Urinary Incontinence
Conditions
Keywords
women, female, urinary incontinence, empowering, EMPOWER, providers, bladder leakage, incontinence
Brief summary
The overall goal is to improve diagnosis and non-operative management of urinary incontinence in women.
Detailed description
In the study, patients will be screened in primary care offices for symptoms of urinary incontinence. Women with positive screening results will be asked if they are interested in participating in an implementation study where women will be assigned to one of the three following groups: 1. Usual Care plus Patient Educational Opportunities - The patient's urinary incontinence will be managed using standard of care treatment by the patient's primary care provider. Patients will be offered educational opportunities about urinary incontinence. 2. Nurse Navigation - Along with the treatment described for "Usual Care plus Patient Educational Opportunities," a nurse navigator will work with the patient to implement behavioral changes and provide education and physical therapy options. In addition, the navigator will be available to answer the patient's questions in a timely fashion and help the patient move through the care pathway. 3. Nurse Navigation and ChatBot - Along with the treatment described for "Usual Care plus Patient Educational Opportunities" and "Nurse Navigation," this group will include a ChatBot feature which will allow a patient to directly and privately communicate with an artificial intelligence-driven ChatBot, also known as a "conversational agent," that will provide education and help the patient navigate the care pathway. All participants will complete questionnaires throughout their enrollment and data will be collected from medical records. The study team will analyze the data at six months after the original appointment/study enrollment, assess adherence to therapy and how the therapy impacted the outcomes the team hopes to improve, such as improvement in symptoms. The study will be implemented over three subsequent time periods called Wave 1, Wave 2 and Wave 3 with primary care practices from two geographic regions being involved in each wave (6 regions total). Participants in Wave 1 will be followed for a total of 18 months, while participants in Wave 2 will be followed for a total of 12 months, and participants in Wave 3 will be followed for 6 months. Primary care providers at all participating practices will be offered educational opportunities related to urinary incontinence.
Interventions
OTHERPatient Education
Patients will be provided educational opportunities.
OTHERNurse Navigation
A nurse navigator will work with the participants to help them navigate the care pathway. The navigator will provide education and recommendations for treatment options.
OTHERChatBot
A ChatBot will allow participants to directly and privately communicate through a smartphone (or other device) with an artificial intelligence-driven ChatBot, also known as a "conversational agent," that will provide education and encouragement to manage their symptoms.
Sponsors
University Hospitals Cleveland Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Female patient having a primary care provider visit at University Hospitals (UH) Cleveland Primary Care Institute (PCI) 2. ≥ 18 years old 3. Scores 1 or higher on the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF)
Exclusion criteria
None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patients' UI Symptoms as Measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) | Baseline (immediately prior to start of intervention) and Months 2 and 6 post start of intervention in each wave | The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) assess frequency, severity and impact on quality of life (QoL) of patients' urinary incontinence symptoms. The result of the ICIQ-UI SF is a composite score ranging from 0 to 21, with higher scores indicating more severe incontinence. |
| Patients' UI Symptoms as Measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) | 12 months post start of intervention in Waves 1 and 2 (no data collected for Wave 3 participants because participation only last 6 months, not 12) | The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) assess frequency, severity and impact on quality of life (QoL) of patients' urinary incontinence symptoms. The result of the ICIQ-UI SF is a composite score ranging from 0 to 21, with higher scores indicating more severe incontinence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients' UI Symptoms as Measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) | 18 months post start of intervention in Wave 1 (no data collected for Wave 2 because participants only participated for 12 months, not 18. Also no data collected for wave 3 participants because they only participated for 6 months, not 18) | The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) assess frequency, severity and impact on quality of life (QoL) of patients' urinary incontinence symptoms. The result of the ICIQ-UI SF is a composite score ranging from 0 to 21, with higher scores indicating more severe incontinence. |
| Change in Patients' Perceived Self-efficacy for UI Communication as Measured by the PEPPI | Baseline (immediately prior to start of intervention) and Months 2 and 6 post start of intervention in each Wave | Patients' perceived confidence in their ability to communicate their health concerns around UI will be assessed by the Patient-Perceived Self-Efficacy in Patient-Physician Interactions (PEPPI) Questionnaire modified for UI. The PEPPI total score ranges from 0 to 50, with higher scores indicating greater self-efficacy. |
| Patients' Perceived Self-efficacy for UI Communication as Measured by the PEPPI | 12 months post start of intervention in Waves 1 and 2 (no data collected for Wave 3 participants because participation only lasted 6 months, not 12) | Patients' perceived confidence in their ability to communicate their health concerns around UI will be assessed by the Patient- Perceived Self-Efficacy in Patient-Physician Interactions (PEPPI) Questionnaire modified for UI. The PEPPI total score ranges from 0 to 50, with higher scores indicating greater self-efficacy. |
