Using Telehealth to Improve Psychiatric Symptom Management

NCT02710344 | Completed DMC

• 2 other identifiers: 28105R01MH107625
• Study Type: interventional
• Target: 303
• Locations: 1 country
• Sites: 2

Brief Summary

The overarching aim of this study is to evaluate whether telehealth leads to better mental health outcomes and decreased use of acute and crisis-based mental health care services by randomly assigning 300 people with serious mental illness (SMI) and psychiatric instability receiving services at 1 of 2 community mental health centers (CMHCs), each of which offers integrated behavioral and primary health care, to either Health Home Usual Care alone or telehealth plus Health Home Usual Care for 12 months, with assessments at baseline, 3, 6 and 12 months.

Conditions

Mental Disorders

Outcome Measures

Primary Outcomes (1)

• Total Cost of Emergency Room Visits and Hospital Days

  Cost of emergency room visits and hospital days

  Change in total cost of emergency room visits and hospital days during the 12 months prior to baseline compared to 12 months after baseline

Secondary Outcomes (1)

• Psychiatric symptom severity as assessed using the Brief Psychiatric Rating Scale

  Change in psychiatric symptom severity as assessed using the Brief Psychiatric Rating Scale from baseline to 3, 6, and 12 months

Study Arms (2)

Usual Care

NO INTERVENTION

Usual care at community mental health care provider

Telehealth

EXPERIMENTAL

Usual care at community mental health care provider PLUS psychiatric telehealth program with remote monitoring.

Behavioral: Telehealth Program

Interventions

Telehealth Program BEHAVIORAL

Psychiatric telehealth program, content assigned based on diagnosis, entry to study requires psychiatric instability defined as use of emergency/high cost psychiatric services.

Telehealth

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older;
• Chart DSM-V Axis I diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, post-traumatic stress disorder, or major depression and meet criteria for serious mental illness;
• Enrolled in treatment at site for at least 3 months;
• Psychiatric instability as indicated by 2 or more emergency room visits or hospitalizations in the past year, or multiple calls to the psychiatric crisis line within 3 months (10 or more);
• Expressed willingness to participate in a telehealth program;
• Must be able to read English.

You may not qualify if:

• Currently residing in a nursing home or group home;
• Terminal physical illness which is expected to result in death within one year;
• Primary diagnosis of dementia, co-morbid diagnosis of dementia, or significant cognitive impairment as indicated by a Mini Mental State Examination (MMSE) score \<24.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Greater Nashua Mental Health Center

Nashua, New Hampshire, United States

Location

The Providence Center

Providence, Rhode Island, United States

Location

MeSH Terms

Conditions

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Psychiatry

Study Record Dates

• First Submitted: March 10, 2016
• First Posted: March 16, 2016
• Study Start: September 1, 2015
• Primary Completion: March 1, 2020
• Study Completion: August 1, 2020
• Last Updated: November 24, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)