No registrations found.
ID
Source
Brief title
Health condition
Fall-related injury of any type requiring consultation to the Emergency Department
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Incidence of further falls;
2. Negative health effects;
3. Costs per prevented fall.
Secondary outcome
1. Fall-related injuries;
2. Generic HRQOL;
3. Compliance;
4. Quality Adjusted Life Years;
5. Genetic polymorphisms;
6. Costs per prevented fall-related injury;
7. Costs per QALY.
Background summary
Objective/ research questions:
To evaluate the effects and cost-effectiveness of a systematic drug assessment and drug modification in older fallers presenting at the Emergency Department (ED). Based on the results of this study, a clinical protocol will be developed for assessment and modification of drug use among older fallers at the ED.
Study design:
RCT with one intervention and one control group. Older fallers (65+) presenting at the ED, and on 1 or more fall-risk increasing drugs, are eligible. In total 620 patients will be randomized. The intervention group will receive a systematic drug assessment. Fall-risk increasing drugs will be stopped, reduced or substituted by safer drugs where possible. The control group will receive usual care and a systematic drug assessment without drug modification. During 1 year of follow-up, fall incidence, fall-related injuries, medication use, recurrence of (disease)symptoms, and health care consumption (costs) will be registered. Also, patients will complete health-related quality of life questionnaires (SF-12v2 and EQ-5D).
Outcome measures:
Primary outcome parameters will be the incidence of further falls and the possible negative health outcomes of drug withdrawal.
Secondary outcome measures will be fall-related injuries, generic health-related quality of life (HRQOL), compliance and quality adjusted life years.
Data analysis:
The intention-to-treat principle will be followed. The hazard ratio (HR) for falling will be calculated with Cox-regression analyses using the time between the intervention till the first/second fall as the outcome measure.
Economic evaluation:
Cost-effectiveness analysis, including costs per prevented fall as primary outcome measure, and costs per prevented fall-related injury and costs per QALY as secondary outcome measures.
Study objective
The withdrawal, reduction or substitution of fall-risk increasing drugs will reduce fall risk in the elderly.
Study design
- t=0: Baseline fall-related (drug) assessment;
- t=3, 6, 9, 12 months: fall / health questionnaire;
- t=12 months: final fall-related assessment.
Intervention
Intervention group:
systematic fall-related drugs assessment combined with drug modification.
Control group:
systematic fall-related drug assessment without subsequent drug modification.
P.O. Box 2040
T.J.M. Cammen, van der
Rotterdam 3000 CA
The Netherlands
+31.10.7035979
t.vandercammen@erasmusmc.nl
P.O. Box 2040
T.J.M. Cammen, van der
Rotterdam 3000 CA
The Netherlands
+31.10.7035979
t.vandercammen@erasmusmc.nl
Inclusion criteria
1. Fall according to the specified definition;
2. Using at least 1 fall-risk increasing drug;
3. Community-dwelling;
4. Age 65 years or older;
5. Independently ambulant;
6. MMSE 21 points or higher;
7. Informed consent.
Exclusion criteria
1. Fall not meeting criteria of specified definition;
2. Not using fall-risk increasing drugs;
3. Not community-dwelling (e.g. living in nursing home);
4. Age <65 years;
5. Not independently ambulant;
6. MMSE <21 points;
7. No informed consent.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1523 |
| NTR-old | NTR1593 |
| CCMO | NL23970.078.08 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |