Clinical trial NCT05449470: A Clinical Decision Support System and Patient Portal for Preventing Medication-related Falls in Older Patients
Official title: Alerting on Adverse Drug Reactions: Falls Prevention Improvement Through Developing a Computerized Clinical Support System: Effectiveness of Individualized medicaTion Withdrawal
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fall
Fall Injury
Fall Patients
Accidental Fall
Deprescriptions
Polypharmacy
Aged
Aged, 80 and Over
Keywords: fall prevention
fall-risk increasing drugs (FRIDs)
older out-clinic patients
injurious falls
prediction model
clinical decision support system
patient portal
Shared Decision Making (SDM)
medication withdrawal
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: VU University of Amsterdam
First posted: 2022-07-08
Enrollment: 800
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Time to first injurious fall
timeFrame: 12 months
Secondary outcomes:
measure: Number of injurious falls
timeFrame: 12 months
measure: Total number of falls
timeFrame: 12 months
measure: Time to first fall resulting in any injuries
timeFrame: 12 months
measure: Total number of falls resulting in any injuries
timeFrame: 12 months
measure: Time to first non-injurious fall
timeFrame: 12 months
measure: EuroQol-5D-5L (EQ-5D-5L)
timeFrame: at baseline, 3 months, 6 months, and 12 months
measure: The Older Persons and Informal Caregivers Minimum Data Set-Short Form (TOPICS-SF)
timeFrame: at baseline and 12 months
measure: iMTA Productivity Cost Questionnaire (iPCQ)
timeFrame: at baseline, 3 months, 6 months, and 12 months
measure: iMTA Medical Consumption Questionnaire (iMCQ)
timeFrame: at baseline, 3 months, 6 months, and 12 months
Other outcomes:
measure: Feasibility assessed by number of CDSS and patient portal use
timeFrame: 12 months
measure: Percentage of physicians attending the CDSS training via a questionnaire
timeFrame: 12 months
measure: Correlation of percentage of physicians attending the CDSS training and CDSS user satisfaction
timeFrame: 12 months
measure: CDSS user satisfaction
timeFrame: 12 months
measure: Technology Acceptance Model (TAM)
timeFrame: at baseline
measure: Website Satisfaction Scale (WSS)
timeFrame: at 3 months
measure: Observer OPTION Multiple Chronic Conditions (OPTION-MCC)
timeFrame: 12 months
measure: Rate of adherence to new medication plan using pharmacy records
timeFrame: 12 months
measure: Number of falls calendar entries
timeFrame: 12 months
measure: iSHARE
timeFrame: 12 months
measure: Decisional Conflict Scale (DCS; low literacy scale)
timeFrame: at baseline
measure: Preparation for Decision-making scale (PrepDM)
timeFrame: at baseline
measure: Netherlands Patient Information Recall Questionnaire (NPIRQ)
timeFrame: 12 months
Locations:
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
state: Friesland
city: Nijmegen
country: Netherlands
facility: Radboud universitair medisch centrum
state: Gelderland
city: Tilburg
country: Netherlands
facility: Elisabeth-TweeSteden Ziekenhuis
state: Noord-Brabant
city: Amstelveen
country: Netherlands
facility: Ziekenhuis Amstelland
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, locatie VUmc
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: OLVG
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, locatie AMC
state: Noord-Holland
city: Haarlem
country: Netherlands
facility: Spaarne Gasthuis
state: Noord-Holland
city: Groningen
country: Netherlands
facility: UMC Groningen
city: Utrecht
country: Netherlands
facility: St. Antonius Ziekenhuis
Study officials:
affiliation: Amsterdam UMC, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands
name: Nathalie van der Velde, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Public Health, Amsterdam, the Netherlands
name: Natasja M van Schoor, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Amsterdam School of Communication Research, University of Amsterdam, Amsterdam, The Netherlands
name: Annemiek J Linn, PhD
role: STUDY_DIRECTOR
References: