Alerting on Adverse Drug Reactions: Falls Prevention Improvement Through Developing a Computerized Clinical Support System: Effectiveness of Individualized medicaTion Withdrawal
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Fall
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Enrollment
- 800
- Locations
- 10
- Primary Endpoint
- Time to first injurious fall
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Prof. dr. Nathalie van der Velde
Full Professor Geriatric medicine (internal medicine)
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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).
Outcomes
Primary Outcomes
Time to first injurious fall
Time Frame: 12 months
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.
Secondary Outcomes
- Number of injurious falls(12 months)
- Total number of falls resulting in any injuries(12 months)
- Total number of falls(12 months)
- The Older Persons and Informal Caregivers Minimum Data Set-Short Form (TOPICS-SF)(at baseline and 12 months)
- iMTA Productivity Cost Questionnaire (iPCQ)(at baseline, 3 months, 6 months, and 12 months)
- Time to first fall resulting in any injuries(12 months)
- Time to first non-injurious fall(12 months)
- EuroQol-5D-5L (EQ-5D-5L)(at baseline, 3 months, 6 months, and 12 months)
- iMTA Medical Consumption Questionnaire (iMCQ)(at baseline, 3 months, 6 months, and 12 months)