Rhode Island Asthma Integrated Response Program

Rhode Island Asthma Integrated Response Program



Sponsors


Source

Rhode Island Hospital

Oversight Info

Has Dmc

Yes

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


Brief Summary

The study's purpose is to evaluate the RI-Asthma Integrated Response (RI-AIR) Asthma Care
Implementation Program (ACIP). RI-AIR ACIP uses an electronic information system to screen
children with asthma and identify what specific services each child needs based on the
child's asthma symptom and health care status. Our main goal is to see if children experience
better asthma outcomes as a result of participation in the program. We will provide our
intervention to 1500 urban, ethnically diverse children, between 2-12 years old with asthma,
and their families and evaluate whether participating in the program improves children's
asthma outcomes. The second goal is to evaluate how well the program is set up and how we can
make improvements to better serve families of children with asthma. The third goal is to
gather information and advice from community experts so that we can make the program
sustainable.

Families that take part in RI-AIR ACIP will participate in the program over the course of a
year, including participating in the intervention, and brief follow up visits at 3, 6, 9 and
12 months after completing the intervention. All families will complete the CASE program,
which takes place over the course of about 4 weeks and involves in-school asthma education
for school aged children, after-school education sessions for their parents, asthma care
training for school staff, and an evaluation of asthma triggers in the school. Families of
children who have more frequent asthma symptoms and emergency healthcare visits will also
compete the HARP program, a home-visiting program consisting of 3 home visits (over about 6
weeks) that include individualized asthma education and strategies and supplies for
controlling environmental asthma triggers. Both CASE and HARP programs are carried out by
certified asthma educators and community health workers.

Each child's healthcare provider (HCP) and school nurse teacher (SNT) will receive a
standardized, secure email indicating the child is participating in RI-AIR. This email will
include a summary of the child's baseline assessment of asthma control and prior health care
use, and a description of the program. At the conclusion of the child's participation, the
HCP and SNT will receive a summary by secure email summarizing the child's asthma control at
the end of the intervention, services delivered, and referrals made, and for HARP
participants, triggers observed in the home and supplies and referrals provided.

Detailed Description

The RI-AIR ACIP is community-based; it addresses community needs and gaps in care by: 1)
enhancing asthma outcomes with services tailored to the child's level of asthma risk, 2)
decreasing family burden by delivering services in homes and the local community, 3)
enhancing communication between school, HCPs, and family, and 4) utilizing the RI-AIR
Information Data System (IDS) to integrate data sources and generate a tailored referral.
This study uses a randomized, stepped wedge trial (SWT) design to evaluate the effectiveness
of the RI-AIR ACIP at both the individual and community levels. In an SWT, groups of
individuals receive the intervention at different time points, the order in which they
receive the treatment is randomized, and data are collected from groups over time.

In this study, groups will be randomized at the community level. Selected high risk
communities are geographic school catchment areas with the highest asthma utilization rates.
High-risk areas will be randomly allocated to the "Step," or year of active trial using a
random numbers table. Thus, the year each catchment area receives intervention (i.e.,
participates in the active trial phase) will be randomized, and all families in this SWT will
participate in both control (standard care) and intervention (active trial). This SWT design
allows us to evaluate both individual-level outcomes as well as community-specific outcomes.
During the active trial phase, families of children with asthma within the randomly selected
communities will receive an asthma intervention. Families of children with asthma will be
assigned to an intervention based on the child's level of asthma control. Individual-level
data will be assessed over the course of the year of the active trial phase, while
community-level data will be assessed annually over the study period.

Overall Status

Not yet recruiting

Start Date

2018-08-01

Completion Date

2024-08-31

Primary Completion Date

2024-08-31

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Change in Asthma Control (Individual-Level)
During Active Trial Period at Baseline, End of Treatment (EOT; which will occur between 1 to 2 months after baseline, depending on intervention assignment), 3 month follow-up after EOT, 6 month follow-up, 9 month follow-up, 12 month follow-up
Change in Asthma Control (Individual Level)
During Active Trial Period at Baseline, End of Treatment (EOT; which will occur between 1 to 2 months after baseline, depending on intervention assignment), 3 month follow-up after EOT, 6 month follow-up, 9 month follow-up, 12 month follow-up

Secondary Outcome

Measure

Time Frame

Change in Asthma Symptom Free Days (Individual-Level)
During Active Trial Period at Baseline, End of Treatment (EOT; which will occur between 1 to 2 months after baseline, depending on intervention assignment), 3 month follow-up after EOT, 6 month follow-up, 9 month follow-up, 12 month follow-up
Change in Asthma Management Efficacy (Individual-Level)
During Active Trial Period at Baseline, End of Treatment (EOT; which will occur between 1 to 2 months after baseline, depending on intervention assignment), 12 month followup after EOT
Change in Quality of Life related to Asthma (Individual-Level)
During Active Trial Period at Baseline, End of Treatment (EOT; which will occur between 1 to 2 months after baseline, depending on intervention assignment), 3 month followup after EOT, 6 month followup, 9 month followup, 12 month followup
Changes in health care utilization rates (Individual-level)
During Active Trial Period at Baseline and 12 month follow-up
Changes in school absences (individual level)
During Active Trial Period at Baseline and 12 month follow-up
Changes in Asthma Health Care Utilization (Community-Level)
12 months pre- and post-intervention year
Changes in number of School Absences (Community-Level)
12 months pre- and post-intervention year

Enrollment

1500

Condition


Intervention

Intervention Type

Behavioral

Intervention Name


Description

Controlling Asthma in Schools Effectively (CASE) provides school-based education and environmental assessments. This program takes place over the course of about 4 weeks and involves in-school asthma education for school aged children, after-school education sessions for their parents, asthma care training for school staff, and an evaluation of asthma triggers in the school.

