Patient Preparedness for Pelvic Organ Prolapse Surgery

NCT ID: NCT03836365

Last Updated: 2020-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-02
• Study Completion Date: 2020-05-01

Brief 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.

Conditions

Pelvic Organ Prolapse; Patient Preparedness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Preoperative counseling office visit

Participants will present for an in-person preoperative counseling office visit (preoperative counseling session). This will occur within a few weeks of surgery. Preoperative counseling topics are standardized and will be identical with each arm.

Group Type: ACTIVE_COMPARATOR

Preoperative counseling office visit

Intervention Type: OTHER

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

Preoperative counseling phone call

Participants will receive a preoperative counseling phone call (preoperative counseling session). This will occur within a few weeks of surgery. Preoperative counseling topics are standardized and will be identical with each arm.

Group Type: ACTIVE_COMPARATOR

Preoperative counseling phone call

Intervention Type: OTHER

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

Interventions

Preoperative counseling office visit

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

Intervention Type: OTHER

Preoperative counseling phone call

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

Intervention Type: OTHER

Other Intervention Names

Office; Call

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh Medical Center

OTHER

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Jessica Sassani

Fellow, Division of Female Pelvic Medicine & Reconstructive Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jessica Sassani

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Magee-Womens' Hospital of UPMC

Pittsburgh, Pennsylvania, United States

Countries

United States

References

Holmes-Rovner M, Kroll J, Schmitt N, Rovner DR, Breer ML, Rothert ML, Padonu G, Talarczyk G. Patient satisfaction with health care decisions: the satisfaction with decision scale. Med Decis Making. 1996 Jan-Mar;16(1):58-64. doi: 10.1177/0272989X9601600114.

Reference Type: BACKGROUND

PMID: 8717600 (View on PubMed)

Sung VW, Kauffman N, Raker CA, Myers DL, Clark MA. Validation of decision-making outcomes for female pelvic floor disorders. Am J Obstet Gynecol. 2008 May;198(5):575.e1-6. doi: 10.1016/j.ajog.2007.12.035. Epub 2008 Mar 7.

Reference Type: BACKGROUND

PMID: 18313632 (View on PubMed)

Kenton K, Pham T, Mueller E, Brubaker L. Patient preparedness: an important predictor of surgical outcome. Am J Obstet Gynecol. 2007 Dec;197(6):654.e1-6. doi: 10.1016/j.ajog.2007.08.059.

Reference Type: RESULT

PMID: 18060968 (View on PubMed)

Other Identifiers

STUDY19010073

Identifier Type: -

Identifier Source: org_study_id