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Supporting Parents to Choose Wisely

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06005337
Recruitment Status : Active, not recruiting
First Posted : August 22, 2023
Last Update Posted : May 16, 2024
Sponsor:
Collaborators:
Women and Children's Health Research Institute, Canada
Pediatric Parent Advisory Group (ARCHE and ECHO)
Information provided by (Responsible Party):
University of Alberta

Brief Summary:

The goal of this multi-method study including a randomized control trial and qualitative interviews is to see how useful blogshots (an image that summarizes information) are at helping parents increase their knowledge and manage their expectations for common acute childhood conditions (e.g. sore throat, ear infection) with respect to Choosing Wisely Canada recommendations.

Participants will be randomly assigned to Group A or Group B in this study. Group A will receive three of six blogshots over a 4-week period (a different blogshot will be sent by email to them each week for three weeks, then in the final week they will receive the same three blogshots in one summary email to review). Group B will receive the other three of six blogshots, following the same email sequence and timing. All participants from both groups will be asked to complete one baseline questionnaire at the start of the study and a follow-up questionnaire at week 5, month 3 and month 6 about different common acute childhood conditions, the blogshots and their content. All participants also have the option to participate in an optional semi-structured interview to give their thoughts on the blogshots and their experience in the study.

Researchers will compared each participant's baseline score to their follow up scores to see if there was a change in their knowledge and expectations.

By developing and evaluating evidence-based Choosing Wisely Canada resources, the researchers aim to make it easier for parents to choose wisely. Empowering parents to be part of conversations with their child's healthcare provider can improve health decision-making and reduce health system costs.


Condition or disease Intervention/treatment Phase
Common Cold Pharyngitis Acute Otitis Media Acute Asthma Bronchiolitis Pediatric ALL Parents Behavioral: Blogshots 1-3 Behavioral: Blogshots 4-6 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Participants will be randomly assigned to Group A or Group B in this study.

Group A will receive three of six blogshots over a 4-week period (a different blogshot will be sent by email to them each week for three weeks, then in the final week they will receive the same three blogshots in one summary email to review). Group B will receive the other three of six blogshots, following the same email sequence and timing. The reason for assigning them into a group is to help us evenly share the blogshots between all participants. Each group will act as their own control.

All participants from both groups will be asked to complete one baseline questionnaire at the start of the study and a follow-up questionnaire at week 5, month 3 and month 6 about different common acute childhood conditions, the blogshots and their content.

All participants can also participate in an optional semi-structured interview to give their thoughts on the blogshots and their experience in the study.

Masking: None (Open Label)
Primary Purpose: Other
Official Title: Supporting Parents to Choose Wisely: A Multi-Method Study to Increase Knowledge and Manage Expectations for Common Acute Childhood Conditions
Actual Study Start Date : June 5, 2023
Actual Primary Completion Date : April 30, 2024
Estimated Study Completion Date : March 31, 2025


Arm Intervention/treatment
Active Comparator: Group A - Sore Throat Swab, Cough and Cold, Asthma

Group A will receive three of six blogshots (different to Group B) over a 4-week period (a different blogshot will be sent by email to them each week for three weeks, then in the final week they will receive the same three blogshots in one summary email to review). They will act as their own control group.

All participants from both groups will be asked to complete one baseline questionnaire at the start of the study and a follow-up questionnaire at week 5, month 3 and month 6 about different common acute childhood conditions, the blogshots and their content.

All participants can also participate in an optional semi-structured interview to give their thoughts on the blogshots and their experience in the study.

Behavioral: Blogshots 1-3
  1. Don't routinely do a throat swab when children present with a sore throat if they have a cough, rhinitis, or hoarseness
  2. Don't recommend the use of cough and cold remedies in children under six years of age
  3. Don't use antibiotics for acute asthma exacerbations without clear signs of bacterial infection

Active Comparator: Group B - Ear Infection, Bronchiolitis, Antibiotics for Sore Throat

Group B will receive three of six blogshots (different to Group A) over a 4-week period (a different blogshot will be sent by email to them each week for three weeks, then in the final week they will receive the same three blogshots in one summary email to review). They will act as their own control group.

All participants from both groups will be asked to complete one baseline questionnaire at the start of the study and a follow-up questionnaire at week 5, month 3 and month 6 about different common acute childhood conditions, the blogshots and their content.

All participants can also participate in an optional semi-structured interview to give their thoughts on the blogshots and their experience in the study.

