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Redesigning Ambulatory Care Delivery to Enhance Asthma Control in Children

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02409277
Recruitment Status : Completed
First Posted : April 6, 2015
Results First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Flory Nkoy, University of Utah

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.


Condition or disease Intervention/treatment Phase
Asthma Other: Experimental: Standard vs Intensive e-AT Intervention Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 926 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: We initially enrolled 327 randomized (at the clinic level) participants who received the e-AT interventions overall, including 267 participants receiving the standard intervention and 60 receiving the intensive intervention. We also included another set of 599 non-randomized matched controls of patients with persistent asthma retrieved electronically from non-participating clinics. This is why we stated that 926 subjects (327+599) overall were included.
Primary Purpose: Prevention
Official Title: Redesigning Ambulatory Care Delivery to Enhance Asthma Control in Children
Actual Study Start Date : August 2013
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Other: 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.

Experimental: 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.
Other: 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.

No Intervention: 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.



Primary Outcome Measures :
  1. Patient Quality of Life (QOL), Compared Mean QOL Change From Baseline at Each Follow-up Assessment Between the Clinics Assigned to the Intensive and Standard e-AT Interventions [ Time Frame: Quality of Life assessed at baseline, then compared to 3 months, 6 months, and 12 months after intervention. ]

    Patient QOL and missed school days was collected longitudinally through surveys of the study population defined above. The QOL questionnaire included the Integrated Therapeutics Group Child Asthma Short Form (ITG-CASF) and was used at baseline (at first assessment), 3, 6, and 12 months in the study.

    Items within QOL scales are summed and linearly transformed from 0 to 100, with higher scores indicating better functioning.


  2. Patient Quality of Life (QOL), Overall Longitudinal Change (From Baseline) Within All Subjects (Who Received the e-AT Intervention) [ Time Frame: Average Baseline QOL was compared to QOL scores at 3, 6 and 12 month follow-up QOL ]
    Patient QOL and missed school days was collected longitudinally through surveys of the study population defined above. The QOL questionnaire included the Integrated Therapeutics Group Child Asthma Short Form - ITG-CASF and was used at baseline (at first assessment), 3, 6, and 12 months in the study. Items within scales are summed and linearly transformed from 0 to 100, with higher scores indicating better functioning.


Secondary Outcome Measures :
  1. Parent Satisfaction With Care, Standard vs Intensive [ Time Frame: Changes in satisfaction was compared between 12 month follow-up and baseline satisfaction across Standard and Intensive interventions ]

    Parent satisfaction data was collected at baseline and at 12 months in the study.

    The scale ranges from 1-5, with 1 being "Very Dissatisfied" and 5 "Very Satisfied".


  2. Child Interrupted/Missed School Days, Standard vs Intensive [ Time Frame: Interrupted/missed school days were collected at baseline, 3, 6, and 12 month follow-ups ]

    Number of child interrupted/missed school days were collected longitudinally at the same time as collecting the QOL scores: baseline, 3, 6, and 12 months in the study.

    Number of child interrupted/missed school days during the 3 months prior to baseline, 3, 6, and 12 months follow-up surveys were counted.


  3. Parent Interrupted/Missed Work Days, Standard vs Intensive [ Time Frame: Interrupted/missed work days were measured baseline 3, 6, and 12 months ]

    Number of parent interrupted/missed work days were collected longitudinally at the same time as collecting the QOL scores: baseline, 3, 6, and 12 months in the study.

    Number of parent interrupted/missed work days during the 3 months prior to baseline, 3, 6, and 12 months follow-up surveys were counted.


  4. Asthma Control Change, Standard vs Intensive [ Time Frame: Average baseline ACT scores compared to average ACT scores at quarter 1, 2, 3 and 4, and between Standard vs. Intensive ]
    Asthma control information was collected weekly through the e-AT for 1 year. Asthma control was measured using the Asthma Control Test (ACT), which had a score ranging from 5 to 25, with 5 being poor control and 25 being optimal control. The analysis compared the mean change in scores from baseline to quarters 1, 2, 3, and 4.

