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

July 6, 2022 updated by: Prof. dr. Nathalie van der Velde, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
800

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • UMC Groningen
        • Contact:
      • Utrecht, Netherlands, 3543 AZ
    • Friesland
      • Leeuwarden, Friesland, Netherlands, 8934 AD
        • Medisch Centrum Leeuwarden
        • Contact:
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525 GA
    • 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:
      • Amsterdam, Noord-Holland, Netherlands, 1081 HV
      • Amsterdam, Noord-Holland, Netherlands, 1105 AZ
      • Haarlem, Noord-Holland, Netherlands, 2035 RC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of injurious falls
Time Frame: 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.
12 months
Total number of falls
Time Frame: 12 months
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
Time Frame: 12 months
I.e. a fall that results in minor, moderate, or severe injuries
12 months
Total number of falls resulting in any injuries
Time Frame: 12 months
I.e. a fall that results in minor, moderate, or severe injuries
12 months
Time to first non-injurious fall
Time Frame: 12 months
I.e. a fall that results in no injuries
12 months
EuroQol-5D-5L (EQ-5D-5L)
Time Frame: 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.
at baseline, 3 months, 6 months, and 12 months
The Older Persons and Informal Caregivers Minimum Data Set-Short Form (TOPICS-SF)
Time Frame: 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.
at baseline and 12 months
iMTA Productivity Cost Questionnaire (iPCQ)
Time Frame: 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).
at baseline, 3 months, 6 months, and 12 months
iMTA Medical Consumption Questionnaire (iMCQ)
Time Frame: 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.
at baseline, 3 months, 6 months, and 12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Feasibility assessed by number of CDSS and patient portal use
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
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)
Time Frame: at baseline
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)
Time Frame: at 3 months
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)
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
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)
Time Frame: at baseline
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)
Time Frame: at baseline
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)
Time Frame: 12 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
VU University of Amsterdam

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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