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.|
|ClinicalTrials.gov 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
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|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||126 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|Primary Purpose:||Health Services Research|
|Study Start Date :||December 2012|
|Estimated Primary Completion Date :||October 2013|
|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
- 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).
- Number of patients who choose surgery over conservative management [ Time Frame: 1 year ]
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 ClinicalTrials.gov identifier (NCT number): NCT01798082
|United States, Connecticut|
|Hartford, Connecticut, United States, 06106|
|Principal Investigator:||Hema Brazell||Hartford Hospital|