Plain English Summary
Background and study aims
Management of allergic patients in the population is becoming more difficult because of increases both in complexity and prevalence. Although general practitioners (GPs) are expected to play an important role in the care of allergic patients, they often feel ill equipped for this task. Therefore, we aim to develop an Allergy Management Support System (AMSS) for primary care and to test the feasibility of this AMSS for primary care. Through literature review, interviewing and testing in secondary and primary care patients, an allergy history questionnaire will be constructed by allergists, dermatologists, GPs, and researchers based on primary care and specialists’ allergy guidelines and their clinical knowledge. Patterns of AMSS questionnaire responses and sIgE-test outcomes will be used to identify diagnostic categories and to develop corresponding management recommendations. Validity of the AMSS will be investigated by comparing specialist (gold standard) and AMSS diagnostic categories. The aim of this feasibility study is to evaluate if the AMSS is feasible when >70% of the AMSS recommendations are sent to the GP within ten working days of sIgE-testing.
Who can participate?
General practitioners and allergy patients/parents of an allergic child.
What does the study involve?
Participants complete the AMSS questionnaire which consists of 12 (mainly) multiple-choice questions on symptoms, triggers, severity, medication and symptom control of their allergic conditions. Participating GPs are allocated to one of two groups. Those in the first group receive the AMSS questionnaire in in addition to sIgE-test results. Those in the second group receive only the to sIgE-test results. GPs in both groups completed a short questionnaire with multiple-choice questions on diagnosis and management (medication, referral and/or non-pharmacotherapeutic recommendations) on two occasions: at the time of inclusion of the patient and at the time the sIgE test outcomes were known.
What are the possible benefits and risks of participating?
Direct benefits for GPs taking part in the study is receiving recommendations in addition to sIgE test outcomes. There are no direct risks for those taking part in the study.
Where is the study run from?
University Medical Center Groningen (Netherlands)
When is the study starting and how long is it expected to run for?
September 2009 to September 2016
Who is funding the study?
1. Phadia BV (Netherlands)
2. ALK Abelló BV (Netherlands)
3. University Medical Center Groningen (Netherlands)
Who is the main contact?
Dr Bertine Flokstra - de Blok
b.m.j.flokstra@umcg.nl
Trial website
Contact information
Type
Scientific
Primary contact
Dr Bertine Flokstra - de Blok
ORCID ID
Contact details
University Medical Center Groningen
PO Box 196
Groningen
9700 AD
Netherlands
+31 (0)50 3616687
b.m.j.flokstra@umcg.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1
Study information
Scientific title
Development and feasibility of an Allergy Management Support System (AMSS) for primary care
Acronym
AMSS
Study hypothesis
The aim of this study is to develop a Allergy Management Support Service for primary care.
Ethics approval
Ethics committee of University Medical Center Groningen, 23/05/2013, refs: METc 2011/273, METc 2013/129
Study design
Interventional
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
GP practices
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information
Condition
Allergy: rhinitis, asthma, atopic dermatitis and food allergy
Intervention
This study uses a cluster randomised controlled design. Participants are randomly allocated to one of two groups: the intervention or the control group. GPs in the intervention group receive Allergy Management Support System (AMSS) recommendations in addition to sIgE test results, while GPs in the control group perform usual care based on sIgE test results only. At inclusion, patients completed the AMSS questionnaire which consists of 12 (mainly) multiple-choice questions on symptoms, triggers, severity, medication and symptom control of their allergic conditions. GPs in both groups completed a short questionnaire with multiple-choice questions on diagnosis and management (medication, referral and/or non-pharmacotherapeutic recommendations) on two occasions: at the time of inclusion of the patient and at the time the sIgE test outcomes were known.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Feasibility of the AMSS is assessed using the percentage of AMSS recommendations sent to the GP within 10 working days of the slgE testing.
Secondary outcome measures
There are no secondary outcome measures.
Overall trial start date
01/09/2009
Overall trial end date
01/09/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. General practitioners (GP)
2. Allergic patient or parent of allergic child with sIgE test
Participant type
Mixed
Age group
Mixed
Gender
Both
Target number of participants
20 GPs and 100 patients
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/02/2010
Recruitment end date
01/09/2015
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Center Groningen
9700 AD
Netherlands
Sponsor information
Organisation
University Medical Center Groningen
Sponsor details
PO Box 196
Groningen
9700 AD
Netherlands
+31 (0)50 3616687
b.m.j.flokstra@umcg.nl
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Phadia BV
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
ALK Abelló BV
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Universitair Medisch Centrum Groningen
Alternative name(s)
University Medical Center Groningen, UMCG
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
Netherlands
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr. B.M.J. Flokstra – de Blok, b.m.j.flokstra@umcg.nl.
Intention to publish date
01/01/2018
Participant level data
Available on request
Basic results (scientific)
Publication list
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29872524