The aim of the study is to optimize therapy of migraine patients, according to the Dutch GP Guideline for headache and consequently reduce the use of triptans. The project will explore the costs and effects of a proactive approach of patients with…
ID
Source
Brief title
Leiden Improvement of MIgraine Therapy in general practice
Condition
- Headaches
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Reduction of score on the HIT-6 questionnaire (measuring headache impact) at
six months after the start of the intervention.
Secondary outcome
HIT-6 questionnaire at 3 and 12 months follow up
*migraine frequency (diary over 1 month as used in Dutch General Practice, to
be filled in at baseline and follow up moments)
*quality of life (questionnaires: visual analogue scale and societal EQ-5D)
*triptan/analgesic use (information from prescriptions registered in EPR)
*prophylactic medication (information from prescriptions registered in EPR)
Background summary
Migraine is characterized by recurrent attacks of disabling headaches, in 25 %
associated with vomiting and hypersensitivity to light, sound and smell (1;2).
Migraine can be treated with analgesics and anti-emetics or with triptans.
Triptans are an adequate but expensive intervention. Over consumption of
triptans is applied by 13% of the triptan users and can lead to an increase in
headache frequency. Moreover, although approximately 60 % of the patients have
one or more attacks per month, only 5% use prophylactic treatment (3).
Study objective
The aim of the study is to optimize therapy of migraine patients, according to
the Dutch GP Guideline for headache and consequently reduce the use of
triptans. The project will explore the costs and effects of a proactive
approach of patients with triptan use by GPs. Proactive approach includes
selecting patients with >=24 DDD triptan use (or >=6 DDDs in the last 3 months)
from the Electronic Patient Records and inviting them by mail for consultation.
After verifying the migraine diagnosis, a treatment strategy is implemented
aiming to optimise migraine therapy. We will investigate whether contacting
triptan users and subsequently give them advise about migraine therapy, will
lead to a lower headache frequency, less severe headache and associated
improved quality of life. Additionally we will investigate changes in triptan
use and the costs involved in this intervention.
Study design
Cluster randomized controlled trial; randomization will be performed on
practice level.
Intervention
Proactive stepped approach based on the Dutch GP Guideline versus usual care.
Step 1: a letter to invite patients for consultation. Step 2: a visit to the
GP, who can give information about headache and therapy, reduce/stop the
triptans, prescribe prophylactic therapy or reconsider the diagnosis of
migraine. Follow-up at 0, 3, 6 and 12 months by using the questionnaires, EPR
and calendars.
Study burden and risks
Burden: participants are asked to fill in 2 short questionnaires and a diary
over 1 month at 4 moments during the follow up. Participants in the
intervention practices are invited for a consultation and subsequently an
average of two consultations during the follow up period will follow.
Risk: no risks are involved in this project.
Postbus 2088
2301 CB Leiden
NL
Postbus 2088
2301 CB Leiden
NL
Listed location countries
Age
Inclusion criteria
1. registered in Electronic Patient Register of the GP
2. prescriptions for triptans, dosed 24 doses or more per year (or 6 or more daily doses in the last 6 months)
Exclusion criteria
younger than 18 years old
cognitive impairment
psychiatric illness
end-stage of a malignant disease
non-Dutch speaking
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 |
|---|---|
| Other | kandidaat trial ntr 2367 |
| CCMO | NL15260.058.06 |