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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Fall; Aged; Fall Injury; Fall Patients; Polypharmacy; Accidental Fall; Aged, 80 and Over; Deprescriptions
• Intervention / Treatment: Device: CDSS; Device: Patient Portal

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 Type: Interventional
• Enrollment (Anticipated): 800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kelly K de Wildt; Phone Number: +31615377082; Email: k.k.dewildt@amsterdamumc.nl
• Study Contact Backup: Name: Bob van de Loo; Email: r.vandeloo@amsterdamumc.nl

Study Locations

• Netherlands
  • Groningen, Netherlands, 9713 GZ
    • UMC Groningen
    • Contact: Harianne Hegge, MD; Phone Number: +31503613921; Email: h.h.m.hegge@umcg.nl
  • Utrecht, Netherlands, 3543 AZ
    • St. Antonius ziekenhuis
    • Contact: Marike van Hengel, MD; Phone Number: +31883204700; Email: m.hengel@antoniusziekenhuis.nl
  • Friesland
    • Leeuwarden, Friesland, Netherlands, 8934 AD
      • Medisch Centrum Leeuwarden
      • Contact: Liesbeth Hempenius, MD, PhD; Phone Number: +31582866840; Email: Liesbeth.Hempenius@ZNB.NL
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6525 GA
      • Radboud Universitair Medisch Centrum
      • Contact: Jurgen Claassen, MD, PhD; Phone Number: +31243605903; Email: Jurgen.Claassen@radboudumc.nl
  • Noord-Brabant
    • Tilburg, Noord-Brabant, Netherlands, 5042 AD
      • Elisabeth-TweeSteden Ziekenhuis
      • Contact: Mariëlle Mensing-Hofman, MD; Phone Number: +31132210090; Email: mr.hofman@etz.nl
  • Noord-Holland
    • Amstelveen, Noord-Holland, Netherlands, 1186 AM
      • Ziekenhuis Amstelland
      • Contact: Marijke Trappenburg, MD; Phone Number: +31207556236; Email: m.trappenburg@zha.nl
    • Amsterdam, Noord-Holland, Netherlands, 1081 HV
      • Amsterdam UMC, locatie VUmc
      • Contact: Majon Muller, Prof.Dr.; Phone Number: +31204441120; Email: majon.muller@amsterdamumc.nl
    • Amsterdam, Noord-Holland, Netherlands, 1105 AZ
      • Amsterdam UMC, locatie AMC
      • Contact: Nathalie van der Velde, Prof.dr.; Phone Number: +31205655991; Email: n.vandervelde@amsterdamumc.nl
    • Haarlem, Noord-Holland, Netherlands, 2035 RC
      • Spaarne Gasthuis
      • Contact: Hester van der Kroon, MD; Phone Number: +31232240045; Email: h.vander.kroon@spaarnegasthuis.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility assessed by number of CDSS and patient portal use	To assess the feasibility of the intervention, the investigators will use data logged by the CDSS and patient portal to understand how (often) the CDSS and patient portal are used	12 months
Percentage of physicians attending the CDSS training via a questionnaire	To assess the feasibility of the intervention, the investigators will look at the percentage of physicians who attended the CDSS training. More specifically, this will be measured by asking physicians whether they attended the CDSS training online, offline or not at all as part of the CDSS user satisfaction questionnaire.	12 months
Correlation of percentage of physicians attending the CDSS training and CDSS user satisfaction	The correlation between the proportion of a department's staff members who did/did not participate in the CDSS training and user satisfaction regarding the CDSS will be assessed.	12 months
CDSS user satisfaction	To assess the feasibility of the intervention, the investigators will study the satisfaction regarding the CDSS (i.e. physician evaluations of the CDSS). Agreement with satisfaction statements will be scored on a 7-point Likert scale (1= totally disagree; 7 = totally agree).	12 months
Technology Acceptance Model (TAM)	The Technology Acceptance Model (TAM) is designed to measure the adoption of a new technology/system based on user attitudes. 6 items aim to measure Perceived Usefulness on a 7-point Likert scale (1=totally disagree; 7 = totally agree), and 6 items aim to measure Perceived Ease of Use on a 7-point Likert scale (1=totally disagree; 7 = totally agree). Intention to use is measured through 1 item on a 7-point Likert scale (1=totally disagree; 7 = totally agree)	at baseline
Website Satisfaction Scale (WSS)	The Website Satisfaction Scale (WSS) measures satisfaction with comprehensibility, satisfaction with attractiveness, and satisfaction with emotional support through 12 items, for each sub scale using a 7-point Likert response scale, ranging from 1 'totally disagree' to 7 'totally agree'.	at 3 months
