AsthmaPAIR-UPNCT01105754
A Multifaceted Prompting Intervention for Urban Children With Asthma
A study testing Multifaceted Prompting Intervention MPI in people with Asthma, run by University of Rochester at 1 site in United States.
Trial summary
The overall goal of this project is to evaluate whether a multifaceted prompting intervention, administered in the urban primary care office setting, reduces morbidity among urban children with asthma. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Asthma
- What is being tested?
- Multifaceted Prompting Intervention MPI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 638 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Physician-diagnosed asthma
- Mild persistent or more severe asthma severity, or poor asthma control
- Age >2 and <12 years.
- Parent or caregiver must give permission to the study, and children >7 will must provide assent.
Who cannot join
- Inability to speak and understand English or Spanish
- No access to a working phone for follow-up surveys
- The child having other significant medical conditions,
- Children in foster care or other situations in which consent cannot be obtained from a guardian.
- Prior enrollment in the study.
- Child will not be seen by a physician or nurse practitioner during their visit
Trial locations and contacts
1 site in 1 country.
About this study
The overall goal of this project is to evaluate whether a multifaceted prompting intervention, administered in the urban primary care office setting, reduces morbidity among urban children with asthma. This study builds on our experience with a pilot study in two urban continuity clinics, in which we found that prompting clinicians about asthma severity and care guidelines at the time of an office visit resulted in improved preventive care delivery to inner-city children. This type of prompting program has the potential to substantially improve care for impoverished children with asthma, and we propose to establish: 1) whether these findings can be replicated in a similar study including a larger sample of urban children from different types of practices, and 2) whether the positive effects can be enhanced by more specific prompting directed towards both the provider and the caregiver and by providing practice-level supports and feedback. We hypothesize that children receiving a multifaceted prompting intervention (MPI) will experience less asthma-related morbidity (defined by symptom-free days at the 2-month follow-up) compared to children receiving usual care. Our secondary hypothesis is that children receiving the MPI will receive improved preventive asthma care (defined by guideline-based corrective actions taken at the index visit) compared to children receiving usual care.
- Conditions
- Asthma
- Being tested
- Multifaceted Prompting Intervention MPI
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifaceted Prompting Intervention MPIBehavioural
Practices assigned to the MPI group will receive a simple prompt given to the provider at the time of the visit with information regarding the child's symptoms, medication use, environmental exposures, and recommendations for guideline-based preventive care. Practices will receive brief interactive seminars, resource guides, access to free asthma education programs, and practice-level feedback regarding their performance on key outcome measures.
Caregivers will receive a simple prompt, community resources, and a blank asthma action plan form.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | Parents of children in the standard care group will complete the baseline assessment, but no asthma prompt will be created for either the caregiver or provider, and no information regarding the interview will be shared with the provider. After the baseline assessment, the office visit will proceed according to usual care. |
| Multifaceted Prompting Intervention | Experimental | Multifaceted Prompting Intervention Receives: Behavioral: Multifaceted Prompting Intervention MPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom Free Days
The primary outcome is asthma morbidity measured by the number of symptom-free asthma days (SFD) reported over 2 weeks at the 2-month follow-up assessment.
Measured: 2 month follow-up assessment
Secondary outcomes (1)
Number of Children Who Received Guideline-based Asthma Care During the Intervention Visit.
The number of children who received guideline-based asthma care (eg: inhaled steroid prescription, counseling for triggers, counseling for adherence) at the intervention visit based on parent interview at the 2-week follow-up and medical record review.
Measured: 2 week follow-up, and medical record review
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2010 (estimated)
- Study startOct 2008
- Primary completionSep 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 638 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jill Halterman, University of Rochester
- Investigators
- Jill S. Halterman, MD, MPH, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01105754
- Sponsor's protocol ID
- 25281
- Other IDs
- 1R01HL091835-01A1
- Acronym
- PAIR-UP
- Status last verified
- Jan 2016
- First submitted
- 15 Apr 2010
- Last updated
- 8 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Fagnano M, Berkman E, Wiesenthal E, Butz A, Halterman JS. Depression among caregivers of children with asthma and its impact on communication with health care providers. Public Health. 2012 Dec;126(12):1051-7. doi: 10.1016/j.puhe.2012.08.007. Epub 2012 Oct 25.
