Telehealth Intervention for Surgical Preparedness

(TIPPS-Urogyn Trial)

Recruiting at 1 trial location

Overseen By Gabriela Halder, MD, MPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Male, Under 18, Non-Hispanic, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

357 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a telehealth intervention to help women feel more prepared for upcoming urogynecologic surgeries, such as those for pelvic organ prolapse or urinary incontinence. The goal is to design and test a new telehealth approach to improve surgical readiness. Participants will receive either standard pre-surgery advice or this new telehealth plan in addition to it. Women who identify as Hispanic, are scheduled for urogynecologic surgery, and can read and write in English or Spanish are well-suited for this trial. As an unphased study, this trial offers a unique opportunity to contribute to innovative healthcare solutions and potentially enhance the surgical experience.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this telehealth intervention is safe for surgical preparedness?

Research has shown that telehealth is generally safe and easy to use. A review of studies found that these programs can lower the chance of needing to return to the hospital. This suggests telehealth can manage care without adding extra risks.

Other studies have found that telehealth calls before surgery help patients better understand their surgery options and possible risks. This indicates telehealth can improve knowledge and readiness without causing harm.

Overall, evidence suggests that telehealth is a safe way to prepare for surgery, with no major safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the telehealth intervention for surgical preparedness because it offers a new layer of support alongside routine preoperative counseling for patients undergoing urogynecologic surgery. Unlike traditional face-to-face counseling sessions, this intervention leverages technology to provide patients with convenient access to additional resources and guidance from the comfort of their homes. This approach could enhance patient understanding and readiness for surgery, potentially leading to better outcomes and reduced anxiety. By integrating telehealth, the intervention aims to make pre-surgery preparation more accessible and personalized, which could revolutionize how patients prepare for surgical procedures.

What evidence suggests that this telehealth intervention is effective for surgical preparedness?

This trial will compare a telehealth intervention with routine preoperative counseling for patients scheduled for urogynecologic surgery. Studies have shown that telehealth can enhance patients' readiness for surgery. For example, one study found that a telehealth call a few days before surgery increased patients' sense of preparedness. Other research indicates that telehealth effectively educates patients about health issues, such as bladder problems. Telehealth has also matched in-person visits in satisfaction for post-surgery follow-ups, indicating its reliability in patient care. These findings suggest that telehealth might boost patients' confidence and readiness for their surgeries. ^{1 2 3 6 7}

Who Is on the Research Team?

Gabriela Halder, MD, MPH

Principal Investigator

Assistant Professor

Are You a Good Fit for This Trial?

This trial is for Latinas dealing with uterovaginal prolapse or bladder control issues. It aims to help them prepare for surgery using a telehealth intervention. Participants will be involved in guiding the research and providing feedback on the intervention's development.

Inclusion Criteria

I regularly perform surgeries for pelvic issues like prolapse or incontinence.

I am scheduled for surgery to address a pelvic condition.

Patients who self-report as Hispanic ethnicity

Exclusion Criteria

Patients who self-report as not of Hispanic ethnicity

Urogynecologists who do not routinely perform urogynecologic surgery

Nurses who do not spend most of their time at a urogynecology clinic

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Discover Phase

Investigators identify preferences for refinement of TIPPS-Latina and its contextual deployment using mixed methods

4-6 weeks

Design/Build Phase

Investigators use an iterative process to generate, modify, and adapt the intervention

4-6 weeks

Test Phase

Pilot testing of TIPPS-Latina using a mixed methods approach to determine feasibility and implementation outcomes

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after surgery

6-8 weeks

Postoperative Visit

What Are the Treatments Tested in This Trial?

Interventions

• Telehealth Intervention

Trial Overview

The study tests a new telehealth program designed to get patients ready for surgery related to prolapse conditions. The program's effectiveness will be evaluated through surveys, design methods, and pilot testing with community input.

How Is the Trial Designed?

Group I: Telehealth intervention Experimental Treatment 1 Intervention

Patient scheduled to undergo urogynecologic surgery will receive routine preoperative counseling in addition to the modified telehealth intervention.

Group II: Routine Preoperative Counseling Active Control 1 Intervention

Participants scheduled to undergo urogynecologic surgery will receive routine preoperative counseling.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

A randomized controlled trial with 46 adults with ADHD demonstrated that the Work-MAP telehealth intervention significantly improved work performance, executive functions, and quality of life over an 11-week period.

Participants maintained these improvements for up to 3 months after the intervention, indicating the long-term efficacy of this self-tailored, metacognitive approach to occupational therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Work-MAP Telehealth Metacognitive Work-Performance Intervention for Adults With ADHD: Randomized Controlled Trial. Grinblat, N., Rosenblum, S.[2023]

A telehealth parent coaching program consisting of ten weekly sessions significantly improved occupational performance and executive function scores in children with ADHD, with the exception of Shift and Emotional Control.

