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

Study Overview
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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.

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.

Official Title
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Alerting on Adverse Drug Reactions: Falls Prevention Improvement Through Developing a Computerized Clinical Support System: Effectiveness of Individualized medicaTion Withdrawal

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

Intervention / Treatment
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* Device: CDSS
* Device: Patient Portal


Participation Criteria
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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).

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CDSS and patient portal<br>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. | Device: CDSS<br>* A clinical decision support system (CDSS) that provides deprescribing advice and a personalized risk prediction<br>* Other names: Clinical Decision Support System;Device: Patient Portal<br>* 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.<br>* Other names: Valportaal;|
| No Intervention: Care as usual<br>Care as usual | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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) | 12 months | 
| Time to first fall resulting in any injuries | I.e. a fall that results in minor, moderate, or severe injuries | 12 months | 
| Total number of falls resulting in any injuries | I.e. a fall that results in minor, moderate, or severe injuries | 12 months | 
| Time to first non-injurious fall | I.e. a fall that results in no injuries | 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. | 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. | 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). | 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. | at baseline, 3 months, 6 months, and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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