| Patient Empowerment as Measured by Number of Participants That Answered Yes to Speaking With Their Provider About UI. | Baseline (immediately prior to start of intervention) in all Waves | Patient empowerment will be measured by a patient survey to measure with percentage of patients answering yes to speaking with their provider about UI. |
| Change in Overactive Bladder Symptom Severity as Measured by the OABSS | Baseline (immediately prior to start of intervention) and Months 2 and 6 post start of intervention in each Wave | Patients' overactive bladder symptom severity will be assessed by the Overactive Bladder Symptom Score (OABSS). The OABSS total score ranges from 0 to 15, with higher scores indicating more severe symptoms. |
| Overactive Bladder Symptom Severity as Measured by the OABSS | 12 months post start of intervention in Waves 1 and 2 (no data collected for Wave 3 participants because participant only last 6 months, not 12) | Patients' overactive bladder symptom severity will be assessed by the Overactive Bladder Symptom Score (OABSS). The OABSS total score ranges from 0 to 15, with higher scores indicating more severe symptoms. |
| Change in Urinary Symptoms as Measured by the UDI-6 | Baseline (immediately prior to start of intervention) and Months 2 and 6 post start of intervention in each Wave | How bothersome a patient's urinary symptoms are will be assessed by the Urinary Distress Inventory (UDI-6). The UDI-6 total score ranges from 0 to 100, with higher scores indicating more bothersome symptoms. |
| Urinary Symptoms as Measured by the UDI-6 | 12 months post start of intervention in Waves 1 and 2 (no data collected for Wave 3 participants because participation only lasted 6 months, not 12) | How bothersome a patient's urinary symptoms are will be assessed by the Urinary Distress Inventory (UDI-6). The UDI-6 total score ranges from 0 to 100, with higher scores indicating more bothersome symptoms. |
| Change in Impact of UI on Patients' Quality of Life as Measured by the ICIQ-LUTSqol | Baseline (immediately prior to start of intervention) and Months 2 and 6 post start of intervention in each Wave | The impact of urinary incontinence on quality of life will be assessed by the Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol). The ICIQ-LUTSqol total score ranges from 19 to 76, with higher scores indicating increased impact on quality of life. |
| Impact of UI on Patients' Quality of Life as Measured by the ICIQ-LUTSqol | 12 months post start of intervention in Waves 1 and 2 (no data collected for Wave 3 participants because participation only last 6 months, not 12) | The impact of urinary incontinence on quality of life will be assessed by the Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol). The ICIQ-LUTSqol total score ranges from 19 to 76, with higher scores indicating increased impact on quality of life. |
| Change in Patients' Perceived Symptom Improvement as Measured by Number of Participants Who Chose 1-3 on the PGI-I Scale. | Months 2 and 6 post start of intervention in each Wave | Patients' perceived improvement in UI symptoms will be assessed with the Patient Global Impression of Improvement (PGI-I). PGI-I measures improvement on a scale of 1 "very much better" to 7 "very much worse." Reported outcome measure is the number of participants that scored better (1, 2, or 3) at each time point. For improvement it was calculated the number of participants who chose 1-3 only. |
| Number of Practices That Maintain a UI Management Intervention as Measured by the Practice Survey | 1 month post completion of each Wave's enrollment period (7 months from beginning of screening period of each Wave) | Maintenance of UI management intervention will be assessed by practice survey completed by participant at the practice with indication of continuation for each intervention component. |
| Number of Practices That Implement a UI Point Person as Measured by the Practice Survey | 1 month post completion of each Wave's enrollment period (7 months from beginning of screening for each Wave) | Implementation of a UI point person will be measured as a percentage of sites answer yes on practice survey. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAdonis Hijaz, MD
University Hospitals Cleveland Medical Center
PRINCIPAL_INVESTIGATORGoutham Rao, MD
University Hospitals Cleveland Medical Center
Participant flow
Recruitment details
Participants were recruited in UH primary care offices after completing a quality improvement initiative screening via the ICIQ-SF incontinence survey. Upon completion of the survey, if the patient scored a 1 or greater, they were invited to join the EMPOWER study. Recruitment timeline was, Wave 1: 6 months of intervention, then 18 months of follow-up, Wave 2: 6 months of intervention, then 12 months of follow-up, and Wave 3: 6 months of intervention, then 6 months of follow-up.
Pre-assignment details
The study design is parallel cluster randomization (i.e., each cluster was randomized to an intervention or control) implemented at different times (i.e., waves). The stepped design was initially considered but we moved away after discussions with funders and need to update the study design section of CT.gov. The medical office was randomized and every eligible patient at the medical office who was interested in participating was recruited. The medical office was assigned the intervention.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 144 Participants |
| Age, Categorical Between 18 and 65 years | 256 Participants |
| BMI | 33 kg/m^2 STANDARD_DEVIATION 9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 96 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 13 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 32 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 296 Participants |
| Sex: Female, Male Female | 103 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 158 | 0 / 139 | 0 / 103 |
| other Total, other adverse events | 11 / 158 | 9 / 139 | 9 / 103 |
| serious Total, serious adverse events | 2 / 158 | 3 / 139 | 5 / 103 |
Outcome results
None listed