FallADFICE_ITNCT05449470
A Clinical Decision Support System and Patient Portal for Preventing Medication-related Falls in Older Patients
A study testing CDSS and Patient Portal in people with Fall and Fall Injury, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 10 sites in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fall, Fall Injury, Fall Patients
- What is being tested?
- CDSS and Patient Portal
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 10 sitesNetherlands
- Study dates
- 7 Jul 2022to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
10 sites in 1 country.
Bob van de Loo contact
10 sites in 1 country
Netherlands10 sites, 10 recruiting
- Not yet recruiting
Ziekenhuis Amstelland
Amstelveen, North Holland, 1186 AM
Marijke Trappenburg, MD, +31207556236, m.trappenburg@zha.nl
- Recruiting
Amsterdam UMC, locatie VUmc
Amsterdam, North Holland, 1081 HV
Majon Muller, Prof.Dr., +31204441120, majon.muller@amsterdamumc.nl
- Not yet recruiting
OLVG
Amsterdam, North Holland, 1091 AC
Fleur van Deudekom, MD, F.J.A.vanDeudekom@olvg.nl
- Recruiting
Amsterdam UMC, locatie AMC
Amsterdam, North Holland, 1105 AZ
Nathalie van der Velde, Prof.dr., +31205655991, n.vandervelde@amsterdamumc.nl
- Not yet recruiting
UMC Groningen
Groningen, 9713 GZ
Harianne Hegge, MD, +31503613921, h.h.m.hegge@umcg.nl
- Not yet recruiting
Spaarne Gasthuis
Haarlem, North Holland, 2035 RC
Hester van der Kroon, MD, +31232240045, h.vander.kroon@spaarnegasthuis.nl
- Not yet recruiting
Medisch Centrum Leeuwarden
Leeuwarden, Provincie Friesland, 8934 AD
Liesbeth Hempenius, MD, PhD, +31582866840, Liesbeth.Hempenius@ZNB.NL
- Not yet recruiting
Radboud universitair medisch centrum
Nijmegen, Gelderland, 6525 GA
Jurgen Claassen, MD, PhD, +31243605903, Jurgen.Claassen@radboudumc.nl
- Recruiting
Elisabeth-TweeSteden Ziekenhuis
Tilburg, North Brabant, 5042 AD
Mariëlle Mensing-Hofman, MD, +31132210090, mr.hofman@etz.nl
- Not yet recruiting
St. Antonius Ziekenhuis
Utrecht, 3543 AZ
Marike van Hengel, MD, +31883204700, m.hengel@antoniusziekenhuis.nl
About this study
Official title: 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.
Read the 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.
- Conditions
- Fall, Fall Injury, Fall Patients, Accidental Fall, Deprescriptions, Polypharmacy
- Being tested
- CDSS, Patient Portal
- Keywords
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDSSDevice
Also called Clinical Decision Support System
A clinical decision support system (CDSS) that provides deprescribing advice and a personalized risk prediction
Patient PortalDevice
Also called Valportaal
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.
| Study group | Role | What they receive |
|---|---|---|
| CDSS and patient portal | Experimental | 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. Receives: Device: CDSS; Device: Patient Portal |
| Care as usual | No intervention | Care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (9)
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.
Measured: 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)
Measured: 12 months
Time to first fall resulting in any injuries
I.e. a fall that results in minor, moderate, or severe injuries
Measured: 12 months
Total number of falls resulting in any injuries
I.e. a fall that results in minor, moderate, or severe injuries
Measured: 12 months
Time to first non-injurious fall
I.e. a fall that results in no injuries
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: at baseline, 3 months, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start7 Jul 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FallStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- VU University of Amsterdam
- Responsible party
- Principal investigator, Prof. dr. Nathalie van der Velde, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Nathalie van der Velde, MD, PhD, Principal investigator, Amsterdam UMC, Academic Medical Center, University of Amsterdam, Amsterdam, The NetherlandsNatasja M van Schoor, PhD, Principal investigator, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Public Health, Amsterdam, the NetherlandsAnnemiek J Linn, PhD, Study director, Amsterdam School of Communication Research, University of Amsterdam, Amsterdam, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05449470
- Sponsor's protocol ID
- 2021_061
- Acronym
- ADFICE_IT
- Status last verified
- Jan 2023
- First submitted
- 24 Mar 2022
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Currently no plan
Publications
Groos SS, de Wildt KK, van de Loo B, Linn AJ, Medlock S, Shaw KM, Herman EK, Seppala LJ, Ploegmakers KJ, van Schoor NM, van Weert JCM, van der Velde N. Development of the ADFICE_IT clinical decision support system to assist deprescribing of fall-risk increasing drugs: A user-centered design approach. PLoS One. 2024 Sep 5;19(9):e0297703. doi: 10.1371/journal.pone.0297703. eCollection 2024.