Arm Group Label

CASE Program only

CASE and HARP Programs



Intervention Type

Behavioral

Intervention Name


Description

Home Asthma Response Program (HARP) is a home-visiting program consisting of 3 home visits (over about 6 weeks). HARP provides individualized asthma education, home-based environmental assessment, and strategies and supplies for controlling environmental asthma triggers.

Arm Group Label

CASE and HARP Programs



Eligibility

Criteria

Inclusion Criteria:

- Child age between 2 to 12 years

- Child lives in the identified catchment area

- Child meets screening criteria for current asthma

- Child's asthma status is not well-controlled or poorly controlled

- Caregiver must speak English or Spanish.

Exclusion Criteria:

- Children with complex medical conditions (i.e., requiring on-site medical supervision
of CHW)

Gender

All

Minimum Age

2 Years

Maximum Age

12 Years

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Elizabeth L McQuaid, PhD
Principal Investigator
Rhode Island Hospital
Daphne Koinis Mitchell, PhD
Principal Investigator
Rhode Island Hospital

Overall Contact

Last Name

Barbara N Jandasek, PhD

Phone

401-793-8450

Email



Location

Facility

Status

Contact

Rhode Island Hospital
Providence Rhode Island 02903 United States
Not yet recruiting
Last Name: Barbara Jandasek, PhD
Phone: 401-793-8450
Email: [email protected]

Location Countries

Country

United States


Verification Date

2018-02-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Responsible Party Type

Sponsor


Has Expanded Access

No

Condition Browse


Number Of Arms

3

Arm Group

Arm Group Label

CASE Program only

Arm Group Type

Active Comparator

Description

During the Active Trial Phase, families of children with asthma status defined as "not well controlled" will complete the CASE program. Outcomes for participants assigned to the CASE program will be compared in a pre-post within subject comparison. Regardless of intervention arm assignment, children are expected show improvement in asthma outcomes. The stepped wedge trial design of the overall study allows for comparison of outcomes of communities in the pre-active trial baseline "control" period, active trial phase, and post-active trial phase follow-up period.


Arm Group Label

CASE and HARP Programs

Arm Group Type

Active Comparator

Description

During the Active Trial Phase, families of children with asthma status that is defined as "poorly controlled" will complete the CASE and HARP programs. Outcomes for participants assigned to this arm (CASE and HARP) will be compared in a pre-post within subject comparison. Regardless of intervention arm assignment, children are expected show improvement in asthma outcomes. The stepped wedge trial design of the overall study allows for comparison of outcomes of communities in the pre-active trial baseline "control" period, active trial phase, and post-active trial phase follow-up period.


Arm Group Label

Standard Care

Arm Group Type

No Intervention

Description

Cluster-based randomization in the Stepped Wedge Trial allows for comparison of Community Based Outcomes for clusters (communities defined by school catchment areas) who are not yet in the active trial phase and are receiving Standard of Care at that time.



Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

Sheryl Kopel, MSc

Phone

401-444-7217

Email



Acronym

RI-AIR

Patient Data

Sharing Ipd

Yes

Ipd Description

Following the NIH data sharing policy (2015), within one year of completion of the studies and dissemination of primary study results, public-use analysis datasets will be made available to the public, along with the final version of the study protocol, data dictionaries, and brief instructions. De-identification for the analysis datasets will follow published guidelines for "limited access data sets" funded by NHLBI (Geller et al., 2004).


Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Non-Randomized

Intervention Model

Parallel Assignment

Intervention Model Description

The overall study utilizes a stepped wedge trial design with cluster randomization at the community level. All communities will have a baseline "control" period, active trial phase, and post-active trial phase follow-up period. During the active trial phase of this project, the strategy used to assign interventions to participants follows a Parallel Assignment study intervention model. During the active trial phase, individuals within that community will be assigned to an asthma intervention (1. CASE or 2. CASE and HARP) based on the child's level of asthma control. The SWT also allows us to compare community-level outcomes for participants who are not in the Active Trial (Intervention) period at that time and who are receiving standard care.

Primary Purpose

Treatment

Masking

None (Open Label)


Study First Submitted

May 1, 2018

Study First Submitted Qc

June 28, 2018

Study First Posted

July 11, 2018

Last Update Submitted

June 28, 2018

Last Update Submitted Qc

June 28, 2018

Last Update Posted

July 11, 2018


ClinicalTrials.gov processed this data on July 11, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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