Pelvic Organ ProlapsePREOPNCT03836365
Patient Preparedness for Pelvic Organ Prolapse Surgery
A study testing Preoperative counseling office visit and Preoperative counseling phone call in people with Pelvic Organ Prolapse and Patient Preparedness, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 99 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse, Patient Preparedness
- What is being tested?
- Preoperative counseling office visit and Preoperative counseling phone call
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2019to 1 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Magee-Womens' Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
About this study
Official title: 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.
Read the 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
- Being tested
- Preoperative counseling office visit, Preoperative counseling phone call
- Keywords
- Pelvic organ prolapse, Patient preparedness, Randomized controlled trial
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative counseling office visitOther
Also called Office
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 callOther
Also called Call
All patients undergo a preoperative counseling session prior to surgery. Participants in this arm will have a preoperative counseling phone call.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Preoperative counseling office visit |
| 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. Receives: Other: Preoperative counseling phone call |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At postoperative visit (about 4-6 weeks after surgery)
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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).
Measured: Postoperative days #1-7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start2 Apr 2019
- Primary completion1 May 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh Medical Center
- Responsible party
- Principal investigator, Jessica Sassani, University of Pittsburgh
- Investigators
- Jessica Sassani, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03836365
- Sponsor's protocol ID
- STUDY19010073
- Acronym
- PREOP
- Status last verified
- Jun 2020
- First submitted
- 7 Feb 2019
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make IPD available to other researchers
Publications
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.
PubMed 8717600Sung 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.
PubMed 18313632Kenton 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.
PubMed 18060968
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Preparedness for Pelvic Organ Prolapse Surgery: A Randomized Controlled Trial of Preoperative Counseling
- ClinicalTrials.gov ID
- NCT03836365
- Acronym / sponsor ID
- PREOP / STUDY19010073
- Conditions
- Pelvic Organ Prolapse, Patient Preparedness
- Keywords
- Pelvic organ prolapse, Patient preparedness, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- University of Pittsburgh Medical Center
- Study start
- 2 Apr 2019 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 11 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative counseling office visit | Active comparator | Other: Preoperative counseling office visitParticipants 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 | Other: Preoperative counseling phone callParticipants 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. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative counseling office visitAlso: OfficeAll patients undergo a preoperative counseling session prior to surgery. Participants in this arm will have an in person preoperative counseling office visit. | Other | Preoperative counseling office visit |
| Preoperative counseling phone callAlso: CallAll patients undergo a preoperative counseling session prior to surgery. Participants in this arm will have a preoperative counseling phone call. | Other | Preoperative counseling phone call |
Primary outcome
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.
3 secondary outcomes
Patient satisfaction: Decision Scale-Pelvic Floor Disorders questionnaire
Time frame: At postoperative visit (about 4-6 weeks after surgery)
Postoperative pain scores
Time frame: Postoperative days #1-7
Postoperative narcotic use
Time frame: Postoperative days #1-7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Background: PubMed 8717600Holmes-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.
- Background: PubMed 18313632Sung 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.
- Results publication: PubMed 18060968Kenton 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.
- Individual participant dataSharing planned: No. There is no plan to make IPD available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Sassani principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative counseling office visit and Preoperative counseling phone call in people with Pelvic Organ Prolapse and Patient Preparedness, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient preparedness (time frame: At postoperative visit (about 4-6 weeks after surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03836365, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.