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IMPLEMENTING MULTICOMPONENT INTERVENTIONS TO TREAT BLOOD DONORS WITH FAMILIAL HYPERCHOLESTEROLEMIA

Award Number: R33HL161753
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 03/01/2022
PERIOD OF PERFORMANCE END DATE: 04/30/2027

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IMPLEMENTING MULTICOMPONENT INTERVENTIONS TO TREAT BLOOD DONORS WITH FAMILIAL HYPERCHOLESTEROLEMIA - PROJECT SUMMARY Familial Hypercholesterolemia (FH) remains woefully underdiagnosed and undertreated in the US. Recent work from the PI demonstrated the ability to identify blood donors with FH at a similar prevalence as would be expected in the general population. The overall objective in this mixed methods study is to apply implementation strategies to improve treatment of blood donors with FH. The central hypothesis is that the blood donation system can be an effective portal to increase receipt of treatment for individuals with FH. The central hypothesis will be tested by pursuing four specific aims: 1) identify barriers and facilitators to receipt of (low-density lipoprotein cholesterol) LDL-C treatment in blood donors with FH to inform implementation strategy development, 2) develop and produce an implementation strategy bundle to increase LDL-C treatment in blood donors with FH, 3) conduct a Type 2 implementation-effectiveness trial for LDL-C lowering in a community-based blood donation center, and 4) evaluate the implementation bundle using mixed methods. This research will be guided by the Consolidated Framework for Implementation Science Research (CFIR), and will use Implementation Mapping, a theory- and evidence-based process, to develop, implement, and evaluate these treatment enhancing strategies. In the first aim, semi-structured interviews will be used to elicit barriers and facilitators of statin treatment from key stakeholders including: a) blood donors with FH b) family members of donors c) blood donation personnel d) community physicians. Stakeholder feedback will be iteratively integrated to develop, produce, and refine an implementation strategies bundle in the second aim, that will be tested in Aim 3. The third aim consists of a two-arm randomized trial among blood donors with FH comparing a) usual notification of high cholesterol or b) the implementation strategies bundle from Aim 2 with the primary outcome of difference in change in LDL-C levels from baseline to 6 months. The fourth aim will assess the acceptability, appropriateness, and feasibility of the implementation strategy bundle and will inform development of a dissemination package to implement an FH program in other blood donor centers. The research proposed in this application is innovative, in our opinion, because it incorporates the blood donor program, an entirely new approach to identifying and treating FH. This novel portal of enhancing FH treatment involves younger individuals who are less likely to seek regular medical care and complements traditional strategies focusing on patients with medical homes. Ultimately, if successful, this program, informed by implementation science methods, can be rapidly scaled to blood donation centers nationally involving 6.4 million donors annually, having an immediate impact on gaps in FH care.


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: 2026 ( Subtotal = $502,305 )
2026	2026	THE UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER	5323 HARRY HINES BLVD	DALLAS	TX	75390	DALLAS	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	000	5	5/22/2026	NON-COMPETING CONTINUATION	$502,305
														Subtotal = $502,305

Issue Date FY: 2025 ( Subtotal = $502,305 )
2025	2025	THE UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER	5323 HARRY HINES BLVD	DALLAS	TX	75390	DALLAS	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	001	4	7/9/2025	NON-COMPETING CONTINUATION	$50,229
2025	2025	THE UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER	5323 HARRY HINES BLVD	DALLAS	TX	75390	DALLAS	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	000	4	4/23/2025	NON-COMPETING CONTINUATION	$452,076
														Subtotal = $502,305

Issue Date FY: 2024 ( Subtotal = $515,504 )
2024	2024	THE UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER	5323 HARRY HINES BLVD	DALLAS	TX	75390	DALLAS	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	002	3	5/7/2024	NON-COMPETING CONTINUATION	$491,456
2024	2023	UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER, THE	5323 HARRY HINES BLVD	DALLAS	TX	75390	DALLAS	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	001	2	1/17/2024	EXTENSION WITH OR WITHOUT FUNDS	$0
2024	2023	THE UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER	5323 HARRY HINES BLVD	DALLAS	TX	75390	DALLAS	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	000	2	12/12/2023	EXTENSION WITH OR WITHOUT FUNDS	$24,048
														Subtotal = $515,504

Issue Date FY: 2023 ( Subtotal = $544,145 )
2023	2023	UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER, THE	5323 HARRY HINES BLVD	DALLAS	TX	75390	DALLAS	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	000	2	5/4/2023	EXTENSION WITH OR WITHOUT FUNDS	$544,145
														Subtotal = $544,145

Grand Total All Awards = $2,064,259

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IMPLEMENTING MULTICOMPONENT INTERVENTIONS TO TREAT BLOOD DONORS WITH FAMILIAL HYPERCHOLESTEROLEMIA

Award Number: R33HL161753

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 03/01/2022

PERIOD OF PERFORMANCE END DATE: 04/30/2027

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