  5. Emergency Department (ED)/Hospitalization, Standard vs Intensive [ Time Frame: Change in 1 year ED/hospital admission between 12-month prior and 12 month post e-AT use ]

    ED and hospital admissions were evaluated using data collected through Intermountain Healthcare claims data and ED visits and hospital encounters.

    We evaluated number ED and hospital admissions 12 months prior to intervention and 12 months post intervention


  6. Parent Satisfaction With Care, Overall (Change Overtime From Baseline to 12 Months) [ Time Frame: Satisfaction at 1 year following e-AT use was compared to baseline satisfaction scores ]

    Parent satisfaction data was collected using a modified version of patient satisfaction survey developed and validated by Varni et al. at baseline and at 12 months in the study.

    The scale ranged from 1-5, with 1=Very Dissatisfied and 5=Very Satisfied.


  7. Child Asthma Control Overall (Comparing Change of Asthma Control From Baseline to Quarter 1, Quarter 2, Quarter 3 and Quarter 4) [ Time Frame: baseline ACT scores were compared to quarters 1, 2, 3, 4. ]

    Asthma control information was collected through the e-AT, comparing change of asthma control from baseline to quarter 1, quarter 2, quarter 3 and quarter 4.

    Asthma control was measured using the Asthma Control Test (ACT), which scale ranged from 5-25, with 5=poorly controlled and 25=well controlled.

    Each patient submitted an ACT score weekly for 12 months.


  8. Child Interrupted/Missed School Days, Overall (Longitudinal Changes Overtime) [ Time Frame: 1 year ]
    Number of child interrupted/missed school days were collected longitudinally (information includes mean at baseline, 3, 6, and 12 months in the study).

  9. Parent Interrupted/Missed Work Days, Overall (Longitudinal Change Overtime) [ Time Frame: 1 year ]
    Number of parent interrupted/missed work days were collected longitudinally at the same time as collecting the QOL scores: Information includes mean at baseline, 3, 6, and 12 months in the study.

  10. ED/Hospital Admissions, e-AT Overall (Pre vs. Post e-AT Use Within Subjects That Received the e-AT Intervention) [ Time Frame: 1 year ]
    ED/hospital re-admission data were compared between prior and post 12 month period (for both intensive and standard interventions overall) when e-AT was administered.

  11. Use of Oral Steroid, Overall [ Time Frame: 1 year ]
    Use of oral steroid was evaluated using data collected through Intermountain Healthcare claims data and oral steroids prescribed. Comparison was made between prior and post e-AT (both interventions) overall.

  12. ED/Hospital Admission, Early vs. Late Patients [ Time Frame: 1 year following e-AT use for early and late starting patients ]
    ED and hospital admission was evaluated using data collected through Intermountain Healthcare claims data and ED visits and hospital encounters. Analyses (at the patient level) comparing the rates of ED/hospital admissions between a 1 year period following initiation of the e-AT for those in both standard and intensive e-AT groups who were enrolled early during the study period (patients with enrollment dates between January 2014 and December 2014) to rates of ED/hospital admissions for patients who started the e-AT later (patients with enrollment dates between January 2015 and December 2015), during a 1-year period prior to the late patient starting the e-AT.

  13. Oral Steroid Use, Early vs. Late Patients [ Time Frame: 1 year ]

    Oral steroid use data was collected through Intermountain Healthcare claims data and clinics prescribing oral steroid.

    Oral steroid use was evaluated using data collected through Intermountain Healthcare claims data and oral steroids prescribed. Analyses (at the patient level) comparing the rates oral steroid use between a 1 year period following initiation of the e-AT for those in both standard and intensive e-AT groups who were enrolled early during the study period (patients with enrollment dates between January 2014 and December 2014) to rates of oral steroid use for patients who started the e-AT later (patients with enrollment dates between January 2015 and December 2015), during a 1-year period prior to the late patient starting the e-AT.


