Trial Outcomes & Findings for Improving Identification of Mental Health/Substance Use Disorders in HIV Primary Care: Pilot Clinical Response (NCT NCT03067948)

NCT ID: NCT03067948

Last Updated: 2018-11-19

Results Overview

Number of participants for whom review and coding of audio recording captured a mental health or substance use issue during their visit

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

32 participants

Primary outcome timeframe

Visit following intervention which will occur on the same day or up to 1 week after the intervention

Results posted on

2018-11-19

Participant Flow

We only enrolled an intervention group (and utilized a historic control). Thus, all patient participants were assigned to the intervention group.

Participant milestones

Participant milestones
Measure
Intervention - Positive Screen Shared
Participants were given the opportunity to determine which positive screen, if any, that the participant wanted to discuss with the participant's provider at the next HIV primary care appointment. The participant was notified that all positive screens would be shared with the provider prior to the participant's next HIV primary care visit, and that any positive screen the patient chose to discuss with the provider would be specified. The received the Patient Reported Outcomes (PROs) result (score, interpretation, and recommendation) prior to the next HIV primary care visit.
Overall Study
STARTED
32
Overall Study
COMPLETED
32
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Improving Identification of Mental Health/Substance Use Disorders in HIV Primary Care: Pilot Clinical Response

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Intervention - Positive Screen Shared
n=32 Participants
In the intervention, participants were given the opportunity to determine which positive screen, if any, that the participant would like to discuss with the participant's provider at the next HIV primary care appointment. The participant was notified that all positive screens will be shared with the provider prior to the participant's next HIV primary care visit, and that any positive screen the patient had chosen to discuss with the provider will be specified. The provider received the PROs result (score, interpretation, and recommendation) prior to the next HIV primary care visit.
Age, Continuous
51.6 years
STANDARD_DEVIATION 8.9 • n=5 Participants
Sex/Gender, Customized
Male
21 participants
n=5 Participants
Sex/Gender, Customized
Female
11 participants
n=5 Participants
Race/Ethnicity, Customized
Black
29 participants
n=5 Participants
Race/Ethnicity, Customized
White
2 participants
n=5 Participants
Race/Ethnicity, Customized
Other
1 participants
n=5 Participants

PRIMARY outcome

Timeframe: Visit following intervention which will occur on the same day or up to 1 week after the intervention

Number of participants for whom review and coding of audio recording captured a mental health or substance use issue during their visit

Outcome measures

Outcome measures
Measure
Intervention - Positive Screen Shared
n=32 Participants
Participants were given the opportunity to determine which positive screen, if any, that the participant wanted to discuss with the participant's provider at the next HIV primary care appointment. The participant was notified that all positive screens would be shared with the provider prior to the participant's next HIV primary care visit, and that any positive screen the patient chose to discuss with the provider would be specified. The received the PROs result (score, interpretation, and recommendation) prior to the next HIV primary care visit.
Mental Health or Substance Use Issue Raised in Visit
32 Participants

PRIMARY outcome

Timeframe: Visit following intervention which will occur on the same day or up to 1 week after the intervention

Number of participants for whom review of transcript of clinic visit characterized discussion of mental health issues and referral for services

Outcome measures

Outcome measures
Measure
Intervention - Positive Screen Shared
n=32 Participants
Participants were given the opportunity to determine which positive screen, if any, that the participant wanted to discuss with the participant's provider at the next HIV primary care appointment. The participant was notified that all positive screens would be shared with the provider prior to the participant's next HIV primary care visit, and that any positive screen the patient chose to discuss with the provider would be specified. The received the PROs result (score, interpretation, and recommendation) prior to the next HIV primary care visit.
Audio Recording Data - Mental Health/Substance Use Action Taken
32 Participants

Adverse Events

Intervention - Positive Screen Shared

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

Anne Monroe MD

Johns Hopkins University SOM (Adjunct)

Phone: 202-994-0251

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place