FallSNOWDROPNCT05611008
Testing the SNOWDROP Intervention: Using a Clinical Decision Support System and Patient Portal for Falls Prevention Among Older Patients in Primary Care
A study testing CDSS and Patient Portal in people with Fall and Fall Injury, run by University of Amsterdam at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fall, Fall Injury, Fall Patients
- What is being tested?
- CDSS and Patient Portal
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 Nov 2022to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Aged 70 years or older
- High fall risk
- Takes at least 1 Fall Risk Increasing Drug (FRID)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Fall, Fall Injury, Fall Patients, Accidental Fall, Deprescribing
- Being tested
- CDSS, Patient Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDSSDevice
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 PortalDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention condition | Experimental | Not described Receives: Device: CDSS; Device: Patient Portal |
| Control condition | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During consultation
Secondary outcomes (10)
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.
Measured: 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.
Measured: At baseline & two weeks after consultation
Patient portal usage
Patients are asked if they used the patient portal and which components they used.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Two weeks after consultation
Changes in medication
Changes in prescriptions of the medication as reported in the electronic health record.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Immediately after each consultation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start21 Nov 2022
- Primary completion30 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FallStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Amsterdam
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julia van Weert, University of Amsterdam
- Investigators
- Julia C.M. van Weert, Principal investigator, Amsterdam School for Communication Research (ASCoR), University of Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611008
- Sponsor's protocol ID
- 2022-PC-15274
- Acronym
- SNOWDROP
- Status last verified
- Jan 2024
- First submitted
- 18 Oct 2022
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Currently no plan
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seniors Empowered Via Big Data to Joint-manage Their Medication-related Risk of Falling in Primary Care
- ClinicalTrials.gov ID
- NCT05611008
- Acronym / sponsor ID
- SNOWDROP / 2022-PC-15274
- Conditions
- Fall, Fall Injury, Fall Patients, Accidental Fall, Deprescribing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of AmsterdamUniversity, hospital or other
- Study start
- 21 Nov 2022 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 9 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention condition | Experimental | Device: CDSS, Device: Patient Portal |
| Control condition | No intervention | – |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Aged 70 years or older
- High fall risk
- Takes at least 1 Fall Risk Increasing Drug (FRID)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CDSSA 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 | Intervention condition |
| Patient PortalA 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. | Device | Intervention condition |
Primary outcome
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.
10 secondary outcomes
Technology Acceptance Model (TAM; patient portal)
Time frame: At baseline & two weeks after consultation
Website Satisfaction Scale (WSS; patient portal)
Time frame: At baseline & two weeks after consultation
Patient portal usage
Time frame: At baseline & two weeks after consultation
Beliefs About Medicines Questionnaire (BMQ)
Time frame: Baseline & two weeks after consultation
Netherlands Patient Information Recall Questionnaire (NPIRQ)
Time frame: Two weeks after consultation
Decisional Conflict Scale (DCS)
Time frame: Two weeks after consultation
Changes in medication
Time frame: 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 Website Satisfaction Scale (WSS; CDSS)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Individual participant dataSharing planned: Undecided. Currently no plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia C.M. van Weert principal investigator
Amsterdam School for Communication Research (ASCoR), University of Amsterdam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CDSS and Patient Portal in people with Fall and Fall Injury, run by University of Amsterdam at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shared decision making (time frame: During consultation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.