The primary objective of the ADFICE_IT study is to investigate the effects of a CDSS and patient portal for optimizing FRID withdrawal on injurious falls. This study has three secondary objectives. First, we will investigate the effect of the CDSS…
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Vallen met letsel
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the time to the first injurious fall.
Secondary outcome
Secondary outcome measures are: number of injurious falls, time to first fall
resulting in minor injuries, number of falls resulting in minor injuries, time
to first fall, total number of falls, (health-related) quality of life, and
patient-reported outcomes. We will also conduct a process evaluation to
evaluate the implementation of the CDSS and patient portal and we will
investigate the cost-effectiveness of the CDSS and patient portal
Background summary
Falls in older adults represents a growing public health challenge. Use of
certain medication is recognized as an important modifiable risk factor for
falls. Research indicates fall-risk increasing drug (FRID) withdrawal is
effective in reducing falls but difficult 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 objective
The primary objective of the ADFICE_IT study is to investigate the effects of a
CDSS and patient portal for optimizing FRID withdrawal on injurious falls. This
study has three secondary objectives. First, we will investigate the effect of
the CDSS and patient portal on a number of secondary outcomes. Second, we will
conduct a process evaluation to evaluate the implementation of the CDSS and
patient portal. Finally, we will investigate the cost-effectiveness of the CDSS
and patient portal.
Study design
Multicenter cluster-randomized controlled trial
Intervention
The concurrent use of a CDSS and a patient portal for personalized FRID
withdrawal.
Study burden and risks
We believe the risks and burden of this study to be negligible. Potential
risks: the provided advices may sometimes be inaccurate; the beneficial effects
of withdrawn medication disappears; and patients may decide to stop taking the
medication if a high fall risk is communicated. However, the advices of the
CDSS will be tested against that of experts prior to the start of the study.
For continuation of the project, the CDSS must give correct advice in 100% of
synthetic cases and the CDSS must give correct advice in 90% of actual cases.
Moreover, deprescribing medication is already part of usual care. Clinicians
currently employ medication reviews and withdrawal mediation if necessary and
we hence consider the advice as an add-on to care as usual. Further, the fall
risk will not be calculated in advance of the consultation, which will allow
the physician to guide the patient in making good decisions based on the
estimated fall risk.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
1. 65 years or older;
2. history of a fall (in the past year);
3. a Mini-Mental State Examination Score of 21 points or higher or a Montreal
Cognitive Assessment - Dutch score of 16 points or higher;
4. willingness to sign informed consent;
5. Use of at least one FRID; and
6. sufficient command of the Dutch language.
Exclusion criteria
1. Life expectancy of less than one year;
2. Immobility (bedridden, e.g. inability to walk short distances with
assistance of a walking aid)
Design
Recruitment
Medical products/devices used
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
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In other registers
Register | ID |
---|---|
CCMO | NL76386.018.21 |