Testing the SNOWDROP Intervention: Using a Clinical Decision Support System and Patient Portal for Falls Prevention Among Older Patients in Primary Care

Fall Clinical Trial

— SNOWDROP  

Official title:

Seniors Empowered Via Big Data to Joint-manage Their Medication-related Risk of Falling in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05611008
• Other study ID #: 2022-PC-15274
• Status: Completed
• Phase: N/A
• Start date: November 21, 2022
• Est. completion date: October 30, 2023

Study information

• Verified date: January 2024
• Source: University of Amsterdam
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Falls are a leading cause of injuries among older patients. Medication use is a major risk factor for falls. Because we lack tools to assess individualized risks, general practitioners (GPs) struggle with fall-related medication management for older patients. Furthermore, these older patients are often not properly equipped to engage in the joint management of their medication. A Clinical Decision Support System (CDSS) for GPs and a patient portal for older patients may stimulate shared decision making between GPs and older patients when discussing the medication-related fall risk. The CDSS provides the GP with advice on how to alter medication in such a way that the fall risk decreases, and the patient portal helps the older patient to prepare for a consultation and to engage in the joint management of their medication.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: October 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• Aged 70 years or older

• High fall risk

• Takes at least 1 Fall Risk Increasing Drug (FRID)

Related Conditions & MeSH terms

• Accidental Fall
• Deprescribing
• Fall
• Fall Injury
• Fall Patients

Intervention

Device:
• CDSS
A Clinical Decision Support System (CDSS) that calculates older patients' personalized fall risk and provides the GP with advice on how to adjust the patient's medication in order to lower the fall risk.
• Patient Portal
A patient portal that provides general information on falls and fall risk to the older patients and helps the patient to prepare for the consultation by filling out a Question Prompt List (QPL). The QPL is a list of possibly relevant questions and topics from which the patient can select those that are important to him/her. These will already be sent to the GP before the consultation takes place.

Locations

Country	Name	City	State
Netherlands	Huisartsenpraktijken	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
University of Amsterdam

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shared decision making	This concerns the extent to which shared decision making between patient and GP during the consultation. This will be assessed using the Observer OPTION Multiple Chronic Conditions (OPTION-MCC). Consultation are audiotaped and will be coded on shared decision making using this coding scheme.	During consultation
Secondary	Technology Acceptance Model (TAM; patient portal)	The Technology Acceptance Model (TAM) measures the adoption of a new technology/system based on user attitudes in relation to the patient portal.	At baseline & two weeks after consultation
Secondary	Website Satisfaction Scale (WSS; patient portal)	The Website Satisfaction Scale (WSS) measures satisfaction with comprehensibility, satisfaction with attractiveness, and satisfaction with emotional support, in relation to the patient portal.	At baseline & two weeks after consultation
Secondary	Patient portal usage	Patients are asked if they used the patient portal and which components they used.	At baseline & two weeks after consultation
Secondary	Beliefs About Medicines Questionnaire (BMQ)	The Beliefs about Medicines Questionnaire measures beliefs about the necessity of medication and concerns about medication.	Baseline & two weeks after consultation
Secondary	Netherlands Patient Information Recall Questionnaire (NPIRQ)	The Netherlands Patient Information Recall Questionnaire consists of open questions measuring patients' recall of what was discussed and decided during the consultation.	Two weeks after consultation
Secondary	Decisional Conflict Scale (DCS)	The decisional conflict scale measures decisional conflict after the consultation related to five subscales: feeling informed, uncertainty, values clarity, support, and effective decision making.	Two weeks after consultation
Secondary	Changes in medication	Changes in prescriptions of the medication as reported in the electronic health record.	Baseline & two weeks after the consultation
Secondary	Technology Acceptance Model (TAM; CDSS)	The Technology Acceptance Model (TAM) measures the adoption of a new technology/system based on user attitudes in relation to the CDSS to be answered by the GP. This is assessed by measuring Perceived Usefulness, Perceived Ease of Use, and Intention to use.	After the first consultation (study beginning) and after the last consultation (study completion after +/- 7 months)
Secondary	The Website Satisfaction Scale (WSS; CDSS)	The Website Satisfaction Scale (WSS) measures satisfaction with comprehensibility, satisfaction with attractiveness, and satisfaction with emotional support, in relation to the CDSS to be answered by the GP.	After the first consultation (study beginning) and after the last consultation (study completion after +/- 7 months)
Secondary	Evaluation of the consultation	Four items to assess the consultation to be answered by the GP. The items assess to what extent the patient was representative, their opinion on the communication during the consultation, the extent to which they are satisfied with any decisions made and the difficulty of the consultation.	Immediately after each consultation