Redesigning Ambulatory Care Delivery to Enhance Asthma Control in Children

NCT ID: NCT02409277

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 926 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2016-12-31

Brief Summary

The investigators have developed a tool to facilitate asthma self-management in children, the electronic-AsthmaTracker (e-AT). The e-AT changes ambulatory asthma care delivery to a new model that is continuous and proactive, focusing on prevention and control, rather than reactive and focusing on management of asthma attacks. The e-AT 1) engages parents in weekly monitoring of their child's chronic asthma symptoms, 2) guides parents to recognize warning signs of asthma attacks in order to prompt appropriate interventions and timely visits to Primary Care Providers, and 3) provides Primary Care Providers with real-time, objective patient data to assess the effectiveness of asthma therapy and prompt adjustments. In a preliminary study of the paper-based version of the AT, frequent users had significantly fewer emergency department (ED) and hospital visits. Parent comments during the e-AT pilot testing revealed that the tool was useful in helping them manage their child's asthma and were interested in assessing the tool's effectiveness and in identifying and addressing barriers to their sustained use of the e-AT.

Improving asthma control in children will be facilitated by broad e-AT dissemination, and by identifying and addressing critical factors that contribute to parent sustained participation in self-management. The investigators propose to assess the effectiveness of the new ambulatory care model supported by the e-AT and conduct an e-AT process evaluation, assessing barriers and facilitators of sustained parent use. The investigators will engage parents throughout this study to identify and address themes that matter to them. The target population is children with persistent asthma, ages 2-17 years. The investigators have engaged 10 parents since conception of this project, from the planning to design and validation of the paper-AT, and the design and pilot testing of the e-AT. Input from parents was received through 3 iterative focus groups (one for the paper-AT and 2 for the e-AT) and facilitated discussions to inform the development of this proposal including research objectives and outcome measures. In addition, the investigators have recruited other key stakeholders for whom the results of the research will be relevant.

Detailed Description

Through the following specific aims, the investigators will:

Aim 1: Assess the effectiveness of the new ambulatory care model, by comparing outcomes at the 1.a. child (child's quality of life (QOL), asthma control, missed school days), 1.b.parent (satisfaction, parent missed work days) and 1.c. clinic (ED/hospital visits) levels, between clinics randomly assigned to either the standard e-AT intervention vs. intensive e-AT intervention. 1.d. Use non randomized comparisons to determine the effectiveness of the e-AT relative to a control group (usual care) in which the e-AT was not used

Aim 2: Assess the association of QOL, asthma control, and ED/hospital admissions with the prior frequency of e-AT use and assess if the association differs between parent subgroups (high vs. low literacy, Medicaid vs. private insurance, and frequent vs. less frequent e-AT users).

Aim 3: Determine the association of demographic, socio-economic, behavioral, and technology factors with sustained parent participation in asthma self-management.

The outcome measures are:

Primary Outcome:

1. Child quality of life (QOL)

Secondary Outcomes:

2. Child asthma control

3. Child interrupted/missed school days

4. Child use of oral steroids (surrogate measure of an asthma exacerbation)

5. Parent satisfaction with care

6. Parent interruption/missed work days

7. Clinics: ED/Hospital admissions

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Standard e-AT Intervention

Patients in Standard e-AT or standard intervention group will receive a daily (if a participant forgets to complete his/her weekly assessment) email and text reminders with a link to the e-AT website to help patient/parent participants to comply with their weekly assessment of patient's level of asthma control. Note: patient/parent participants are required to complete their asthma control assessment 1x/week. The e-AT is now set up to send a weekly reminder to participants with a link to the website. If a participant does not complete an assessment within a week of the last assessment, the reminder will be sent daily until the patient/parent complies and the system resets to weekly.

Group Type: EXPERIMENTAL

Experimental: Standard vs Intensive e-AT Intervention

Intervention Type: OTHER

Patients will be self-monitoring their symptoms weekly using the e-AT, either the Standard or Intensive versions of the e-AT, completing the Asthma Control Test. As patients complete their assessments each week, the clinics will be able to see how each patient is doing, and follow-up when a patient is showing high symptoms for that week, potentially avoiding Emergency Room visit, and/or hospitalization.

Intensive e-AT Intervention

Participants in the intensive e-AT or adherence support intervention will receive everything as those in Standard Intervention. In addition, they will see a progress bar display, which adds 25 points each time they complete an assessment. When this bar reaches 100 points, a pop-up message with fireworks will appear to congratulate them about the milestone. The progress bar resets to zero after it reaches 100 points. Participants will also see a leader board allowing them to compare themselves with the 5 best users to increase compliance.

Group Type: EXPERIMENTAL

Experimental: Standard vs Intensive e-AT Intervention

Intervention Type: OTHER

Patients will be self-monitoring their symptoms weekly using the e-AT, either the Standard or Intensive versions of the e-AT, completing the Asthma Control Test. As patients complete their assessments each week, the clinics will be able to see how each patient is doing, and follow-up when a patient is showing high symptoms for that week, potentially avoiding Emergency Room visit, and/or hospitalization.

Usual Care (Non-Randomized Cohort)

Both arms (Intensive and standard e-AT interventions) will be compared to each other as well as to a non-randomized cohort who did not receive the e-AT interventions. These non-randomized cohort will be matched 2:1 to each randomized individuals.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Experimental: Standard vs Intensive e-AT Intervention

Patients will be self-monitoring their symptoms weekly using the e-AT, either the Standard or Intensive versions of the e-AT, completing the Asthma Control Test. As patients complete their assessments each week, the clinics will be able to see how each patient is doing, and follow-up when a patient is showing high symptoms for that week, potentially avoiding Emergency Room visit, and/or hospitalization.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Primary care clinics with the clinical leadership to adopt use of e-AT for asthma management.

2. Have patients between 2 and 17 years of age with persistent asthma.

3. Ability of the facility to accommodate patient enrollment and training about use of e-AT.

1. Children ages 2 through 17 years and their parents (main parents or caregiver)

2. English speakers

3. Children who received or are receiving asthma treatment (at participating clinics).

4. Parents have Internet access

5. Children with persistent asthma.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Flory Nkoy

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Flory Nkoy, MD, MS, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

University of Utah

Salt Lake City, Utah, United States

Countries

United States

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Other Identifiers

51002874

Identifier Type: -

Identifier Source: org_study_id