Clinical trial NCT05274958: Effectiveness of Telepsychiatry With Randomized Waitlist Control Utilizing Patient Reported Outcome Measures
Official title: A Comparison of the Effectiveness of Telepsychiatry With a Randomized Waitlist Control Utilizing Patient Reported Outcome Measures (PROMs)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PROMs
Waitlist
Telemedicine
Mental Health Disorder
Psychiatric or Mood Diseases or Conditions
Keywords: Measurement-based Care
Lead sponsor: Carilion Clinic
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Virginia Polytechnic Institute and State University
name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2022-03-11
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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 (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.

Detailed description: Patient-reported outcome measures are a component of Measurement-Based Care (MBC) that involves collaboration between patient and clinician using structured evaluations of patient symptoms to inform behavioral health treatment and clinical decisions. In clinical settings, MBC has been found to improve outcomes and decrease dropout. Since patient-reported outcome measures can be performed by patients or clinicians, in session or out of session, and in-person or via telemedicine, their application is particularly pertinent during or after a crisis. The COVID-19 pandemic abruptly accelerated the transition to telehealth for many and necessitated alterations to traditional therapeutic means. PROMs are a tool that can improve the telehealth experience by strengthening patient-clinician relationships strained by the use of telemedicine, and allows for tracking of patient symptoms, which can be discussed and intervened upon in session.

Over the last 2 years, research members of Carilion Clinic Psychiatry and Virginia Tech Psychology departments have been actively using PROM data to assess psychiatric health outcomes before and after the outbreak of COVID-19 in the United States (IRB approved protocol 20-905). 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 telemedicine plus PROMs remains unclear. A wait-list control group design would allow investigators to compare participants receiving telemedicine and repeated completion of PROMs (current practice) to participants referred to psychiatry, but not receiving telemedicine treatment or completing PROMs during the same time period. Investigators propose randomizing wait-list individuals 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 reviewing 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.

As of July 2021, 32 Carilion psychiatric clinicians are engaged in Owl Insights, an MBC vendor. Approximately 500 unique individuals complete monthly PROMs through this system as part of routine clinical care. The research group recently conducted analyses of nearly 900 ambulatory adult psychiatric patients in ambulatory psychiatry at Carilion Clinic (CC\&PBM) engaging in PROMs via telepsychiatry and in-person modalities. PROM results of a patient cohort in clinical care prior to the onset of COVID-19 (November 2019) through March 2021 demonstrated that depression, anxiety and psychological functioning did not decline as hypothesized but statistically improved. Data also show that the engagement rates range from 33 to 74% depending on demographic factors, and completion rates were significantly different for diagnostic group and payor status of the patient. The standard goal for MBC utilization is 80%, while the department goal is to have all patients participate in PROM completion. The research group has also completed focus groups of psychiatric clinicians and staff with regards to Owl Insights and PROMs within the past year, identifying barriers and facilitators to its use and plan training implementation for improved adherence and satisfaction (summary of focus group data and training outline- included in grant application, IRB approved protocol 20-1065). Since March 2020, CC-P\&BM has been engaging with patients via telephone and several telehealth platforms. Currently, ambulatory psychiatry uses AmWell (Amwell telemedicine) service, a telehealth platform that provides secure telemedicine visits between clinician and patient. The department has documented between 2100-2300 adult telemedicine sessions monthly and 200-700 in-person visits per month between June 2020 and June 2021.

CC-P\&BM currently has a wait-list of over 300 adults referred for mental health evaluation and treatment. Access to psychiatric clinicians remains insufficient despite increasing numbers of providers in the local clinic and the mental health needs associated with the pandemic are rising. As a result, a clinical intake coordinator (Licensed Professional Counselor) began in the CC-P\&BM ambulatory clinic September 2021. This coordinator will individually contact people on the wait-list for psychiatric care by phone as part of routine care, beginning with the referrals most remote in time. The coordinator will complete an intake assessment for each wait-list individual who wants a psychiatric referral. Prior to the initial intake assessment by the intake coordinator, wait-list individuals will receive a bundle of PROMs automatically (through Owl Insights) to complete. These measures include the Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder survey (GAD-7), Brief Adjustment Scale (BASE-6), Drug Assessment Screening Test (DAST-10), US Alcohol Use Disorder Identification Test (USAUDIT), Covid Event Checklist and the Adult Behavioral Health Screen (ABHS), all of which are currently used in routine ambulatory care. The intake coordinator will complete the intake assessment, noting the completion, and scores of, the PROMs. Scores of the PHQ-9, GAD-7 and BASE-6 will be utilized to triage the most severe referrals and move them up for a sooner appointment (the triage system of scores and Nurse-Practitioner vs Medical Doctor screening questions are attached to this application). Any concern about patient safety is also addressed immediately during this intake and is also noted in the materials attached to this application. Up to this point, all intake coordinator/referral interaction are part of routine care.

If eligible and capable of consent based on intake coordinator clinical judgement, individuals will then be randomized to participate to the no intervention group (completion of screening PROMs only during the intake coordinator assessment) or the minimal intervention group (intake coordinator assessment, including PROM screening and then prospective monthly PROM completion in addition to assigned microlearning patient education videos). Investigators will analyze changes in PROM scores for individuals engaged in both wait-list groups and compare results to their PROM scores at the initial provider telemedicine visit and over time (6 months post first provider assessment). Consent may be in-person with hard copy consent forms and signatures or through e-Consent either in-person or remotely.

The goals of this study are to (1) measure the symptomology and well-being of adult individuals on a waitlist group referred to CC-P\&BM clinic from their initial referral to their initial psychiatric session with PROMs monthly versus only at entry to the waitlist and entry to clinic and (2) use PROMs to assess whether there is a difference in clinical symptomology and well-being for patients during tele-treatment with their practitioner compared to waitlist Individuals.

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

Primary outcomes:
measure: Measurement of Symptomatology of Patients on Waitlist Via Patient Health Questionnaire (PHQ-9)
timeFrame: 11 months
measure: Measurement of Symptomatology of Patients on Waitlist Via Generalized Anxiety Disorder Survey (GAD-7)
timeFrame: 11 months
measure: Measurement of Symptomatology of Patients on Waitlist Via Brief Adjustment Scale (BASE-6)
timeFrame: 11 months
measure: Measurement of Symptomatology of Patients on Waitlist Via US Alcohol Use Disorder Identification Test (USAUDIT)
timeFrame: Baseline
measure: Measurement of Symptomatology of Patients on Waitlist Via Drug Assessment Screening Test (DAST-10)
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Anita Kablinger
state: Virginia
Study officials:
affiliation: Carilion Clinic
name: Virginia O'Brien, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Torous J, Wykes T. Opportunities From the Coronavirus Disease 2019 Pandemic for Transforming Psychiatric Care With Telehealth. JAMA Psychiatry. 2020 Dec 1;77(12):1205-1206. doi: 10.1001/jamapsychiatry.2020.1640. No abstract available.
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citation: Douglas S, Jensen-Doss A, Ordorica C, Comer JS. Strategies to enhance communication with telemental health measurement-based care (tMBC). Pract Innov (Wash D C). 2020 Jun;5(2):143-149. doi: 10.1037/pri0000119.