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

Not Applicable

Recruiting

• Conditions: Deprescriptions; Fall Patients; Aged, 80 and Over; Fall Injury; Accidental Fall; Fall; Polypharmacy; Aged
• Interventions: Device: CDSS; Device: Patient Portal

• Registration Number: NCT05449470
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Study Timeline

• Study First Submitted: 2022-03-24
• Study First Submitted QC: 2022-07-06
• Study Start: 2022-07-07
• Study First Posted: 2022-07-08
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-31
• Last Update Posted: 2023-02-02
• Primary Completion: 2023-12-31
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CDSS and patient portal	CDSS	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.
CDSS and patient portal	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.

Primary Outcome Measures

Name	Time	Method
Time to first injurious fall	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 Outcome Measures

Name	Time	Method
Number of injurious falls	12 months	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.
Total number of falls resulting in any injuries	12 months	I.e. a fall that results in minor, moderate, or severe injuries
Total number of falls	12 months	Total number of any fall (I.e. a fall that results in no injuries, or minor, moderate, or severe injuries)
The Older Persons and Informal Caregivers Minimum Data Set-Short Form (TOPICS-SF)	at baseline and 12 months	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.
iMTA Productivity Cost Questionnaire (iPCQ)	at baseline, 3 months, 6 months, and 12 months	Direct and indirect costs related to the intervention and care as usual will be assessed using the iMTA Productivity Cost Questionnaire (iPCQ).
Time to first fall resulting in any injuries	12 months	I.e. a fall that results in minor, moderate, or severe injuries
Time to first non-injurious fall	12 months	I.e. a fall that results in no injuries
EuroQol-5D-5L (EQ-5D-5L)	at baseline, 3 months, 6 months, and 12 months	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.
iMTA Medical Consumption Questionnaire (iMCQ)	at baseline, 3 months, 6 months, and 12 months	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.

Trial Locations

Locations (10)

Amsterdam UMC, locatie AMC; 🇳🇱 Amsterdam, Noord-Holland, Netherlands

Spaarne Gasthuis; 🇳🇱 Haarlem, Noord-Holland, Netherlands

UMC Groningen; 🇳🇱 Groningen, Netherlands

Elisabeth-TweeSteden Ziekenhuis; 🇳🇱 Tilburg, Noord-Brabant, Netherlands

Amsterdam UMC, locatie VUmc; 🇳🇱 Amsterdam, Noord-Holland, Netherlands

OLVG; 🇳🇱 Amsterdam, Noord-Holland, Netherlands

St. Antonius Ziekenhuis; 🇳🇱 Utrecht, Netherlands

Ziekenhuis Amstelland; 🇳🇱 Amstelveen, Noord-Holland, Netherlands

Medisch Centrum Leeuwarden; 🇳🇱 Leeuwarden, Friesland, Netherlands

Radboud universitair medisch centrum; 🇳🇱 Nijmegen, Gelderland, Netherlands