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Effectiveness of a multi-component mHealth intervention to improve post-hospital transitions of care for patients with SMI

Award Number: R01MH130496
ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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PROJECT SUMMARY/ABSTRACT The period immediately following discharge from acute psychiatric hospitalization is a time fraught with gaps and discontinuities in care for many patients. Despite this time of elevated risk, patients often lack sufficient transitional supports and related resources for returning to the community and resuming long-term outpatient treatment. The long-term goal is to improve the continuity of care for patients with serious mental illness (SMI) by supporting a safer and more efficient bridge from hospital to outpatient care. The objective of this proposal is to test the effectiveness of our empirically-supported, multi-component mHealth intervention called tFOCUS in comparison to enhanced assessment and monitoring to ensure safety and an adequate standard of care (“SAFE”). tFOCUS will be deployed during the high-risk period directly from hospital to outpatient care and provide real-time assessment and intervention to patients via a mobile app, plus user engagement and clinical status updates to clinicians via a web-based “dashboard.” To speed the translation of findings to clinical practice, we will rigorously test the effectiveness of tFOCUS in a fully-powered Hybrid Type 1 Effectiveness-Implementation trial, while collecting information on implementation barriers/facilitators to promote uptake in real world settings. The central hypothesis is that tFOCUS will improve illness self-coping and treatment attitudes, which will lead to reduced: psychiatric symptoms, rehospitalizations, and suicidal ideation/behaviors. tFOCUS will also lead to improved post-discharge treatment engagement and illness recovery. The aims of this proposal are: (1) to conduct a fully-powered, RCT (n=180) to test the effectiveness of treatment-as-usual (TAU) + tFOCUS vs TAU + SAFE; (2) to examine potential mediators and moderators of treatment effects; and, (3) to identify patient, staff, and organizational/system-level factors that may facilitate/hinder tFOCUS implementation. The primary outcome will be overall psychiatric symptoms. The approach is innovative because it is one of the first randomized controlled trials conducted in the U.S. specifically evaluating an mHealth aftercare support program for patients with SMI directly moving from hospital to outpatient care. Also, this study is unique in that it will collect data to generate hypotheses about implementation strategies via a multi-pronged approach involving key stakeholders and additional implementation ata. Upon successful completion of the proposed R01 research, this study will contribute significant actionable data that will lay the groundwork for a large-scale Hybrid Type 3 trial of tFOCUS in diverse hospital settings.


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 = $719,042 )
2024	2024	BUTLER HOSPITAL	345 BLACKSTONE BLVD STE 2	PROVIDENCE	RI	02906	PROVIDENCE	USA	Mental Health Research Grants	000	3	7/25/2024	NON-COMPETING CONTINUATION	$719,042
														Subtotal = $719,042

Issue Date FY: 2023 ( Subtotal = $726,442 )
2023	2023	BUTLER HOSPITAL	345 BLACKSTONE BLVD	PROVIDENCE	RI	02906	PROVIDENCE	USA	Mental Health Research Grants	000	2	7/25/2023	NON-COMPETING CONTINUATION	$726,442
														Subtotal = $726,442

Issue Date FY: 2022 ( Subtotal = $771,162 )
2022	2022	BUTLER HOSPITAL	345 BLACKSTONE BLVD	PROVIDENCE	RI	02906	PROVIDENCE	USA	Mental Health Research Grants	000	1	8/31/2022	NEW	$771,162
														Subtotal = $771,162

Grand Total All Awards = $2,216,646

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Effectiveness of a multi-component mHealth intervention to improve post-hospital transitions of care for patients with SMI

Award Number: R01MH130496

ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

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