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Using Telehealth to Improve Psychiatric Symptom Management

Primary Purpose

Mental Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telehealth Program
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Mental Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Greater Nashua Mental Health Center
  • The Providence Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care

Telehealth

Arm Description

Usual care at community mental health care provider

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

Outcomes

Primary Outcome Measures

Total Cost of Emergency Room Visits and Hospital Days
Cost of emergency room visits and hospital days

Secondary Outcome Measures

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

Full Information

First Posted
March 10, 2016
Last Updated
November 23, 2020
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT02710344
Brief Title
Using Telehealth to Improve Psychiatric Symptom Management
Official Title
Automated Telehealth to Improve Psychiatric Self-Management and Community Tenure
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
March 2020 (Actual)
Study Completion Date
August 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorders

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
303 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Usual care at community mental health care provider
Arm Title
Telehealth
Arm Type
Experimental
Arm Description
Usual care at community mental health care provider PLUS psychiatric telehealth program with remote monitoring.
Intervention Type
Behavioral
Intervention Name(s)
Telehealth Program
Intervention Description
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 Measure Information:
Title
Total Cost of Emergency Room Visits and Hospital Days
Description
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
Secondary Outcome Measure Information:
Title
Psychiatric symptom severity as assessed using the Brief Psychiatric Rating Scale
Description
psychiatric symptom severity
Time Frame
Change in psychiatric symptom severity as assessed using the Brief Psychiatric Rating Scale from baseline to 3, 6, and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Greater Nashua Mental Health Center
City
Nashua
State/Province
New Hampshire
Country
United States
Facility Name
The Providence Center
City
Providence
State/Province
Rhode Island
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Using Telehealth to Improve Psychiatric Symptom Management

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