COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Effect of a Decision Aid on Decision Making for the Treatment of Pelvic Organ Prolapse

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01798082
Recruitment Status : Unknown
Verified August 2013 by Hema Brazell, Hartford Hospital.
Recruitment status was:  Active, not recruiting
First Posted : February 25, 2013
Last Update Posted : August 28, 2013
Information provided by (Responsible Party):
Hema Brazell, Hartford Hospital

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Decisional Conflict Other: Pelvic organ prolapse decision aid Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Health Services Research
Study Start Date : December 2012
Estimated Primary Completion Date : October 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Standard counseling
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.
Other: Pelvic organ prolapse decision aid

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. Number of patients who choose surgery over conservative management [ Time Frame: 1 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01798082

Layout table for location information
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06106
Sponsors and Collaborators
Hartford Hospital
Layout table for investigator information
Principal Investigator: Hema Brazell Hartford Hospital
Layout table for additonal information
Responsible Party: Hema Brazell, Principal Investigator, Hartford Hospital Identifier: NCT01798082    
Other Study ID Numbers: BRAZ003846HU
First Posted: February 25, 2013    Key Record Dates
Last Update Posted: August 28, 2013
Last Verified: August 2013