  14. ED/Hospital Admission, Early vs Late Starting Clinics (During the 3 Months When Late Starting Clinics Have Not Used the e-AT) [ Time Frame: 3-month period prior to the late clinics starting the e-AT ]
    ED and hospital admission evaluated using data collected through Intermountain Healthcare claims data and ED visits and hospital encounters. Statistical analysis was not conducted since the numbers of ED/Hospital admissions was very small (2 and 0) in both group (during the 3 months study window). Here we used intent-to-treat analysis and included the overall 325 (rather than 318 used in analysis of other outcomes) participants.

  15. Oral Steroid Use, Early vs Late Starting Clinics (During the 3 Months When Late Starting Clinics Have Not Started the e-AT) [ Time Frame: 3 month period prior to the late clinics starting the e-AT ]
    Use of oral steroid was evaluated using data collected through Intermountain Healthcare claims data and oral steroids prescribed. Statistical analysis was not conducted since the numbers of ED/Hospital admissions was very small (2 and 0) in both group (during the 3 months study window). Here we used intent-to-treat analysis and included the overall 325 (rather than 318 used in analysis of other outcomes) participants

  16. ED/Hospital Admissions, e-AT vs Usual Care [ Time Frame: 1 year ]
    Non randomized comparison of ED and hospital admissions between e-AT interventions (both intensive and standard) compared usual care (matched control patients drawn from non-participating clinics) in the prior vs. post e-AT intervention time periods.

  17. Oral Steroid Use, e-AT vs Usual Care [ Time Frame: 1 year ]
    Non randomized comparison of use of oral steroid between e-AT interventions (both intensive and standard) compared usual care (matched control patients drawn from non-participating clinics) in the prior vs. post e-AT intervention time periods.



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.


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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Facility Eligibility

Clinics are eligible for participation if they meet the following 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.

Patient Inclusion Criteria

  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.

Patient Exclusion Criteria:

As this is a pragmatic trial assessing evidence of the e-AT in a real clinical environment, no patients will be excluded as long as they meet inclusion criteria. However, during the time of analysis, we will conduct a sub-analysis, comparing the effectiveness of the new care model among patients with or without co-morbid conditions that may affect measured asthma outcomes. These include patients with a history or increased risk of pulmonary disease (cystic fibrosis, bronco-pulmonary dysplasia, aspiration pneumonia, severe Cerebral Palsy (CP) with aspiration risk, technology dependency (gastrostomy tube, tracheostomy), history of congenital heart disease requiring surgical correction or with complicating congestive heart failure requiring medical management, immunodeficiency (including patients on immunosuppressants), and malignancies.


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): NCT02409277


Locations
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United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84113
Sponsors and Collaborators
University of Utah
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Flory Nkoy, MD, MS, MPH University of Utah
Publications:
CDC. National Health Interview Survey (NHIS) Data2009. http://www.cdc.gov/asthma/nhis/09/data.htm
CDC. Healthy Youth! Health Topics, Asthma2009.
Wessel L, Spain J. The Chronic Care Model: A Collaborative Approach to Preventing and Treating Asthma in Infants and Young Children. January 2005. EJ847179
Association AL. Asthma & Children Fact Sheet 2012. http://www.lung.org/lung-disease/asthma/resources/facts-and-figures/asthma-children-fact-sheet.html
McGowan P. Self-Managment: A Background Paper. Centre on Aging New Perspectives: International Conference on Patient Self-Management 2006:1-10.
NHLBI. So You Have Asthma. 2007(NIH Publication No. 07-5248). https://www.nhlbi.nih.gov/files/docs/public/lung/have_asthma.pdf.
NHLBI-EPR-3. Guidelines for the diagnosis ane management of asthma. Periodic Assessment and Monitoring: Essential for Asthma Management. 2007. http://www.nhlbi.nih.gov/files/docs/guidelines/asthsumm.pdf

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Responsible Party: Flory Nkoy, Associate Professor, University of Utah
ClinicalTrials.gov Identifier: NCT02409277    
Other Study ID Numbers: 51002874
First Posted: April 6, 2015    Key Record Dates
Results First Posted: February 5, 2020
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We can only share completely de-identified data. Request can be sent to my email: flory.nkoy@hsc.utah.edu
Keywords provided by Flory Nkoy, University of Utah:
Self-Management
Asthma
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases