as no diagnosis has been made
- BP>95th percentile + 30mm or >180/120 or symptomatic patient
- Prior diagnosis of congenital heart disease, chronic kidney disease, urologic disease (e.g. posterior urethral valve, vesicoureteral reflux) or organ transplant,
- Previously included in BP-CATCH data entry
- Acute care visit (e.g., fever, viral illness, asthma attack, pain in any body part, etc.)
- Conditions
- Pediatric Hypertension
- Being tested
- Control condition, QIC with PCP and without subspecialist, QIC with Subspecialist, Hub and Spoke co-management, Sustainability of changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control conditionBehavioural
Practices will submit control data and not receive centralized data feedback. They will also begin tracking data on a HTN registry and learn how to ensure accurate BP measurement is completed in their clinic.
QIC with PCP and without subspecialistBehavioural
During this phase, practice will begin working on improving HTN practices within their clinic via a QIC, while the other cohort will act as a control (usual care) with data collection. They will attend an initial 1-day interactive video webinar learning session where they will learn QI methodology, enhance and practice QI skills, identify local 30-60 day aims to improve local HTN practices and increase their understanding of pediatric HTN. They will also begin tracking data on a HTN registry and learn how to ensure accurate BP measurement is completed in their clinic. They will participate in QI coaching, monthly video conferences, and monthly mini-root cause analyses (Mini-RCAs).
QIC with SubspecialistBehavioural
Practices will integrate their HTN subspecialist into the QIC and focus on issues at the boundary of PCP and subspecialty care (e.g. pre-referral work-up, communication across providers, and time for next available appointment).
Hub and Spoke co-managementBehavioural
Practices will continue QIC components and implement a hub and spoke model, where the PCP diagnoses and provides definitive management for pediatric HTN with subspecialist support.
Sustainability of changesBehavioural
Practices will sustain their changes, illustrating the durability of these system changes even after QIC completion and without central feedback and regular meetings.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 0-6 months: Quality Improvement Collaborative (QIC) with PCP and without subspecialist, Registry \& BP measurement 7-12 months: QIC with Subspecialist to improve communication and standardize, 13-18 months: Hub and Spoke co-management QIC with Primary care and Subspecialist 19-24 months: Sustainability of changes Receives: Behavioral: QIC with PCP and without subspecialist; Behavioral: QIC with Subspecialist; Behavioral: Hub and Spoke co-management; Behavioral: Sustainability of changes |
| Cohort 2 | Active comparator | 0-6 months: Control condition Usual Care and Registry \& BP measurement, 7-12 months: Quality Improvement Collaborative (QIC) with PCP and without subspecialist 13-18 months: QIC with Subspecialist to improve communication and standardize 19-24 months: Hub and Spoke co-management QIC with Primary care and Subspecialist Receives: Behavioral: Control condition; Behavioral: QIC with PCP and without subspecialist; Behavioral: QIC with Subspecialist; Behavioral: Hub and Spoke co-management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients without all correct diagnostic and management decisions
Number of patients without all correct diagnostic and management decisions per 100 patients with measured elevated BP
Measured: average 34 months
Secondary outcomes (12)
Number of patients without re-measuring of BP twice in clinic via auscultation
Number of patients without re-measuring of BP twice in clinic via auscultation at specified points per 100 patients with measured elevated BP
Measured: average 34 months
Number of patients without weight counseling management decisions
Number of patients without weight counseling at specified points per 100 patients with measured elevated BP
Measured: average 34 months
Number of patients without lifestyle modification counseling management decisions
Number of patients without lifestyle modification counseling management decisions at specified points per 100 patients with measured elevated BP
Measured: average 34 months
Number of patients without nutrition counseling management decisions
Number of patients without nutrition counseling management decisions at specified points per 100 patients with measured elevated BP
Measured: average 34 months
Number of patients without repeat BP measurement visits appropriately timed
Number of patients without repeat BP measurement visits appropriately timed at specified points per 100 patients with measured elevated BP
Measured: average 34 months
Number of patients without initial laboratory workup diagnostic decisions
Number of patients without initial laboratory workup at specified points per 100 patients with measured elevated BP
Measured: average 34 months
Number of patients without Subspecialist referral
Number of patients without Subspecialist referral at specified points per 100 patients with measured elevated BP
Measured: average 34 months
Number of patients without echocardiogram workup diagnostic decisions
Number of patients without echocardiogram workup diagnostic decisions at specified points per 100 patients with measured elevated BP
Measured: average 34 months
Number of patients without echocardiogram diagnostic decisions
Number of patients without echocardiogram diagnostic decisions at specified points per 100 patients with measured elevated BP
Measured: average 34 months
Number of patients without radiology diagnostic decisions
Number of patients without radiology diagnostic decisions at specified points per 100 patients with measured elevated BP
Measured: average 34 months
BPs measured correctly that met specific criteria
Number of measured BPs correctly per 100 patients with BP measured with appropriately screened patient, patient position, cuff size, inflation, BP percentiles correctly documented and interpreted
Measured: average 34 months
Time to third new next available subspecialist appointment
Third new next available appointment for pediatric patients to subspecialist clinics in order to assess the effects of pediatric primary care providers referring and managing different types of patients with hypertension.
Measured: average 33 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2018
- Study start1 Sep 2018
- Primary completion14 Jul 2020
- Study completion14 Jul 2020
Why it stopped: Study halted prematurely and will not resume due to the COVID-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pediatric HypertensionStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Michael Rinke, Montefiore Medical Center
- Investigators
- Michael L Rinke, MD, Principal investigator, Albert Einstein College of Medicine and The Children's Hospital at Montefiore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03783650
- Sponsor's protocol ID
- 2018-9287
- Other IDs
- R01HS026239
- Acronym
- BP-CATCH
- Status last verified
- Sep 2020
- First submitted
- 19 Dec 2018
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heo M, Rea CJ, Brady TM, Bundy DG, Melikam ES, Orringer K, Tarini BA, Giuliano K, Twombley K, Goilav B, Kelly P, Faith MS, Pietrobelli A, Rinke ML. Racial and Ethnic Disparities in Pediatric Counseling on Nutrition, Lifestyle, and Weight: A Secondary Analysis of the BP-CATCH Randomized Clinical Trial. JAMA Netw Open. 2025 Jan 2;8(1):e2456238. doi: 10.1001/jamanetworkopen.2024.56238.
PubMed 39878982Rea CJ, Brady TM, Bundy DG, Heo M, Faro E, Giuliano K, Goilav B, Kelly P, Orringer K, Tarini BA, Twombley K, Rinke ML. Pediatrician Adherence to Guidelines for Diagnosis and Management of High Blood Pressure. J Pediatr. 2022 Mar;242:12-17.e1. doi: 10.1016/j.jpeds.2021.11.008. Epub 2021 Nov 10.
PubMed 34774574
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BP-CATCH: Boosting Primary Care Awareness and Treatment of Childhood Hypertension
- ClinicalTrials.gov ID
- NCT03783650
- Acronym / sponsor ID
- BP-CATCH / 2018-9287
- Conditions
- Pediatric Hypertension
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study halted prematurely and will not resume due to the COVID-19 pandemic.
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 14 Jul 2020 (actual)
- Study completion
- 14 Jul 2020 (actual)
- First posted
- 21 Dec 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.
The proposed research, building on an ongoing AHRQ-funded research project to prevent pediatric diagnostic errors in primary care (R01HS023608) and using a prospective, cluster-randomized, stepped wedge design, will investigate whether 1) a quality improvement collaborative (QIC) intervention without subspecialist involvement, 2) a QIC with subspecialists and primary care physicians (PCPs) mutually engaged, and/or 3) a hub and spoke co-diagnosis, co-management model where PCPs diagnose and manage pediatric hypertension (HTN) with a supporting subspecialist advisor, reduce errors in pediatric HTN diagnosis and management compared to each other and usual care.
Detailed description
Pediatric HTN causes appreciable morbidity in pediatric patients and errors in diagnosis and management are frequent and understudied, jeopardizing pediatric safety in ambulatory settings. Additionally, the gap between the number of pediatric subspecialist providers and the number needed for patient care continues to widen, and it is unclear how to best reduce burden on subspecialists, improve PCP and subspecialist communication, and improve patient outcomes. This research team, with significant experience researching ambulatory pediatric safety, conducting QICs and HTN interventions, identified six large pediatric practice groups in rural, suburban and urban locations that are committed to reducing preventable HTN patient harm, to testing the effectiveness of a QIC to improve PCP HTN diagnosis and management, and to a hub and spoke HTN co-diagnosis and co-management model. The effect demonstrated by this project using a rigorous research design and the new 2017 pediatric HTN guidelines, will motivate pediatric clinics across the country to adopt these newly-identified best practices to improve pediatric HTN care. Primary care pediatricians have an imperative to diagnose and manage HTN and elevated BP (EBP) more accurately and earlier, and to improve interactions with subspecialists to reduce the lifelong preventable harm that results from these chronic conditions. This proposal, will identify a clear implementation strategy for rigorous, evidenced-based pediatric HTN diagnosis and management, and highlight a model to increase primary and subspecialty care integration that can be reproduced across other chronic conditions.
The primary human subjects of this work are the physicians and staff within the primary care pediatric practices and their associated pediatric hypertension subspecialists whose behavior the QIC is attempting to change. In order to know if these practices and subspecialists have changed their behaviors, we will look at patient data. To be included in the data cohort, patients must have a blood pressure (BP) measurement that is elevated (>= 90th percentile for patient's sex, age, and height, or >=120/80 (regardless of sex/age/ height) at a healthcare maintenance visit or non-acute care visit (e.g. chronic disease follow-up visit). The following patients would be excluded from the data cohort:
- Prior hypertension or elevated BP diagnosis. Patient can have prior elevated BP measurements as long as no diagnosis has been made
- BP>95th percentile + 30mm or >180/120 or symptomatic patient
- Prior diagnosis of congenital heart disease, chronic kidney disease, urologic disease (e.g. posterior urethral valve, vesicoureteral reflux) or organ transplant,
- Previously included in BP-CATCH data entry
- Acute care visit (e.g., fever, viral illness, asthma attack, pain in any body part, etc.)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Behavioral: QIC with PCP and without subspecialist, Behavioral: QIC with Subspecialist, Behavioral: Hub and Spoke co-management, Behavioral: Sustainability of changes0-6 months: Quality Improvement Collaborative (QIC) with PCP and without subspecialist, Registry \& BP measurement 7-12 months: QIC with Subspecialist to improve communication and standardize, 13-18 months: Hub and Spoke co-management QIC with Primary care and Subspecialist 19-24 months: Sustainability of changes |
| Cohort 2 | Active comparator | Behavioral: Control condition, Behavioral: QIC with PCP and without subspecialist, Behavioral: QIC with Subspecialist, Behavioral: Hub and Spoke co-management0-6 months: Control condition Usual Care and Registry \& BP measurement, 7-12 months: Quality Improvement Collaborative (QIC) with PCP and without subspecialist 13-18 months: QIC with Subspecialist to improve communication and standardize 19-24 months: Hub and Spoke co-management QIC with Primary care and Subspecialist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Primary care pediatric practices who see children ages 3-22 years old.
- Practice must be able to field a 3-person core improvement team who can participate in the quality improvement collaborative.
