Development and Pilot Test of an Elective Bilateral Salpingo-Oophorectomy (BSO) Decision Support Guide
Condition: Surgical Procedure, Unspecified
Study type: Interventional

Summary: 
      The investigators propose to conduct formative research to gain an understanding of patients'
      needs and desires regarding elective Bilateral Salpingo-Oophorectomy (BSO) decision making,
      and to develop and pilot test a BSO Decision Support Guide, in preparation for a randomized,
      controlled trial of the effect of this decision aid on decision quality and use of BSO. The
      proposed study will consist of 3 phases. In phase 1, the investigators plan to conduct focus
      groups among women who have had a hysterectomy with or without bilateral
      salpingo-oophorectomy (BSO) to gain an understanding of what they understood about BSO and
      its possible outcomes at the time of their hysterectomy and what they would have liked to
      have known, the extent and manner in which they were included in decision making regarding
      BSO, and how they feel about the decision now. The investigators also will collect
      qualitative data from women who are scheduled for hysterectomy and currently facing the
      decision whether or not to undergo elective BSO. In phase 2, the investigators plan to create
      a BSO Decision Support Guide using information obtained from the literature, from our
      formative research, and the experience of providers who have counseled women about this
      choice. In phase 3, the investigators plan to pilot test the BSO Decision Support Guide among
      women scheduled to undergo hysterectomy for benign conditions to assess its usefulness and
      usability for patients and their providers and to prepare for a randomized study of its
      impact on decision quality and use of BSO. 62 women who are scheduled to undergo hysterectomy
      for a non-cancerous uterine condition will participate in the pilot study. These women will
      participate in a baseline interview, during which they will be provided access to the BSO
      Decision Support Guide, and 2 follow up telephone interviews (one as they are making their
      final BSO decision and a second after they have undergone and recovered from their
      hysterectomy (with or without BSO). Data will be used to generate the final version of the
      Decision Support Guide, to finalize evaluation measures for future studies of the
      effectiveness of the guide, and to determine effect sizes for the outcomes of knowledge, BSO
      use, decision satisfaction and decisional conflict.
    

Detailed description: 
      Specific Aim 1) Conduct formative research to assess how sociodemographically diverse women
      who will be undergoing hysterectomy for non-cancerous conditions view elective BSO and to
      assess their information needs and desires regarding shared decision making in this context.

      Specific Aim 2) Create a BSO Decision Support Guide using information obtained from the
      literature, from our formative research, and the experience of providers who have counseled
      women about this choice.

      Specific Aim 3) Pilot test the BSO Decision Support Guide among women scheduled to undergo
      hysterectomy for benign conditions to assess its usefulness and usability for patients and
      their providers and to prepare for a randomized study of its impact on decision quality and
      use of BSO.
    

Intervention name(s): Computerized decision aid with 1 type of value clarification
Intervention type(s): Behavioral
Intervention description(s): Women will be instructed to view a computerized BSO decision support guide.
Other intervention name(s): Computerized decision aid with 2 types
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: hysterectomy with Bilateral Salpingo Oophorectomy; Oophorectomy; Gynecologic condition