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Improving Patient Decisions About Bariatric Surgery (PCORI)

25. september 2018 opdateret af: Amir Ghaferi, University of Michigan

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Our specific aims are:

  1. 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).
  2. 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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

1000

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • University of Michigan

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Control
Potential bariatric surgery patients who receive both the baseline questionnaire and follow-up questionnaire.
Andet: Decision Aid
Potential bariatric surgery patients who receive both the baseline questionnaire decision aid/conjoint analysis and follow-up questionnaire.
Adfærdsmæssigt: Decider Guider: Weight Loss
Decision aid tool about weight loss treatment

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Decision outcome by Decider Guider Questionnaire
Tidsramme: 24 months
Decisional measures
24 months
Patient specific outcome by Decider Guider Questionnaire
Tidsramme: 24 months
24 months

Sekundære resultatmål

Resultatmål
Tidsramme
Vægt
Tidsramme: 24 måneder
24 måneder
Knowledge, as measured by a follow-up Decider Guider questionnaire to test knowledge
Tidsramme: 24 months
24 months
Preferences as measured by Decider Guider Questionnaire
Tidsramme: 24 months
24 months
Quality of Life as measured by Decider Guider Questionnaire
Tidsramme: 24 months
24 months
Comorbidity Resolution as measured by Decider Guider Questionnaire
Tidsramme: 24 months
24 months
Patient Satisfaction as measured by Decider Guider Questionnaire
Tidsramme: 24 months
24 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Michigan

Samarbejdspartnere

Patient-Centered Outcomes Research Institute

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2014

Primær færdiggørelse (Faktiske)

15. september 2018

Studieafslutning (Faktiske)

15. september 2018

Datoer for studieregistrering

Først indsendt

22. januar 2015

Først indsendt, der opfyldte QC-kriterier

13. februar 2015

Først opslået (Skøn)

16. februar 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. september 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. september 2018

Sidst verificeret

1. september 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HUM00083670

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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