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

NCT05274958 | Completed Results

• 2 other identifiers: 21-1426UL1TR003015
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Measurement-based Care

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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.

  Baseline

• 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.

  Baseline

Study Arms (2)

Initial PROM plus monthly PROM plus educational video

EXPERIMENTAL

These patients receive usual care plus monthly PROMs and educational video(s) while on the waitlist

Behavioral: Patient-rated outcome measures and educational videos

Usual Care

NO INTERVENTION

Patients will complete the initial bundle of PROMs, then no further PROMs while they remain on the waitlist

Interventions

Patient-rated outcome measures and educational videos BEHAVIORAL

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.

Initial PROM plus monthly PROM plus educational video

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Carilion Clinic: lead
• National Institutes of Health (NIH): collaborator
• Virginia Polytechnic Institute and State University: collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Anita Kablinger

Roanoke, Virginia, 24014, United States

Location

Related Publications (6)

• Kalin ML, Garlow SJ, Thertus K, Peterson MJ. Rapid Implementation of Telehealth in Hospital Psychiatry in Response to COVID-19. Am J Psychiatry. 2020 Jul 1;177(7):636-637. doi: 10.1176/appi.ajp.2020.20040372. No abstract available.

  PMID: 32605442 BACKGROUND

• Lambert MJ, Whipple JL, Kleinstauber M. Collecting and delivering progress feedback: A meta-analysis of routine outcome monitoring. Psychotherapy (Chic). 2018 Dec;55(4):520-537. doi: 10.1037/pst0000167.

  PMID: 30335463 BACKGROUND

• Lewis CC, Boyd M, Puspitasari A, Navarro E, Howard J, Kassab H, Hoffman M, Scott K, Lyon A, Douglas S, Simon G, Kroenke K. Implementing Measurement-Based Care in Behavioral Health: A Review. JAMA Psychiatry. 2019 Mar 1;76(3):324-335. doi: 10.1001/jamapsychiatry.2018.3329.

  PMID: 30566197 BACKGROUND

• 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.

  PMID: 32391857 BACKGROUND

• Augusterfer EF, Mollica RF, Lavelle J. Leveraging Technology in Post-Disaster Settings: the Role of Digital Health/Telemental Health. Curr Psychiatry Rep. 2018 Aug 28;20(10):88. doi: 10.1007/s11920-018-0953-4.

  PMID: 30155744 RESULT

• 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.

  PMID: 34888414 RESULT

MeSH Terms

Conditions

Mental Disorders

Limitations and Caveats

This study has several limitations. There was no control group who underwent psychiatric treatment without PROMs. PROM scores were not shared with patients in the waitlist groups, nor were they given education about what the scores meant clinically. Data was collected during the COVID-19 pandemic from a single adult academic clinic, and patients were predominantly white and female, limiting the generalizability of the results to other settings or populations.

Results Point of Contact

• Title: Director Psychiatry Clinical Research
• Organization: Carilion Clinic

askablinger@carilionclinic.org

540-527-4900

Study Officials

• Virginia O'Brien, MD

  Carilion Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: February 16, 2022
• First Posted: March 11, 2022
• Study Start: October 18, 2021
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: June 26, 2024
• Results First Posted: June 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)