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

January 9, 2024 updated by: Julia van Weert, University of Amsterdam

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
85

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands
        • Huisartsenpraktijken

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Shared decision making
Time Frame: During consultation
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Technology Acceptance Model (TAM; patient portal)
Time Frame: At baseline & two weeks after consultation
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)
Time Frame: At baseline & two weeks after consultation
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
Time Frame: At baseline & two weeks after consultation
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)
Time Frame: Baseline & two weeks after consultation
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)
Time Frame: Two weeks after consultation
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)
Time Frame: Two weeks after consultation
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
Time Frame: Baseline & two weeks after the consultation
Changes in prescriptions of the medication as reported in the electronic health record.
Baseline & two weeks after the consultation
Technology Acceptance Model (TAM; CDSS)
Time Frame: After the first consultation (study beginning) and after the last consultation (study completion after +/- 7 months)
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)
Time Frame: After the first consultation (study beginning) and after the last consultation (study completion after +/- 7 months)
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
Time Frame: Immediately after each 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Amsterdam

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Julia C.M. van Weert, Amsterdam School for Communication Research (ASCoR), University of Amsterdam

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 21, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 18, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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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