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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
800
A clinical decision support system (CDSS) that provides deprescribing advice and a personalized risk prediction
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.
Radboud universitair medisch centrum
Nijmegen, Gelderland, Netherlands
NOT_YET_RECRUITINGElisabeth-TweeSteden Ziekenhuis
Tilburg, North Brabant, Netherlands
RECRUITINGZiekenhuis Amstelland
Amstelveen, North Holland, Netherlands
NOT_YET_RECRUITINGAmsterdam UMC, locatie VUmc
Amsterdam, North Holland, Netherlands
RECRUITINGOLVG
Amsterdam, North Holland, Netherlands
NOT_YET_RECRUITINGAmsterdam UMC, locatie AMC
Amsterdam, North Holland, Netherlands
RECRUITINGSpaarne Gasthuis
Haarlem, North Holland, Netherlands
NOT_YET_RECRUITINGMedisch Centrum Leeuwarden
Leeuwarden, Provincie Friesland, Netherlands
NOT_YET_RECRUITINGUMC Groningen
Groningen, Netherlands
NOT_YET_RECRUITINGSt. Antonius Ziekenhuis
Utrecht, Netherlands
NOT_YET_RECRUITINGTime to first injurious fall
This concerns the time to the first injurious fall. An injurious fall is defined as a fall resulting in wounds, bruises, sprains, cuts, medically recorded fractures, head or internal injury, requiring medical/health professional examination, accident and emergency treatment, or inpatient treatment.
Time frame: 12 months
Number of injurious falls
This concerns the total number of injuirous falls over the course of 12 months. An injurious fall is defined as a fall resulting in wounds, bruises, sprains, cuts, medically recorded fractures, head or internal injury, requiring medical/health professional examination, accident and emergency treatment, or inpatient treatment.
Time frame: 12 months
Total number of falls
Total number of any fall (I.e. a fall that results in no injuries, or minor, moderate, or severe injuries)
Time frame: 12 months
Time to first fall resulting in any injuries
I.e. a fall that results in minor, moderate, or severe injuries
Time frame: 12 months
Total number of falls resulting in any injuries
I.e. a fall that results in minor, moderate, or severe injuries
Time frame: 12 months
Time to first non-injurious fall
I.e. a fall that results in no injuries
Time frame: 12 months
EuroQol-5D-5L (EQ-5D-5L)
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension in the EQ-5D-5L has five response levels: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5). Furthermore, it includes a visual analogue scale (EQ-VAS) which provides a single global rating of self-perceived health and is scored on a 0 (worst health imaginable) to 100 (best health imaginable) scale.
Time frame: at baseline, 3 months, 6 months, and 12 months
The Older Persons and Informal Caregivers Minimum Data Set-Short Form (TOPICS-SF)
Data as measured by the The Older Persons and Informal Caregivers Minimum Data Set-Short Form (TOPICS-SF) will be analysed based on the preference-weighted score, ranging from 1.90 to 9.78, with higher scores reflecting a better health status, as perceived by the respondent. The TOPICS - Short Form 2017 including Casemix forms were developed in collaboration with the Nederlandse Vereniging voor Klinische Geriatrie (NvKG - Dutch Association for Clinical Geriatrics) to use as a Patient Reported Outcome Measure (PROM) in the Dutch outpatient and clinical daily practice.
Time frame: at baseline and 12 months
iMTA Productivity Cost Questionnaire (iPCQ)
Direct and indirect costs related to the intervention and care as usual will be assessed using the iMTA Productivity Cost Questionnaire (iPCQ).
Time frame: at baseline, 3 months, 6 months, and 12 months
iMTA Medical Consumption Questionnaire (iMCQ)
The iMTA Medical Consumption Questionnaire (iMCQ) is an instrument for measuring medical consumption. The iMCQ includes questions related to frequently occurring contacts with health care providers.
Time frame: at baseline, 3 months, 6 months, and 12 months
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