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The allergy in the community trial: Reducing the burden of food allergy care in tertiary services

Reducing the burden of food Allergy Care in Tertiary services: A controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN50355615
Enrollment
376
Registered
2017-03-01
Start date
2015-09-06
Completion date
Unknown
Last updated
2020-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Food allergy Digestive System Food Allergy

Interventions

Participants are allocated to the control or to the intervention group based on when they were recruited. During May and June 2016, general community-based pediatricians are trained in the diagnosis a

Sponsors

Murdoch Children's Research Institute
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Families of children aged 0 to 12 years 2. Referred to the RCH Allergy Clinic waitlist by GPs (or non-paediatrician specialists) 3. Suspected/known simple food allergy to the following foods: peanuts, soy, wheat, cow’s milk, egg, shellfish, sesame, and treenuts (i.e. cashew nuts, walnut, almond, pecan, pistachio)

Exclusion criteria

Exclusion criteria: 1. Complex food allergy 1.1. History of anaphylaxis as the primary presentation for new assessment or review (difficulty breathing, persistent cough, wheeze, change in voice, or pale and floppy/collapse within 2 hours of food ingestion) 1.2. Severe eczema as the primary presentation (these children often have more complex allergies) 1.3. Multiple food group allergy (i.e. clinical reaction to > 3 foods; each treenut is treated as a different food) 2. Drug allergy, or any other non-food allergy (e.g. dust, chemicals) 3. Urticaria with no identified allergen (ie unknown if allergy is food or non-food related) 4. Insufficient English to complete questionnaires 5. Children referred by a pediatrician or allergist (these children are fast tracked for an allergy appointment at The RCH) 6. Children referred by The RCH Dermatology department (these children usually have severe eczema as the primary presentation) 7. Children referred specifically for oral food challenges. These challenges need to be done in a hospital setting. These include children who have been seen previously by an RCH allergy clinician, and have been referred for oral food challenge/s 8. Referrals initially made outside the study period

Design outcomes

Primary

MeasureTime frame
Time to assessment by an allergy clinician or general pediatrician is measured from the date of enrollment in the trial to the date of the first consultation as recorded on the community pediatrician-completed Consultation Records (new model) or the RCH electronic medical record system (IBA/EPIC, RCH Allergy Clinic) as soon as possible after the initial consultation has occurred.

Secondary

MeasureTime frame
Current secondary outcome measures as of 30/11/2017: Child / family outcome measures: 1. Safety of care is measured by the number of food-related adverse events (including anaphylaxis), to any food, experienced by each child. A food-related adverse event is based on parent report of reactions the child had to any food in the last 6 months. 2. Parent satisfaction with the overall process is measured on a study-designed Likert scale where 1 = not at all satisfied and 7 = extremely satisfied and The Parent Medical Interview Satisfaction Scale (PMISS) collected via parent surveys at 6 and 12 months 3. Food allergy-related child anxiety and family quality of life are measured by the Food Allergy Quality of Life Questionnaire Parent Form (FAQLQ-PF) at baseline, 6 and 12 months 4. Health service use and costs for food allergies including use of pharmaceuticals, alternative therapies and other health professional attendances are collected via parent surveys at baseline, 6 and 12 months Consultation outcomes: 1. Quality of care delivered by the clinician (community pediatrician and RCH allergy clinician) at the initial consultation(s) based on an assessment of the clinician’s management as documented in the Consultation Record. The assessors will be blinded to the identity of the clinician but not to the clinician’s discipline (ie community pediatrician or RCH allergist) as the consultation record form is slightly different for pediatricians and allergists. 2. Acceptability of the new model, measured by the proportion of eligible families in the intervention cohort who consent to attend and actually attended general pediatrician care. 3. Change in community-based pediatrician knowledge of food allergy diagnosis and management is measured using study-designed allergy questions to assess practices taught in the training, 11 items from

Countries

Australia

Contacts

Public ContactHarriet Hiscock

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026