Observer OPTION Multiple Chronic Conditions (OPTION-MCC)	Videotaped consultations will be coded on triadic decision making in older patients with multiple chronic conditions by using the Observer OPTION Multiple Chronic Conditions (OPTION-MCC) coding scheme. Six types of physicians', patients', and caregivers' behaviors are coded. Physicians' behavior is coded on a 5-point scale (0= The behavior is not observed; 4=The behavior is executed to a very high standard), patients' behavior is coded on a 3-point scale (0=No or minimal participation, e.g. only yes or no; 2=Active participation, answers questions and asks questions, brings in own ideas and shares perceptions), and informal caregivers' behavior is coded on a 3-point scale (0=No or minimal participation, e.g. only yes or no; 2=Active participation, answers questions and asks questions, brings in own ideas and shares perceptions)	12 months
Rate of adherence to new medication plan using pharmacy records	To assess adherence to the medication advice, the investigators will compare a patient's new medication advice with their pharmacy records to determine whether a patient adheres to the new medication advice or whether they (eventually) change back to their old medication	12 months
Number of falls calendar entries	To assess adherence to the medication advice, the investigators will compare the new medication advice with falls calender entries on medication use to determine whether a patient adheres to the new medication advice or whether they (eventually) change back to their old medication	12 months
iSHARE	To evaluate how the intervention facilitates SDM, the investigators will use the iSHAREpatient and iSHAREphysician questionnaires. The iSHAREphysician consists of 16 items scored on a 6-point Likert scale (1= did not do this at all; 6 = completely did this). The iSHAREpatient consists of 16 items scored on a 6-point Likert scale (1= did not do this at all; 6 = completely did this). Dimension scores (range, 0-5) and a total score (the sum of the dimension scores; range, 0-30) for both iSHARE questionnaires will be calculated. The investigators will then apply a linear transformation to obtain a 0 to 100 total score ((score/30)*100). Higher dimension and total scores indicate higher levels of SDM.	12 months
Decisional Conflict Scale (DCS; low literacy scale)	To evaluate how the intervention facilitates SDM, the investigators will use the Decisional Conflict Scale (DCS; low literacy scale). This scale consists of 10 questions, scored on 3 response categories (yes, do not know, no).	at baseline
Preparation for Decision-making scale (PrepDM)	To evaluate how the intervention facilitates SDM, the investigators will use the Preparation for Decision-making scale (PrepDM). This scale consists of 10 items, scored on a 5-point Likert scale (1= not at all; 5 = a great deal)	at baseline
Netherlands Patient Information Recall Questionnaire (NPIRQ)	To evaluate how the intervention facilitates SDM, the investigators will use the Netherlands Patient Information Recall Questionnaire (NPIRQ). This questionnaire consists of open questions.	12 months

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborators: VU University of Amsterdam
• Investigators: Principal Investigator: Nathalie van der Velde, MD, PhD, Amsterdam UMC, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands; Principal Investigator: Natasja M van Schoor, PhD, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Public Health, Amsterdam, the Netherlands; Study Director: Annemiek J Linn, PhD, Amsterdam School of Communication Research, University of Amsterdam, Amsterdam, The Netherlands

Publications and helpful links

Helpful Links

• ADFICE_IT study group website

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: March 24, 2022
• First Submitted That Met QC Criteria: July 6, 2022
• First Posted (Actual): July 8, 2022

Study Record Updates

• Last Update Posted (Actual): July 8, 2022
• Last Update Submitted That Met QC Criteria: July 6, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: prediction model; fall prevention; patient portal; clinical decision support system; fall-risk increasing drugs (FRIDs); older out-clinic patients; injurious falls; Shared Decision Making (SDM); medication withdrawal
• Other Study ID Numbers: 2021_061

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Currently no plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No