A Clinical Decision Support System and Patient Portal for Preventing Medication-related Falls in Older Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-07

Study Completion Date

2024-06-30

Brief Summary

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Falls in older adults represents a growing public health challenge. The use of certain medication is recognized as an important modifiable risk factor for falls. Research indicates fall-risk increasing drug (FRID) deprescribing is effective in reducing falls but difficult to initiate and to sustain over longer periods of follow-up. A clinical decision support system (CDSS) and patient portal for communicating medication-related fall risk to fall clinic patients may improve joint medication management between patients and physicians and consequently reduce the incidence of injurious falls.

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Detailed Description

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This study investigates the effectiveness and cost-effectiveness of the concurrent use of a CDSS and a patient portal for personalized FRID deprescribing, and will be assessed through a multicenter cluster-randomized controlled trial among new fall clinic patients, aged 65 years or older. The main study parameter is the time to first injurious fall. The primary objective of the ADFICE\_IT study is to investigate the effects of a CDSS and accompanying patient portal for optimizing FRID deprescribing on injurious falls. This study has three secondary objectives. First, the effect of the CDSS and patient portal on a number of secondary outcomes will be investigated. Second, a process evaluation to evaluate the implementation of the CDSS and patient portal will be conducted. Third, the cost-effectiveness of the CDSS and patient portal will be investigated.

Conditions

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Fall Fall Injury Fall Patients Accidental Fall Deprescriptions Polypharmacy Aged Aged, 80 and Over

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients (in both arms) who schedule an appointment will receive a letter containing information on the objectives and procedures of the study and an invitation to participate. For patients in the intervention arm, the invitation letter will also include a printed QPL and a link to the Patient portal. At this point, the Patient portal will only provide information on their upcoming visit as well as educational material regarding falls prevention.

At the falls clinic the assessments will be carried out as usual. In the intervention group, the physician will use the CDSS during the consultation. Consultations in the control group are carried out as usual. After the consultation, patients and their caregivers (if applicable) will be asked to fill out a set of questionnaires. After the visit to the falls clinic, patients in the intervention group will be able to review their consultation with the physician and their estimated fall risk in the patient portal.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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CDSS and patient portal

The intervention includes the combined use of the clinical decision support system (CDSS) that provides deprescribing advice and a personalized risk prediction and a patient portal.

Group Type EXPERIMENTAL

CDSS

Intervention Type DEVICE

A clinical decision support system (CDSS) that provides deprescribing advice and a personalized risk prediction

Patient Portal

Intervention Type DEVICE

A Patient Portal that helps patients prepare for their fall clinic visit by giving them information about falls, falls prevention, and medication-related falls. After the fall clinic visit, the Patient Portal also shows the personalized fall-risk and treatment advice.

Care as usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CDSS

A clinical decision support system (CDSS) that provides deprescribing advice and a personalized risk prediction

Intervention Type DEVICE

Patient Portal

A Patient Portal that helps patients prepare for their fall clinic visit by giving them information about falls, falls prevention, and medication-related falls. After the fall clinic visit, the Patient Portal also shows the personalized fall-risk and treatment advice.

Intervention Type DEVICE

Other Intervention Names

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Clinical Decision Support System Valportaal

Eligibility Criteria

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Inclusion Criteria

* History of at least one fall in the past year;
* A Mini-Mental State Examination (MMSE) score of 21 points or higher or equivalently a Montreal Cognitive Assessment (MOCA) Dutch score of 16 points or higher;
* Use of at least one fall-risk increasing drug (FRID); and
* Sufficient command of the Dutch language in speech and writing.

Exclusion Criteria

* Active participation in another study;
* Life expectancy of less than one year: and/or
* Suffering from severe mobility impairment (i.e. bedridden, e.g. inability to walk short distances with assistance of a walking aid).

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Prof. dr. Nathalie van der Velde

Full Professor Geriatric medicine (internal medicine)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nathalie van der Velde, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands

Natasja M van Schoor, PhD

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Public Health, Amsterdam, the Netherlands

Annemiek J Linn, PhD

Role: STUDY_DIRECTOR

Amsterdam School of Communication Research, University of Amsterdam, Amsterdam, The Netherlands

Locations

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