Tuesday, October 15, 2024 10/15/2024

A Comparative Effectiveness Trial of Strategies to Implement Firearm Safety Promotion as a Universal Suicide Prevention Strategy in Pediatric Primary Care

Award Number: R01MH123491
ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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The primary goal of our parent study, the Adolescent Suicide Prevention in Routine clinical Encounters (ASPIRE) trial, is to compare the effectiveness of an electronic health record (EHR) nudge alone to an EHR nudge plus facilitation with respect to delivery of a secure firearm storage program during pediatric well-child visits. We captured clinician-reported reach in the EHR for the entire patient population (~45,000 visits) and obtained fidelity (i.e., parent-reported receipt of the program) from a subset of parents with whom we engaged in an intensive sampling approach to collect a post-visit survey. Reach was documented by clinicians for a large sample of patients and therefore does not suffer from the potential non-response bias that may affect parent-reported fidelity. However, reach may suffer from measurement error if clinicians incorrectly reported program delivery or exited out of the EHR prompt without responding to the questions. The proposed aims of this supplement will develop statistical methods to combine information contained in each outcome (reach, fidelity), effectively mitigating their respective limitations. The proposed methods will offer a powerful statistical analysis tool for comparing the effectiveness of the implementation strategies using multiple sources of data from a cluster randomized trial like ASPIRE. In Aim 1, we will derive a statistical estimator for comparing interventions in a two-arm cluster randomized trial to addresses non-response bias in survey-based fidelity by leveraging the large, complete sample provided by EHR-based reach, the latter of which may be subject to measurement error. We will also propose methods to obtain p-values and confidence intervals for the comparison of study arms. The methods will account for correlation due to inherent clustering of outcomes (patients within providers within clinics) while controlling Type I error and maximizing power to detect a difference between study arms. In Aim 2, we will use simulation studies to assess the statistical properties of the proposed estimator and inferential methods (i.e., p-values, confidence intervals). We will study bias, variability, Type I error, power, and coverage of 95% confidence intervals using simulations across a range of design factors such as the level of parent non-response in fidelity, amount of measurement error in reach, magnitude of the treatment effect, and intra-cluster correlation. In Aim 3, we will apply the proposed methods to data from ASPIRE. We will apply our methodology to jointly analyze parent-reported fidelity and EHR-based reach from the active implementation period of the ASPIRE trial. The methodology developed within our supplemental work will provide increased accuracy and precision in analyses of important implementation outcomes collected as part of the ASPIRE trial and will offer a new analytic framework for future cluster randomized trials in implementation science.


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: 2024 ( Subtotal = $836,263 )
2024	2024	NORTHWESTERN UNIVERSITY	633 CLARK ST	EVANSTON	IL	60208	COOK	USA	Mental Health Research Grants	001	6	8/1/2024	SUPPLEMENT FOR EXPANSION	$195,950
2024	2024	NORTHWESTERN UNIVERSITY	633 CLARK ST	EVANSTON	IL	60208	COOK	USA	Mental Health Research Grants	000	6	7/24/2024	NON-COMPETING CONTINUATION	$640,313
														Subtotal = $836,263

Issue Date FY: 2023 ( Subtotal = $655,522 )
2023	2023	NORTHWESTERN UNIVERSITY	633 CLARK ST	EVANSTON	IL	60208	COOK	USA	Mental Health Research Grants	003	5	7/28/2023	NON-COMPETING CONTINUATION	$649,728
2023	2022	NORTHWESTERN UNIVERSITY	633 CLARK ST	EVANSTON	IL	60208	COOK	USA	Mental Health Research Grants	002	4	5/1/2023	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	-$86,041
2023	2022	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT ST STE 440A	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Mental Health Research Grants	000	3	4/20/2023	NON-COMPETING CONTINUATION	-$716,249
2023	2022	NORTHWESTERN UNIVERSITY	633 CLARK ST	EVANSTON	IL	60208	COOK	USA	Mental Health Research Grants	001	4	4/20/2023	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$808,084
														Subtotal = $655,522

Issue Date FY: 2022 ( Subtotal = $725,861 )
2022	2022	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT ST STE 440A	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Mental Health Research Grants	000	3	7/12/2022	NON-COMPETING CONTINUATION	$725,861
														Subtotal = $725,861

Issue Date FY: 2021 ( Subtotal = $874,259 )
2021	2021	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT ST STE 440A	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Mental Health Research Grants	002	2	8/13/2021	SUPPLEMENT FOR EXPANSION	$0
2021	2021	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT ST STE 440A	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Mental Health Research Grants	000	2	7/13/2021	NON-COMPETING CONTINUATION	$738,708
2021	2021	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT ST STE 440A	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Mental Health Research Grants	001	2	7/14/2021	SUPPLEMENT FOR EXPANSION	$135,551
														Subtotal = $874,259

Issue Date FY: 2020 ( Subtotal = $796,624 )
2020	2020	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT ST STE 440A	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Mental Health Research Grants	000	1	8/14/2020	NEW	$796,624
														Subtotal = $796,624

Grand Total All Awards = $3,888,529

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A Comparative Effectiveness Trial of Strategies to Implement Firearm Safety Promotion as a Universal Suicide Prevention Strategy in Pediatric Primary Care

Award Number: R01MH123491

ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

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