Clinical trial NCT01798082: Effect of a Decision Aid on Decision Making for the Treatment of Pelvic Organ Prolapse
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Decisional Conflict
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
First posted: 2013-02-25
Enrollment: 126
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in decisional conflict
timeFrame: 1 year
Secondary outcomes:
measure: Number of patients who choose surgery over conservative management
timeFrame: 1 year
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
Study officials:
affiliation: Hartford Hospital
name: Hema Brazell
role: PRINCIPAL_INVESTIGATOR
References: