Informing Patients About Their Surgery's Environmental Impact: an Effective Pathway to Sustainable Healthcare?

NCT07505238 | Not Yet Recruiting

• 2 other identifiers: UvA-FMG-12737KICH1.MV02.22.017
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Decision Aid; Decision Making ,Shared; Sustainability; Gallstone

Outcome Measures

Primary Outcomes (1)

• Treatment preference (surgery or wait-and-see)

  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 Outcomes (2)

• Treatment certainty

  baseline, pre-intervention

• Treatment decision

  Assessment 3 months after the participants receive the decision aid

Study Arms (2)

Intervention condition

EXPERIMENTAL

Intervention condition, in which a decision aid includes a page with information about the environmental impact of surgical removal of the gallbladder.

Behavioral: Sustainability added to decision aid

Control condition

NO INTERVENTION

A control condition, which includes no information on sustainability in the decision aid.

Interventions

Sustainability added to decision aid BEHAVIORAL

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.

Intervention condition

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• University of Amsterdam: lead
• Radboud University Medical Center: collaborator
• Leiden University Medical Center: collaborator

Study Sites (1)

University of Amsterdam

Amsterdam, North Holland, Netherlands

Location

MeSH Terms

Conditions

Gallstones

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Monique Chambon, PhD

CONTACT

+31 (0)20 525 5340; m.chambon@uva.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Since random allocation is not feasible due to technical limitations, the investigators will alternate conditions (control versus intervention) approximately every 50 patients. PatientPlus (provider of decisoin aid) will collect the data and the analyst will remain blind to condition labels until all primary analyses are completed. This ensures that the analyses will be performed blind to experimental conditions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral researcher

Model Details: This between-subject experimental study follows a design with an intervention condition, in which a 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. Participants will be assigned to either the intervention or control condition without being informed about their experimental condition (assignment to conditions alters in blocks of 50 participants).

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: April 1, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

NL (1)