跳至主要内容
临床试验/NCT04704011
NCT04704011撤回不适用

Evaluating the Impact of Basic Needs Assessment and Support to Improve Colposcopy Show Rates: The BASICS Trial

Washington University School of Medicine0 个研究点开始时间: 2022年5月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
主要终点
Adherence to colposcopy visit

研究概览

简要总结

This randomized controlled, single-site study hopes to determine the effectiveness of a tailored phone call reminder to improve low-income patients' adherence to colposcopy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •≥ 21 years of age
  • •English speaking
  • •Able to provide verbal consent

排除标准

  • •Incarcerated
  • •Unable to consent
  • •Does not have access to a working contact phone number

研究组 & 干预措施

Arm 1: Basic Needs Assessment

Experimental

-Patients will receive a phone call from a research team member 2-4 weeks before their colposcopy appointment. The team member will remind the patient of the date and time of their appointment and conduct a basic needs assessment. Those who have at least one unmet basic need or are unsure of their current needs will be referred to the 24-hr assistance hotline, 2-1-1 United Healthy Way Missouri. After the date of their appointment, patients will be contacted to ask whether they contacted 2-1-1 and used any recommended services.

干预措施: 2-1-1 United Way Healthy Missouri Hotline (Other)

Arm 1: Basic Needs Assessment

Experimental

-Patients will receive a phone call from a research team member 2-4 weeks before their colposcopy appointment. The team member will remind the patient of the date and time of their appointment and conduct a basic needs assessment. Those who have at least one unmet basic need or are unsure of their current needs will be referred to the 24-hr assistance hotline, 2-1-1 United Healthy Way Missouri. After the date of their appointment, patients will be contacted to ask whether they contacted 2-1-1 and used any recommended services.

干预措施: National Comprehensive Cancer Network (NCCN) Distress Thermometer (Other)

Arm 1: Basic Needs Assessment

Experimental

-Patients will receive a phone call from a research team member 2-4 weeks before their colposcopy appointment. The team member will remind the patient of the date and time of their appointment and conduct a basic needs assessment. Those who have at least one unmet basic need or are unsure of their current needs will be referred to the 24-hr assistance hotline, 2-1-1 United Healthy Way Missouri. After the date of their appointment, patients will be contacted to ask whether they contacted 2-1-1 and used any recommended services.

干预措施: Basic needs survey (Other)

Arm 1: Basic Needs Assessment

Experimental

-Patients will receive a phone call from a research team member 2-4 weeks before their colposcopy appointment. The team member will remind the patient of the date and time of their appointment and conduct a basic needs assessment. Those who have at least one unmet basic need or are unsure of their current needs will be referred to the 24-hr assistance hotline, 2-1-1 United Healthy Way Missouri. After the date of their appointment, patients will be contacted to ask whether they contacted 2-1-1 and used any recommended services.

干预措施: 2-1-1 survey (Other)

Arm 2: Usual Care Cohort

Active Comparator

-Patients will receive an automated phone call two weeks before their colposcopy appointment to remind them of the date and time of their visit.

干预措施: Usual Care Reminder Call (Other)

结局指标

主要结局

Adherence to colposcopy visit

时间窗: Within 6 weeks of study enrollment

次要结局

  • Distress scores related to indications for colposcopy(At the time of enrollment)
  • Patient self-reported use of 2-1-1 services as measured by 2-1-1 Survey(After or within 1 week after colposcopy visit (estimated to be 6 weeks))
  • General distress scores as measured by NCCN Distress Thermometer(At the time of enrollment)
  • Number and type of unmet basic needs as measured by Unmet Basic Needs Survey(At the time of enrollment; at least 2 weeks prior to colposcopy appointment)
  • Causes of distress as measured by NCCN Distress Problem List(At the time of enrollment)

研究者

申办方类型
Other
责任方
Sponsor

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