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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hema Brazell, Hartford Hospital
ClinicalTrials.gov Identifier:
NCT01798082
First received: February 20, 2013
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

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 Intervention
Decisional Conflict
Other: Pelvic organ prolapse decision aid

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Health Services Research

Resource links provided by NLM:


Further study details as provided by Hartford Hospital:

Primary Outcome Measures:
  • Difference in decisional conflict [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    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:
  • Number of patients who choose surgery over conservative management [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 126
Study Start Date: December 2012
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01798082

Locations
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06106
Sponsors and Collaborators
Hartford Hospital
Investigators
Principal Investigator: Hema Brazell Hartford Hospital
  More Information

No publications provided

Responsible Party: Hema Brazell, Principal Investigator, Hartford Hospital
ClinicalTrials.gov Identifier: NCT01798082     History of Changes
Other Study ID Numbers: BRAZ003846HU, 333590
Study First Received: February 20, 2013
Last Updated: August 27, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 19, 2014