Decisional ConflictNCT01798082
Effect of a Decision Aid on Decision Making for the Treatment of Pelvic Organ Prolapse
A study testing Pelvic organ prolapse decision aid in people with Decisional Conflict, run by Hartford Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Decisional Conflict
- What is being tested?
- Pelvic organ prolapse decision aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female
- ≥18 years old
- Scheduled for consultation visit for pelvic organ prolapse of any type (cystocele, rectocele, enterocele, uterine prolapse, and/or uterovaginal prolapse)
Who cannot join
- <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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Decisional Conflict
- Being tested
- Pelvic organ prolapse decision aid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic organ prolapse decision aidOther
| Study group | Role | What they receive |
|---|---|---|
| Standard counseling | No intervention | Not described |
| 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. Receives: Other: Pelvic organ prolapse decision aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 year
Secondary outcomes (1)
Number of patients who choose surgery over conservative management
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2013 (estimated)
- Study startDec 2012
- Primary completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decisional ConflictStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hartford Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hema Brazell, Hartford Hospital
- Investigators
- Hema Brazell, Principal investigator, Hartford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01798082
- Sponsor's protocol ID
- BRAZ003846HU
- Other IDs
- 333590
- Status last verified
- Aug 2013
- First submitted
- 20 Feb 2013
- Last updated
- 28 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Decision Aid on Decision Making for the Treatment of Pelvic Organ Prolapse
- ClinicalTrials.gov ID
- NCT01798082
- Acronym / sponsor ID
- BRAZ003846HU
- Conditions
- Decisional Conflict
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Hartford HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Oct 2013 (estimated)
- First posted
- 25 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard counseling | No intervention | – |
| Standard counseling, pelvic organ prolapse decision aid | Experimental | Other: Pelvic organ prolapse decision aidIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female
- ≥18 years old
- Scheduled for consultation visit for pelvic organ prolapse of any type (cystocele, rectocele, enterocele, uterine prolapse, and/or uterovaginal prolapse)
Key exclusion criteria (5 listed)
- <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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic organ prolapse decision aid | Other | Standard counseling, pelvic organ prolapse decision aid |
Primary outcome
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).
1 secondary outcome
Number of patients who choose surgery over conservative management
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hema Brazell principal investigator
Hartford Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic organ prolapse decision aid in people with Decisional Conflict, run by Hartford Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in decisional conflict (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2013; AzTrials last refreshed its copy on 6 Nov 2026.