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
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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 |
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Common Cold Pharyngitis Acute Otitis Media Acute Asthma Bronchiolitis Pediatric ALL Parents | Behavioral: Blogshots 1-3 Behavioral: Blogshots 4-6 | Not Applicable |
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
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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
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- 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).
- 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).
- 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).
- 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).
- 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.
- 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)
- 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'.
- 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.
- 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).
- 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.
- 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)
- 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.
- 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.
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.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.
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
Canada, Alberta | |
University of Alberta | |
Edmonton, Alberta, Canada, T6G 2R3 |
Principal Investigator: | Lisa Hartling, PhD | University of Alberta |
Documents provided by University of Alberta:
Publications:
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Common Acute Childhood Conditions Choosing Wisely Canada Blogshots |
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 |