Improving Patient Decisions About Bariatric Surgery (PCORI)
Patient-Centered Outcomes Research Institute (PCORI)- Improving Patient Decisions About Bariatric Surgery
At least 15 million Americans are morbidly obese, or more than 100 pounds overweight. Medical treatments including drugs and behavior modification have proven ineffective in producing significant and lasting weight loss in this group. While bariatric surgery is extremely effective for most patients, it also carries risks for both short and long-term complications. There are currently four different types of bariatric surgery available and the risks and benefits of these procedures vary widely and are strongly affected by patient and clinical characteristics.
Decision making under these circumstances should reflect informed patient's values and preferences regarding these trade-offs. Instead, the choice of bariatric procedure is more often driven by the beliefs and experiences of the bariatric surgeon that a patient happens to see. Variability in the type of surgery recommended to patients likely results from some combination of surgeons' subjective opinions and personal experiences with regard to the risks and benefits of the treatment options and delegated decision making on the part of patients.
The goals of this research proposal are to develop, implement, and evaluate an informed decision support tool for treatment of morbid obesity. This project will be conducted within the context of the Michigan Bariatric Surgery Collaborative (MBSC), which is a statewide clinical registry and quality improvement program that has the participation of virtually every bariatric surgeon and program in the state of Michigan. The MBSC registry now includes externally audited clinical data for more than 80,000 consecutive bariatric surgery patients. MBSC outcome measures include complications occurring within 30 days as well as weight loss, comorbidity resolution, quality of life and satisfaction at 1, 2, and 3 years after bariatric surgery.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
Our specific aims are:
- To develop a web-based interactive decision support tool to incorporate tailored information regarding risks and benefits of the treatment options (from regression-based prediction models derived on the 35,000 patients already in the MBSC registry) with information regarding other salient attributes of the treatment options (derived from focus groups and semi-structured interviews with stakeholders including bariatric surgery patients, bariatric program staff, and surgeons).
- To perform a quasi-experimental study comparing the decision support tool with usual care to determine its effects on patient decisions (treatment choice, knowledge, treatment-preference concordance, and decisional conflict) and on patient outcomes including weight loss, patient satisfaction, and improvements in quality of life after surgery.
This research is closely aligned with the goals of PCORI and will have direct impacts on patients and caregivers by providing information that is required to improve healthcare decision-making for this prevalent, damaging, and costly condition.
Typ studiów
Zapisy (Oczekiwany)
Faza
- Faza 2
Kontakty i lokalizacje
Lokalizacje studiów
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Michigan
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Ann Arbor, Michigan, Stany Zjednoczone, 48109
- University of Michigan
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- All patients considering undergoing bariatric surgery in the state of Michigan who are 18 or older.
- All patients, regardless of gender or racial/ethnic background, will be recruited to participate in the study in the same way.
Exclusion Criteria:
- Patients under the age of 18
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Brak interwencji: Control
Potential bariatric surgery patients who receive both the baseline questionnaire and follow-up questionnaire.
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Inny: Decision Aid
Potential bariatric surgery patients who receive both the baseline questionnaire decision aid/conjoint analysis and follow-up questionnaire.
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Decision aid tool about weight loss treatment
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Decision outcome by Decider Guider Questionnaire
Ramy czasowe: 24 months
|
Decisional measures
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24 months
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Patient specific outcome by Decider Guider Questionnaire
Ramy czasowe: 24 months
|
24 months
|
Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
|---|---|
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Waga
Ramy czasowe: 24 miesiące
|
24 miesiące
|
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Knowledge, as measured by a follow-up Decider Guider questionnaire to test knowledge
Ramy czasowe: 24 months
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24 months
|
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Preferences as measured by Decider Guider Questionnaire
Ramy czasowe: 24 months
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24 months
|
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Quality of Life as measured by Decider Guider Questionnaire
Ramy czasowe: 24 months
|
24 months
|
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Comorbidity Resolution as measured by Decider Guider Questionnaire
Ramy czasowe: 24 months
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24 months
|
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Patient Satisfaction as measured by Decider Guider Questionnaire
Ramy czasowe: 24 months
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24 months
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Współpracownicy i badacze
Sponsor
Współpracownicy
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 (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- HUM00083670
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