PubMed 39236057de Wildt KK, van de Loo B, Linn AJ, Medlock SK, Groos SS, Ploegmakers KJ, Seppala LJ, Bosmans JE, Abu-Hanna A, van Weert JCM, van Schoor NM, van der Velde N; ADFICE_IT study team. Effects of a clinical decision support system and patient portal for preventing medication-related falls in older fallers: Protocol of a cluster randomized controlled trial with embedded process and economic evaluations (ADFICE_IT). PLoS One. 2023 Sep 26;18(9):e0289385. doi: 10.1371/journal.pone.0289385. eCollection 2023.
PubMed 37751429
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alerting on Adverse Drug Reactions: Falls Prevention Improvement Through Developing a Computerized Clinical Support System: Effectiveness of Individualized medicaTion Withdrawal
- ClinicalTrials.gov ID
- NCT05449470
- Acronym / sponsor ID
- ADFICE_IT / 2021_061
- Conditions
- Fall, Fall Injury, Fall Patients, Accidental Fall, Deprescriptions, Polypharmacy
- Keywords
- 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)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- VU University of Amsterdam
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 8 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| CDSS and patient portal | Experimental | Device: CDSS, Device: Patient PortalThe 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. |
| Care as usual | No intervention | –Care as usual |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CDSSAlso: Clinical Decision Support SystemA clinical decision support system (CDSS) that provides deprescribing advice and a personalized risk prediction | Device | CDSS and patient portal |
| Patient PortalAlso: ValportaalA 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. | Device | CDSS and patient portal |
Primary outcome
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.
9 secondary outcomes
Number of injurious falls
Time frame: 12 months
Total number of falls
Time frame: 12 months
Time to first fall resulting in any injuries
Time frame: 12 months
Total number of falls resulting in any injuries
Time frame: 12 months
Time to first non-injurious fall
Time frame: 12 months
EuroQol-5D-5L (EQ-5D-5L)
Time frame: 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
iMTA Productivity Cost Questionnaire (iPCQ)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Derived from this study: PubMed 39236057Groos SS, de Wildt KK, van de Loo B, Linn AJ, Medlock S, Shaw KM, Herman EK, Seppala LJ, Ploegmakers KJ, van Schoor NM, van Weert JCM, van der Velde N. Development of the ADFICE_IT clinical decision support system to assist deprescribing of fall-risk increasing drugs: A user-centered design approach. PLoS One. 2024 Sep 5;19(9):e0297703. doi: 10.1371/journal.pone.0297703. eCollection 2024.
- Derived from this study: PubMed 37751429de Wildt KK, van de Loo B, Linn AJ, Medlock SK, Groos SS, Ploegmakers KJ, Seppala LJ, Bosmans JE, Abu-Hanna A, van Weert JCM, van Schoor NM, van der Velde N; ADFICE_IT study team. Effects of a clinical decision support system and patient portal for preventing medication-related falls in older fallers: Protocol of a cluster randomized controlled trial with embedded process and economic evaluations (ADFICE_IT). PLoS One. 2023 Sep 26;18(9):e0289385. doi: 10.1371/journal.pone.0289385. eCollection 2023.
- Individual participant dataSharing planned: Undecided. Currently no plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bob van de Loo contact
Nathalie van der Velde, MD, PhD principal investigator
Amsterdam UMC, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands
Natasja M van Schoor, PhD principal investigator
Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Public Health, Amsterdam, the Netherlands
Annemiek J Linn, PhD study director
Amsterdam School of Communication Research, University of Amsterdam, Amsterdam, The Netherlands
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CDSS and Patient Portal in people with Fall and Fall Injury, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 10 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kelly K de Wildt (+31615377082, k.k.dewildt@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first injurious fall (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05449470, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.