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BREATHE: An efficacy-implementation trial of a brief shared decision making intervention among Black adults with uncontrolled Asthma in Federally Qualified Health Centers (FQHC).

Award Number: R01NR019275
ORGANIZATION: NATIONAL INSTITUTE OF NURSING RESEARCH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/06/2021
PERIOD OF PERFORMANCE END DATE: 02/28/2026

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BREATHE: An efficacy-implementation trial of a brief shared decision making intervention among Black adults with uncontrolled Asthma in Federally Qualified Health Centers (FQHC). - Background and Rationale: Black adults with asthma are an appropriate target for shared decision-making (SDM) interventions that support disease self-management as they experience a higher asthma burden and worse clinical outcomes than non-black adults and/or children with asthma of any racial-ethnic background. To date, the application of SDM and community-based interventions targeting black adults have failed to address these disparities. Therefore, we used input from Black patients to develop BREATHE - BRief intervention to Evaluate Asthma THErapy – a 9-minute SDM intervention focused on reducing the impact of erroneous beliefs on asthma control - and established its efficacy in this health disparity population. Our intervention is unique in that is a one-time brief, tailored intervention integrated into office visits, using the patient’s own provider as the interventionist (e.g. scalable). Our pilot trial demonstrated high fidelity to BREATHE delivery and improved asthma control and reduced symptoms among Black BREATHE participants compared to Black patients who received a dose-matched attention control condition. Objective: We propose an efficacy-implementation trial to: (1) evaluate systematically the efficacy of BREATHE in 200 black adults receiving care at urban federally qualified health centers (FQHCs) for uncontrolled asthma; and (2) identify multi-level barriers and facilitators to the widespread adoption and implementation of BREATHE. Hypotheses: Hyp 1.1 (primary outcome): Over 1 year, relative to Black controls, Black BREATHE participants will have significantly better asthma control as measured by higher scores on the Asthma Control Questionnaire. Hyp 1.2 (secondary outcomes): Over 1 year, relative to Black controls, Black BREATHE participants will have significantly better (a) SDM scores, (b) ICS adherence, (c) asthma and ICS beliefs, (d) asthma quality of life; and significantly lower rates of (e) asthma exacerbations, (f) symptoms days, (g) nights woken, (h) activity limitations, (i) shortness of breath, (j) wheeze, and (k) rescue medicine use. Methods: We will enroll 200 black adults with uncontrolled asthma from 2 New York City and 2 New Jersey urban FQHCs. Using a group-randomized design, clinicians in the FQHCs will be randomized to either BREATHE or a dose-matched attention control condition and trained to deliver the 9-minute active or control intervention to Black patients during clinic visits. We will follow patient participants for 12-months post-treatment. For the process evaluation, which uses all dimensions of RE-AIM and all CFIR constructs together, we will collect qualitative and quantitative data from patient participants, their loved ones and providers. Together with stakeholders, we will develop strategies for the widespread implementation of BREATHE informed by our clinical efficacy and implementation results. Significance: The study has high public health significance because (1) it targets a population impacted greatly by asthma in unique care settings, (2) it concurrently targets the influence of asthma and treatment beliefs on asthma control, (3) it offers a highly scalable intervention, and (4) it bridges a gap between research and practice by identifying factors associated with implementation.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $479,581 )
2025	2025	THE TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK	630 W 168TH ST FL 4	NEW YORK	NY	10032	NEW YORK	USA	Nursing Research	002	5	8/15/2025	NON-COMPETING CONTINUATION	$0
2025	2025	THE TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK	630 W 168TH ST FL 4	NEW YORK	NY	10032	NEW YORK	USA	Nursing Research	000	5	3/4/2025	NON-COMPETING CONTINUATION	$431,623
2025	2025	THE TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK	630 W 168TH ST FL 4	NEW YORK	NY	10032	NEW YORK	USA	Nursing Research	001	5	8/14/2025	NON-COMPETING CONTINUATION	$47,958
														Subtotal = $479,581

Issue Date FY: 2024 ( Subtotal = $470,529 )
2024	2024	THE TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK	630 W 168TH ST FL 4	NEW YORK	NY	10032	NEW YORK	USA	Nursing Research	002	4	5/21/2024	NON-COMPETING CONTINUATION	$0
2024	2024	THE TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK	630 W 168TH ST FL 4	NEW YORK	NY	10032	NEW YORK	USA	Nursing Research	001	4	5/3/2024	NON-COMPETING CONTINUATION	$47,052
2024	2024	THE TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK	630 W 168TH ST FL 4	NEW YORK	NY	10032	NEW YORK	USA	Nursing Research	000	4	2/8/2024	NON-COMPETING CONTINUATION	$423,477
														Subtotal = $470,529

Issue Date FY: 2023 ( Subtotal = $475,626 )
2023	2023	TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK, THE	630 W 168TH ST FL 4	NEW YORK	NY	10032	NEW YORK	USA	Nursing Research	001	3	2/1/2023	NON-COMPETING CONTINUATION	$475,626
2023	2023	TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK, THE	630 W 168TH ST FL 4	NEW YORK	NY	10032	NEW YORK	USA	Nursing Research	002	3	3/29/2023	NON-COMPETING CONTINUATION	$0
2023	2022	TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK, THE	630 W 168TH ST FL 4	NEW YORK	NY	10032	NEW YORK	USA	Nursing Research	000	2	10/12/2022	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $475,626

Issue Date FY: 2022 ( Subtotal = $609,841 )
2022	2022	TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK, THE	630 W 168TH ST FL 4	NEW YORK	NY	10032	NEW YORK	USA	Nursing Research	002	2	5/9/2022	NON-COMPETING CONTINUATION	$0
2022	2022	TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK, THE	630 W 168TH ST FL 4	NEW YORK	NY	10032	NEW YORK	USA	Nursing Research	000	2	3/9/2022	NON-COMPETING CONTINUATION	$440,217
2022	2022	TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK, THE	630 W 168TH ST FL 4	NEW YORK	NY	10032	NEW YORK	USA	Nursing Research	001	2	4/19/2022	NON-COMPETING CONTINUATION	$48,915
2022	2022	TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK, THE	630 W 168TH ST FL 4	NEW YORK	NY	10032	NEW YORK	USA	Nursing Research	003	2	8/24/2022	SUPPLEMENT FOR EXPANSION	$120,709
														Subtotal = $609,841

Issue Date FY: 2021 ( Subtotal = $532,602 )
2021	2021	TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK, THE	630 W 168TH ST FL 4	NEW YORK	NY	10032	NEW YORK	USA	Nursing Research	000	1	5/6/2021	NEW	$532,602
														Subtotal = $532,602

Grand Total All Awards = $2,568,179

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BREATHE: An efficacy-implementation trial of a brief shared decision making intervention among Black adults with uncontrolled Asthma in Federally Qualified Health Centers (FQHC).

Award Number: R01NR019275

ORGANIZATION: NATIONAL INSTITUTE OF NURSING RESEARCH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 05/06/2021

PERIOD OF PERFORMANCE END DATE: 02/28/2026

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