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| Name | Class |
|---|---|
| Sophiahemmet University | OTHER |
| Sormland County Council, Sweden | OTHER |
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The aim is to evaluate different strategies to improve the experience and effect of the first visit for a cervical screening test (CST).
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.
The aim is to evaluate different strategies to improve the experience and effect of the first visit for a cervical screening test (CST).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | No Intervention | Standard care for cervical screening test (CST) at the midwifery clinic (control group) | |
| Group 2 | Experimental | Standard care for CST at the youth clinic (intervention group 1) |
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| Group 3 | Experimental | Standard care for CST at the youth clinic with extra time allotted (intervention group 2) |
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| Group 4 | Experimental | Standard care for CST at the youth clinic with extra time allotted and the RLP-information (intervention group 3) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Changed clinical context | Other | Changed clinical context: from midwifery clinic to youth clinic |
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| Measure | Description | Time Frame |
|---|---|---|
| Experience of CST | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Knowledge of and attitudes towards CST and cervical cancer | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jenny Stern, PhD | Uppsala University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Region Sörmland | Eskilstuna | Sweden |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| Extra time allotted | Behavioral | Extra time allotted for each visit for CST |
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| RLP-information | Behavioral | Midwife-initiated discussion of the Reproductive Life Plan |
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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 |
| Attitude towards contacting a midwife regarding sexual and reproductive health in the future | 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 | 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 | 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 |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |