Strategies to Improve the Experience of Gynaecological Screening
The First Visit for Gynaecological Screening - How do we Make it as Valuable as Possible?
The aim is to evaluate different strategies to improve the experience and effect of the first visit for a cervical screening test (CST).
- How do the context and the allotted time for the first visit for a CST affect women's i) experience of CST ii) knowledge of and attitudes towards CST and cervical cancer and iii) attitude towards contacting a midwife regarding sexual and reproductive health in the future
- What effects do the RLP have, when used as a starting point for counselling at the first visit for a CST, on women's i) experience of CST ii) knowledge of and attitudes towards CST and cervical cancer iii) attitude towards contacting a midwife regarding sexual and reproductive health in the future and iv) knowledge of and attitudes towards fertility and preconception health
Method: cluster randomised control trial evaluating the effect of different strategies, including RLP-based information, to improve the experience and effect of the first visit for a CST.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The aim is to evaluate different strategies to improve the experience and effect of the first visit for a cervical screening test (CST).
- How do the context and the allotted time for the first visit for a CST affect women's i) experience of CST ii) knowledge of and attitudes towards CST and cervical cancer and iii) attitude towards contacting a midwife regarding sexual and reproductive health in the future
- What effects do the RLP have, when used as a starting point for counselling at the first visit for a CST, on women's i) experience of CST ii) knowledge of and attitudes towards CST and cervical cancer iii) attitude towards contacting a midwife regarding sexual and reproductive health in the future and iv) knowledge of and attitudes towards fertility and preconception health
The study is a cluster randomized controlled trial evaluating different strategies, RLP-based information, to improve the experience and effect of the first visit for a cervical screening test (CST). The study will be conducted in a strategically chosen area which includes both rural and urban areas, high and low socioeconomic status and high and low percentage of immigrant visitors. The study is conducted in four steps: 1. Standard care for CST at the midwifery clinic (control group) 2. Standard care for CST at the youth clinic (intervention group 1) 3. Standard care for CST at the youth clinic with extra time allotted (intervention group 2) 4. Standard care for CST at the youth clinic with extra time allotted and the RLP-information (intervention group 3)
Step 2-4 will be conducted during different time periods at the same youth clinics. Recruitment for each step will be ongoing until the necessary number of participants are reached. All participating providers will be carefully instructed during educational sessions and provided with material on how to inform their visitors about the study. The providers at youth clinics will also receive oral information regarding how to execute the intervention and written materials (intervention guide, checklist) to ensure uniformity. During the project period, all providers will approach all adolescents visiting for CST and keep log over the visits to enable analysis of non-participants.
Participating adolescents in all groups will be asked to complete digital questionnaires after their visit. Primary outcomes: knowledge and awareness of CST, cervical cancer, fertility, and preconception health. Secondary outcomes: experience of the visit and likelihood to contact a midwife regarding questions about sexual or reproductive health in the future.
The power calculation is based on results by Stern et al. (2013) showing that university students increased knowledge by 40% after an RLP-intervention. The calculation assumed both greater variety in and lower increase in knowledge among adolescents than among university students. To detect a difference between the intervention and control group with 80% power and with a significance level of p< 0.05, 50 adolescents are needed in each group. We expect high participation rate and plan to recruit 75 adolescents in each group, i.e. 300 adolescents.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Eskilstuna, Sweden
- Region Sörmland
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Persons with cervix
- 23 years of age
- Visiting midwife for their first cervical screening test
Exclusion Criteria:
- Non-Swedish-speaking
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Group 1
Standard care for cervical screening test (CST) at the midwifery clinic (control group)
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Experimental: Group 2
Standard care for CST at the youth clinic (intervention group 1)
|
Changed clinical context: from midwifery clinic to youth clinic
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Experimental: Group 3
Standard care for CST at the youth clinic with extra time allotted (intervention group 2)
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Changed clinical context: from midwifery clinic to youth clinic
Extra time allotted for each visit for CST
|
|
Experimental: Group 4
Standard care for CST at the youth clinic with extra time allotted and the RLP-information (intervention group 3)
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Changed clinical context: from midwifery clinic to youth clinic
Extra time allotted for each visit for CST
Midwife-initiated discussion of the Reproductive Life Plan
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Experience of CST
Time Frame: Day 1. The patients receives a QR-code to the digital questionnaire at the end of the visit and can choose when and were to fill out the questionnaire, but are encouraged to do so in the waiting room
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The outcome is measured through self-reported data, collected through a digital questionnaire.
The items are developed based on Kvalitet Ur Patientens Perspektiv (KUPP), which is a widely used measure within Swedish health care to measure PREM- Patient Reported Experience Measures
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Day 1. The patients receives a QR-code to the digital questionnaire at the end of the visit and can choose when and were to fill out the questionnaire, but are encouraged to do so in the waiting room
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knowledge of and attitudes towards CST and cervical cancer
Time Frame: Day 1. The patients receives a QR-code to the digital questionnaire at the end of the visit and can choose when and were to fill out the questionnaire, but are encouraged to do so in the waiting room
|
The outcome is measured through self-reported data, collected through a digital questionnaire.
The item is developed based on previous research regarding knowledge of and attitudes towards CST and cervical cancer.
The item is posed as 13 statements and the respondent is asked to tick the alternative that apply to her opinion: highly agree, partially agree, neither agree nor diagree, partially disagree, highly disagree, don't know.
|
Day 1. The patients receives a QR-code to the digital questionnaire at the end of the visit and can choose when and were to fill out the questionnaire, but are encouraged to do so in the waiting room
|
|
Attitude towards contacting a midwife regarding sexual and reproductive health in the future
Time Frame: Day 1. The patients receives a QR-code to the digital questionnaire at the end of the visit and can choose when and were to fill out the questionnaire, but are encouraged to do so in the waiting room
|
The outcome is measured through self-reported data, collected through a digital questionnaire.
The item is formulated as the following "If you have questions about sexual and reproductive health in the future, how likely are you to turn to…midwife at the youth clinic?
midwife at the midwifery clinic?
nurse/doctor at the health center?
1177/UMO/YOUMO?"
With the response alternatives: Very likely / Fairly likely / Neither likely nor unlikely / Fairly unlikely / Very unlikely
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Day 1. The patients receives a QR-code to the digital questionnaire at the end of the visit and can choose when and were to fill out the questionnaire, but are encouraged to do so in the waiting room
|
|
Knowledge of and attitudes towards fertility and preconception health
Time Frame: Day 1. The patients receives a QR-code to the digital questionnaire at the end of the visit and can choose when and were to fill out the questionnaire, but are encouraged to do so in the waiting room
|
The outcome is measured through self-reported data, collected through a digital questionnaire.
The item is developed based on the Health Belief Model and previous research on knowledge of and attitudes towards fertility and preconception health.
|
Day 1. The patients receives a QR-code to the digital questionnaire at the end of the visit and can choose when and were to fill out the questionnaire, but are encouraged to do so in the waiting room
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jenny Stern, PhD, Uppsala University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Uterine Diseases
- Genital Diseases, Female
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Neoplasms
- Uterine Cervical Neoplasms
Other Study ID Numbers
- UU-RLP-Cellprov-2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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