Patient Preparedness for Pelvic Organ Prolapse Surgery
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 21 - 99 |
| Updated: | 2/13/2019 |
| Start Date: | April 2019 |
| End Date: | October 2020 |
| Contact: | Jessica Sassani, MD |
| Email: | sassanijc@upmc.edu |
| Phone: | 3153822807 |
Patient Preparedness for Pelvic Organ Prolapse Surgery: A Randomized Controlled Trial of Preoperative Counseling
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.
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.
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.
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.
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
We found this trial at
1
site
300 Halket St.
Pittsburgh, Pennsylvania 15213
Pittsburgh, Pennsylvania 15213
1-866-MyMagee (696-2433)
Magee-Womens Hospital of UPMC Magee-Womens Hospital of UPMC is a world-class center for both women's...
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