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

NCT05449470 | Unknown

• 1 other identifier: 2021_061
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 10

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.

Conditions

Fall; Fall Injury; Fall Patients; Accidental Fall; Deprescriptions; Polypharmacy; Aged; Aged, 80 and Over

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Number of injurious falls

  12 months

• Total number of falls

  12 months

• Time to first fall resulting in any injuries

  12 months

• Total number of falls resulting in any injuries

  12 months

• Time to first non-injurious fall

  12 months

Other Outcomes (13)

• Feasibility assessed by number of CDSS and patient portal use

  12 months

• Percentage of physicians attending the CDSS training via a questionnaire

  12 months

• Correlation of percentage of physicians attending the CDSS training and CDSS user satisfaction

  12 months

Study Arms (2)

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.

Device: CDSS; Device: Patient Portal

Care as usual

NO INTERVENTION

Care as usual

Interventions

CDSS DEVICE

A clinical decision support system (CDSS) that provides deprescribing advice and a personalized risk prediction

Also known as: Clinical Decision Support System

CDSS and patient portal

Patient Portal DEVICE

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.

Also known as: Valportaal

CDSS and patient portal

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• VU University of Amsterdam: collaborator

Study Sites (10)

Radboud universitair medisch centrum

Nijmegen, Gelderland, 6525 GA, Netherlands

NOT YET RECRUITING

Elisabeth-TweeSteden Ziekenhuis

Tilburg, North Brabant, 5042 AD, Netherlands

RECRUITING

Ziekenhuis Amstelland

Amstelveen, North Holland, 1186 AM, Netherlands

NOT YET RECRUITING

Amsterdam UMC, locatie VUmc

Amsterdam, North Holland, 1081 HV, Netherlands

RECRUITING

OLVG

Amsterdam, North Holland, 1091 AC, Netherlands

NOT YET RECRUITING

Amsterdam UMC, locatie AMC

Amsterdam, North Holland, 1105 AZ, Netherlands

RECRUITING

Spaarne Gasthuis

Haarlem, North Holland, 2035 RC, Netherlands

NOT YET RECRUITING

Medisch Centrum Leeuwarden

Leeuwarden, Provincie Friesland, 8934 AD, Netherlands

NOT YET RECRUITING

UMC Groningen

Groningen, 9713 GZ, Netherlands

NOT YET RECRUITING

St. Antonius Ziekenhuis

Utrecht, 3543 AZ, Netherlands

NOT YET RECRUITING

Related Publications (2)

• 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.

  PMID: 39236057 DERIVED

• de 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.

  PMID: 37751429 DERIVED

MeSH Terms

Interventions

Patient Portals

Intervention Hierarchy (Ancestors)

Health Records, Personal; Medical Records; Records; Data Collection; Epidemiologic Methods; Investigative Techniques

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Annemiek J Linn, PhD

  Amsterdam School of Communication Research, University of Amsterdam, Amsterdam, The Netherlands

  STUDY DIRECTOR

Central Study Contacts

Kelly K de Wildt

CONTACT

+31615377082; k.k.dewildt@amsterdamumc.nl

Bob van de Loo

CONTACT

r.vandeloo@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor Geriatric medicine (internal medicine)

Model Details: 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.

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: July 8, 2022
• Study Start: July 7, 2022
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: February 2, 2023

Record last verified: 2023-01

Locations

NL (10)