Trial Outcomes & Findings for Effectiveness of Telepsychiatry With Randomized Waitlist Control Utilizing Patient Reported Outcome Measures (NCT NCT05274958)
NCT ID: NCT05274958
Last Updated: 2024-06-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
148 participants
Primary outcome timeframe
11 months
Results posted on
2024-06-26
Participant Flow
286 people on the waitlist for ambulatory psychiatry were contacted for participation and assessed for eligibility. 138 were excluded: not meeting inclusion criteria, n=21 and declined to participate, n=117. N=148 agreed to participate
Participant milestones
| Measure |
Initial PROM Plus Monthly PROM
These patients receive usual care plus monthly PROMs while on the waitlist
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. All patients receive PROMs on entering our clinic. The difference in this intervention is those randomized to the active treatment will receive monthly PROMs 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.
|
Usual Care
Patients will complete the initial bundle of PROMs, then no further PROMs while they remain on the waitlist
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
78
|
|
Overall Study
COMPLETED
|
48
|
43
|
|
Overall Study
NOT COMPLETED
|
22
|
35
|
Reasons for withdrawal
| Measure |
Initial PROM Plus Monthly PROM
These patients receive usual care plus monthly PROMs while on the waitlist
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. All patients receive PROMs on entering our clinic. The difference in this intervention is those randomized to the active treatment will receive monthly PROMs 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.
|
Usual Care
Patients will complete the initial bundle of PROMs, then no further PROMs while they remain on the waitlist
|
|---|---|---|
|
Overall Study
Only completed 1 set of PROMs
|
22
|
35
|
Baseline Characteristics
Effectiveness of Telepsychiatry With Randomized Waitlist Control Utilizing Patient Reported Outcome Measures
Baseline characteristics by cohort
| Measure |
Initial PROM Plus Monthly PROM
n=70 Participants
These patients received usual care plus monthly PROMs while on the waitlist.
Patient-rated outcome measures: 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. All patients receive PROMs on entering our clinic. The difference in this intervention is those randomized to the active treatment will receive monthly PROMs 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.
|
Usual Care
n=78 Participants
Patients completed the initial bundle of PROMs, then no further PROMs while they remained on the waitlist.
|
Total
n=148 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37 years
STANDARD_DEVIATION 13 • n=99 Participants
|
36 years
STANDARD_DEVIATION 12 • n=107 Participants
|
36 years
STANDARD_DEVIATION 12 • n=206 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
106 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
70 Participants
n=99 Participants
|
78 Participants
n=107 Participants
|
148 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
62 Participants
n=99 Participants
|
66 Participants
n=107 Participants
|
128 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
PHQ-9 score
|
14 units on a scale
STANDARD_DEVIATION 6 • n=99 Participants
|
14 units on a scale
STANDARD_DEVIATION 6 • n=107 Participants
|
14 units on a scale
STANDARD_DEVIATION 6 • n=206 Participants
|
|
GAD-7 score
|
13 units on a scale
STANDARD_DEVIATION 6 • n=99 Participants
|
12 units on a scale
STANDARD_DEVIATION 5 • n=107 Participants
|
13 units on a scale
STANDARD_DEVIATION 6 • n=206 Participants
|
|
BASE-6 score
|
27 units on a scale
STANDARD_DEVIATION 9 • n=99 Participants
|
28 units on a scale
STANDARD_DEVIATION 9 • n=107 Participants
|
27 units on a scale
STANDARD_DEVIATION 9 • n=206 Participants
|
|
DAST-10 score
|
1 units on a scale
STANDARD_DEVIATION 1 • n=99 Participants
|
1 units on a scale
STANDARD_DEVIATION 2 • n=107 Participants
|
1 units on a scale
STANDARD_DEVIATION 2 • n=206 Participants
|
|
USAUDIT
|
5 units on a scale
STANDARD_DEVIATION 6 • n=99 Participants
|
4 units on a scale
STANDARD_DEVIATION 4 • n=107 Participants
|
5 units on a scale
STANDARD_DEVIATION 5 • n=206 Participants
|
PRIMARY outcome
Timeframe: 11 monthsPopulation: Final PHQ-9 scores for each arm compared to baseline scores.
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.
Outcome measures
| Measure |
PROM Plus Monthly PROM
n=43 Participants
These patients receive usual care plus monthly PROMs while on the waitlist
Patient-rated outcome measures: 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. All patients receive PROMs on entering our clinic. The difference in this intervention is those randomized to the active treatment will receive monthly PROMs 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.
|
Usual Care
n=48 Participants
Patients will complete the initial bundle of PROMs, then no further PROMs while they remain on the waitlist
|
|---|---|---|
|
Measurement of Symptomatology of Patients on Waitlist Via Patient Health Questionnaire (PHQ-9)
Initial
|
13.41 score on a scale
Standard Deviation 6.18
|
13.48 score on a scale
Standard Deviation 6.90
|
|
Measurement of Symptomatology of Patients on Waitlist Via Patient Health Questionnaire (PHQ-9)
Final
|
13.60 score on a scale
Standard Deviation 6.80
|
13.00 score on a scale
Standard Deviation 6.32
|
PRIMARY outcome
Timeframe: 11 monthsPopulation: Final GAD-7 scores for each arm compared to baseline scores.
