Addressing Unmet Basic Needs to Improve Adherence Among Women With an Abnormal Pap
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Participant adherence to initial colposcopy visit
研究概览
简要总结
The investigators aim to improve adherence to follow-up recommendations for an abnormal Pap and effectively reduce disparities in cervical cancer risk and disease among rural and low-income urban women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Newly referred patients to colposcopy clinic at SIUM and WUSM
- •Aged 18 years or older
- •English speaking
- •Able to provide verbal consent
- •Diagnosis of abnormal pap will be confirmed by pathology report
- •Member of all races and ethnic groups
排除标准
- •Established colposcopy clinic patients
- •Known diagnosis of cancer
- •Pregnancy
- •Incarcerated
- •Unable to consent
- •No access to a working contact phone number
研究组 & 干预措施
Phase I:
- In Phase 1 of the study (first five months), the investigators will enroll new patients when they call them to remind them of their first colposcopy appointment. If patients consent, the investigators also will assess their basic needs during the call. Those who screen positive for at least one unmet basic need, will be referred to the 2-1-1 helpline at their clinic visit (or this information will be sent to them if they miss their clinic visit).
- All women enrolled in our study will be asked to complete our basic needs survey and take a follow-up survey at the time of their first colposcopy visit.
- For patients in phase 1, the follow-up survey will only assess acceptability of the basic needs survey (five questions)
干预措施: Basic needs survey (Other)
Phase I:
- In Phase 1 of the study (first five months), the investigators will enroll new patients when they call them to remind them of their first colposcopy appointment. If patients consent, the investigators also will assess their basic needs during the call. Those who screen positive for at least one unmet basic need, will be referred to the 2-1-1 helpline at their clinic visit (or this information will be sent to them if they miss their clinic visit).
- All women enrolled in our study will be asked to complete our basic needs survey and take a follow-up survey at the time of their first colposcopy visit.
- For patients in phase 1, the follow-up survey will only assess acceptability of the basic needs survey (five questions)
干预措施: Follow-up survey (Other)
Phase 2:
-In Phase 2 of the study (second five months), new colposcopy patients will be approached and consented in a similar fashion as in Phase 1 and asked to complete the basic needs survey. However, this time, patients who screen positive with at least one unmet basic need will be offered assistance by a life navigator (a trained case manager) who will contact the patients by phone within 2 business days of completing the survey.
The life navigator will connect patients with community resources in each area to help with their unmet basic needs.
- All women enrolled in our study will be asked to complete our basic needs survey and take a follow-up survey at the time of their first colposcopy visit.
- Patients enrolled in phase 2 will be asked the same five questions in addition to seven more assessing perceived effectiveness of the life navigator
干预措施: Basic needs survey (Other)
Phase 2:
-In Phase 2 of the study (second five months), new colposcopy patients will be approached and consented in a similar fashion as in Phase 1 and asked to complete the basic needs survey. However, this time, patients who screen positive with at least one unmet basic need will be offered assistance by a life navigator (a trained case manager) who will contact the patients by phone within 2 business days of completing the survey.
The life navigator will connect patients with community resources in each area to help with their unmet basic needs.
- All women enrolled in our study will be asked to complete our basic needs survey and take a follow-up survey at the time of their first colposcopy visit.
- Patients enrolled in phase 2 will be asked the same five questions in addition to seven more assessing perceived effectiveness of the life navigator
干预措施: Life Navigator (Behavioral)
Phase 2:
-In Phase 2 of the study (second five months), new colposcopy patients will be approached and consented in a similar fashion as in Phase 1 and asked to complete the basic needs survey. However, this time, patients who screen positive with at least one unmet basic need will be offered assistance by a life navigator (a trained case manager) who will contact the patients by phone within 2 business days of completing the survey.
The life navigator will connect patients with community resources in each area to help with their unmet basic needs.
- All women enrolled in our study will be asked to complete our basic needs survey and take a follow-up survey at the time of their first colposcopy visit.
- Patients enrolled in phase 2 will be asked the same five questions in addition to seven more assessing perceived effectiveness of the life navigator
干预措施: Follow-up survey (Other)
Phase 2:
-In Phase 2 of the study (second five months), new colposcopy patients will be approached and consented in a similar fashion as in Phase 1 and asked to complete the basic needs survey. However, this time, patients who screen positive with at least one unmet basic need will be offered assistance by a life navigator (a trained case manager) who will contact the patients by phone within 2 business days of completing the survey.
The life navigator will connect patients with community resources in each area to help with their unmet basic needs.
- All women enrolled in our study will be asked to complete our basic needs survey and take a follow-up survey at the time of their first colposcopy visit.
- Patients enrolled in phase 2 will be asked the same five questions in addition to seven more assessing perceived effectiveness of the life navigator
干预措施: Follow-up survey (phase II participants only) (Other)
结局指标
主要结局
Participant adherence to initial colposcopy visit
时间窗: At the time of initial colposcopy visit
-Will use weekly clinic schedules to track adherence rates
次要结局
- Number of unmet basic needs(-2 weeks prior to initial colposcopy visits)
- Type of unmet basic needs(-2 weeks prior to initial colposcopy visits)
- Participant adherence to recommended follow-up after initial colposcopy visit(At the time of initial colposcopy visit)
- Participant acceptability of the unmet basic needs survey(At the time of initial colposcopy visit)
- Participant perception of effectiveness of life navigator to assist with their unmet basic needs(At the time of initial colposcopy visit)