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

> **NIH NIH R01** · BUTLER HOSPITAL (PROVIDENCE, RI) · 2024 · $719,042

## Abstract

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.

## Key facts

- **NIH application ID:** 10893442
- **Project number:** 5R01MH130496-03
- **Recipient organization:** BUTLER HOSPITAL (PROVIDENCE, RI)
- **Principal Investigator:** BRANDON A GAUDIANO
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $719,042
- **Award type:** 5
- **Project period:** 2022-09-01 → 2027-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10893442

## Citation

> US National Institutes of Health, RePORTER application 10893442, Effectiveness of a multi-component mHealth intervention to improve post-hospital transitions of care for patients with SMI (5R01MH130496-03). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10893442. Licensed CC0.

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