Trial Outcomes & Findings for Impact of Decision Aids in Urogynecology (NCT NCT04369404)

Last Updated: 2024-04-16

Results Overview

Patients completed four multiple choice knowledge items for each condition and a total knowledge score (0-4) was calculated. The score was converted to a 0-100% scale, with higher scores indicating higher knowledge.

Recruitment status

COMPLETED

Study phase

Target enrollment

66 participants

Primary outcome timeframe

Within 1 day

Results posted on

2024-04-16

Participant Flow

Eligible participants were patients who had scheduled a visit with the Female Pelvic Medicine and Reconstructive Surgery Division of the Obstetrics and Gynecology Department at Massachusetts General Hospital between February 2019 - April 2019 Eligible patients were English speaking and between 18-95 years old. They had scheduled a visit for either pelvic organ prolapse, stress urinary incontinence, or overactive bladder.

Patients with prior surgery for pelvic organ prolapse or incontinence, or did not attend the scheduled visit were ineligible.

Participant milestones

Participant milestones
Measure	Usual Care In the usual care group, the providers do not have access to the decision aids.	Patient Decision Aid Providers have access to patient decision aids to review and discuss during the visit. Pelvic organ prolapse decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of pelvic organ prolapse Stress urinary incontinence decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of stress urinary incontinence. Overactive bladder decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of overactive bladder.
Overall Study STARTED	33	33
Overall Study COMPLETED	33	33
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Impact of Decision Aids in Urogynecology

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Care n=33 Participants In the usual care group, the providers do not have access to the decision aids.	Patient Decision Aid n=33 Participants Providers have access to patient decision aids to review and discuss during the visit. Pelvic organ prolapse decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of pelvic organ prolapse Stress urinary incontinence decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of stress urinary incontinence. Overactive bladder decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of overactive bladder.	Total n=66 Participants Total of all reporting groups
Age, Continuous	57.6 years STANDARD_DEVIATION 14.7 • n=5 Participants	60.2 years STANDARD_DEVIATION 14.6 • n=7 Participants	58.9 years STANDARD_DEVIATION 14.6 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	33 Participants n=7 Participants	66 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants	28 Participants n=7 Participants	53 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants	33 participants n=7 Participants	66 participants n=5 Participants

PRIMARY outcome

Timeframe: Within 1 day

Population: Anyone who answered the knowledge items.

Outcome measures

Outcome measures
Measure	Usual Care n=33 Participants In the usual care group, the providers do not have access to the decision aids.	Patient Decision Aid n=33 Participants Providers have access to patient decision aids to review and discuss during the visit. Pelvic organ prolapse decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of pelvic organ prolapse Stress urinary incontinence decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of stress urinary incontinence. Overactive bladder decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of overactive bladder.
Patient Knowledge	60 percentage of questions answered correct Standard Deviation 30	72 percentage of questions answered correct Standard Deviation 21

PRIMARY outcome

Timeframe: Within 1 day

1 item assess patients' preferred treatment- Response options included no treatment at this time, conservative and non conservative options, or I am not sure. Responses were categorized into clear treatment preference (no treatment, conservative and non-conservative options) vs unsure (I am not sure) treatment preference.

Outcome measures

Outcome measures
Measure	Usual Care n=33 Participants In the usual care group, the providers do not have access to the decision aids.	Patient Decision Aid n=33 Participants Providers have access to patient decision aids to review and discuss during the visit. Pelvic organ prolapse decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of pelvic organ prolapse Stress urinary incontinence decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of stress urinary incontinence. Overactive bladder decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of overactive bladder.
Patient Treatment Preference clear treatment preference	22 Participants	28 Participants
Patient Treatment Preference unsure treatment preference	11 Participants	5 Participants

PRIMARY outcome

Timeframe: Within 1 day

Population: Physicians were not considered enrolled in the study, but did contribute to this assessment.