Key exclusion criteria (1 listed)
- Non-pediatric practices
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 |
|---|---|---|
| Control conditionPractices will submit control data and not receive centralized data feedback. They will also begin tracking data on a HTN registry and learn how to ensure accurate BP measurement is completed in their clinic. | Behavioural | Cohort 2 |
| QIC with PCP and without subspecialistDuring this phase, practice will begin working on improving HTN practices within their clinic via a QIC, while the other cohort will act as a control (usual care) with data collection. They will attend an initial 1-day interactive video webinar learning session where they will learn QI methodology, enhance and practice QI skills, identify local 30-60 day aims to improve local HTN practices and increase their understanding of pediatric HTN. They will also begin tracking data on a HTN registry and learn how to ensure accurate BP measurement is completed in their clinic. They will participate in QI coaching, monthly video conferences, and monthly mini-root cause analyses (Mini-RCAs). | Behavioural | Cohort 1, Cohort 2 |
| QIC with SubspecialistPractices will integrate their HTN subspecialist into the QIC and focus on issues at the boundary of PCP and subspecialty care (e.g. pre-referral work-up, communication across providers, and time for next available appointment). | Behavioural | Cohort 1, Cohort 2 |
| Hub and Spoke co-managementPractices will continue QIC components and implement a hub and spoke model, where the PCP diagnoses and provides definitive management for pediatric HTN with subspecialist support. | Behavioural | Cohort 1, Cohort 2 |
| Sustainability of changesPractices will sustain their changes, illustrating the durability of these system changes even after QIC completion and without central feedback and regular meetings. | Behavioural | Cohort 1 |
Primary outcome
Number of patients without all correct diagnostic and management decisions
Time frame: average 34 months
Number of patients without all correct diagnostic and management decisions per 100 patients with measured elevated BP
12 secondary outcomes
Number of patients without re-measuring of BP twice in clinic via auscultation
Time frame: average 34 months
Number of patients without weight counseling management decisions
Time frame: average 34 months
Number of patients without lifestyle modification counseling management decisions
Time frame: average 34 months
Number of patients without nutrition counseling management decisions
Time frame: average 34 months
Number of patients without repeat BP measurement visits appropriately timed
Time frame: average 34 months
Number of patients without initial laboratory workup diagnostic decisions
Time frame: average 34 months
Number of patients without Subspecialist referral
Time frame: average 34 months
Number of patients without echocardiogram workup diagnostic decisions
Time frame: average 34 months
Number of patients without echocardiogram diagnostic decisions
Time frame: average 34 months
Number of patients without radiology diagnostic decisions
Time frame: average 34 months
BPs measured correctly that met specific criteria
Time frame: average 34 months
Time to third new next available subspecialist appointment
Time frame: average 33 months
Results and safety
The study was stopped early (reason given: Study halted prematurely and will not resume due to the COVID-19 pandemic.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Derived from this study: PubMed 39878982Heo M, Rea CJ, Brady TM, Bundy DG, Melikam ES, Orringer K, Tarini BA, Giuliano K, Twombley K, Goilav B, Kelly P, Faith MS, Pietrobelli A, Rinke ML. Racial and Ethnic Disparities in Pediatric Counseling on Nutrition, Lifestyle, and Weight: A Secondary Analysis of the BP-CATCH Randomized Clinical Trial. JAMA Netw Open. 2025 Jan 2;8(1):e2456238. doi: 10.1001/jamanetworkopen.2024.56238.
- Derived from this study: PubMed 34774574Rea CJ, Brady TM, Bundy DG, Heo M, Faro E, Giuliano K, Goilav B, Kelly P, Orringer K, Tarini BA, Twombley K, Rinke ML. Pediatrician Adherence to Guidelines for Diagnosis and Management of High Blood Pressure. J Pediatr. 2022 Mar;242:12-17.e1. doi: 10.1016/j.jpeds.2021.11.008. Epub 2021 Nov 10.
- 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.
Michael L Rinke, MD principal investigator
Albert Einstein College of Medicine and The Children's Hospital at Montefiore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QIC with PCP and without subspecialist, QIC with Subspecialist and Hub and Spoke co-management in people with Pediatric Hypertension, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Sep 2020. 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 was stopped early (reason given: Study halted prematurely and will not resume due to the COVID-19 pandemic.). Results are not available in the source record.
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?
Number of patients without all correct diagnostic and management decisions (time frame: average 34 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03783650, which also lists 2 linked publications.
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 3 Sep 2020.