PubMed 23102501Yee AB, Fagnano M, Halterman JS. Preventive asthma care delivery in the primary care office: missed opportunities for children with persistent asthma symptoms. Acad Pediatr. 2013 Mar-Apr;13(2):98-104. doi: 10.1016/j.acap.2012.10.009. Epub 2013 Jan 5.
PubMed 23294977Gutierrez SJ, Fagnano M, Wiesenthal E, Koehler AD, Halterman JS. Discrepancies between medical record data and parent reported use of preventive asthma medications. J Asthma. 2014 May;51(4):446-50. doi: 10.3109/02770903.2013.878351. Epub 2014 Jan 30.
PubMed 24404799Lewis P, Fagnano M, Koehler A, Halterman JS. Racial disparities at the point of care for urban children with persistent asthma. J Community Health. 2014 Aug;39(4):706-11. doi: 10.1007/s10900-013-9815-5.
PubMed 24435717Carlin C, Yee AB, Fagnano M, Halterman JS. The influence of Hispanic ethnicity on parent-provider communication about asthma. Clin Pediatr (Phila). 2014 Apr;53(4):380-6. doi: 10.1177/0009922813510598. Epub 2013 Nov 26.
PubMed 24281159Halterman JS, Fagnano M, Tremblay PJ, Fisher SG, Wang H, Rand C, Szilagyi P, Butz A. Prompting asthma intervention in Rochester-uniting parents and providers (PAIR-UP): a randomized trial. JAMA Pediatr. 2014 Oct;168(10):e141983. doi: 10.1001/jamapediatrics.2014.1983. Epub 2014 Oct 6.
PubMed 25288141Goldstein NPN, Frey SM, Fagnano M, Okelo SO, Halterman JS. Identifying Which Urban Children With Asthma Benefit Most From Clinician Prompting: Subgroup Analyses From the Prompting Asthma Intervention in Rochester-Uniting Parents and Providers (PAIR-UP) Trial. Acad Pediatr. 2018 Apr;18(3):305-309. doi: 10.1016/j.acap.2017.08.015. Epub 2017 Sep 9.
PubMed 28899842
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multifaceted Prompting Intervention for Urban Children With Asthma
- ClinicalTrials.gov ID
- NCT01105754
- Acronym / sponsor ID
- PAIR-UP / 25281
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 638 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Oct 2008
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 16 Apr 2010 (estimated)
- Results
- Posted 16 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal of this project is to evaluate whether a multifaceted prompting intervention, administered in the urban primary care office setting, reduces morbidity among urban children with asthma. This study builds on our experience with a pilot study in two urban continuity clinics, in which we found that prompting clinicians about asthma severity and care guidelines at the time of an office visit resulted in improved preventive care delivery to inner-city children. This type of prompting program has the potential to substantially improve care for impoverished children with asthma, and we propose to establish: 1) whether these findings can be replicated in a similar study including a larger sample of urban children from different types of practices, and 2) whether the positive effects can be enhanced by more specific prompting directed towards both the provider and the caregiver and by providing practice-level supports and feedback. We hypothesize that children receiving a multifaceted prompting intervention (MPI) will experience less asthma-related morbidity (defined by symptom-free days at the 2-month follow-up) compared to children receiving usual care. Our secondary hypothesis is that children receiving the MPI will receive improved preventive asthma care (defined by guideline-based corrective actions taken at the index visit) compared to children receiving usual care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –Parents of children in the standard care group will complete the baseline assessment, but no asthma prompt will be created for either the caregiver or provider, and no information regarding the interview will be shared with the provider. After the baseline assessment, the office visit will proceed according to usual care. |
| Multifaceted Prompting Intervention | Experimental | Behavioral: Multifaceted Prompting Intervention MPIMultifaceted Prompting Intervention |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Physician-diagnosed asthma
- Mild persistent or more severe asthma severity, or poor asthma control
- Age >2 and <12 years.
