Virtual Navigator Program for Postpartum Depression

Recruiting in Palo Alto (17 mi)

Overseen by James Guevara, MD, MPH

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Children's Hospital of Philadelphia

Disqualifiers: Suicidality, Severe depression, Child maltreatment, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the Virtual Navigator Program treatment for Postpartum Depression?

The research highlights the importance of patient-reported outcomes (PROs) in improving care quality and patient-provider communication, which are key components of the Virtual Navigator Program. These outcomes have been shown to enhance the delivery of care and facilitate better health management, suggesting potential benefits for postpartum depression treatment. ^{1 2 3 4 5}

How is the Virtual Navigator Program for Postpartum Depression different from other treatments?

The Virtual Navigator Program for Postpartum Depression is unique because it uses patient navigation, a patient-centered approach that helps new mothers overcome barriers to accessing mental health care. This program involves trained personnel who assist with logistical, financial, and cultural challenges, making it distinct from traditional treatments that may not address these specific obstacles. ^{6 7 8 9 10}

Research Team

Rhonda C. Boyd, PhD

Principal Investigator

Children's Hospital of Philadelphia

James Guevara, MD, MPH

Principal Investigator

Children's Hospital of Philadelphia

Eligibility Criteria

This trial is for women experiencing persistent postpartum depression symptoms. The study aims to understand and improve access to virtual mental health services for these individuals.

Inclusion Criteria

Women who have access to a smart phone or computer tablet with internet access

Women who 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

I am a woman aged 18 or older.

Exclusion Criteria

I am currently receiving mental health services.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Qualitative Phase

Participants engage in semi-structured interviews to identify barriers and facilitators to accessing virtual mental health services

1-2 weeks

1 visit (virtual or in-person)

Intervention Phase

Participants receive the adapted virtual navigator program using rapid cycle testing over a 2-month period

8 weeks

Weekly virtual check-ins

Follow-up

Participants are monitored for depressive symptoms and suicidality monthly

2 months

Monthly virtual assessments

Treatment Details

Interventions

• Virtual Navigator Program (Behavioural Intervention)

Trial Overview The trial is testing an adapted virtual navigator program designed to help women with postpartum depression. It includes interviews to identify barriers and facilitators, followed by a test of the navigation service over two months.

Participant Groups

Group I: Intervention Phase Experimental Treatment 1 Intervention

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.

Group II: Qualitative phase Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

Joseph W. St. Geme III

Children's Hospital of Philadelphia

Chief Medical Officer since 2021

MD, PhD, MPH

Madeline Bell

Children's Hospital of Philadelphia

Chief Executive Officer since 2015

BSc in Nursing from Villanova University, MSc in Organizational Dynamics from the University of Pennsylvania

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Dr. Joshua A. Gordon

National Institute of Mental Health (NIMH)

Chief Executive Officer since 2016

MD, PhD

Dr. Shelli Avenevoli

National Institute of Mental Health (NIMH)

Chief Medical Officer

PhD

Findings from Research

Patient-reported outcomes (PROs) are increasingly recognized as valuable data for evaluating product safety, effectiveness, and quality of care, reflecting a shift towards more patient-centered healthcare practices.

Integrating PROs into electronic health records and patient portals can improve care delivery and communication, although challenges such as implementation costs and data standardization need to be addressed for broader application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New frontiers in patient-reported outcomes: adverse event reporting, comparative effectiveness, and quality assessment. Basch, E.[2014]

Patient-reported outcome measures (PROM) are effective tools for assessing treatment outcomes, focusing on improving patients' functional, cognitive, and mental states, as well as their overall quality of life.

Despite the benefits of integrating electronic PROM into clinical practice, barriers such as financial, personnel, and technical challenges hinder their widespread adoption, which is necessary for enhancing patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Patient reported outcome measures in public reporting : Objectification of quality information via physicians and hospitals]. Eberle, KR., Schlagbauer, K.[2020]

Patient-centered outcome measurement is crucial for assessing the quality, effectiveness, and value of care in the evolving US healthcare system, emphasizing the importance of understanding disease impact.

The paper highlights how using outcome measurement tools in neurosurgery can enhance practice-based learning and quality improvement, ultimately demonstrating the value of neurosurgical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome science in practice: an overview and initial experience at the Vanderbilt Spine Center. McGirt, MJ., Speroff, T., Godil, SS., et al.[2022]

Implementing best practices in clinical care is crucial for improving patient outcomes, highlighting the importance of understanding this connection.

