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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United Kingdom

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.

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.

  1. Behavioural intention to prescribe antibiotics

  2. Behavioural simulation (prescribing behaviour)

Secondary outcomes (2)
  1. Process measurement pre-intervention

  2. 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.

  1. First posted14 Sep 2006 (estimated)
  2. Study startApr 2005
  3. Study completionNov 2005

Resources

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
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 18194527
  • Hrisos 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

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.

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