The program also enhanced parent self-efficacy, indicating that telehealth coaching can be a valuable support for families dealing with ADHD and related challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Telehealth Parent Coaching on Occupational Performance and Executive Function of Children with Attention-Deficit/Hyperactivity Disorders, and Parent Self-Efficacy: A Preliminary Study. Pijarnvanit, P., Sriphetcharawut, S.[2023]

In a pilot study involving 21 children with ADHD, blended parent training (online program with therapist support) was not as effective as traditional face-to-face parent training in reducing behavioral problems.

Parents using the blended approach had higher dropout rates and lower satisfaction compared to those in the face-to-face group, and therapists spent significantly less time with parents in the blended condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-directed or therapist-led parent training for children with attention deficit hyperactivity disorder? A randomized controlled non-inferiority pilot trial. Breider, S., de Bildt, A., Nauta, MH., et al.[2022]

The Children's ADHD Telemental Health Treatment Study (CATTS) involved 223 children and showed that a telehealth service model providing pharmacological treatment and caregiver training was significantly more effective than traditional primary care for improving ADHD symptoms and related impairments.

Children receiving telehealth treatment demonstrated greater improvements in attention, hyperactivity, and overall role performance compared to those receiving augmented primary care, highlighting the potential of telehealth to enhance access to effective ADHD care in underserved communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a telehealth service delivery model for treating attention-deficit/hyperactivity disorder: a community-based randomized controlled trial. Myers, K., Vander Stoep, A., Zhou, C., et al.[2018]

In a study involving 223 children with ADHD and their caregivers, the hybrid telehealth service delivery model (CATTS) led to significantly greater improvements in caregiver distress compared to a standard care model, as measured by various assessment tools over 25 weeks.

The improvements in caregiver outcomes were linked to reductions in child ADHD symptoms and oppositional defiant disorder (ODD) behaviors, indicating that addressing the child's condition can positively impact caregiver well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Children's Attention-Deficit Hyperactivity Disorder Telemental Health Treatment Study: Caregiver Outcomes. Vander Stoep, A., McCarty, CA., Zhou, C., et al.[2022]

Many children experience significant anxiety and pain during outpatient surgery, and current preparation programs are often generic and not tailored to individual needs.

The development of tailored, web-based behavioral preparation programs could improve children's coping skills and reduce anxiety and pain, leading to better recovery outcomes and future medical interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating perioperative anxiety and pain in children: a tailored and innovative approach. Fortier, MA., Kain, ZN.[2022]

The innovative telehealth program effectively identifies and engages patients with behavioral health issues, leading to significant reductions in symptoms of depression, anxiety, and stress.

A retrospective evaluation showed high patient satisfaction and demonstrated the program's national reach, highlighting its potential to improve clinical outcomes for patients with comorbid medical conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Telehealth to Implement Cognitive-Behavioral Therapy. Dent, L., Peters, A., Kerr, PL., et al.[2019]

In a study of 638 pediatric patients undergoing ambulatory surgery, having parents present during anesthesia induction significantly reduced postoperative maladaptive behavioral changes compared to those who were not premedicated or only given midazolam.

The combination of parental presence and midazolam (PPIA + MDZ) was particularly effective, with a higher odds ratio for reducing behavioral issues, especially in children under 5 years old.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parental Presence during Induction of Anesthesia and Emergence Delirium Influence the Incidence of Postoperative Maladaptive Behavioral Changes. Gil Mayo, D., Sanabria Carretero, P., Gajate Martin, L., et al.[2023]

A randomized controlled trial with 22 participants showed that group parent training for ADHD delivered via videoconferencing is as effective as traditional face-to-face training, improving parents' disciplinary practices and children's global functioning.

Parents in the videoconference group reported statistically greater improvements in hyperactive symptoms compared to the face-to-face group, indicating that this method is not only effective but also well-accepted by parents, making it a valuable option for areas lacking ADHD treatment services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A study on the effectiveness of videoconferencing on teaching parent training skills to parents of children with ADHD. Xie, Y., Dixon, JF., Yee, OM., et al.[2013]

Telephone-based coping skills training for patients with chronic obstructive pulmonary disease improved psychological and somatic quality of life, but did not reduce mortality or rehospitalization compared to an education control.

A web-based distress management program for patients receiving an implantable cardioverter defibrillator showed no significant improvement in psychological outcomes compared to usual care, highlighting the need for careful trial design in telehealth interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Distance therapy to improve symptoms and quality of life: complementing office-based care with telehealth. Kroenke, K.[2018]

A collaborative digital mental health intervention (DMHI) showed promising results in reducing symptoms of inattention and hyperactivity in children and adolescents with ADHD, with 71% of participants improving in inattention and 60% in hyperactivity after an average of 5.52 months of care.

The study found that longer duration of care was associated with greater reductions in symptom severity, indicating that ongoing support may enhance treatment outcomes for ADHD, although improvements in oppositional symptoms were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Digital Measurement-Based Care to Address Symptoms of Inattention, Hyperactivity, and Opposition in Youth: Retrospective Analysis of Bend Health. Lawrence-Sidebottom, D., Huffman, LG., Huberty, J., et al.[2023]

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