As outcomes-driven measures like OBQI become more prevalent, healthcare providers must adapt their clinical interventions to align with these quality standards for better patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standards of care and best practices: the link to patient outcomes. Huffman, MH.[2019]

Patient-reported outcomes (PROs) provide valuable insights directly from patients about their health conditions, but their role in guiding healthcare decisions is not yet fully understood.

The review highlights challenges in implementing PROs in clinical settings and proposes an evidence-based framework to enhance their use, along with future developments like individualized measurement and computer-adaptive testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Framework and guidance for implementing patient-reported outcomes in clinical practice: evidence, challenges and opportunities. Porter, I., Gonçalves-Bradley, D., Ricci-Cabello, I., et al.[2022]

Postpartum patient navigation significantly improves attendance at postpartum visits for low-income women, especially those with antenatal depressive symptoms, as shown in a study of 474 women.

In the navigation cohort, the presence of antenatal depressive symptoms did not affect attendance, indicating that patient navigation effectively mitigates this risk factor for nonattendance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is Postpartum Patient Navigation Uniquely Beneficial for Women with Antenatal Depressive Symptoms? Martinez, NG., Yee, LM., Miller, ES.[2022]

Women are at a higher risk for perinatal mood and anxiety disorders (PMADs) during the perinatal period, and many do not receive the necessary mental health care despite the availability of effective treatments.

The development of a patient navigation (PN) service in an intensive outpatient program has shown promise in improving treatment attendance and engagement for women with PMADs, suggesting that this model could be beneficial for other care facilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Stepped Care Model of Patient Navigation to Enhance Engagement with Perinatal Mental Health Care. DiSanza, CB., Geller, PA., Bonacquisti, A., et al.[2020]

The postpartum period is crucial for improving maternal health, but many individuals face barriers to effective care, leading to poor health outcomes; patient navigation is a promising intervention to help overcome these obstacles.

A comprehensive training guide for postpartum patient navigators was developed, emphasizing six core elements essential for effective navigation, which can be adapted for various healthcare settings to enhance postpartum care access and quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bridging the postpartum gap: best practices for training of obstetrical patient navigators. Yee, LM., Williams, B., Green, HM., et al.[2023]

A survey of 794 care team members revealed that while 96.7% have a protocol for screening peripartum depression (PPD), only 69.6% routinely screen all pregnant patients, indicating a gap in consistent screening practices.

Despite high self-reported rates of screening and training, 96.5% of respondents believe their organizations would benefit from additional training, suggesting that current efforts may not be sufficient to address the ongoing risks of maternal suicide and poor mental health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving maternal mental health: assessing the extent of screening and training about peripartum depression. Valdes, EG., Sparkman, L., Aamar, R., et al.[2023]

Only 64% of primary maternal and child health workers in Hunan Province were able to accurately diagnose postpartum depression, indicating a need for improved training and resources.

The study found that treatment accuracy was even lower at 50.9%, with workers from more economically developed areas showing better treatment capabilities, highlighting the influence of regional economic factors on healthcare competency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using virtual patient to assess primary health workers' competence to detect postpartum depression in Hunan, China. Zhang, C., Jin, X., Luo, D., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

New frontiers in patient-reported outcomes: adverse event reporting, comparative effectiveness, and quality assessment. [2014]

2. Germany pubmed.ncbi.nlm.nih.gov

[Patient reported outcome measures in public reporting : Objectification of quality information via physicians and hospitals]. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Outcome science in practice: an overview and initial experience at the Vanderbilt Spine Center. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Standards of care and best practices: the link to patient outcomes. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Framework and guidance for implementing patient-reported outcomes in clinical practice: evidence, challenges and opportunities. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Is Postpartum Patient Navigation Uniquely Beneficial for Women with Antenatal Depressive Symptoms? [2022]

7. United States pubmed.ncbi.nlm.nih.gov

A Stepped Care Model of Patient Navigation to Enhance Engagement with Perinatal Mental Health Care. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Bridging the postpartum gap: best practices for training of obstetrical patient navigators. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Improving maternal mental health: assessing the extent of screening and training about peripartum depression. [2023]

10. China pubmed.ncbi.nlm.nih.gov

Using virtual patient to assess primary health workers' competence to detect postpartum depression in Hunan, China. [2022]