Upper Respiratory Tract InfectionNCT00376142
Translating Clinicians' Beliefs Into Implementation Interventions (TRACII)
A study testing Psychological theory-based behaviour change interventions in people with Upper Respiratory Tract Infection and URTI, run by Newcastle University at 1 site in United Kingdom.
Trial summary
Using a theory-based approach, the purpose of this study is to identify modifiable factors underlying professional behaviour in order to identify those processes to target with an implementation intervention and to gain an understanding of how interventions might work and thus be optimised. Read more about this study
- Who is it for?
- Ages 0 years and olderHealthy volunteers can take part
- Conditions the study is for
- Upper Respiratory Tract Infection, URTI
- What is being tested?
- Psychological theory-based behaviour change interventions
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2005to Nov 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- General Practitioner registered with a practice in the target Primary Care Trusts
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Institute of Health and Society, Newcastle University
Newcastle upon Tyne, NE2 4AA
About this study
Official title: Translating Clinicians' Beliefs Into Implementation Interventions (TRACII): a Modelling Experiment to Change Clinicians' Intentions to Implement Evidence-Based Practice.
Using a theory-based approach, the purpose of this study is to identify modifiable factors underlying professional behaviour in order to identify those processes to target with an implementation intervention and to gain an understanding of how interventions might work and thus be optimised.
Our principal objective is to develop interventions to change beliefs that have already been identified as antecedents to antibiotic prescribing for sore throats and then to experimentally evaluate these interventions to identify those which have the largest impact on behavioural intention
Read the detailed description
It is a consistent finding that changing clinical practice is unpredictable and can be a slow and haphazard process. Over the last decade a considerable body of literature has been reviewed suggesting that a range of interventions (e.g. reminder systems, interactive education) can be effective in changing health care professionals' behaviour. However, studies have substantial heterogeneity of interventions used, targeted behaviours, and study settings that make generalising their findings to routine healthcare settings problematic - there is no underlying generalisable taxonomy for either research or service settings by which to characterise individuals, settings and interventions. The assumption that clinical practice is a form of human behaviour and can be described in terms of general theories relating to human behaviour offers the basis for a taxonomy for Implementation Research. For example, the effectiveness of interventions may be influenced by factors such as health professionals' beliefs or perceived control over their practice - generalisable concepts that can be used across different contexts. Two steps are necessary to design a theory-based intervention for a behaviour change trial: Step 1) The identification of modifiable factors underlying professional behaviour in order to identify those processes to target with an intervention (process modelling) Step 2) To gain an understanding of how interventions might work and thus be optimised (intervention modelling).
Our previous work has focussed on Step 1. The next step is to develop interventions to change beliefs based on identified theoretical predictors, and this is the focus of the present study. We will develop interventions to change the salient beliefs distinguishing high and low intenders, using previously identified GPs salient beliefs that predict their intention to prescribe antibiotics for patients with uncomplicated sore throat.
Design Theoretical framework: Theory of Planned Behaviour Methods: Postal questionnaire survey Clinical behaviour: Prescribing antibiotics for uncomplicated sore throat Participants: General Practitioners We will develop a sampling frame from lists of general practitioners supplied by Primary Care Groups in the North East of England. We will then sample to recruit sufficient general practitioners for the sample size of the experiments.
Previous work by the applicants has identified the salient beliefs of GPs that distinguish between those who intend to prescribe antibiotics and those who do not. Based on this information (and on-going work to produce a taxonomy of clinical behaviours and potential psychological behavioural technologies)we will select and develop two interventions designed to address changing the discriminative beliefs in the prescribing of antibiotics for sore throat.
The interventions will be evaluated in a three arm randomised controlled trial embedded in a questionnaire survey, using postal methods. The questionnaire package will be administered on two occasions.
For each administration of the questionnaire package, two reminders will be mailed to non-responding clinicians. In the light of our experience of the response rate in our previous study we plan to offer a £10 incentive to each subject to increase response rates. Subjects will receive a letter of invitation, and a study package that will include: a set instructions, an individually packaged set of materials for measuring behavioural simulation (patient scenarios), behavioural intention and process measures(Questionnaire) which they will be asked to read in this order. On the second administration the package will also contain the intervention, which GPs will be asked to open prior to completing the outcome and process measures.
