Virtual Patient Navigation During a Pandemic

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Children's Hospital of Philadelphia
Study ID
NCT06208852
Status
Recruiting

Conditions

  • Post-partum Depression

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Virtual Navigator Program — OTHER
    For the intervention phase of the sub-study, 30 women with persistent PPD symptoms will be recruited to participate in the adapted virtual navigator program using rapid cycle testing over a 2-month period. These women will be enrolled and consented to receive virtual patient navigation for 2 months. Investigators will conduct rapid cycle testing in which we will evaluate satisfaction, feasibility, and target engagement of the intervention after every 10 participants in order to make rapid cycle changes prior to enrolling the next 10 participants. Women will communicate virtually with the PN by means of telephone, text messaging, Facetime, or other virtual modality of their choice. The Primary Navigator (PN) will meet with families at the beginning of the study to review results of depression screens and community mental health (MH) resources. The PN will partner with participants, engage them in the program, and provide ongoing communication with participants and MH clinicians.

Study Details

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.

Key Dates

Start date
Jun 29, 2023
Status verified
Jan 2026
Primary completion
May 31, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SCREENING

Arms

  • No Intervention: Qualitative phase
    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 during the pandemic. This information will be used to adapt an evidence-based patient navigation intervention for virtual use.
  • Experimental: Intervention Phase
    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.

Primary Outcome Measure

Qualitative: Barriers and facilitators to virtual and in-person mental health services [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
James Guevara, MD, MPH
215-590-1130

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