Overactive Bladder, Pelvic Organ Prolapse, Stress Urinary Incontinence
Conditions
Keywords
shared decision making
Brief summary
To evaluate how patient knowledge and confidence in decision making can be impacted by shared decision making in common urogynecology conditions.
Detailed description
The investigators will enroll patients seeing a specialist to discuss treatment of pelvic organ prolapse, overactive bladder and stress urinary incontinence in this pilot study. The study will evaluate the feasibility and acceptability of three decision aids designed to promote shared decision making conversations for these three condition. The investigators use a quasi-experimental design in which the investigators first enroll patients in the control arm and measure their outcomes. Then, the investigators enroll patients into the intervention arm and measure their outcomes. The investigators estimate that it will take about one month to recruit the control arm and one month to recruit the intervention arm. Patients will be surveyed after the clinic visit with a specialist and surveys will assess patients' knowledge, treatment preferences, shared decision making, decisional conflict and acceptability of the tool. A clinician survey will be administered and completed after each patient visit, that details how the physician felt about the length of the visit, how informed the patient was, and how far along they may be with their decision.
Interventions
BEHAVIORALPelvic organ prolapse decision aid
Paper-based educational tool to guide shared decision making conversations for treatment of pelvic organ prolapse
BEHAVIORALStress urinary incontinence decision aid
Paper-based educational tool to guide shared decision making conversations for treatment of stress urinary incontinence.
BEHAVIORALOveractive bladder decision aid
Paper-based educational tool to guide shared decision making conversations for treatment of overactive bladder.
Sponsors
Massachusetts General Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
A usual care arm was recruited first, then the intervention arm was recruited.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
* Adults 18-95 years only * English speaking * Pelvic organ prolapse defined by noticeable (to the patient) vaginal bulging * Symptoms of stress urinary incontinence (cough, sneeze, laugh, exercise) * Presenting for initial consultation for either of the above symptoms
Exclusion criteria
* Primary complaint is not vaginal bulging or stress urinary incontinence * Prior surgery for pelvic organ prolapse or any incontinence procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Knowledge | Within 1 day | 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. |
| Patient Treatment Preference | 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. |
| Physician Visit Satisfaction | Within 1 day | Physicians answered 1 item on how satisfied they were with the visit: Extremely satisfied, Very satisfied, Somewhat satisfied, and Not at all satisfied |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SURE Scale | 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 |
| MD Perceptions of Length of Visit | Within 1 day | 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. |
| CollaboRATE | 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. |
| SDM Process Scale | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Patients with prior surgery for pelvic organ prolapse or incontinence, or did not attend the scheduled visit were ineligible.
Participants by arm
| Arm | Count |
|---|---|
| Usual Care In the usual care group, the providers do not have access to the decision aids. | 33 |
| 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. | 33 |
| Total | 66 |
Baseline characteristics
| Characteristic | Usual Care | Total | Patient Decision Aid |
|---|---|---|---|
| Age, Continuous | 57.6 years STANDARD_DEVIATION 14.7 | 58.9 years STANDARD_DEVIATION 14.6 | 60.2 years STANDARD_DEVIATION 14.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 6 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants | 60 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 8 Participants | 3 Participants |
| Race (NIH/OMB) White | 25 Participants | 53 Participants | 28 Participants |
| Region of Enrollment United States | 33 participants | 66 participants | 33 participants |
| Sex: Female, Male Female | 33 Participants | 66 Participants | 33 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 33 |
| other Total, other adverse events | 0 / 33 | 0 / 33 |
| serious Total, serious adverse events | 0 / 33 | 0 / 33 |
Outcome results
Primary
Patient Knowledge
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.
Time frame: Within 1 day
Population: Anyone who answered the knowledge items.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Patient Knowledge | 60 percentage of questions answered correct | Standard Deviation 30 |
| Patient Decision Aid | Patient Knowledge | 72 percentage of questions answered correct | Standard Deviation 21 |
p-value: 0.0695% CI: [0.7, 24.6]t-test, 2 sided
Primary
Patient Treatment Preference
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.
Time frame: Within 1 day
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Patient Treatment Preference | clear treatment preference | 22 Participants |
| Usual Care | Patient Treatment Preference | unsure treatment preference | 11 Participants |
| Patient Decision Aid | Patient Treatment Preference | clear treatment preference | 28 Participants |
| Patient Decision Aid | Patient Treatment Preference | unsure treatment preference | 5 Participants |
Comparison: a chisquare test was conducted to determine if the proportion of treatment unsure responses were different between the usual care and intervention arms.p-value: 0.085Chi-squared
Primary
Physician Visit Satisfaction
Physicians answered 1 item on how satisfied they were with the visit: Extremely satisfied, Very satisfied, Somewhat satisfied, and Not at all satisfied
Time frame: Within 1 day
Population: Physicians were not considered enrolled in the study, but did contribute to this assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Physician Visit Satisfaction | Not at all satisfied | 0 Participants |
| Usual Care | Physician Visit Satisfaction | Somewhat satisfied | 5 Participants |
| Usual Care | Physician Visit Satisfaction | Very satisfied | 23 Participants |
| Usual Care | Physician Visit Satisfaction | Extremely satisfied | 5 Participants |
| Patient Decision Aid | Physician Visit Satisfaction | Extremely satisfied | 5 Participants |
| Patient Decision Aid | Physician Visit Satisfaction | Not at all satisfied | 0 Participants |
| Patient Decision Aid | Physician Visit Satisfaction | Very satisfied | 19 Participants |
| Patient Decision Aid | Physician Visit Satisfaction | Somewhat satisfied | 9 Participants |
p-value: 0.47Chi-squared
Secondary
CollaboRATE
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.
Time frame: Within 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | CollaboRATE | 17 Participants |
| Patient Decision Aid | CollaboRATE | 25 Participants |
Secondary
MD Perceptions of Length of Visit
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.
Time frame: Within 1 day
Population: Physicians were not considered enrolled in the study, but did contribute to this assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | MD Perceptions of Length of Visit | 25 Participants |
| Patient Decision Aid | MD Perceptions of Length of Visit | 23 Participants |
Secondary
SDM Process Scale
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.
Time frame: Within 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | SDM Process Scale | 3.18 score on a scale | Standard Deviation 0.88 |
| Patient Decision Aid | SDM Process Scale | 3.17 score on a scale | Standard Deviation 0.85 |
Secondary
SURE Scale
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
Time frame: Within 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | SURE Scale | 24 Participants |
| Patient Decision Aid | SURE Scale | 30 Participants |