This trial is active, not recruiting.

Condition asthma
Treatment multifaceted prompting intervention mpi
Sponsor University of Rochester
Collaborator National Heart, Lung, and Blood Institute (NHLBI)
Start date October 2008
End date July 2015
Trial size 638 participants
Trial identifier NCT01105754, 1R01HL091835-01A1, 25281


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose health services research
(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
multifaceted prompting intervention mpi
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.

Primary Outcomes

Symptom Free Days
time frame: 2 month follow-up assessment

Secondary Outcomes

Number of children who received guideline-based asthma care during the intervention visit.
time frame: 2 week follow-up, and medical record review

Eligibility Criteria

Male or female participants from 2 years up to 12 years old.

Inclusion Criteria: - 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. Exclusion Criteria: - 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

Additional Information

Official title A Multifaceted Prompting Intervention for Urban Children With Asthma
Principal investigator Jill S. Halterman, MD, MPH
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by University of Rochester.