- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01798082
Effect of a Decision Aid on Decision Making for the Treatment of Pelvic Organ Prolapse
Pelvic organ prolapse is a common condition that affects millions of women every year. There are many options for treatment and it can be difficult to make a decision as how best to proceed. Previous studies have shown that decisional aids (DAs) may improve knowledge, physician-patient communication, decisional conflict, and patient satisfaction. However, no study has evaluated the role of a decisional aid among women presenting for evaluation and management of prolapse. We would like to determine if a decision aid for prolapse decreases the amount of decisional conflict women face when choosing a plan of care.
We hypothesize that there will be a difference in the level/amount of decisional conflict between women who receive a DA and those who do not. Specifically, we anticipate that women randomized to receiving standard counseling and a DA with have less decisional conflict than the cohort receiving standard counseling alone.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Women scheduled for the evaluation and management of pelvic organ prolapse at Hartford Hospital will be contacted via telephone prior to the initial consultation visit to ascertain interest for this study. If they are interested, they will be randomized to one of two groups: those that receive a DA and those that do not.
This study requires you to answer some questions about the information packet you received in the mail. We routinely send a packet to all of our new patients. Half of the participants received a decision aid to supplement their information packet and the other half received our routine informational packet. You will be asked to complete a set of 2 questionnaires. It will take less than 10 minutes to complete these questions.
All data will be extracted and used by only the investigators on this study. The data will be stored on a restricted-access network drive and results will be reported in aggregate and no personal health history will be disclosed. Our primary outcome for this analysis is decisional conflict differences in those who receive a DA and those who do not.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Connecticut
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Hartford, Connecticut, United States, 06106
- Hartford Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Female
- ≥18 years old
- Scheduled for consultation visit for pelvic organ prolapse of any type (cystocele, rectocele, enterocele, uterine prolapse, and/or uterovaginal prolapse)
Exclusion Criteria:
- <18 years old
- Non-English speaking
- Any patient who declines, or expresses unwillingness to being contacted for participation in the study
- Planned concomitant non-gynecologic procedure
- Established patient in the practice
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: Standard counseling
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Experimental: Standard counseling, pelvic organ prolapse decision aid
In addition to standard counseling at the time of the initial new patient visit, the patients randomized to the experimental arm will recieve a pelvic organ prolapse decision aid prior to their initial visit.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in decisional conflict
Time Frame: 1 year
|
The primary outcome for this analysis is decisional conflict differences in those who receive a DA and those who do not. The investigators will administer the 16-item traditional Decisional Conflict Scale (DCS). The DCS comprises 3 subscales: decision uncertainty, factors contributing to uncertainty, and perceived effective decision making. The investigators will use the statement format of this scale in which patients respond to a series of Likert-scale statements using response categories of strongly agree, agree, neither agree nor disagree, disagree, or strongly disagree, which are scored as 0-4, respectively, and added. Based on previous research, scores will be tabulated and patients will be grouped as either having "high level of decisional conflict" versus "low level of decisional conflict." Values will be assessed for normality and compared between groups (i.e. those receiving the DA versus those who did not). |
1 year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of patients who choose surgery over conservative management
Time Frame: 1 year
|
1 year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hema Brazell, Hartford Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- BRAZ003846HU
- 333590
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Pelvic organ prolapse decision aid
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University of Southern DenmarkCompleted
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Massachusetts General HospitalCompletedOveractive Bladder | Pelvic Organ Prolapse | Stress Urinary IncontinenceUnited States
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National Taiwan University HospitalUnknown
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Kenneth Peters, MDWilliam Beaumont HospitalsCompleted
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University Of PerugiaCompletedUrinary Incontinence | Pelvic Organ ProlapseItaly
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Boston Scientific CorporationCompletedVaginal Vault Prolapse
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IRCCS San RaffaeleNot yet recruitingPelvic Organ Prolapse | Vaginal ProlapseItaly