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Using Telehealth to Improve Psychiatric Symptom Management

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ClinicalTrials.gov Identifier: NCT02710344
Recruitment Status : Recruiting
First Posted : March 16, 2016
Last Update Posted : June 28, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Sarah Pratt, Dartmouth-Hitchcock Medical Center

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.

Condition or disease Intervention/treatment Phase
Mental Disorders Behavioral: Telehealth Program Not Applicable

Detailed Description:

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.

This study will evaluate the effectiveness of an automated, algorithmically-driven, customizable telehealth platform that provides education, teaches illness self-management, prompts users to enact coping strategies, and monitors symptoms on a daily basis to remotely detect early warning signs among people with SMI, moving beyond the existing telehealth approaches (mainly educational websites and videoconferencing) for assessing and providing education and therapy to people with SMI.

This study has two specific aims. Aim 1 is to compare the effectiveness of telehealth with Health Home Usual Care by measuring improvements at 6 and 12 months in illness self-management, psychiatric symptoms, and health self-efficacy. Aim 2 is to compare the effectiveness of telehealth with Health Home Usual Care by comparing total cost of emergency room visits and hospital days during the 12 months prior to baseline to total costs of emergency room visits and hospital days during the 12 months after baseline.

This study will evaluate a widely used automated telehealth program that has been modified and upgraded by the research team to incorporate curriculum drawn from illness self-management interventions for SMI developed by the investigators (i.e., Integrated Illness Management and Recovery (I-IMR) and HOPES). Unlike other telehealth devices, it does not require an internet connection and is an efficient and innovative way to provide illness self-monitoring and self-management education. Responses are entered by the user and forwarded to a secure server via cellular signal. The telehealth specialist will access the server daily through a secure website using a username and password.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Automated Telehealth to Improve Psychiatric Self-Management and Community Tenure
Study Start Date : September 2015
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Disorders

Arm Intervention/treatment
No Intervention: Usual Care
Usual care at community mental health care provider
Experimental: Telehealth
Usual care at community mental health care provider PLUS psychiatric telehealth program with remote monitoring.
Behavioral: Telehealth Program
Psychiatric telehealth program, content assigned based on diagnosis, entry to study requires psychiatric instability defined as use of emergency/high cost psychiatric services.




Primary Outcome Measures :
  1. Total Cost of Emergency Room Visits and Hospital Days [ Time Frame: Change in total cost of emergency room visits and hospital days during the 12 months prior to baseline compared to 12 months after baseline ]
    Cost of emergency room visits and hospital days


Secondary Outcome Measures :
  1. Psychiatric symptom severity as assessed using the Brief Psychiatric Rating Scale [ Time Frame: Change in psychiatric symptom severity as assessed using the Brief Psychiatric Rating Scale from baseline to 3, 6, and 12 months ]
    psychiatric symptom severity



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02710344


Contacts
Contact: Meghan M Santos, MSW 603-271-8336 meghan.m.santos@dartmouth.edu
Contact: Gail Williams, BA 603-271-8347 gail.e.williams@dartmouth.edu

Locations
United States, New Hampshire
Greater Nashua Mental Health Center Recruiting
Nashua, New Hampshire, United States
Contact: Susan Flynn, RN    603-889-6147    flynns@gnmhc.org   
Contact: Meghan M Santos, MSW    603-271-8336    meghan.m.santos@dartmouth.edu   
United States, Rhode Island
The Providence Center Recruiting
Providence, Rhode Island, United States
Contact: Holly Fitting       HFitting@provctr.org   
Contact: Mackenzie Wild         
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
National Institute of Mental Health (NIMH)

Responsible Party: Sarah Pratt, Assistant Professor in Psychiatry, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT02710344     History of Changes
Other Study ID Numbers: 28105
R01MH107625 ( U.S. NIH Grant/Contract )
First Posted: March 16, 2016    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders