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

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

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.

Study Overview

• Status: Completed
• Conditions: Deprescribing; Fall; Fall Injury; Fall Patients; Accidental Fall
• Intervention / Treatment: Device: CDSS; Device: Patient Portal

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Huisartsenpraktijken

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Aged 70 years or older
• High fall risk
• Takes at least 1 Fall Risk Increasing Drug (FRID)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention condition	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.; Device: 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.
No Intervention: Control condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Patient portal usage	Patients are asked if they used the patient portal and which components they used.	At baseline & two weeks after consultation
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
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
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
Changes in medication	Changes in prescriptions of the medication as reported in the electronic health record.	Baseline & two weeks after the consultation
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)
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)
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

Collaborators and Investigators

• Sponsor: University of Amsterdam
• Investigators: Principal Investigator: Julia C.M. van Weert, Amsterdam School for Communication Research (ASCoR), University of Amsterdam

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2022
• Primary Completion (Actual): October 30, 2023
• Study Completion (Actual): October 30, 2023

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: November 3, 2022
• First Posted (Actual): November 9, 2022

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2022-PC-15274

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Currently no plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No