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

NCT01798082 | Unknown

• 2 other identifiers: BRAZ003846HU333590
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Decisional Conflict

Outcome Measures

Primary Outcomes (1)

• Difference in decisional conflict

  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

Secondary Outcomes (1)

• Number of patients who choose surgery over conservative management

  1 year

Study Arms (2)

Standard counseling

NO INTERVENTION

Standard counseling, pelvic organ prolapse decision aid

EXPERIMENTAL

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

Interventions

Pelvic organ prolapse decision aid OTHER

Standard counseling, pelvic organ prolapse decision aid

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• ≥18 years old
• Scheduled for consultation visit for pelvic organ prolapse of any type (cystocele, rectocele, enterocele, uterine prolapse, and/or uterovaginal prolapse)

You may not qualify if:

• \<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

Sponsors & Collaborators

• Hartford Hospital: lead

Study Sites (1)

Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

Study Officials

• Hema Brazell

  Hartford Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 20, 2013
• First Posted: February 25, 2013
• Study Start: December 1, 2012
• Primary Completion: October 1, 2013
• Last Updated: August 28, 2013

Record last verified: 2013-08

Locations

US (1)