Telemedicine Clinical Trial
— PROMsOfficial title:
A Comparison of the Effectiveness of Telepsychiatry With a Randomized Waitlist Control Utilizing Patient Reported Outcome Measures (PROMs)
Verified date | December 2023 |
Source | Carilion Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 148 |
Est. completion date | January 31, 2023 |
Est. primary completion date | January 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Anita Kablinger | Roanoke | Virginia |
Lead Sponsor | Collaborator |
---|---|
Carilion Clinic | National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH), Virginia Polytechnic Institute and State University |
United States,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measurement of symptomatology of patients on waitlist via Patient Health Questionnaire (PHQ-9) | 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. | 11 months | |
Primary | Measurement of symptomatology of patients on waitlist via Generalized Anxiety Disorder survey (GAD-7) | 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. | 11 months | |
Primary | Measurement of symptomatology of patients on waitlist via Brief Adjustment Scale (BASE-6) | 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. | 11 months | |
Primary | Measurement of symptomatology of patients on waitlist via US Alcohol Use Disorder Identification Test (USAUDIT) | 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. | 11 months | |
Primary | Measurement of symptomatology of patients on waitlist via Drug Assessment Screening Test (DAST-10) | 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. | 11 months | |
Primary | 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) | determine whether an educational video and monthly symptom monitoring helps improve symptoms of patients randomized to the intervention group versus those in usual care | 11 months | |
Primary | 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) | determine whether an educational video and monthly symptom monitoring helps improve symptoms of patients randomized to the intervention group versus those in usual care | 11 months | |
Primary | 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) | determine whether an educational video and monthly symptom monitoring helps improve symptoms of patients randomized to the intervention group versus those in usual care | 11 months |
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