- Conditions
- Upper Respiratory Tract Infection, URTI
- Being tested
- Psychological theory-based behaviour change interventions
- Keywords
- Intention, Behaviour, Evidence-based practice, Intervention
- Medical subject headings
- Respiratory Tract Infections, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological theory-based behaviour change interventionsBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioural intention to prescribe antibiotics
Behavioural simulation (prescribing behaviour)
Secondary outcomes (2)
Process measurement pre-intervention
Process measurement post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2006 (estimated)
- Study startApr 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Upper Respiratory Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 1,200 participants
Sponsor and investigators
- Lead sponsor
- Newcastle University
- Sponsor type
- University, hospital or other
- Collaborators
- Newcastle Primary Care Trust
- Investigators
- Martin P Eccles, MD, FMedSci, Principal investigator, University of Newcastle Upon-Tyne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00376142
- Sponsor's protocol ID
- TIME2005
- Other IDs
- QLRT-2001-00657
- Status last verified
- Sep 2006
- First submitted
- 13 Sep 2006
- Last updated
- 14 Sep 2006
- Results posted
- No
Publications
Hrisos S, Eccles M, Johnston M, Francis J, Kaner EF, Steen N, Grimshaw J. Developing the content of two behavioural interventions: using theory-based interventions to promote GP management of upper respiratory tract infection without prescribing antibiotics #1. BMC Health Serv Res. 2008 Jan 14;8:11. doi: 10.1186/1472-6963-8-11.
PubMed 18194527Hrisos S, Eccles M, Johnston M, Francis J, Kaner EF, Steen N, Grimshaw J. An intervention modelling experiment to change GPs' intentions to implement evidence-based practice: using theory-based interventions to promote GP management of upper respiratory tract infection without prescribing antibiotics #2. BMC Health Serv Res. 2008 Jan 14;8:10. doi: 10.1186/1472-6963-8-10.
PubMed 18194526
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translating Clinicians' Beliefs Into Implementation Interventions (TRACII): a Modelling Experiment to Change Clinicians' Intentions to Implement Evidence-Based Practice.
- ClinicalTrials.gov ID
- NCT00376142
- Acronym / sponsor ID
- TIME2005
- Conditions
- Upper Respiratory Tract Infection, URTI
- Keywords
- Intention, Behaviour, Evidence-based practice, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants
- Lead sponsor
- Newcastle UniversityUniversity, hospital or other
- Collaborators
- Newcastle Primary Care Trust
- Study start
- Apr 2005
- Study completion
- Nov 2005
- First posted
- 14 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Using a theory-based approach, the purpose of this study is to identify modifiable factors underlying professional behaviour in order to identify those processes to target with an implementation intervention and to gain an understanding of how interventions might work and thus be optimised.
Our principal objective is to develop interventions to change beliefs that have already been identified as antecedents to antibiotic prescribing for sore throats and then to experimentally evaluate these interventions to identify those which have the largest impact on behavioural intention
Detailed description
It is a consistent finding that changing clinical practice is unpredictable and can be a slow and haphazard process. Over the last decade a considerable body of literature has been reviewed suggesting that a range of interventions (e.g. reminder systems, interactive education) can be effective in changing health care professionals' behaviour. However, studies have substantial heterogeneity of interventions used, targeted behaviours, and study settings that make generalising their findings to routine healthcare settings problematic - there is no underlying generalisable taxonomy for either research or service settings by which to characterise individuals, settings and interventions. The assumption that clinical practice is a form of human behaviour and can be described in terms of general theories relating to human behaviour offers the basis for a taxonomy for Implementation Research. For example, the effectiveness of interventions may be influenced by factors such as health professionals' beliefs or perceived control over their practice - generalisable concepts that can be used across different contexts. Two steps are necessary to design a theory-based intervention for a behaviour change trial: Step 1) The identification of modifiable factors underlying professional behaviour in order to identify those processes to target with an intervention (process modelling) Step 2) To gain an understanding of how interventions might work and thus be optimised (intervention modelling).