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.
Outcome measures
| Measure |
PROM Plus Monthly PROM
n=43 Participants
These patients receive usual care plus monthly PROMs while on the waitlist
Patient-rated outcome measures: 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. All patients receive PROMs on entering our clinic. The difference in this intervention is those randomized to the active treatment will receive monthly PROMs 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.
|
Usual Care
n=48 Participants
Patients will complete the initial bundle of PROMs, then no further PROMs while they remain on the waitlist
|
|---|---|---|
|
Measurement of Symptomatology of Patients on Waitlist Via Generalized Anxiety Disorder Survey (GAD-7)
Initial
|
12.53 score on a scale
Standard Deviation 5.76
|
12.42 score on a scale
Standard Deviation 5.40
|
|
Measurement of Symptomatology of Patients on Waitlist Via Generalized Anxiety Disorder Survey (GAD-7)
Final
|
12.35 score on a scale
Standard Deviation 5.99
|
11.54 score on a scale
Standard Deviation 5.65
|
PRIMARY outcome
Timeframe: 11 monthsPopulation: Final BASE-6 scores for each arm compared to baseline scores.
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.
Outcome measures
| Measure |
PROM Plus Monthly PROM
n=43 Participants
These patients receive usual care plus monthly PROMs while on the waitlist
Patient-rated outcome measures: 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. All patients receive PROMs on entering our clinic. The difference in this intervention is those randomized to the active treatment will receive monthly PROMs 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.
|
Usual Care
n=48 Participants
Patients will complete the initial bundle of PROMs, then no further PROMs while they remain on the waitlist
|
|---|---|---|
|
Measurement of Symptomatology of Patients on Waitlist Via Brief Adjustment Scale (BASE-6)
Initial
|
26.74 score on a scale
Standard Deviation 9.23
|
27.10 score on a scale
Standard Deviation 9.23
|
|
Measurement of Symptomatology of Patients on Waitlist Via Brief Adjustment Scale (BASE-6)
Final
|
27.32 score on a scale
Standard Deviation 9.24
|
25.47 score on a scale
Standard Deviation 9.10
|
PRIMARY outcome
Timeframe: BaselinePopulation: The USAUDIT was administered at baseline only; patients with primary or significant substance use disorders were referred to the addiction medicine service.
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.
Outcome measures
| Measure |
PROM Plus Monthly PROM
n=70 Participants
These patients receive usual care plus monthly PROMs while on the waitlist
Patient-rated outcome measures: 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. All patients receive PROMs on entering our clinic. The difference in this intervention is those randomized to the active treatment will receive monthly PROMs 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.
|
Usual Care
n=78 Participants
Patients will complete the initial bundle of PROMs, then no further PROMs while they remain on the waitlist
|
|---|---|---|
|
Measurement of Symptomatology of Patients on Waitlist Via US Alcohol Use Disorder Identification Test (USAUDIT)
Female
|
3.54 score on a scale
Standard Deviation 4.07
|
3.52 score on a scale
Standard Deviation 3.74
|
|
Measurement of Symptomatology of Patients on Waitlist Via US Alcohol Use Disorder Identification Test (USAUDIT)
Male
|
3.22 score on a scale
Standard Deviation 3.56
|
5.83 score on a scale
Standard Deviation 7.52
|
PRIMARY outcome
Timeframe: BaselinePopulation: DAST-10 was administered at baseline only; patients with primary or significant substance use disorders were referred to the addiction medicine service.
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.
Outcome measures
| Measure |
PROM Plus Monthly PROM
n=70 Participants
These patients receive usual care plus monthly PROMs while on the waitlist
Patient-rated outcome measures: 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. All patients receive PROMs on entering our clinic. The difference in this intervention is those randomized to the active treatment will receive monthly PROMs 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.
|
Usual Care
n=78 Participants
Patients will complete the initial bundle of PROMs, then no further PROMs while they remain on the waitlist
|
|---|---|---|
|
Measurement of Symptomatology of Patients on Waitlist Via Drug Assessment Screening Test (DAST-10)
|
0.90 units on a scale
Standard Deviation 1.87
|
0.55 units on a scale
Standard Deviation 1.05
|
Adverse Events
Initial PROM Plus Monthly PROM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place