- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07505238
Informing Patients About Their Surgery's Environmental Impact: an Effective Pathway to Sustainable Healthcare?
March 25, 2026 updated by: Monique Chambon, University of Amsterdam
The healthcare sector contributes significantly to climate change.
Reducing the number of patients receiving resource-intensive procedures such as surgery can lower carbon emissions, particularly when two treatments with comparable clinical outcomes are available.
Nevertheless, the impact of incorporating environmental considerations into patients' decision-making processes remains underexplored.
The investigators examine how including information about the environmental impact of treatment options in a gallstone decision aid affects patients' real-life choice between surgery and the more sustainable alternative of conservative treatment.
Moreover, the investigators examine whether factors such as severity of symptoms moderate the relation between sustainability information and patients' treatment choice.
An exploratory vignette study informed the hypotheses that will be tested among actual patients with gallstones making actual treatment decisions.
The results of this ecologically valid study have implications for both clinical practice and healthcare policy by offering insight into the effectiveness of pathways to include patients in the transition towards sustainable healthcare.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
400
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Monique Chambon, PhD
- Phone Number: +31 (0)20 525 5340
- Email: m.chambon@uva.nl
Study Locations
-
-
North Holland
-
Amsterdam, North Holland, Netherlands
- University of Amsterdam
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients who were referred to three participating hospitals located across the Netherlands
- Patients who received PatientPlus' gallstone decision aid in preparation for their surgical consultation
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention condition
Intervention condition, in which a decision aid includes a page with information about the environmental impact of surgical removal of the gallbladder.
|
The intervention decision aid includes a page with information about the environmental impact of surgical removal of the gallbladder, and a control condition, which includes no such information.
Besides information about the environmental impact of gallbladder surgery, the intervention and control conditions will be identical.
At the end of the decision aid patients will be debriefed in general phrasing (i.e., the aim of this study was to examine which factors affect treatment choice) to prevent influencing the actual decision.
Approximately three months after patients received the decision aid, patients will receive an invitation via the PatientPlus portal to complete a survey in which the investigators inquire about their final treatment decision (first reminder after one week, second reminder after two weeks).
At the end of this survey, patients will be debriefed about the aim of examining how information about the environmental impact of surgery affects treatment choice.
|
|
No Intervention: Control condition
A control condition, which includes no information on sustainability in the decision aid.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Treatment preference (surgery or wait-and-see)
Time Frame: baseline, pre-intervention
|
The primary outcome is treatment preference.
Specifically, participants will indicate their treatment preference by selecting either the option 'Surgery' or 'Wait and see' (dichotomous variable)
|
baseline, pre-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Treatment certainty
Time Frame: baseline, pre-intervention
|
Combination of treatment preference and certainty.
Treatment certainty will be determined by answering the question 'How sure are you about what you want?' on a scale from 1 (Very uncertain) to 10 (Very certain).
Treatment preference*certainty will be calculated after data collection by multiplying treatment preference (coded as 1 for surgery and -1 for wait and see thus no surgery) with treatment certainty, resulting in a scale from -10 (Very certain about choosing no surgery) to +10 (Very certain about choosing surgery).
Adding this continuous measure allows for capturing more nuanced differences between the intervention and control conditions compared to dichotomous measures.
|
baseline, pre-intervention
|
|
Treatment decision
Time Frame: Assessment 3 months after the participants receive the decision aid
|
Secondary outcome is treatment decision (number of patients that choose surgery and number of patients that choose wait-and-see)
|
Assessment 3 months after the participants receive the decision aid
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 1, 2026
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
July 1, 2027
Study Registration Dates
First Submitted
March 20, 2026
First Submitted That Met QC Criteria
March 25, 2026
First Posted (Actual)
April 1, 2026
Study Record Updates
Last Update Posted (Actual)
April 1, 2026
Last Update Submitted That Met QC Criteria
March 25, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UvA-FMG-12737
- KICH1.MV02.22.017 (Other Grant/Funding Number: Dutch Research Council (NWO) for the CAREFREE consortium)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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