Behavioral: Blogshots 4-6
  1. Don't routinely use antibiotics in children with uncomplicated sore throats
  2. Don't prescribe antibiotics in adults with bronchitis/asthma and children with bronchiolitis
  3. Don't use antibiotics in adults and children with uncomplicated acute otitis media




Primary Outcome Measures :
  1. Knowledge - Quantitative true/false [ Time Frame: baseline (week 0), follow-up 1 (week 5), follow-up 2 (month 3), follow-up 3 (month 6) ]

    Primary outcome will be knowledge. Change will be compared from baseline between groups (i.e. average change in knowledge scores specific to Choosing Wisely recommendations, expecting that knowledge will improve with respect to the content received).

    There will be 8 'true/false' questions to assess knowledge. Each question is worth 2 points.

    Knowledge will be assessed by comparing participant's scores on baseline to follow-up 1 (knowledge change) and comparing scores to follow-up 2 and 3 (knowledge retention).


  2. Knowledge - Quantitative Multiple Choice [ Time Frame: baseline (week 0), follow-up 1 (week 5), follow-up 2 (month 3), follow-up 3 (month 6) ]

    Primary outcome will be knowledge. Change will be compared from baseline between groups (i.e. average change in knowledge scores specific to Choosing Wisely recommendations, expecting that knowledge will improve with respect to the content received).

    There will be 7 'multiple choice' questions to assess knowledge. Each question is worth 2 points.

    Knowledge will be assessed by comparing participant's scores on baseline to follow-up 1 (knowledge change) and comparing scores to follow-up 2 and 3 (knowledge retention).


  3. Knowledge - Quantitative Select all that apply [ Time Frame: baseline (week 0), follow-up 1 (week 5), follow-up 2 (month 3), follow-up 3 (month 6) ]

    Primary outcome will be knowledge. Change will be compared from baseline between groups (i.e. average change in knowledge scores specific to Choosing Wisely recommendations, expecting that knowledge will improve with respect to the content received).

    There will be 6 'select all that apply' questions to assess knowledge. Each question is worth 2 points.

    Knowledge will be assessed by comparing participant's scores on baseline to follow-up 1 (knowledge change) and comparing scores to follow-up 2 and 3 (knowledge retention).


  4. Knowledge - Quantitative [ Time Frame: baseline (week 0), follow-up 1 (week 5), follow-up 2 (month 3), follow-up 3 (month 6) ]

    Primary outcome will be knowledge. Change will be compared from baseline between groups (i.e. average change in knowledge scores specific to Choosing Wisely recommendations, expecting that knowledge will improve with respect to the content received). The outcome will be assessed two ways:

    1. Quantitatively via questionnaires:

    21 knowledge questions with about 8 'true/false', 7 'multiple choice' and 6 'select all that apply' in each questionnaire (baseline, follow-up 1, 2 & 3). Each question is worth 2 points, total score per questionnaire ranging from 0-42 pts.

    Knowledge will be assessed by comparing participant's scores on baseline to follow-up 1 (knowledge change) and comparing scores to follow-up 2 and 3 (knowledge retention).


  5. Knowledge - Qualitative [ Time Frame: interviews will be conducted between week 5 - month 3 ]
    Interviews will be used to clarify, expand on and provide to context to the questionnaire responses - two open-ended questions addressing knowledge and will undergo thematic analysis.


Secondary Outcome Measures :
  1. Intentions - Quantitative Likert [ Time Frame: week 0 (baseline), week 5 (follow-up 1) ]

    A secondary outcome will be intentions. The research team will explore if the outcome was influenced by whether a child had one of the conditions (and identify actual behaviour).

    Participants will be asked questions about their intentions at baseline and follow-up 1 when they seek healthcare i.e. are they seeking antibiotics from a healthcare professional.

    This includes 4 questions based on a five-point Likert scale (strongly agree to strongly disagree)


  2. Intentions - Quantitative Multiple Choice [ Time Frame: week 0 (baseline), week 5 (follow-up 1) ]

    A secondary outcome will be intentions. The research team will explore if the outcome was influenced by whether a child had one of the conditions (and identify actual behaviour).

    Participants will be asked questions about their intentions at baseline and follow-up 1 when they seek healthcare i.e. are they seeking antibiotics from a healthcare professional.

    This includes 2 questions that are 'multiple choice'.


  3. Intentions - Qualitative [ Time Frame: interviews will be conducted between week 5 - month 3 ]
    Interviews will be used to clarify, expand on and provide to context to the questionnaire responses - three open-ended questions addressing intentions and will undergo thematic analysis.

