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Improving Communication During a Pandemic Flu Outbreak

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ClinicalTrials.gov Identifier: NCT03431012
Recruitment Status : Completed
First Posted : February 13, 2018
Last Update Posted : February 13, 2018
Sponsor:
Collaborators:
National Institute for Health Research, United Kingdom
Public Health England
Information provided by (Responsible Party):
King's College London

Brief Summary:
During the last pandemic influenza antivirals were prescribed both as prophylaxis and treatment. However, adherence rates were suboptimal. This study assessed the effect of theory-based and evidence-based health messages, which promoted the use of antivirals as prophylaxis for pandemic influenza, on intentions to use antivirals. Using hypothetical scenarios, the investigators tested whether written health communications about pandemic flu and recommended preventative medication (i.e. a prophylactic treatment with antivirals) had an effect on study participants' beliefs about the pandemic flu and the advice received, and their intention to adhere to the recommendation. In particular, the investigators assessed the behavioural impact of health messages presented in four different linguistic formats, defined by a 2×2 (agency assignment × attribute framing) factorial design. The originality of this study relies on the attempt to maximise the behavioural impact of written health messages by combining the agency assignment and attribute framings, which have never been tested together, and by systematically targeting specific predictors of adherence intentions through these messages. The findings of this study may be used to improve the behavioural impact of health communications to the general public in case of a pandemic flu outbreak in the UK.

Condition or disease Intervention/treatment Phase
Healthy Other: Agency Assignment framing Other: Attribute framing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 349 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: This study was a vignette-based randomised controlled trial, with a 2 (human vs virus agency assignment) x 2 (negative vs positive frame of antivirals side effects) between-participants factorial design. All participants were presented with a hypothetical pandemic flu scenario describing moderate health consequences (i.e. about 1 in 1000 infected people dying). The scenario: 1) in the initial scenario participants were told to imagine that their GP (although not confirming whether it was a pandemic case) had advised them to take antivirals as a precaution; 2) after measuring baseline intentions, participants were introduced to the second part of the scenario where they were asked to imagine being at their local pharmacy where a pharmacist provided them with some health messages and information about the antivirals. Participants were randomised to one of the four health messages described below. After reading the health messages their intentions to use antivirals were re-measured.
Masking: Single (Participant)
Masking Description: Participants were blinded to group assignment.
Primary Purpose: Prevention
Official Title: Improving Communication During a Pandemic Flu Outbreak
Actual Study Start Date : May 26, 2016
Actual Primary Completion Date : June 8, 2016
Actual Study Completion Date : June 8, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu

Arm Intervention/treatment
Experimental: Virus Agency/Negative Attribute Framing
Participants in this condition, after reading a hypothetical scenario, received health messages describing the pandemic flu and the efficacy of the antivirals using linguistic expressions that assigned transmission to the pandemic flu virus itself (Virus Agency Assignment framing), whilst describing the side effects of the antivirals in terms of chances of experiencing side effects after using them (Negative Framing).
Other: Agency Assignment framing
Linguistic framing used in written health messages. Each version of the messages described the pandemic flu and the efficacy of the antivirals using linguistic expressions that assigned transmission to either humans (HA: 'You can contract the virus when you touch…') or the pandemic flu virus itself (VA: 'It can infect you when you touch…')
Other Name: Framing effect on behavioural intentions

Other: Attribute framing
Linguistic framing used in written health messages. Each message described the side effects of the antivirals in terms of chances of either experiencing (negative framing: 'Uncommon side effects (10% of people will be affected)') or not experiencing side effects (positive framing: 'Uncommon side effects (90% of people will not be affected)') after using them.
Other Name: Framing effect on behavioural intentions

Experimental: Human Agency/Negative Attribute Framing
Participants in this arm, after reading a hypothetical scenario, received a health message describing the pandemic flu and the efficacy of the antivirals using linguistic expressions that assigned transmission to humans (Human Agency Assignment framing), whilst describing the side effects of the antivirals in terms of chances of experiencing side effects after using them (Negative Framing health messages).
Other: Agency Assignment framing
Linguistic framing used in written health messages. Each version of the messages described the pandemic flu and the efficacy of the antivirals using linguistic expressions that assigned transmission to either humans (HA: 'You can contract the virus when you touch…') or the pandemic flu virus itself (VA: 'It can infect you when you touch…')
Other Name: Framing effect on behavioural intentions

Other: Attribute framing
Linguistic framing used in written health messages. Each message described the side effects of the antivirals in terms of chances of either experiencing (negative framing: 'Uncommon side effects (10% of people will be affected)') or not experiencing side effects (positive framing: 'Uncommon side effects (90% of people will not be affected)') after using them.
Other Name: Framing effect on behavioural intentions

Experimental: Human Agency /Positive Attribute Framing
Participants in this arm, after reading a hypothetical scenario, received a health message describing the pandemic flu and the efficacy of the antivirals using linguistic expressions that assigned transmission to humans (Human Agency Assignment framing), whilst describing the side effects of the antivirals in terms of chances of not experiencing side effects after using them (Positive Framing).
Other: Agency Assignment framing
Linguistic framing used in written health messages. Each version of the messages described the pandemic flu and the efficacy of the antivirals using linguistic expressions that assigned transmission to either humans (HA: 'You can contract the virus when you touch…') or the pandemic flu virus itself (VA: 'It can infect you when you touch…')
Other Name: Framing effect on behavioural intentions

