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Completed

NCT Number: NCT03836365

Patient Preparedness for Pelvic Organ Prolapse Surgery

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.

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Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Patient Preparedness Prolapse

Age range

21 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Magee-Womens' Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women planning to undergo same-day surgery to correct pelvic organ prolapse by the University of Pittsburgh Division of Urogynecology. Women remain eligible if they are admitted for observation following their surgery.

Exclusion criteria

  • Non-English speaking patients
  • A preoperative exam requirement that would necessitate an in person office visit (i.e. need for pessary removal, self-catheterization teaching)
  • Plan for concomitant surgical management with gynecology oncology or colorectal surgery
  • Residence in a nursing home

Treatment and study plan

Preoperative counseling office visit

Other

All patients undergo a preoperative counseling session prior to surgery. Participants in this arm will have an in person preoperative counseling office visit.

Other names: Office

Preoperative counseling phone call

Other

All patients undergo a preoperative counseling session prior to surgery. Participants in this arm will have a preoperative counseling phone call.

Other names: Call

Primary outcomes

  1. Patient preparedness

    Time frame: At postoperative visit (about 4-6 weeks after surgery)

    The percent of patients reporting preparedness on Preoperative Preparedness Questionnaire. Participants who answer "strongly agree" or "agree" to the statement "Overall, I felt prepared for my surgery" will be considered prepared. This instrument is a 9-item questionnaire and scored on a 5-point Likert scale with answers ranging from "5=strongly disagree" to "1=strongly agree" with "3=neutral." Therefore, scores of "1=strongly agree" or "2=agree" will be considered a positive answer for preparedness. It was adopted from a study by Kenton et al in 2007.

Secondary outcomes

  1. Patient satisfaction: Decision Scale-Pelvic Floor Disorders questionnaire

    Time frame: At postoperative visit (about 4-6 weeks after surgery)

    The percent of patients reporting satisfaction on the Satisfaction with Decision Scale-Pelvic Floor Disorders questionnaire. This is a validated, 5-item questionnaire with answers on a 5-point likert scale with "1=strongly agree," "3=neutral" and "5=strongly disagree." Answers of "1=strongly agree" or "2=agree" to the statement "I am satisfied with my decision" will be considered satisfied.

  2. Postoperative pain scores

    Time frame: Postoperative days #1-7

    Postoperative pain scores on postoperative days #1-7 on a scale of 0-10. Participants will complete a daily pain diary which will assess their pain score with 0=no pain and 10=worst pain imaginable.

  3. Postoperative narcotic use

    Time frame: Postoperative days #1-7

    Postoperative narcotics used which will be assessed by the daily pain diary (question: "How many narcotic pills did you use today?" with the answer being the number of pills used that day).

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • University of Pittsburgh Medical Center

Registry information

Official study title

Patient Preparedness for Pelvic Organ Prolapse Surgery: A Randomized Controlled Trial of Preoperative Counseling

Acronym: PREOP

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 11, 2019
Registry last updated
Jun 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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