Physicians answered 1 item on how satisfied they were with the visit: Extremely satisfied, Very satisfied, Somewhat satisfied, and Not at all satisfied

Outcome measures

Outcome measures
Measure	Usual Care n=33 Participants In the usual care group, the providers do not have access to the decision aids.	Patient Decision Aid n=33 Participants Providers have access to patient decision aids to review and discuss during the visit. Pelvic organ prolapse decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of pelvic organ prolapse Stress urinary incontinence decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of stress urinary incontinence. Overactive bladder decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of overactive bladder.
Physician Visit Satisfaction Not at all satisfied	0 Participants	0 Participants
Physician Visit Satisfaction Somewhat satisfied	5 Participants	9 Participants
Physician Visit Satisfaction Very satisfied	23 Participants	19 Participants
Physician Visit Satisfaction Extremely satisfied	5 Participants	5 Participants

SECONDARY outcome

Timeframe: Within 1 day

Measures decisional conflict, consists of 4 yes/no items. Total scores range 0-4 where 4 indicates no decisional conflict and scores less than or equal to 3 indicate decisional conflict. The number of participants who got a total score of 4, indicating no decisional conflict, is reported

Outcome measures

Outcome measures
Measure	Usual Care n=33 Participants In the usual care group, the providers do not have access to the decision aids.	Patient Decision Aid n=33 Participants Providers have access to patient decision aids to review and discuss during the visit. Pelvic organ prolapse decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of pelvic organ prolapse Stress urinary incontinence decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of stress urinary incontinence. Overactive bladder decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of overactive bladder.
SURE Scale	24 Participants	30 Participants

SECONDARY outcome

Timeframe: Within 1 day

Three items ask patients to rate their provider on a scale of 1-10, with 10 being outstanding. The measure is a dichotomized score. Participants who reported a "10" on all 3 items were "topscored" into one group; everyone else were categorized into another group. The number of participants who gave a topscore (a "10" for all 3 items) was reported.

Outcome measures

Outcome measures
Measure	Usual Care n=33 Participants In the usual care group, the providers do not have access to the decision aids.	Patient Decision Aid n=33 Participants Providers have access to patient decision aids to review and discuss during the visit. Pelvic organ prolapse decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of pelvic organ prolapse Stress urinary incontinence decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of stress urinary incontinence. Overactive bladder decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of overactive bladder.
CollaboRATE	17 Participants	25 Participants

SECONDARY outcome

Timeframe: Within 1 day

Four items that measures the amount of shared decision making that occurs in an interaction. Total scores ranged from 0-4, with higher scores indicating more shared decision making occurred.

Outcome measures

Outcome measures
Measure	Usual Care n=33 Participants In the usual care group, the providers do not have access to the decision aids.	Patient Decision Aid n=33 Participants Providers have access to patient decision aids to review and discuss during the visit. Pelvic organ prolapse decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of pelvic organ prolapse Stress urinary incontinence decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of stress urinary incontinence. Overactive bladder decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of overactive bladder.
SDM Process Scale	3.18 score on a scale Standard Deviation 0.88	3.17 score on a scale Standard Deviation 0.85

SECONDARY outcome

Timeframe: Within 1 day

Population: Physicians were not considered enrolled in the study, but did contribute to this assessment.

One item assessed how physician felt about the length of the visit. Responses were: Shorter than normal, About normal, Longer than normal. Number of physicians who responded that the visit was "shorter than normal" or "about normal" is reported.

Outcome measures

Outcome measures
Measure	Usual Care n=33 Participants In the usual care group, the providers do not have access to the decision aids.	Patient Decision Aid n=33 Participants Providers have access to patient decision aids to review and discuss during the visit. Pelvic organ prolapse decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of pelvic organ prolapse Stress urinary incontinence decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of stress urinary incontinence. Overactive bladder decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of overactive bladder.
MD Perceptions of Length of Visit	25 Participants	23 Participants

Adverse Events

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Patient Decision Aid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Karen Sepucha, PhD

Massachusetts General Hospital

Phone: 617-724-3350

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place