Assessing Patient Satisfaction and Confidence After Use of Educational Video to Augment Surgical Consent for Thyroid Surgery

NCT06918223 | Recruiting

• 2 other identifiers: 20E.663STRYKER
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Cancer

Outcome Measures

Primary Outcomes (5)

• Patient knowledge score using a 10-item internally validated Thyroid Surgery Knowledge Assessment

  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.

  Immediately after study enrollment (pre-consent) and immediately following the surgical consent process (post-consent)

• Decisional Conflict Score using the Decisional Conflict Scale (DCS)

  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.

  Preoperatively (after the consent process and before surgery)

• Satisfaction with Decision Score using the Satisfaction with Decision Scale (SDS)

  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.

  Immediately after consent (Preoperative), Postoperative Day 22, and Postoperative Day 100

• Decision Regret Score using the Decision Regret Scale (DRS)

  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.

  Postoperative Day 22 and Postoperative Day 100

• Anxiety Score using the Visual Analog Scale for Anxiety (VAS-A)

  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.

  Immediately after consent (Preoperative), Postoperative Day 22, and Postoperative Day 100

Study Arms (2)

Intervention: TISCAV

EXPERIMENTAL

Behavioral: Thyroid Informed Surgical Consent Augmenting Video (TISCAV)

Control: Standard Consent

PLACEBO COMPARATOR

Behavioral: Standard Consent

Interventions

Thyroid Informed Surgical Consent Augmenting Video (TISCAV) BEHAVIORAL

Participants randomized to the intervention group will receive a surgeon-created Thyroid Informed Surgical Consent Augmenting Video (TISCAV). This 8-minute video includes animated visuals and a surgeon voiceover explaining thyroid anatomy, surgical options (lobectomy vs. total thyroidectomy), risks, benefits, and expectations. The TISCAV was designed and reviewed by an endocrine surgery team to improve patient comprehension, confidence, satisfaction, and reduce decision regret compared to standard verbal consent alone.

Intervention: TISCAV

Standard Consent BEHAVIORAL

Participants receiving the Standard Consent intervention will undergo the routine informed consent process for thyroid surgery provided by their surgeon. This process includes a verbal discussion covering thyroidectomy procedure details, potential risks and complications, benefits, alternatives such as active surveillance, and an opportunity to ask questions.

Control: Standard Consent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English is Primary Language
• ≥18 years old at time of consent
• Eligible for Thyroidectomy, lobectomy, isthmusectomy for any indication

You may not qualify if:

• History of prior thyroid surgery
• Previously consented for thyroid surgery

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Related Publications (16)

• Levy N, Landmann L, Stermer E, Erdreich M, Beny A, Meisels R. Does a detailed explanation prior to gastroscopy reduce the patient's anxiety? Endoscopy. 1989 Nov;21(6):263-5. doi: 10.1055/s-2007-1012965.

  PMID: 2612430 BACKGROUND

• Kindler CH, Harms C, Amsler F, Ihde-Scholl T, Scheidegger D. The visual analog scale allows effective measurement of preoperative anxiety and detection of patients' anesthetic concerns. Anesth Analg. 2000 Mar;90(3):706-12. doi: 10.1097/00000539-200003000-00036.

  PMID: 10702461 BACKGROUND

• Thomas T, Robinson C, Champion D, McKell M, Pell M. Prediction and assessment of the severity of post-operative pain and of satisfaction with management. Pain. 1998 Apr;75(2-3):177-85. doi: 10.1016/s0304-3959(97)00218-2.

  PMID: 9583753 BACKGROUND

• McCleane GJ, Cooper R. The nature of pre-operative anxiety. Anaesthesia. 1990 Feb;45(2):153-5. doi: 10.1111/j.1365-2044.1990.tb14285.x.

  PMID: 2321720 BACKGROUND

• Domar AD, Everett LL, Keller MG. Preoperative anxiety: is it a predictable entity? Anesth Analg. 1989 Dec;69(6):763-7.

  PMID: 2589657 BACKGROUND

• D'Souza V, Blouin E, Zeitouni A, Muller K, Allison PJ. Do multimedia based information services increase knowledge and satisfaction in head and neck cancer patients? Oral Oncol. 2013 Sep;49(9):943-949. doi: 10.1016/j.oraloncology.2013.06.005. Epub 2013 Jul 16.

  PMID: 23870712 BACKGROUND

• Hakimi AA, Standiford L, Chang E, Wong BJ. Development and Assessment of a Video-Based Intervention to Improve Rhinoplasty Informed Consent. Facial Plast Surg. 2021 Oct;37(5):585-589. doi: 10.1055/s-0041-1722912. Epub 2021 Feb 25.

  PMID: 33634455 BACKGROUND

• Siu JM, Rotenberg BW, Franklin JH, Sowerby LJ. Multimedia in the informed consent process for endoscopic sinus surgery: A randomized control trial. Laryngoscope. 2016 Jun;126(6):1273-8. doi: 10.1002/lary.25793. Epub 2015 Nov 30.

  PMID: 26615812 BACKGROUND

• Nehme J, El-Khani U, Chow A, Hakky S, Ahmed AR, Purkayastha S. The use of multimedia consent programs for surgical procedures: a systematic review. Surg Innov. 2013 Feb;20(1):13-23. doi: 10.1177/1553350612446352. Epub 2012 May 14.

  PMID: 22589017 BACKGROUND

• Sudore RL, Landefeld CS, Williams BA, Barnes DE, Lindquist K, Schillinger D. Use of a modified informed consent process among vulnerable patients: a descriptive study. J Gen Intern Med. 2006 Aug;21(8):867-73. doi: 10.1111/j.1525-1497.2006.00535.x.

  PMID: 16881949 BACKGROUND

• Burns P, Keogh I, Timon C. Informed consent: a patients' perspective. J Laryngol Otol. 2005 Jan;119(1):19-22. doi: 10.1258/0022215053222860.

  PMID: 15807957 BACKGROUND

• Hekkenberg RJ, Irish JC, Rotstein LE, Brown DH, Gullane PJ. Informed consent in head and neck surgery: how much do patients actually remember? J Otolaryngol. 1997 Jun;26(3):155-9.

  PMID: 9176798 BACKGROUND

• Oosthuizen JC, Burns P, Timon C. The changing face of informed surgical consent. J Laryngol Otol. 2012 Mar;126(3):236-9. doi: 10.1017/S0022215111003021. Epub 2011 Nov 4.

  PMID: 22051081 BACKGROUND

• Kessels RP. Patients' memory for medical information. J R Soc Med. 2003 May;96(5):219-22. doi: 10.1177/014107680309600504. No abstract available.

  PMID: 12724430 BACKGROUND

• Sherlock A, Brownie S. Patients' recollection and understanding of informed consent: a literature review. ANZ J Surg. 2014 Apr;84(4):207-10. doi: 10.1111/ans.12555.

  PMID: 24812707 BACKGROUND

• Mulsow JJ, Feeley TM, Tierney S. Beyond consent--improving understanding in surgical patients. Am J Surg. 2012 Jan;203(1):112-20. doi: 10.1016/j.amjsurg.2010.12.010. Epub 2011 Jun 8.

  PMID: 21641573 BACKGROUND

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Elizabeth Cottrill Assistant Professor and Program Director, MD

  Assistant Professor and Program Director

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annie Moroco Assistant Professor, MD

CONTACT

215-955-6826; Annie.Moroco@jefferson.edu

Hani Research Fellow, BS

CONTACT

3216091134; hxs597@jefferson.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: April 9, 2025
• Study Start: November 10, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

US (1)