University of North Carolina-Healthwise Partnership Project on Birth Options Decision Aid (B-READY)
Pilot Study to Assess the Effectiveness of a Decision Tool for Cesarean Delivery vs. Trial of Labor
This is pilot quasi-experimental study of women with one or two prior cesarean deliveries who are now pregnant and eligible for a trial of labor after cesarean delivery, to assess whether a decision aid, providing knowledge about trial of labor (VBAC) and planned repeat cesarean delivery can improve the birth options decision-making process for patients.
Participants are screened for eligibility through electronic health records. Once an individual is screened eligible, and email invite is sent providing information about the study and assessing the interest in participation. An on-line consent is completed and women are entered sequentially into the usual care group and then through further recruitment, another sample of women are entered into the decision aid group. The primary outcome is satisfaction with the shared decision-making process with their provider.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
Once a potential participant is screened eligible, completes the on-line informed consent, they are officially enrolled in the study and sent a link confirming their enrollment and the study group in which they have been assigned. Participants are sequentially enrolled in the study with enrollment first into the usual care group. Once enrollment in the usual care group is complete, enrollment into the decision aid group will occur.
The study includes two non-randomized groups:
Arm 1 (Usual care group): Women in this group will undergo usual care and complete the survey questions on knowledge of risks and benefits of TOLAC (also referred to as VBAC) and planned repeat cesarean (PRCS), certainty of their decision, and involvement in the decision for trial of labor (TOLAC) or repeat cesarean delivery.
Arm 2: (Decision aid group- group receiving the decision tool): Women in this group will receive a decision aid prior to undergoing counseling by their physician. Following completion of the decision aid and physician counseling, they will complete a series of survey questions to assess their knowledge of the risks and benefits of TOLAC and PRCS, certainty of their decision, and involvement in the decision for repeat cesarean or TOLAC.
The decision aid group will be compared with women who do not receive the decision aid (usual care group).
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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North Carolina
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Chapel Hill, North Carolina, Stany Zjednoczone, 27517
- University of North Carolina - Chapel Hill
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Gestational age between 19/0 and 36/6 weeks
- History of 1 or 2 prior cesarean deliveries
Exclusion Criteria:
- No contraindications to trial of labor after cesarean (TOLAC)
- No history of prior TOLAC
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Badania usług zdrowotnych
- Przydział: Nielosowe
- Model interwencyjny: Zadanie sekwencyjne
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Brak interwencji: Usual care
Women in this group will undergo usual care and the complete the survey questions on knowledge and involvement in the decision for trial of labor after cesarean (TOLAC) or repeat cesarean.
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Aktywny komparator: Decision Aid
Women in this group will receive a decision aid prior to undergoing counseling by their physician.
Following completion of the decision aid and physician counseling, they will complete a series of survey questions to assess their perceptions of their knowledge and involvement in the decision for trial of labor after cesarean (TOLAC) or repeat cesarean delivery.
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The decision aid is a series of web pages that includes videos, questions, and evidence-based information.
The decision aid is designed to help women think about what matters to them and what questions they may have for their doctor or midwife.
At the end, they receive a summary of which way they are leaning and what matters most to them.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Shared Decision Making (SDM) Process score
Ramy czasowe: Up to 6 months prior to delivery
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This is a measure of the patient's involvement in the decision.
1 point is assigned for discussing the pros 'a lot' or 'some'; 1 point is assigned for discussing the cons 'a lot' or 'some'; 1 point is assigned for responding 'yes' if the provider explained the options; and 1 point is assigned for responding 'yes' that the provider asked the patient what treatment she wanted.
The tool's score range is 0-4.
A higher score indicates more involvement in the decision.
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Up to 6 months prior to delivery
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Number of Participants (by category) With the Intent to Deliver by Repeat Cesarean Section or by Vaginal Delivery
Ramy czasowe: Date of Admission
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Intended mode of delivery (repeat cesarean or vaginal) prior to actual delivery
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Date of Admission
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Number of Participants (by category) who Delivered by Repeat Cesarean or Vaginal Delivery
Ramy czasowe: Up to 72 hours after delivery
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Actual method of delivery (repeat cesarean or vaginal delivery)
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Up to 72 hours after delivery
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Maternal or Fetal Complications at Delivery
Ramy czasowe: Up to 72 hours after delivery
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Number of complication events: maternal postpartum hemorrhage, infection, fetal admission to neonatal intensive care unit.
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Up to 72 hours after delivery
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Number of Participants (by Category) who desired Repeat Cesarean, Vaginal Delivery or Are Undecided after completion of the study survey
Ramy czasowe: Up to 6 months prior to delivery
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Participant responses are: 1) repeat cesarean delivery, 2) vaginal delivery and 3) undecided
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Up to 6 months prior to delivery
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Współpracownicy i badacze
Współpracownicy
Śledczy
- Główny śledczy: Wanda K Nicholson, MD, Univerisity of North Carolina - Chapel Hill
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- 17-2023
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Ramy czasowe udostępniania IPD
Kryteria dostępu do udostępniania IPD
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- ICF
- ANALITYCZNY_KOD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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