  4. Expectations of care - quantitative [ Time Frame: week 0 (baseline), week 5 (follow-up 1) ]

    A secondary outcome will be expectations of care. The research team will explore if the outcome was influenced by whether a child had one of the conditions (and identify actual behaviour).

    Participants will be asked questions about their expectations of healthcare professionals at baseline and follow-up 1 questionnaires. The research team will compare at baseline and follow up 1 to assess if the blogshots led to a change in expectations of healthcare professionals.

    There are 6 expectation questions in each questionnaire for baseline and follow-up 1. All questions are based on a five-point Likert scale (strongly agree to strongly disagree).


  5. Expectations of care - qualitative [ Time Frame: interviews will be conducted between week 5 - month 3 ]

    A secondary outcome will be expectations of care. The research team will explore if the outcome was influenced by whether a child had one of the conditions (and identify actual behaviour).

    Interviews will be used to clarify, expand on and provide to context to the questionnaire responses - one open-ended question addressing expectations and will undergo thematic analysis.


  6. Usability of the blogshots - Likert [ Time Frame: week 5 (follow-up 1) ]

    A secondary outcome will be usability of the blogshots. The research team will explore if the outcome was influenced by whether a child had one of the conditions (and identify actual behaviour).

    Participants will complete usability questions about the blogshots focusing on topics such as if the blogshots increase knowledge, aid in decision-making and are relevant to parents.

    This includes 5 questions based on a five-point Likert scale (strongly agree to strongly disagree)


  7. Usability of the blogshots - open ended questions [ Time Frame: week 5 (follow-up 1) ]

    A secondary outcome will be usability of the blogshots. The research team will explore if the outcome was influenced by whether a child had one of the conditions (and identify actual behaviour).

    Participants will complete usability questions about the blogshots focusing on topics such as if the blogshots increase knowledge, aid in decision-making and are relevant to parents. This will be completed at follow-up 1.

    This includes two open-ended questions.


  8. Usability of the blogshots - qualitative [ Time Frame: interviews will be conducted between week 5 - month 3 ]

    A secondary outcome will be usability of the blogshots. The research team will explore if the outcome was influenced by whether a child had one of the conditions (and identify actual behaviour).

    Interviews will be used to clarify, expand on and provide to context to the questionnaire responses - four open-ended questions addressing usability and will undergo thematic analysis.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Over the age of 18 years
  • Parent or legal guardian of a child under 5 years of age
  • Live in Canada
  • Able to complete the questionnaire and interview in English (speak/read)
  • Access to an electronic device (e.g. computer, tablet or smart phone), Internet and email.

Exclusion Criteria:

  • Under the age of 18 years
  • Does not identify as a parent or legal guardian of a child under 5 years of age
  • Does not live in Canada
  • Unable to complete the interview and questionnaire in English (speak/read)
  • No access to an electronic device (e.g. computer, tablet or smart phone), Internet and email.

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): NCT06005337


Locations
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Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2R3
Sponsors and Collaborators
University of Alberta
Women and Children's Health Research Institute, Canada
Pediatric Parent Advisory Group (ARCHE and ECHO)
Investigators
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Principal Investigator: Lisa Hartling, PhD University of Alberta
  Study Documents (Full-Text)

Documents provided by University of Alberta:
Informed Consent Form  [PDF] January 19, 2023

Additional Information:
Publications:
Braun V, Clarke V. Using thematic analysis in psychology. Qualitative Research in Psychology. 2006; 3(2): 77-101.
Lincoln YS, Guba EG. But is it rigorous? Trustworthiness and authenticity in naturalistic evaluation. New Directions for Program Evaluation. 1986; 1986(30): 73-84.
Nisson C, Earl A. The Theories of Reasoned Action and Planned Behavior, in The Wiley Encyclopedia of Health Psychology. 2020. p. 55-761.
Ltd, Q.S.R.I.P., NVivo qualitative data analysis software. Version 10, 2012.

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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT06005337    
Other Study ID Numbers: Pro00116449
First Posted: August 22, 2023    Key Record Dates
Last Update Posted: May 16, 2024
Last Verified: May 2024
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 University of Alberta:
Common Acute Childhood Conditions
Choosing Wisely Canada
Blogshots
Additional relevant MeSH terms:
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Bronchiolitis
Common Cold
Pharyngitis
Otitis Media
Bronchitis
Respiratory Tract Infections
Infections
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Otitis
Ear Diseases
Otorhinolaryngologic Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Pharyngeal Diseases
Stomatognathic Diseases