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| ID | Type | Description | Link |
|---|---|---|---|
| KICH1.MV02.22.017 | Other Grant/Funding Number | Dutch Research Council (NWO) for the CAREFREE consortium |
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| Name | Class |
|---|---|
| Radboud University Medical Center | OTHER |
| Leiden University Medical Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Control condition | No Intervention | A control condition, which includes no information on sustainability in the decision aid. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment certainty | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Monique Chambon, PhD | Contact | +31 (0)20 525 5340 | m.chambon@uva.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Amsterdam | Amsterdam | North Holland | Netherlands |
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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).
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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.
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| baseline, pre-intervention |
| Treatment decision | 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 |
| ID | Term |
|---|---|
| D042882 | Gallstones |
| ID | Term |
|---|---|
| D002769 | Cholelithiasis |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D041761 | Cholecystolithiasis |
| D005705 | Gallbladder Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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