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Effectiveness of Telepsychiatry With Randomized Waitlist Control Utilizing Patient Reported Outcome Measures (PROMs)

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ClinicalTrials.gov Identifier: NCT05274958
Recruitment Status : Recruiting
First Posted : March 11, 2022
Last Update Posted : November 9, 2022
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Virginia Polytechnic Institute and State University
Information provided by (Responsible Party):
Carilion Clinic

Brief Summary:
The utilization of patient reported outcome measures (PROMs) during in-person care allows for on-going assessment of the severity of mental illness and patient outcomes across treatment. Additionally, it provides immediate feedback on the patient's psychiatric status to both the patient and practitioner. Carilion Clinic - Psychiatry & Behavioral Medicine ambulatory clinic implemented PROMs prior to the start of the COVID-19 pandemic and continues to utilize them as part of patient care. All new patients are asked to complete an initial PROM bundle of assessments 24 hours before their initial appointment, including the Brief Adjustment Scale, Patient Health Questionnaire, Generalized Anxiety Disorder survey, US Alcohol Use Disorder Identification Test, and Drug Assessment Screening Test. Automatic monthly reminders to complete the assessments continue after the first visit with the clinician. Over the last 2 years, research members of Carilion Clinic Psychiatry and Virginia Tech Psychology have been actively using PROM data to assess psychiatric health outcomes before and after the outbreak of COVID-19 in the United States. Initial results indicate that patients who received care via telepsychiatry not only did not experience worsening symptoms, but showed improvements in depression, anxiety and psychological functioning. However, without a control group of untreated patients to compare, the impact of telepsychiatry plus PROMs remains unclear. A waitlist control group design would allow investigators to compare patients receiving telepsychiatry and repeated completion of PROMs (current practice) to patients referred to psychiatry, but not receiving telepsychiatry treatment or completing PROMs during the same period. In this study, investigators plan to randomize individuals on the waitlist to one of two groups to assess the influence of time alone awaiting initial psychiatric clinician assessment (no intervention) versus minimal intervention using repeated PROMs and microlearning patient education videos while awaiting initial psychiatric clinician assessment. This kind of design allows assessment for the influence of time and the type of health service contact that replicates the basics of measurement-based psychiatric services (measurement of symptomology and well-being), but with none of the benefits of psychiatric supports, interventions, and techniques.

Condition or disease Intervention/treatment Phase
PROMs Waitlist Telemedicine Mental Health Disorder Psychiatric or Mood Diseases or Conditions Behavioral: Patient-rated outcome measures and educational videos Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients on a waitlist to see psychiatry will be enrolled then randomized to usual care or an intervention with monthly PROMs and an educational video
Masking: Single (Outcomes Assessor)
Masking Description: The intervention and data collection will take place before the patient sees the psychiatry clinician. The outcomes assessor will not be involved in the patient care.
Primary Purpose: Treatment
Official Title: A Comparison of the Effectiveness of Telepsychiatry With a Randomized Waitlist Control Utilizing Patient Reported Outcome Measures (PROMs)
Actual Study Start Date : October 18, 2021
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Initial PROM plus monthly PROM plus educational video
These patients receive usual care plus monthly PROMs and educational video(s) while on the waitlist
Behavioral: Patient-rated outcome measures and educational videos
PROMs are scales that are validated in behavioral health for tracking symptoms of depression, anxiety, and other conditions. They can be self-administered or given by a clinician. Mytonomy videos are short, educational videos about the patient's primary condition. All patients receive PROMs on entering our clinic. The difference in this intervention is those randomized to the active treatment will receive monthly PROMs and mytonomy video(s) until their appointment with the clinician. Usual care patients will only have PROMs at the intake and then at the appointment with their assigned clinician.

No Intervention: Usual Care
Patients will complete the initial bundle of PROMs, then no further PROMs while they remain on the waitlist



Primary Outcome Measures :
  1. Measurement of symptomatology of patients on waitlist via Patient Health Questionnaire (PHQ-9) [ Time Frame: 11 months ]
    assess symptoms of patients on waiting list to see psychiatry from their initial referral to their initial psychiatric session. Score 0-27, higher is more severe depression.

  2. Measurement of symptomatology of patients on waitlist via Generalized Anxiety Disorder survey (GAD-7) [ Time Frame: 11 months ]
    assess symptoms of patients on waiting list to see psychiatry from their initial referral to their initial psychiatric session. Score 0-21, higher is more anxious.

  3. Measurement of symptomatology of patients on waitlist via Brief Adjustment Scale (BASE-6) [ Time Frame: 11 months ]
    assess symptoms of patients on waiting list to see psychiatry from their initial referral to their initial psychiatric session. Score 6-42, higher is poorer function.

  4. Measurement of symptomatology of patients on waitlist via US Alcohol Use Disorder Identification Test (USAUDIT) [ Time Frame: 11 months ]
    assess symptoms of patients on waiting list to see psychiatry from their initial referral to their initial psychiatric session. Score 0-46, higher is greater alcohol use severity.

  5. Measurement of symptomatology of patients on waitlist via Drug Assessment Screening Test (DAST-10) [ Time Frame: 11 months ]
    assess symptoms of patients on waiting list to see psychiatry from their initial referral to their initial psychiatric session. Score 0-10, higher indicates greater substance use.

  6. Difference between symptomatology of patients on waitlist who receive usual care versus those who record monthly Patient Health Questionnaire (PHQ-9) and watch an educational video (mytonomy) [ Time Frame: 11 months ]
    determine whether an educational video and monthly symptom monitoring helps improve symptoms of patients randomized to the intervention group versus those in usual care

  7. Difference between symptomatology of patients on waitlist who receive usual care versus those who record monthly Generalized Anxiety Disorder survey (GAD-7) and watch an educational video (mytonomy) [ Time Frame: 11 months ]
    determine whether an educational video and monthly symptom monitoring helps improve symptoms of patients randomized to the intervention group versus those in usual care

  8. Difference between symptomatology of patients on waitlist who receive usual care versus those who record monthly Brief Adjustment Scale (BASE-6) and watch an educational video (mytonomy) [ Time Frame: 11 months ]
    determine whether an educational video and monthly symptom monitoring helps improve symptoms of patients randomized to the intervention group versus those in usual care



Information from the National Library of Medicine

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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: A:

  • all patients referred and see in an academic outpatient psychiatry clinic who wish to enroll

Exclusion Criteria:

  • patients unable to engage in measurement-based care, such as those with dementia or other cognitive disorder

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): NCT05274958


Contacts
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Contact: Daniel Harrington, MD 540-526-2550 irb@carilionclinic.org
Contact: Anita Kablinger, MD 540-981-8025 askablinger@carilionclinic.org

Locations
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United States, Virginia
Anita Kablinger Recruiting
Roanoke, Virginia, United States, 24014
Contact: Intake Coordinator       askablinger@carilionclinic.org   
Sponsors and Collaborators
Carilion Clinic
National Institutes of Health (NIH)
Virginia Polytechnic Institute and State University
Investigators
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Principal Investigator: Virginia O'Brien, MD Carilion Clinic
Publications of Results:
Other Publications:
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Responsible Party: Carilion Clinic
ClinicalTrials.gov Identifier: NCT05274958    
Other Study ID Numbers: 21-1426
UL1TR003015 ( U.S. NIH Grant/Contract )
First Posted: March 11, 2022    Key Record Dates
Last Update Posted: November 9, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carilion Clinic:
Measurement-based Care
Additional relevant MeSH terms:
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Mental Disorders