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N/A N=148 Randomized Single-blind Treatment

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

PROMs · Waitlist · Telemedicine · Mental Health Disorder · Psychiatric or Mood Diseases or Conditions

Enrolled (actual)
148
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Measurement of Symptomatology of Patients on Waitlist Via Patient Health Questionnaire (PHQ-9) — 13.41; 13.48; 13.60; 13.00 score on a scale — p=<0.05

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Patient-rated outcome measures and educational videos (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Carilion Clinic
Primary completion
Jan 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Measurement of Symptomatology of Patients on Waitlist Via Patient Health Questionnaire (PHQ-9)
13.41; 13.48; 13.60; 13.00 <0.05 sig
PRIMARY
Measurement of Symptomatology of Patients on Waitlist Via Generalized Anxiety Disorder Survey (GAD-7)
12.53; 12.42; 12.35; 11.54
PRIMARY
Measurement of Symptomatology of Patients on Waitlist Via Brief Adjustment Scale (BASE-6)
26.74; 27.10; 27.32; 25.47
PRIMARY
Measurement of Symptomatology of Patients on Waitlist Via US Alcohol Use Disorder Identification Test (USAUDIT)
3.54; 3.52; 3.22; 5.83
PRIMARY
Measurement of Symptomatology of Patients on Waitlist Via Drug Assessment Screening Test (DAST-10)
0.90; 0.55

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.

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05274958). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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