NCT05611008

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 9, 2022

Completed
12 days until next milestone

Study Start

First participant enrolled

November 21, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

January 10, 2024

Status Verified

January 1, 2024

Enrollment Period

11 months

First QC Date

October 18, 2022

Last Update Submit

January 9, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Technology Acceptance Model (TAM; patient portal)

    At baseline & two weeks after consultation

  • Website Satisfaction Scale (WSS; patient portal)

    At baseline & two weeks after consultation

  • Patient portal usage

    At baseline & two weeks after consultation

  • Beliefs About Medicines Questionnaire (BMQ)

    Baseline & two weeks after consultation

  • Netherlands Patient Information Recall Questionnaire (NPIRQ)

    Two weeks after consultation

  • +5 more secondary outcomes

Study Arms (2)

Intervention condition

EXPERIMENTAL
Device: CDSSDevice: Patient Portal

Control condition

NO INTERVENTION

Interventions

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.

Intervention condition

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.

Intervention condition

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huisartsenpraktijken

Amsterdam, Netherlands

Location

MeSH Terms

Interventions

Patient Portals

Intervention Hierarchy (Ancestors)

Health Records, PersonalMedical RecordsRecordsData CollectionEpidemiologic MethodsInvestigative Techniques

Study Officials

  • Julia C.M. van Weert

    Amsterdam School for Communication Research (ASCoR), University of Amsterdam

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr. Julia van Weert

Study Record Dates

First Submitted

October 18, 2022

First Posted

November 9, 2022

Study Start

November 21, 2022

Primary Completion

October 30, 2023

Study Completion

October 30, 2023

Last Updated

January 10, 2024

Record last verified: 2024-01

Locations