Patient Preparedness for Pelvic Organ Prolapse Surgery
Condition: Pelvic Organ Prolapse; Patient Preparedness
MeSH terms: Prolapse; Pelvic Organ Prolapse
Study type: Interventional

Summary: 
      Patient preparedness has been associated with increased patient satisfaction, decreased
      postoperative pain and decreased postoperative narcotic use; however, little is known
      regarding the optimal way to prepare patients prior to pelvic reconstructive surgery. The
      primary aim of this study is to determine if a preoperative counseling in person visit has
      similar rates of patient preparedness as a preoperative counseling phone call for women
      undergoing same-day pelvic organ prolapse surgery. Secondary aims evaluate patient
      satisfaction, postoperative pain scores and postoperative narcotic usage. Women who plan to
      undergo pelvic organ prolapse surgery will be randomized to a preoperative in person
      counseling visit or a preoperative counseling phone call. Participants will complete
      questionnaires to assess their preparedness, satisfaction and postoperative pain. The goal of
      this study is to gather information that will allow clinicians to improve patient surgical
      preparedness and satisfaction.
    

Detailed description: 
      This will be a randomized controlled trial to assess patient preparedness following a
      preoperative counseling in person visit when compared to a preoperative counseling phone
      call.

      Recruitment & Enrollment: Participants will be recruited and enrolled from the urogynecology
      office during their surgical planning visit. The study will be introduced at this visit and
      participants will have the opportunity to bring the consent home to review and consider their
      participation prior to signing.

      Randomization: Participants will be block randomized in a 1:1 ratio in block size of 2.
      Randomization will be done by REDCap. The participant will not be blinded given the nature of
      the intervention. Additionally, the attending surgeon, fellow and office staff (advanced
      practice providers, research staff, medical assistants) will be aware of the randomization
      group as they will be participating in the preoperative intervention or perioperative
      clinical care.

      Intervention: Both the preoperative counseling visit and preoperative phone call will contain
      the same components of discussion and counseling which include surgical details, risks and
      benefits, preoperative and postoperative instructions and expectations. The visit will take
      place in the urogynecology office and the visits and phone calls will be done by either a
      fellow or advanced practice provider, all of whom have extensive experience with the
      standardized preoperative visit.

      Follow up: A postoperative phone call will be completed either POD#1 or POD#2 to remind the
      participant to complete their daily pain diary. Each participant will follow up for their
      standard postoperative visit approximately 4-6 weeks postoperative. All patients routinely
      receive a call on POD#1 from our nurses to assess how they are doing postoperatively. This
      phone call will continue unchanged for all participants.
    

Intervention name(s): Preoperative counseling office visit; Preoperative counseling phone call
Intervention type(s): Other; Other
Intervention description(s): All patients undergo a preoperative counseling session prior to surgery. Participants in this arm will have an in person preoperative counseling office visit.; All patients undergo a preoperative counseling session prior to surgery. Participants in this arm will have a preoperative counseling phone call.
Other intervention name(s): Office; Call
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Pelvic organ prolapse; Patient preparedness; Randomized controlled trial