Physician Awareness for Pelvic Floor Dysfunction

Overseen By Thythy Pham, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Loyola University

Disqualifiers: Established patients, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how doctors can better understand patients' preferences in health decisions, specifically for those with pelvic floor dysfunction. The study compares two approaches: one where doctors have increased awareness of patients' decision-making preferences beforehand (Physician Awareness) and another where they do not (Usual Care). Participants should be Spanish-speaking women visiting a specific clinic for the first time and comfortable completing study questionnaires in Spanish. As an unphased trial, this study provides a unique opportunity to enhance patient-doctor communication and decision-making in healthcare.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this protocol is safe?

Research has shown that increasing doctors' awareness of pelvic floor problems can be beneficial. One study found that when primary care doctors have more knowledge about these issues, they can better identify and understand them. This is crucial because pelvic floor problems are common but often go unnoticed.

Increasing doctor awareness poses no safety concerns. In fact, well-informed doctors about pelvic health often lead to more satisfied patients and better treatment outcomes.

This trial focuses on improving understanding and awareness, not on using drugs or invasive treatments. Therefore, the "Physician Awareness" approach carries no specific safety risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how increasing physician awareness can impact the treatment of pelvic floor dysfunction. Unlike usual care, where doctors don’t have access to specific patient preferences before consultations, this approach allows physicians to see pre-visit survey results, potentially tailoring their care more effectively. The trial aims to find out if this added layer of awareness can lead to better patient outcomes, making healthcare more personalized and responsive to individual needs.

What evidence suggests that this trial's treatments could be effective for pelvic floor dysfunction?

This trial will compare two approaches: Physician Awareness and Usual Care. Research has shown that when doctors understand their patients' preferences, treatment satisfaction for pelvic floor issues can increase. In the Physician Awareness arm, doctors will access pre-visit survey results about patient preferences, which studies suggest can enhance satisfaction. Meanwhile, the Usual Care arm will proceed without this additional information. Good communication and understanding between doctors and patients can lead to better health outcomes. Although specific clinical data on this exact method is lacking, the idea is that knowing a patient's preferences helps tailor the treatment to their needs. This approach aims to improve decision-making and potentially increase overall patient satisfaction. ^{1 3 6 7 8}

Who Is on the Research Team?

Thythy Pham, MD

Principal Investigator

Loyola Medical Center

Are You a Good Fit for This Trial?

This trial is for Spanish-speaking adults who are visiting the Loyola Urogynecology clinic for the first time with pelvic floor disorders. They must be able to read, write, and speak in Spanish. It's not open to current patients of the clinic or those unable to complete study questionnaires.

Inclusion Criteria

Agree to complete the study questionnaires

Present to Loyola Urogynecology clinic for their initial evaluation and identify as Spanish-speaking (as primary language)

Must be able to read, speak and write in Spanish

Exclusion Criteria

Established patients at Loyola's Urogynecology clinic

Unable to complete the study questionnaires

Unable to read, speak and write in Spanish

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are involved in decision-making processes with or without physician awareness of their preferences

1 day

1 visit (in-person)

Follow-up

Participants are monitored for satisfaction and understanding of treatment plans

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Physician Awareness
• Usual Care

Trial Overview

The study is looking at how raising physician awareness about patient decision-making preferences affects care compared to usual treatment practices. The goal is to see if this improves satisfaction among patients who primarily speak Spanish.

How Is the Trial Designed?

Group I: Physician Awareness Experimental Treatment 1 Intervention

The physician will have access to the pre-visit Control Preference Scale survey results for women assigned to this group.

Group II: Usual Care Active Control 1 Intervention

The physician will not have access to the pre-visit Control Preference Scale survey results for women assigned to this group.

Who Is Running the Clinical Trial?

Loyola University

Lead Sponsor

Trials

161

Recruited

31,400+

Published Research Related to This Trial

Only about one-third of primary care physicians (PCPs) routinely screen for pelvic floor disorders (PFDs), and many lack comfort in diagnosing conditions like pelvic organ prolapse and fecal incontinence, indicating a gap in training or awareness.

A significant portion of PCPs (48%) are unaware of the Female Pelvic Medicine and Reconstructive Surgery (FPMRS) subspecialty, leading to a reliance on referrals to other specialists rather than treating PFDs themselves.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FACE: Female Pelvic Medicine and Reconstructive Surgery Awareness Campaign: Increasing Exposure. Barr, SA., Crisp, CC., White, AB., et al.[2021]

Pelvic floor muscle training (PFMT) is an effective first-line treatment for urinary incontinence and pelvic organ prolapse, yet awareness among healthcare professionals is limited, as shown in a study of 44 staff members.

Only 53% of healthcare professionals felt confident in performing pelvic-floor assessments, and many were unaware of standardized assessment methods, indicating a need for improved education and resources to better support patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Staff awareness of pelvic floor muscle training (PFMT) in tertiary care - a qualitative cross-sectional study. Soundararajan, K., Dilruksha Chandrasiri, M., Balchandra, P.[2022]

A survey of 391 primary care physicians revealed that while most are familiar with urinary incontinence (UI) and overactive bladder (OAB), many lack knowledge about pelvic organ prolapse (POP) and urogynecologists, which could limit patient referrals.

Female providers were more proactive in screening for OAB and POP, indicating that gender may influence the management of pelvic floor disorders in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary care providers' experience, management, and referral patterns regarding pelvic floor disorders: A national survey. Mazloomdoost, D., Crisp, CC., Kleeman, SD., et al.[2018]

Medical errors, including medication errors, are a significant cause of patient deaths, with estimates ranging from 44,000 to 98,000 deaths annually, highlighting the urgent need for improved safety measures in healthcare.

