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To evaluate how patient knowledge and confidence in decision making can be impacted by shared decision making in common urogynecology conditions.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | No Intervention | In the usual care group, the providers do not have access to the decision aids. | |
| Patient Decision Aid | Experimental | Providers have access to patient decision aids to review and discuss during the visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pelvic organ prolapse decision aid | Behavioral | Paper-based educational tool to guide shared decision making conversations for treatment of pelvic organ prolapse |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 1 day |
| 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. | Within 1 day |
| 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 | Within 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Within 1 day |
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Inclusion Criteria:
Exclusion Criteria:
Recruiting only female patients as Urogynecology conditions only affect women's pelvic organs and pelvic floor.
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| Name | Affiliation | Role |
|---|---|---|
| Karen Sepucha, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34905749 | Derived | Marques F, Josloff K, Hung K, Wakamatsu M, Sepucha KR. Decision aids and shared decision making in urogynecology. Menopause. 2021 Dec 13;29(2):178-183. doi: 10.1097/GME.0000000000001901. |
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Patients with prior surgery for pelvic organ prolapse or incontinence, or did not attend the scheduled visit were ineligible.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | In the usual care group, the providers do not have access to the decision aids. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | In the usual care group, the providers do not have access to the decision aids. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Anyone who answered the knowledge items. | Posted | Mean | Standard Deviation | percentage of questions answered correct | Within 1 day |
|
Participants were assessed within one day of survey receipt. The surveys were completed within 2 weeks of the visit and were checked as they came in for evidence of adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | In the usual care group, the providers do not have access to the decision aids. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karen Sepucha, PhD | Massachusetts General Hospital | 617-724-3350 | ksepucha@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 5, 2023 | Jun 7, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| D014550 | Urinary Incontinence, Stress |
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014549 | Urinary Incontinence |
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A usual care arm was recruited first, then the intervention arm was recruited.
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| Stress urinary incontinence decision aid | Behavioral | Paper-based educational tool to guide shared decision making conversations for treatment of stress urinary incontinence. |
|
| Overactive bladder decision aid | Behavioral | Paper-based educational tool to guide shared decision making conversations for treatment of overactive bladder. |
|
| 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. |
| Within 1 day |
| 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. | Within 1 day |
| 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. | Within 1 day |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Participants were recruited from the Urogynecology Clinic at the Massachusetts General Hospital in Boston, MA | Number | participants |
|
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| 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. | Posted | Count of Participants | Participants | Within 1 day |
|
|
|
|
| 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 | Physicians were not considered enrolled in the study, but did contribute to this assessment. | Posted | Count of Participants | Participants | Within 1 day |
|
|
|
|
| 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 | Posted | Count of Participants | Participants | Within 1 day |
|
|
|
| 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. | Posted | Count of Participants | Participants | Within 1 day |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Within 1 day |
|
|
|
| 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. | Physicians were not considered enrolled in the study, but did contribute to this assessment. | Posted | Count of Participants | Participants | Within 1 day |
|
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | 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. | 0 | 33 | 0 | 33 | 0 | 33 |
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| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D001745 | Urinary Bladder Diseases |
| Very satisfied |
|
| Extremely satisfied |
|