- Parent or caregiver must give permission to the study, and children >7 will must provide assent.
Key exclusion criteria (6 listed)
- Inability to speak and understand English or Spanish
- No access to a working phone for follow-up surveys
- The child having other significant medical conditions,
- Children in foster care or other situations in which consent cannot be obtained from a guardian.
- Prior enrollment in the study.
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 |
|---|---|---|
| Multifaceted Prompting Intervention MPIPractices assigned to the MPI group will receive a simple prompt given to the provider at the time of the visit with information regarding the child's symptoms, medication use, environmental exposures, and recommendations for guideline-based preventive care. Practices will receive brief interactive seminars, resource guides, access to free asthma education programs, and practice-level feedback regarding their performance on key outcome measures. Caregivers will receive a simple prompt, community resources, and a blank asthma action plan form. | Behavioural | Multifaceted Prompting Intervention |
Primary outcome
Symptom Free Days
Time frame: 2 month follow-up assessment
The primary outcome is asthma morbidity measured by the number of symptom-free asthma days (SFD) reported over 2 weeks at the 2-month follow-up assessment.
1 secondary outcome
Number of Children Who Received Guideline-based Asthma Care During the Intervention Visit.
Time frame: 2 week follow-up, and medical record review
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23102501Fagnano M, Berkman E, Wiesenthal E, Butz A, Halterman JS. Depression among caregivers of children with asthma and its impact on communication with health care providers. Public Health. 2012 Dec;126(12):1051-7. doi: 10.1016/j.puhe.2012.08.007. Epub 2012 Oct 25.
- Background: PubMed 23294977Yee AB, Fagnano M, Halterman JS. Preventive asthma care delivery in the primary care office: missed opportunities for children with persistent asthma symptoms. Acad Pediatr. 2013 Mar-Apr;13(2):98-104. doi: 10.1016/j.acap.2012.10.009. Epub 2013 Jan 5.
- Background: PubMed 24404799Gutierrez SJ, Fagnano M, Wiesenthal E, Koehler AD, Halterman JS. Discrepancies between medical record data and parent reported use of preventive asthma medications. J Asthma. 2014 May;51(4):446-50. doi: 10.3109/02770903.2013.878351. Epub 2014 Jan 30.
- Background: PubMed 24435717Lewis P, Fagnano M, Koehler A, Halterman JS. Racial disparities at the point of care for urban children with persistent asthma. J Community Health. 2014 Aug;39(4):706-11. doi: 10.1007/s10900-013-9815-5.
- Background: PubMed 24281159Carlin C, Yee AB, Fagnano M, Halterman JS. The influence of Hispanic ethnicity on parent-provider communication about asthma. Clin Pediatr (Phila). 2014 Apr;53(4):380-6. doi: 10.1177/0009922813510598. Epub 2013 Nov 26.
- Results publication: PubMed 25288141Halterman JS, Fagnano M, Tremblay PJ, Fisher SG, Wang H, Rand C, Szilagyi P, Butz A. Prompting asthma intervention in Rochester-uniting parents and providers (PAIR-UP): a randomized trial. JAMA Pediatr. 2014 Oct;168(10):e141983. doi: 10.1001/jamapediatrics.2014.1983. Epub 2014 Oct 6.
- Derived from this study: PubMed 28899842Goldstein NPN, Frey SM, Fagnano M, Okelo SO, Halterman JS. Identifying Which Urban Children With Asthma Benefit Most From Clinician Prompting: Subgroup Analyses From the Prompting Asthma Intervention in Rochester-Uniting Parents and Providers (PAIR-UP) Trial. Acad Pediatr. 2018 Apr;18(3):305-309. doi: 10.1016/j.acap.2017.08.015. Epub 2017 Sep 9.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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.
Jill S. Halterman, MD, MPH principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multifaceted Prompting Intervention MPI in people with Asthma, run by University of Rochester 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 8 Feb 2016. 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?
Yes. Results are posted in the registry (first posted 16 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Symptom Free Days (time frame: 2 month follow-up assessment). 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 NCT01105754, which also lists 7 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 8 Feb 2016.