Decisional Conflict Clinical Trial
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.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Health Services Research
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03427177 -
Mychoice: Testing an Interactive mHealth Tool
|
N/A |