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| Name | Class |
|---|---|
| University of Pittsburgh Medical Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preoperative counseling office visit | Active Comparator | 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. |
|
| Preoperative counseling phone call | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient preparedness | 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. | At postoperative visit (about 4-6 weeks after surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction: Decision Scale-Pelvic Floor Disorders questionnaire | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica Sassani | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Magee-Womens' Hospital of UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8717600 | Background | 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. | |
| 18313632 | Background | 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. |
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There is no plan to make IPD available to other researchers
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000092922 | Working Conditions |
| D019002 | CD56 Antigen |
| ID | Term |
|---|---|
| D017132 | Workplace |
| D004651 | Employment |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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|
| 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. |
|
|
| At postoperative visit (about 4-6 weeks after surgery) |
| Postoperative pain scores | 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. | Postoperative days #1-7 |
| Postoperative narcotic use | 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). | Postoperative days #1-7 |
| 18060968 | Result | 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. |
| D010559 |
| Personnel Management |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| D019006 | Neural Cell Adhesion Molecules |
| D015816 | Cell Adhesion Molecules, Neuronal |
| D015815 | Cell Adhesion Molecules |
| D008562 | Membrane Glycoproteins |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D008565 | Membrane Proteins |
| D000945 | Antigens, Differentiation, T-Lymphocyte |
| D000943 | Antigens, Differentiation |
| D000954 | Antigens, Surface |
| D000941 | Antigens |
| D001685 | Biological Factors |
| D015415 | Biomarkers |