Effectiveness of Telepsychiatry With Randomized Waitlist Control Utilizing Patient Reported Outcome Measures
NCT05274958 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 148
Last updated 2024-06-26
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 (Coronavirus Disease 2019) 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.
Conditions
- PROMs
- Waitlist
- Telemedicine
- Mental Health Disorder
- Psychiatric or Mood Diseases or Conditions
Interventions
- 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.
Sponsors & Collaborators
-
National Institutes of Health (NIH)
collaborator NIH -
Virginia Polytechnic Institute and State University
collaborator OTHER -
National Center for Advancing Translational Sciences (NCATS)
collaborator NIH -
Carilion Clinic
lead OTHER
Principal Investigators
-
Virginia O'Brien, MD · Carilion Clinic
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-10-18
- Primary Completion
- 2023-01-31
- Completion
- 2023-01-31
Countries
- United States
Study Locations
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