Our previous work has focussed on Step 1. The next step is to develop interventions to change beliefs based on identified theoretical predictors, and this is the focus of the present study. We will develop interventions to change the salient beliefs distinguishing high and low intenders, using previously identified GPs salient beliefs that predict their intention to prescribe antibiotics for patients with uncomplicated sore throat.
Design Theoretical framework: Theory of Planned Behaviour Methods: Postal questionnaire survey Clinical behaviour: Prescribing antibiotics for uncomplicated sore throat Participants: General Practitioners We will develop a sampling frame from lists of general practitioners supplied by Primary Care Groups in the North East of England. We will then sample to recruit sufficient general practitioners for the sample size of the experiments.
Previous work by the applicants has identified the salient beliefs of GPs that distinguish between those who intend to prescribe antibiotics and those who do not. Based on this information (and on-going work to produce a taxonomy of clinical behaviours and potential psychological behavioural technologies)we will select and develop two interventions designed to address changing the discriminative beliefs in the prescribing of antibiotics for sore throat.
The interventions will be evaluated in a three arm randomised controlled trial embedded in a questionnaire survey, using postal methods. The questionnaire package will be administered on two occasions.
For each administration of the questionnaire package, two reminders will be mailed to non-responding clinicians. In the light of our experience of the response rate in our previous study we plan to offer a £10 incentive to each subject to increase response rates. Subjects will receive a letter of invitation, and a study package that will include: a set instructions, an individually packaged set of materials for measuring behavioural simulation (patient scenarios), behavioural intention and process measures(Questionnaire) which they will be asked to read in this order. On the second administration the package will also contain the intervention, which GPs will be asked to open prior to completing the outcome and process measures.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- General Practitioner registered with a practice in the target Primary Care Trusts
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological theory-based behaviour change interventions | Behavioural | – |
Primary outcome
Behavioural intention to prescribe antibiotics
Behavioural simulation (prescribing behaviour)
2 secondary outcomes
Process measurement pre-intervention
Process measurement post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2006.
- Derived from this study: PubMed 18194527Hrisos S, Eccles M, Johnston M, Francis J, Kaner EF, Steen N, Grimshaw J. Developing the content of two behavioural interventions: using theory-based interventions to promote GP management of upper respiratory tract infection without prescribing antibiotics #1. BMC Health Serv Res. 2008 Jan 14;8:11. doi: 10.1186/1472-6963-8-11.
- Derived from this study: PubMed 18194526Hrisos S, Eccles M, Johnston M, Francis J, Kaner EF, Steen N, Grimshaw J. An intervention modelling experiment to change GPs' intentions to implement evidence-based practice: using theory-based interventions to promote GP management of upper respiratory tract infection without prescribing antibiotics #2. BMC Health Serv Res. 2008 Jan 14;8:10. doi: 10.1186/1472-6963-8-10.
Related trials for Upper Respiratory Tract Infection
Not yet recruitingObservational study
Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS
VAP - Ventilator Associated Pneumonia
Not yet recruiting
Enhanced Telemedicine in Primary Care for Acute Respiratory Tract Infections Study
Acute Respiratory Tract Infection, Ear Infection
Not yet recruitingObservational study
Severe Pediatric Respiratory Syncytial Virus Infections Occurring in the Era of Antiviral Prophylaxis
Children <24 Months Hospitalized for RSV-related Lower Respiratory Tract Infection
Recruiting
A Study to Investigate the Effect of Probiotics (Limosilactobacillus Reuteri DSM 17938 and Limosilactobacillus Reuteri DSM 33633) on Symptoms of Viral Upper Respiratory Tract Infections in Children
Virus Diseases in Children
RecruitingPhase 2
A Study of S-337395 in Symptomatic Nonhospitalized Adults With Respiratory Syncytial Virus (RSV) Who Are at High Risk of Progression to Severe Disease
Respiratory Syncytial Virus Infections
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin P Eccles, MD, FMedSci principal investigator
University of Newcastle Upon-Tyne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological theory-based behaviour change interventions in people with Upper Respiratory Tract Infection and URTI, run by Newcastle University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioural intention to prescribe antibiotics. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00376142, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2006.