Other: Attribute framing
Linguistic framing used in written health messages. Each message described the side effects of the antivirals in terms of chances of either experiencing (negative framing: 'Uncommon side effects (10% of people will be affected)') or not experiencing side effects (positive framing: 'Uncommon side effects (90% of people will not be affected)') after using them.
Other Name: Framing effect on behavioural intentions

Experimental: Virus Agency /Positive Attribute Framing
Participants in this arm, after reading a hypothetical scenario, received a health message describing the pandemic flu and the efficacy of the antivirals using linguistic expressions that assigned transmission to the pandemic flu virus itself (Virus Agency Assignment framing), whilst describing the side effects of the antivirals in terms of chances of not experiencing side effects after using them (Positive Framing).
Other: Agency Assignment framing
Linguistic framing used in written health messages. Each version of the messages described the pandemic flu and the efficacy of the antivirals using linguistic expressions that assigned transmission to either humans (HA: 'You can contract the virus when you touch…') or the pandemic flu virus itself (VA: 'It can infect you when you touch…')
Other Name: Framing effect on behavioural intentions

Other: Attribute framing
Linguistic framing used in written health messages. Each message described the side effects of the antivirals in terms of chances of either experiencing (negative framing: 'Uncommon side effects (10% of people will be affected)') or not experiencing side effects (positive framing: 'Uncommon side effects (90% of people will not be affected)') after using them.
Other Name: Framing effect on behavioural intentions




Primary Outcome Measures :
  1. Change in intentions to take antivirals for pandemic flu [ Time Frame: Baseline and at 20 minutes (i.e. straight after exposure to the health messages) ]
    Change in intentions pre- post- exposure to the health information. Intentions were measured by self-report items: participants were asked to agree with statements about their adherence intentions on 9-point scale, where 1=strongly disagree to 9=strongly agree.


Secondary Outcome Measures :
  1. Worry of the pandemic flu threat [ Time Frame: At 20 minutes (i.e. straight after exposure to the health messages) ]
    Measured by self-report items adapted from Witte et al. (2001): participants were asked to agree with statements about their perceived worry on 9-point scale, where 1=strongly disagree to 9=strongly agree.

  2. Perceived susceptibility to the pandemic flu [ Time Frame: At 20 minutes (i.e. straight after exposure to the health messages) ]
    Measured by self-report items: participants were asked to state how likely they were to get sick with pandemic flu, had they not taken prophylactic medication o a 9-point scale, where 1=not likely at all, to 9=extremely likely.

  3. Perceived severity of the pandemic [ Time Frame: At 20 minutes (i.e. straight after exposure to the health messages) ]
    Measured by one self-report item (adapted from Witte et al. (2001): participants were asked to agree with statements about their perception of the severity of the pandemic flu on 9-point scale, where 1=strongly disagree to 9=strongly agree.

  4. Perceived self-efficacy [ Time Frame: At 20 minutes (i.e. straight after exposure to the health messages) ]
    Measured by one self-report item (adapted from Witte et al. (2001): participants were asked to agree with statements about their perceived ability to take the antivirals as recommended on 9-point scale, where 1=strongly disagree to 9=strongly agree.

  5. Perceived efficacy of the antivirals [ Time Frame: At 20 minutes (i.e. straight after exposure to the health messages) ]
    Measured by two self-report items (adapted from Godinho et al. (2016): participants were asked to agree with statements about their perception of the efficacy of the antivirals against pandemic flu on 9-point scale, where 1=strongly disagree to 9=strongly agree.

  6. Perceived response costs [ Time Frame: At 20 minutes (i.e. straight after exposure to the health messages) ]
    Measured by self-report items adapted from Godinho et al. (2016): participants were asked to agree with statements about their beliefs about the side effects and negative consequences of using antivirals on 9-point scale, where 1=strongly disagree to 9=strongly agree.

  7. Information credibility [ Time Frame: At 20 minutes (i.e. straight after exposure to the health messages) ]
    Meyer's credibility index (1988)

  8. Information clarity [ Time Frame: At 20 minutes (i.e. straight after exposure to the health messages) ]
    Measured on one self-report item on a 9-point scale, where 1=not clear at all; to 9=extremely clear.

  9. Informed choice [ Time Frame: At 20 minutes (i.e. straight after exposure to the health messages) ]
    Measured on one self-report item on a 9-point scale, where 1=strongly disagree to 9=strongly agree.


Other Outcome Measures:
  1. Numeracy skills moderating effect on intentions [ Time Frame: At 20 minutes (i.e. straight after exposure to the health messages) ]
    If attribute framing has an impact on intentions, do people's numeracy skills moderate these effects? Numeracy measured using the Schwartz scale and Berlin Numeracy Test (Composite score)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • To be eligible to participate, respondents had to be members of the UK general public in the adult age range (18-65 years), and be fluent in English.

Exclusion Criteria:

  • non-UK residents
  • younger than 18 or older than 65
  • not fluent in English

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03431012


Sponsors and Collaborators
King's College London
National Institute for Health Research, United Kingdom
Public Health England
Investigators
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Principal Investigator: Donatella D'Antoni King's College London

Publications:
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Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT03431012     History of Changes
Other Study ID Numbers: LRS-15/16-2297
First Posted: February 13, 2018    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by King's College London:
Adherence, medication
Pandemic Influenza

Additional relevant MeSH terms:
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Antiviral Agents
Anti-Infective Agents