Health TrialsbyHealthPanel

Videos to Aid Decision Making for Fibroid Treatment

ConditionsUterine BleedingDecision Aid
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorUniversity of Pennsylvania

About this trial

Uterine fibroids are a common condition that can cause heavy and/or painful menstrual bleeding. There are many treatment options, but they vary in efficacy, side effects, short-term recovery and long-term implications for future fertility. Patients can have difficulty deciding between these options. In this study, the investigators will randomly assign patients seeking treatment for fibroids to receive an educational video on fibroids and their treatment, versus usual care (no video). The investigators will assess their decisional conflict with and without exposure to the video using a validated survey to see if exposure to the educational video helps them make decisions.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of uterine fibroids

Scheduled appointment to discuss management of fibroids in an outpatient clinical site associated with the Hospital of the University of Pennsylvania

Disqualifiers

Age <18 or >55

Uterine or cervical cancer

Cervical dysplasia grade 2-3 within the last 12 mo

Pregnancy

Trial design

Design model

Single group

Treatments tested in this trial

  • Video on uterine fibroids

    Behavioral

    Patients will be sent a link to a 5 minute video on uterine fibroids including their diagnosis, symptoms and treatment options prior to their scheduled appointment.

Treatment groups

154 Participants
are divided into 2 treatment groups
Group A: Usual careNo intervention 0 interventions
Group B: VideoExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Decisional Conflict Scale

Patients complete a 10 question Decisional Conflict Scale 10 Item Version (DCS-10) via text message up to 1 week after their completed appointment. Each of the 10 questions asks patients on a 0-5 Likert scale. Higher scores indicate more decisional conflict. Minimum score of 0 = no decisional conflict. Maximum score of 40 = high decisional conflict.

Time frame
1 weeks after appointment

Secondary outcomes

1

Treatment selected

Patients will be assigned one of four treatment options based on documentation from initial consultation or from chart review within 12 weeks after appointment completion. 1. Expectant management, defined as no medical or surgical intervention 2. Medical management, defined as acceptance of prescribed medications such as oral contraceptive pills, GnRH modifiers (oral or injected), Injectable medications (such as Depo-Provera), Intrauterine devices. 3. Surgical management, defined as myomectomy or hysterectomy. 4. Other procedural management, defined as uterine artery embolization or high intensity focused ultrasound.

Time frame
12 weeks post appointment
2

Time to treatment

Patients time to selected treatment will be determined based on documentation within the medical chart with regards to acceptance of treatment. 1. Expectant management group, based on documentation within the medical record from initial visit. 2. Medical management group, based on the date of prescription of medication or date of documented decision for intrauterine device placement. 3. Surgical management group, based on the date of decision for surgical intervention as confirmed by scheduled procedure in chart. 4. Other procedural management group, based on the date of decision for management as confirmed by scheduled appointment in chart.

Time frame
12 weeks post appointment
3

Length of visit

Length of visit will be collected for all patients at baseline visit. This information is accessible by reviewing documented billing codes and documentation within the note from providers. Specifically for telehealth visits total minutes are available for all patients. If total time is not documented, pts will be assigned by level of visit billed to low end of the billable minutes. Level 2 10-19 min (assigned time would be 10 min) Level 3 20-29 min (assigned time would be 20 min) Level 4 30-39 min (assigned time would be 30 min) Level 5 40-54 min (assigned time would be 50 min)

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pennsylvania

Lead sponsor

OptumRx

Collaborator

Source ClinicalTrials.gov
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