Educating healthcare providers and patients about medication complexities and potential interactions is essential for enhancing therapeutic outcomes, and utilizing electronic resources can help keep providers informed about these critical issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Problems and pitfalls in cardiac drug therapy. Stone, SM., Rai, N., Nei, J.[2005]

The study found that only 37% of women with pelvic floor symptoms in the U.S. seek care, indicating a low utilization rate for pelvic floor care services.

Factors influencing care-seeking behavior include increased symptom severity and a history of depression promoting utilization, while barriers include lower income, fear, and misinformation, particularly affecting Asian and Black women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers and Promotors to Health Service Utilization for Pelvic Floor Disorders in the United States: Systematic Review and Meta-analysis of Qualitative and Quantitative Studies. Mou, T., Gonzalez, J., Gupta, A., et al.[2023]

The implementation of electronic health record alerts at the point of computerized provider order entry did not significantly reduce the overall rate of potentially inappropriate medications (PIMs) prescribed to older veterans, but it did lead to a notable decrease in the most commonly prescribed PIMs, from 9.0% to 8.3%.

The study involved 1539 patients before the alert system and 1490 patients after, indicating that while the overall PIM prescribing rate remained stable, targeted alerts effectively reduced the prescribing of specific high-risk medications among older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Impact of Medication Safety Alerts on Prescribing of Potentially Inappropriate Medications for Older Veterans in an Ambulatory Care Setting. Vanderman, AJ., Moss, JM., Bryan, WE., et al.[2017]

The introduction of a departmental prescribing feedback system in a pediatric unit significantly reduced medication prescribing errors from 8.8% to 1.8% over three months, based on an analysis of 205 medication orders.

While there was an improvement in patient safety attitudes among the medical staff, this change was not statistically significant, suggesting that while the feedback system is effective in reducing errors, further research is needed to enhance safety attitudes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel system of prescribing feedback to reduce errors: A pilot study. Gordon, M., Bose-Haider, B.[2012]

The average annual cost of ambulatory physician services for female pelvic floor disorders (PFDs) in the U.S. increased from $190 million in 1996-1997 to $298 million in 2005-2006, indicating a significant rise in healthcare expenses related to these conditions.

When accounting for deductibles and copayments, the costs rose from $262 million to $412 million over the same period, highlighting the growing financial burden of PFDs on patients and the healthcare system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Costs of ambulatory care related to female pelvic floor disorders in the United States. Sung, VW., Washington, B., Raker, CA.[2018]

A study involving 60 primary care providers in Flanders, Belgium, revealed that while 90% were aware of botulinum toxin injections for pelvic floor dysfunction, only 73% knew about sacral neuromodulation, and a mere 5% were familiar with percutaneous tibial nerve stimulation.

The results indicate a significant gap in knowledge among general practitioners compared to trainees, highlighting the need for increased education on second-line therapies to improve patient care for those with refractory pelvic floor dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary care providers' knowledge about the therapeutic management of refractory pelvic floor dysfunctions in Flanders, Belgium: a cross-sectional study. Ghijselings, L., Pauwaert, K., Verla, W., et al.[2022]

A survey of 266 clerkship directors revealed that while 95% of third-year medical students received some education on pelvic floor disorders (PFD), only 60% had practical exposure in an urogynecology practice, indicating a gap in hands-on training.

Despite the recognition of the importance of PFD in women's health, 80% of medical students had no exposure to PFD topics during their first two years, suggesting a significant opportunity for improvement in medical education regarding conditions that affect women's quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are we missing an opportunity to teach future physicians about female pelvic floor disorders? Mueller, ER., Kenton, K., Rogers, RG., et al.[2021]

A survey of 768 female university students revealed that most had poor knowledge about pelvic floor dysfunction (PFD), particularly regarding pelvic organ prolapse, indicating a significant gap in awareness.

Health science students scored higher in knowledge about PFD compared to their peers, and those who received information on pelvic floor muscle training were more informed, suggesting that education could improve awareness and understanding of PFD among women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What do female university students know about pelvic floor disorders? A cross-sectional survey. Bailón Queiruga, M., Delgado-Morell, A., Peró Garcia, M., et al.[2022]

The initial visit with a specialist significantly improved women's understanding of their pelvic floor disorders, helping to alleviate fears about the severity of their conditions.

While patients had a good grasp of their treatment plans, they often struggled with understanding specific diagnostic terms, indicating a need for clearer communication regarding diagnoses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' understanding of pelvic floor disorders: what women want to know. Kiyosaki, K., Ackerman, AL., Histed, S., et al.[2021]

In a study reviewing 1289 charts of older adults with cardiovascular diagnoses, 50% had triggers indicating potential adverse drug events (ADEs), with 232 of these triggers confirmed as ADEs, highlighting the prevalence of medication-related issues in this population.

Only nine out of 39 triggers were highly predictive of ADEs, accounting for 94.4% of the detected events, suggesting that a more streamlined trigger tool could be developed to improve the identification of ADEs in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience with a trigger tool for identifying adverse drug events among older adults in ambulatory primary care. Singh, R., McLean-Plunckett, EA., Kee, R., et al.[2022]

The Medication Safety in Primary Care Practice project demonstrated significant improvements in reducing preventable prescribing and monitoring errors across 20 primary care practices over a 2-year period.

Key strategies included using electronic health record (EHR) tools for audit and feedback, medication reconciliation, and decision-support systems, which can be applied to enhance medication safety in other primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication Safety in Primary Care Practice: results from a PPRNet quality improvement intervention. Wessell, AM., Ornstein, SM., Jenkins, RG., et al.[2013]

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