Evidence map›Paper›PMID 38431134›Full record

ArticleContemporary clinical trials2024

A Hybrid Type 1 trial of a multi-component mHealth intervention to improve post-hospital transitions of care for patients with serious mental illness: Study protocol.

Ethan Moitra, Toni M Amaral, Madeline B Benz, Simranjeet Cambow, A Rani Elwy, Zachary J Kunicki, Zhengduo Lu, Neil S Rafferty, Ana Rabasco, Rita Rossi and 2 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Contemporary clinical trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05703412 (Effectiveness of a Multi-component mHealth Intervention to Improve Post-hospital Transitions of Care for Patients With SMI), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05703412 naenrolling by invitationnot on this map

Effectiveness of a Multi-component mHealth Intervention to Improve Post-hospital Transitions of Care for Patients With SMI

TypeinterventionalSponsorButler HospitalRan2023 to 2027Enrolled180ConditionsBipolar Disorder, Major Depression, SchizophreniaArmsTransition-FOCUS mHealth Intervention, Check-In
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Ethan MoitraDepartment of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, USA. Electronic address: ethan_moitra@brown.edu.
Toni M AmaralPsychosocial Research Program, Butler Hospital, Providence, RI 02906, USA.
Madeline B BenzDepartment of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, USA; Psychosocial Research Program, Butler Hospital, Providence, RI 02906, USA.
Simranjeet CambowPsychosocial Research Program, Butler Hospital, Providence, RI 02906, USA.
A Rani ElwyDepartment of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, USA; Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, USA.
Zachary J KunickiDepartment of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, USA.
Zhengduo LuPsychosocial Research Program, Butler Hospital, Providence, RI 02906, USA.
Neil S RaffertyPsychosocial Research Program, Butler Hospital, Providence, RI 02906, USA.
Ana RabascoDepartment of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, USA; Psychosocial Research Program, Butler Hospital, Providence, RI 02906, USA.
Rita RossiPsychosocial Research Program, Butler Hospital, Providence, RI 02906, USA.
Heather T SchattenDepartment of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, USA; Psychosocial Research Program, Butler Hospital, Providence, RI 02906, USA.
Brandon A GaudianoDepartment of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, USA; Psychosocial Research Program, Butler Hospital, Providence, RI 02906, USA; Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, USA.

Funding

Effectiveness of a multi-component mHealth intervention to improve post-hospital transitions of care for patients with SMIR01MH130496 · NIMH · BUTLER HOSPITAL (PROVIDENCE, RI) · PI BRANDON A GAUDIANO, Ethan Moitra · 2022 to 2026
$3.6M
Postdoctoral Training in Suicide ResearchT32MH126426 · NIMH · BROWN UNIVERSITY · PI IVAN W. MILLER, LAUREN M WEINSTOCK · 2021 to 2026
$1.8M
HSR&D Research Career Scientist AwardIK6HX003765 · VA · EDITH NOURSE ROGERS MEMORIAL VETERANS HOSPITAL · PI Anashua RANI Elwy · 2023 to 2026
–
HSRD VA IK6 HX003765NIMH NIH HHS R01 MH130496NIMH NIH HHS T32 MH126426
6 · The paper itself

Abstract

backgroundThe transition from acute (e.g., psychiatric hospitalization) to outpatient care is associated with increased risk for rehospitalization, treatment disengagement, and suicide among people with serious mental illness (SMI). Mobile interventions (i.e., mHealth) have the potential to increase monitoring and improve coping post-acute care for this population. This protocol paper describes a Hybrid Type 1 effectiveness-implementation study, in which a randomized controlled trial will be conducted to determine the effectiveness of a multi-component mHealth intervention (tFOCUS) for improving outcomes for adults with SMI transitioning from acute to outpatient care.

methodsAdults meeting criteria for schizophrenia-spectrum or major mood disorders (n = 180) will be recruited from a psychiatric hospital and randomized to treatment-as-usual (TAU) plus standard discharge planning and aftercare (CHECK-IN) or TAU plus tFOCUS. tFOCUS is a 12-week intervention, consisting of: (a) a patient-facing mHealth smartphone app with daily self-assessment prompts and targeted coping strategies; (b) a clinician-facing web dashboard; and, (c) mHealth aftercare advisors, who will conduct brief post-hospital clinical calls with patients (e.g., safety concerns, treatment engagement) and encourage app use. Follow-ups will be conducted at 6-, 12-, and 24-weeks post-discharge to assess primary and secondary outcomes, as well as target mechanisms. We also will assess barriers and facilitators to future implementation of tFOCUS via qualitative interviews of stakeholders and input from a Community Advisory Board throughout the project.

conclusionsInformation gathered during this project, in combination with successful study outcomes, will inform a potential tFOCUS intervention scale-up across a range of psychiatric hospitals and healthcare systems. CLINICALTRIALS: govregistration: NCT05703412.

Indexed as

SchizophreniaTelemedicineAdultAftercareHospitalsHumansPatient DischargeRandomized Controlled Trials as TopicEcological momentary interventionHybrid Type 1mHealthPost-acute carePsychiatric hospitalizationSerious mental illness

Identifiers

PMID38431134
PMCPMC10960682

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.