Trial Outcomes & Findings for Developing and Evaluating Interventions to Reduce Inappropriate Prescribing of Antibiotics in Primary Care (NCT NCT01206738)

Results Overview

Eight simulated clinical scenarios where presented to the GP and he/she was asked whether an antibiotic should be prescribed. The outcome measures was the number of scenarios where an antibiotic was not prescribed.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

270 participants

Primary outcome timeframe

Immediately after completion of questionnaire

Results posted on

2017-06-02

Participant Flow

For email vs postal study, 880 physicians received email and 880 received postal invitations. 138 and 132 responded respectively. Other recruitment data presented below are for the main trial component, which involved a subset of the 270 (ie. 138+132) responding to the initial invitation. See arm descriptions for further explanation.

Note this study has two parts: 1) an email vs postal invitation study (with 270 enrolled) and 2) a trial involving a subset (172) of those involved in the email vs postal invitation study. The trial enrolled 198 participants in total, with 26 participants not being involved in the email study. See arm descriptions for further explanations.

Participant milestones

Participant milestones
Measure	Persuasive Communication The persuasive intervention aimed to reinforce the GP's beliefs about the positive consequences of managing sore throat without prescribing antibiotics. Note: for the Overall study, the best 25% of prescribers completing the email vs postal invitation sub study (which 270 individuals completed) were not eligible by definition (we only wanted to trial our interventions with doctors not prescribing according to best practice). Of the 270, only 201 were eligible. All were invited to participate, along with 313 other family doctors who had not taken part in the email vs. postal invitation study. Of the 514 (201 + 313) invited to the Overall study, 198 responded and these are the participants for the Overall study.	Alternative Intervention Action Plan. The work linking simulated prescribing behaviour to predictors of that behaviour suggested that an action plan, detailing situations where GPs found it difficult to not prescribe an antibiotic and offering ways in which the GP could avoid prescribing an antibiotic when this was not necessary. Note: for the Overall study, the best 25% of prescribers completing the email vs postal invitation sub study (which 270 individuals completed) were not eligible by definition (we only wanted to trial our interventions with doctors not prescribing according to best practice). Of the 270, only 201 were eligible. All were invited to participate, along with 313 other family doctors who had not taken part in the email vs. postal invitation study. Of the 514 (201 + 313) invited to the Overall study, 198 responded and these are the participants for the Overall study.	General Information No information beyond the information that GPs already have from guidelines and other diverse sources (ie. usual care). Note: for the Overall study, the best 25% of prescribers completing the email vs postal invitation sub study (which 270 individuals completed) were not eligible by definition (we only wanted to trial our interventions with doctors not prescribing according to best practice). Of the 270, only 201 were eligible. All were invited to participate, along with 313 other family doctors who had not taken part in the email vs. postal invitation study. Of the 514 (201 + 313) invited to the Overall study, 198 responded and these are the participants for the Overall study.
Overall Study STARTED	63	74	61
Overall Study COMPLETED	40	49	42
Overall Study NOT COMPLETED	23	25	19

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Developing and Evaluating Interventions to Reduce Inappropriate Prescribing of Antibiotics in Primary Care

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Persuasive Communication n=63 Participants The persuasive intervention aimed to reinforce the GP's beliefs about the positive consequences of managing sore throat without prescribing antibiotics.	Alternative Intervention n=74 Participants Action Plan. The work linking simulated prescribing behaviour to predictors of that behaviour suggested that an action plan, detailing situations where GPs found it difficult to not prescribe an antibiotic and offering ways in which the GP could avoid prescribing an antibiotic when this was not necessary.	General Information n=61 Participants No information beyond the information that GPs already have from guidelines and other diverse sources (ie. usual care)	Total n=198 Participants Total of all reporting groups
Age, Customized Years qualified	22 years STANDARD_DEVIATION 9 • n=5 Participants	20 years STANDARD_DEVIATION 9 • n=7 Participants	22 years STANDARD_DEVIATION 8 • n=5 Participants	21 years STANDARD_DEVIATION 9 • n=4 Participants
Sex/Gender, Customized Female	27 participants n=5 Participants	34 participants n=7 Participants	27 participants n=5 Participants	88 participants n=4 Participants
Sex/Gender, Customized Male	35 participants n=5 Participants	36 participants n=7 Participants	32 participants n=5 Participants	103 participants n=4 Participants
Region of Enrollment United Kingdom	63 participants n=5 Participants	74 participants n=7 Participants	61 participants n=5 Participants	198 participants n=4 Participants

PRIMARY outcome

Timeframe: Immediately after completion of questionnaire

Eight simulated clinical scenarios where presented to the GP and he/she was asked whether an antibiotic should be prescribed. The outcome measures was the number of scenarios where an antibiotic was not prescribed.

Outcome measures

Outcome measures
Measure	Persuasive Communication n=40 Participants The persuasive intervention aimed to reinforce the GP's beliefs about the positive consequences of managing sore throat without prescribing antibiotics. Persuasive communication: The persuasive intervention aimed to reinforce the GP's beliefs about the positive consequences of managing sore throat without prescribing antibiotics.	Alternative Intervention n=49 Participants This intervention was an action plan, supporting the GP to deal with two difficult prescribing situations: 1) a distressed patient (or often distressed parent of a child patient) 2) a patient demanding an antibiotic Action plan: This intervention was an action plan, supporting the GP to deal with two difficult prescribing situations: 1) a distressed patient (or often distressed parent of a child patient) 2) a patient demanding an antibiotic	General Information n=42 Participants No additional information was provided; the general information was the information already available to GPs about antibiotic prescribing. General intervention: No additional information was provided; the general information was the information already available to GPs about antibiotic prescribing.
Number of Simulated Scenarios Where an Antibiotic Was Not Prescribed	5 scenarios Standard Deviation 1.4	5 scenarios Standard Deviation 1.6	4.2 scenarios Standard Deviation 1.1

PRIMARY outcome

Timeframe: 27/1/20111 - 15/5/2011

Population: 880 physicians received email and 880 received postal invitations. 138 and 132 responded respectively.

GPs were randomly allocated to receive their invitation to take part by email or by post. Outcome measure was proportion of GPs responding by completing the first questionnaire

Outcome measures

Outcome measures
Measure	Persuasive Communication n=880 Participants The persuasive intervention aimed to reinforce the GP's beliefs about the positive consequences of managing sore throat without prescribing antibiotics. Persuasive communication: The persuasive intervention aimed to reinforce the GP's beliefs about the positive consequences of managing sore throat without prescribing antibiotics.	Alternative Intervention n=880 Participants This intervention was an action plan, supporting the GP to deal with two difficult prescribing situations: 1) a distressed patient (or often distressed parent of a child patient) 2) a patient demanding an antibiotic Action plan: This intervention was an action plan, supporting the GP to deal with two difficult prescribing situations: 1) a distressed patient (or often distressed parent of a child patient) 2) a patient demanding an antibiotic	General Information No additional information was provided; the general information was the information already available to GPs about antibiotic prescribing. General intervention: No additional information was provided; the general information was the information already available to GPs about antibiotic prescribing.
Email vs Postal Recruitment: Number of GPs Completing the First Questionnaire	138 participants	132 participants	—

Adverse Events

Persuasive Communication

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Alternative Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

General Information

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof Shaun Treweek

University of Aberdeen

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place