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The purpose of this study is to test and evaluate the Preparing Heart and Mindâ„¢ (PHMâ„¢) patient engagement pathway as a nurse-guided intervention to lower psychological distress and enhance caregiving competencies among mothers/birthing persons and their caregiving partners after a major fetal anomaly diagnosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention (PHM) | Experimental | This pathway is intended to be a tool to enhance support for a mother/birthing person and her caregiving partner, facilitate communication with healthcare providers, and promote development of caregiving to optimize maternal-fetal, infant, and family health. |
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| Usual Care Group (UC) | No Intervention | The control group participants will receive care as usual. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PHMâ„¢ Pathway | Behavioral | The technological platform referred to as Preparing Heart and Mindâ„¢ (PHMâ„¢) is designed as a patient engagement pathway. This platform includes GetWellNetwork's proprietary workflow engine, Patient Pathwaysâ„¢ and functionality of the Health Loop platform. Specifically, PHMâ„¢ will be created on a customized GetWellNetwork patient engagement pathway, getwell | Loop, which is a secure platform with a parent-facing app and an interactive dashboard for healthcare providers. The PHMâ„¢ getwell | Loop is a care program with chapters that incorporate interactive resources for patient information and education, trackers as touch points for psycho-social/educational support, and tailors care with condition-specific content, as well as action items. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in State-Trait Anxiety Inventory score | State subscale, 20 items, 4-point scale; State Anxiety cut point score ≥40 | 12 weeks after birth |
| Change in Center for Epidemiology Scale-Depression (CES-D) score | 20 items, 4-point scale; cut point score ≥16 | 12 weeks after birth |
| Change in Impact of Event Scale score | 22 items, 4-point scale; cut point score ≥ 24 | 12 weeks after birth |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne C McKechnie, PhD, RN | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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| ID | Term |
|---|---|
| D000013 | Congenital Abnormalities |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D002318 | Cardiovascular Diseases |
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This small pilot study is designed as a mixed methods randomized controlled trial to estimate and test the effect of a nurse-guided PHMâ„¢ intervention on psychological distress and perceived caregiving competencies using longitudinal, repeated measures. Qualitative and quantitative data are expected to provide crucial insights regarding app usage patterns, interactions with the nurse interventionist, and impacts of the intervention on the individual/dyad.
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