ClinicalTrials.gov
ClinicalTrials.gov Menu

Promoting Asthma Guidelines and Management Through Technology-Based Intervention and Care Coordination (PRAGMATIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03066596
Recruitment Status : Recruiting
First Posted : February 28, 2017
Last Update Posted : July 25, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Marina Reznik, Montefiore Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The overall goal of this research study is to test the effectiveness of a multifaceted and multi-level prompting intervention in a real world urban primary care office setting on improving provider-delivered guideline-based asthma care and reducing asthma morbidity among urban children with persistent or uncontrolled asthma.

Condition or disease Intervention/treatment Phase
Asthma Childhood Behavioral: PRAGMATIC Not Applicable

Detailed Description:

Investigators will conduct a cluster randomized trial comparing the intervention to enhanced usual care (eUC) in 20 Bronx practices serving over 5,000 children ages 2-12 years with persistent or uncontrolled asthma. Eleven eUC practices will receive guideline information and assess children's asthma severity and control, but active intervention components will not be provided. Practices will join the study in 4 waves over 4 years (4-6 practices per year). Provider adoption of guidelines and utilization of care in all patients (~5,000) ages 2-12 years with persistent or uncontrolled asthma from intervention and eUC practices will be evaluated using Electronic Health Records (EHR) data and practice-based screening for asthma severity and control. Investigators will also enroll a random subset of 512 caregivers of children with persistent/uncontrolled asthma from both study arms to systematically evaluate caregiver-reported child morbidity outcomes and obtain measures not available in EHR.

Intervention consists of academic detailing in the EHR that follow national asthma guidelines and outreach worker care coordination for patients with persistent or uncontrolled asthma.


Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 512 participants
Intervention Model: Single Group Assignment
Intervention Model Description: enhanced Usual Care and Intervention sites
Masking: None (Open Label)
Masking Description: Follow up assessments will be collected by blinded interviewers
Primary Purpose: Supportive Care
Official Title: Promoting Asthma Guidelines and Management Through Technology-Based Intervention and Care Coordination
Actual Study Start Date : March 7, 2017
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: PRAGMATIC
Intervention practices will receive guideline information and assess children's asthma severity and control. For children with persistent/uncontrolled asthma, academic detailing and prompt in EHR following asthma guidelines will guide asthma management; outreach worker will follow up with patients referred to the by providers to receive care coordination to assure that provider management plan is followed by patient at home.
 Behavioral: PRAGMATIC
Provider educational seminar, EHR prompt, outreach-worker care coordination


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Proportion of visits with >1 guideline-based corrective actions [ Time Frame: through study completion, an average of 5 years ]
    provider adoption of guidelines


Secondary Outcome Measures :
  1. Symptom free days [ Time Frame: 14 days ]
    number of days without symptoms in the past 14 days


Other Outcome Measures:
  1. Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) [ Time Frame: 3-12 months ]
    caregiver asthma related quality of life

  2. Health care utilization: number of ED visits for asthma [ Time Frame: 3-12 months ]
    number of ED visits for asthma

  3. Health care utilization: number hospitalizations for asthma [ Time Frame: 3-12 months ]
    number hospitalizations for asthma


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

The criteria listed below will apply to ~5,000 children from eMPI and eUC practices:

  • Physician-diagnosed asthma (based on EHR).
  • Persistent or uncontrolled asthma as per clinic assessment. Based on NHLBI guidelines, any one of the following: in past month, > 2 days/week with asthma symptoms, >2 days/week with rescue medication use, >2 days/month with nighttime symptoms, or > 2 episodes in the past year that required systemic corticosteroids.
  • Age 2 and 12 years, inclusive.

Additional inclusion criteria will apply to a subset of 512 of children whose caregivers will be interviewed to obtain caregiver-reported morbidity outcomes:

  • Caregiver is able to speak and understand either English or Spanish. Participants unable to read will be eligible as all surveys will be administered verbally by research personnel.
  • Consent from the primary caregiver, caregiver permission for the child to participate as well as assent from the child (>7 years). If there are eligible siblings, only one child will be randomly selected.

Exclusion Criteria:

  • The child has other significant medical conditions, such as congenital heart disease, cystic fibrosis, or other chronic lung disease, that could interfere with the assessment of asthma-related measures.

Additional exclusion criteria will apply to a subset of 512 children/caregivers as described above:

  • No access to a telephone to conduct follow-up surveys.
  • Children in foster care or other situations in which consent cannot be obtained from a guardian.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03066596


Contacts
Contact: Marina Reznik 7187412494 mreznik@montefiore.org
Contact: Guadalupe Salazar guadalupe.salazar@einstein.yu.edu

Locations
United States, New York
Children's Hospital at Montefiore, Albert Einstein College of Medicine Recruiting
Bronx, New York, United States, 10467
Contact: Marina Reznik, MD, MS    718-741-2494    mreznik@montefiore.org   
Principal Investigator: Marina Reznik, MD, MS         
Sponsors and Collaborators
Montefiore Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Marina Reznik, MD, MS Montefiore Medical Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Marina Reznik, Associate Professor, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT03066596     History of Changes
Other Study ID Numbers: 2016-6258
1R01HL133789-01 ( U.S. NIH Grant/Contract )
First Posted: February 28, 2017    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Investigators will share de-identified data using Data Sharing Agreement process after the study is completed and main study aims manuscripts have been published.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases