Assessing Patient Satisfaction and Confidence After Use of Educational Video to Augment Surgical Consent for Thyroid Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Thomas Jefferson University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Patient knowledge score using a 10-item internally validated Thyroid Surgery Knowledge Assessment
Study Overview
Brief Summary
This study looks at how a short educational video can help people better understand thyroid surgery. Patients who have thyroid nodules and need surgery will be part of the study. Some patients will get the usual information from their doctor, while others will also watch a video that explains the surgery in a simple and clear way. The study will check if the video helps patients feel more confident about their decision, lowers anxiety, and helps them remember important information about their surgery. Patients will answer surveys before surgery, after surgery, and 3 months later.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Fluent in English
- •English is Primary Language
- •≥18 years old at time of consent
- •Eligible for Thyroidectomy, lobectomy, isthmusectomy for any indication
Exclusion Criteria
- •History of prior thyroid surgery
- •Previously consented for thyroid surgery
Arms & Interventions
Intervention: TISCAV
Intervention: Thyroid Informed Surgical Consent Augmenting Video (TISCAV) (Behavioral)
Control: Standard Consent
Intervention: Standard Consent (Behavioral)
Outcomes
Primary Outcomes
Patient knowledge score using a 10-item internally validated Thyroid Surgery Knowledge Assessment
Time Frame: Immediately after study enrollment (pre-consent) and immediately following the surgical consent process (post-consent)
This outcome measures patient knowledge of thyroid surgery, including indications, procedural options, risks, and benefits. A 10-question internally developed and validated multiple-choice questionnaire will be administered before and after the informed consent process. Each correct answer is scored as 1 point, with a total score ranging from 0 to 10. Higher scores indicate greater understanding and retention of surgical information.
Decisional Conflict Score using the Decisional Conflict Scale (DCS)
Time Frame: Preoperatively (after the consent process and before surgery)
This outcome measures patient uncertainty and confidence related to thyroid surgery decision-making using the validated 16-item Decisional Conflict Scale (DCS). The DCS evaluates five subdomains: uncertainty, feeling informed, values clarity, support, and perceived effectiveness of the decision. Each item is scored from 0 (strongly agree) to 4 (strongly disagree), then standardized to a total score ranging from 0 to 100. Higher scores reflect greater decisional conflict and more difficulty with making a decision.
Satisfaction with Decision Score using the Satisfaction with Decision Scale (SDS)
Time Frame: Immediately after consent (Preoperative), Postoperative Day 22, and Postoperative Day 100
This outcome assesses patient satisfaction with their decision to undergo thyroid surgery using the validated 6-item Satisfaction with Decision Scale (SDS). Each item is scored from 1 (not satisfied) to 5 (very satisfied), with a total score ranging from 6 to 30. Higher scores indicate greater satisfaction with the decision-making process and outcome.
Decision Regret Score using the Decision Regret Scale (DRS)
Time Frame: Postoperative Day 22 and Postoperative Day 100
This outcome evaluates postoperative regret related to undergoing thyroid surgery using the validated 5-item Decision Regret Scale (DRS). Each item is scored from 1 (strongly agree) to 5 (strongly disagree), with scores converted to a 0-100 scale. Higher scores reflect greater decision regret.
Anxiety Score using the Visual Analog Scale for Anxiety (VAS-A)
Time Frame: Immediately after consent (Preoperative), Postoperative Day 22, and Postoperative Day 100
This outcome measures patients' current level of anxiety using the validated Visual Analog Scale for Anxiety (VAS-A), a single-item scale presented as a 100 mm line ranging from "calm" to "anxious." Participants place a mark on the scale reflecting their current state. The score is recorded as a number from 0 to 100, with higher scores indicating greater anxiety.
Secondary Outcomes
No secondary outcomes reported