Interventions to promote informed consent for patients undergoing surgical and other invasive healthcare procedures.
Paul Kinnersley, Katie Phillips, Katherine Savage...
https://pubmed.ncbi.nlm.nih.gov/23832767Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06059599
Active Informed Consent: a New Solution to Improve and Objectively Test the Patient Understanding of Complex Surgical Procedures Proposals
Led by Istituto Ortopedico Rizzoli · Updated on 2026-02-02
300
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new way to provide preoperative information to patients who are candidates for spinal or urological surgery. This study is an interventional, randomized controlled trial conducted at multiple centers. It aims to compare a new multimedia-based method that objectively checks patient understanding against the standard informed consent process to see which better supports patient decision-making about surgery. Participants in the experimental group will receive detailed information through videos with surgical options, graphics, and animations. They will also have interviews with the surgeon and caregivers using 3D-printed models to guide shared decision-making. After deciding on surgery, patients will join educational programs to reinforce understanding before a final surgeon interview and signing of informed consent. The control group will receive the usual care, including a standard explanatory interview and consent signing. Throughout the study, participants will complete questionnaires assessing satisfaction, comprehension, mental health, pain, disability, urinary and sexual function, and legal outcomes at multiple time points: before surgery, at discharge, and at two and six months after surgery. The research team will monitor these measures to evaluate the impact of the new method on patient understanding and decision satisfaction over time.
CONDITIONS
Brief Title
Active Informed Consent: a New Solution to Improve and Objectively Test the Patient Understanding of Complex Surgical Procedures Proposals
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 218 years or older with full legal capacity to consent
- Scheduled for elective spinal surgery or radical prostatectomy
- Ability to understand and communicate in Italian
- Basic computer or internet skills to access multimedia content
You will not qualify if you...
- Under 18 years of age
- Unable to provide informed consent due to cognitive impairment or severe mental illness
- Cases requiring urgent or emergency surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Preoperative Information and Decision Making
Duration - Up to 4 weeks before surgery
Participants receive detailed information about their surgery options through multimedia tools, interviews with surgeons including shared decision making, and educational programs to enhance understanding before giving informed consent.
Multiple visits including video sessions, surgeon interviews, and educational program visits
Surgery
Duration - Day of surgery
Participants undergo the scheduled elective spinal surgery or radical prostatectomy.
1 visit (in-person)
Follow-up and Outcome Assessment
Duration - 6 months after surgery
Participants are monitored with questionnaires and scales to assess satisfaction, comprehension, mental health, pain, disability, and other relevant outcomes at discharge and at 2 and 6 months post-surgery.
3 visits (discharge, 2 months follow-up, and 6 months follow-up)
Trial Site Locations
Total: 1 location
1
Istituto Ortopedico Rizzoli
Bologna, Italy, 40136
Actively Recruiting
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Research Team
L
Luca Boriani, MD
B
Bruna Maccaferri, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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Published Research Related To This Trial
Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures: An Updated Systematic Review.
Johanna Glaser, Sarah Nouri, Alicia Fernandez...
https://pubmed.ncbi.nlm.nih.gov/31948345The Challenges of Informed Consent in High-Stakes, Randomized Oncology Trials: A Systematic Review.
Julia M Nathe, Elizabeth F Krakow
https://pubmed.ncbi.nlm.nih.gov/30944886The Quality of Informed Consent Forms-a Systematic Review and Critical Analysis.
Julia Lühnen, Ingrid Mühlhauser, Anke Steckelberg
https://pubmed.ncbi.nlm.nih.gov/29932049Protocol RCT for active informed consent in spine and urologic surgery in the metropolitan city of Bologna: does an increased patient engagement improve satisfaction of complex surgical procedures?
Luca Boriani, Irene Quattrini, Bruna Maccaferri...
https://pubmed.ncbi.nlm.nih.gov/41806994