Virtual Patient Navigation During a Pandemic (NCT06208852) | Clinical Trial Compass
RecruitingNot Applicable
Virtual Patient Navigation During a Pandemic
United States40 participantsStarted 2023-06-29
Plain-language summary
The sub-study will involve a rigorous mixed-methods design. The qualitative phase of the sub-study will consist of semi-structured interviews. During the semi-structured interviews, 10 eligible women will be recruited to identify barriers and facilitators to accessing virtual mental health services. This information will be used to adapt an evidence-based patient navigation intervention for virtual use. For the intervention phase of the sub-study, 30 women with persistent postpartum depression symptoms will be recruited to participate in the adapted virtual navigator program using rapid cycle testing over a 2-month period.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
ā. Are either former participants from the R61 Phase (IRB 19-016174) of the Main RCT, or have been referred, are actively enrolled, or withdrawn from the R33 Phase (IRB 22-019784) of the Main RCT.
ā. Are \> 18 years of age
ā. Speak and read in English
ā. Have access to a smart phone or computer tablet with internet access
ā. Have an infant \< 12 months of age
ā. Are not actively engaged with MH services
ā. Screen positive for postpartum depression (score\>9) on the EPDS
ā. Are \> 18 years of age
Exclusion criteria
ā. Report suicidality (i.e., suicidal ideation and/or behavior) on the EPDS (Question #10) at enrollment.
ā. Report severe depressive symptoms (EPDS\>20) at enrollment.
What they're measuring
1
Qualitative: Barriers and facilitators to virtual and in-person mental health services
Timeframe: Baseline
2
Intervention: Target engagement of the Patient Navigator
. Have a substantiated report of child maltreatment
ā. Were born premature (estimated gestational age\<35 weeks)
ā. Have been diagnosed with congenital malformations or genetic syndromes which place them at risk of developmental delays
ā. Are already currently receiving early intervention services for developmental delays at baseline
ā. Report suicidality (i.e., suicidal ideation and/or behavior) on the EPDS (Question #10) with a response of "sometimes," or "yes, quite often" at participating pediatric practice
ā. Report suicidality (i,e, suicidal ideation and/or behavior) on the EPDS (Question #10) and also endorse any of the follow up questions at a participating pediatric practice: