Impact of Basic Needs Assessment and Support to Improve Colposcopy Show Rate
- Conditions
- Cervical Cancer
- Interventions
- Behavioral: Social needs navigator programBehavioral: Enhanced usual care
- Registration Number
- NCT05458960
- Lead Sponsor
- Washington University School of Medicine
- Brief Summary
The investigators will perform a randomized controlled trial in which 72 eligible patients (low-income, uninsured, or on Medicaid) who are referred for colposcopy at Washington University School of Medicine, are enrolled and then screened for unmet social needs and distress. The participants will then be randomized 1:1 into either receive the social needs navigator program (n=36) or enhanced usual care (n=36).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 81
- Abnormal cervical cancer screen
- Missed appointment at BJH colposcopy clinic and need to reschedule
- Age 21 years or older
- Able to provide verbal consent
- Diagnosis of an abnormal cervical screen confirmed by cytology or pathology
- Individual without a cervix
- Known diagnosis or history of cancer
- Unable to consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1: Social needs navigator program Social needs navigator program Participants will be paired with a community health worker who will provide tailored support to address unmet social needs. The number and frequency of calls will be limited only by participants' needs, interest, and willingness to interact. The type of contact could include phone calls, or home/community visits. The community health worker will: (1) identify and assess patients' unmet social needs; (2) jointly generate solutions; (3) help prioritize among multiple needs; (4) identify community resources that could help resolve the problem(s); (5) determine eligibility for services; (6) help patients access available resources by scheduling appointments and providing appointment reminders; (7) prepare patients to interact with service agencies and/or act as an advocate; (8) provide support such as arranging transportation; (9) oversee follow-up problem-solving actions; and (10) review progress made towards resolving unmet social needs and adapt solutions. Arm 2: Enhanced usual care Enhanced usual care Participants will receive verbal referral to a federally funded, free, 24-hr assistance hotline, United Way 2-1-1, which connects callers with community services to help address unmet social needs.
- Primary Outcome Measures
Name Time Method Adherence to colposcopy visit as measured as number of participants who complete colposcopy visit 6 weeks after enrollment
- Secondary Outcome Measures
Name Time Method Patients' satisfaction with intervention Completion of study enrollment (estimated to be 18 months) -The interview guide has two questions that relate to patient satisfaction related to the intervention. 1) Was the \[community health worker or 2-1-1 operator\] helpful to you? 2) Would you recommend \[the community healthworker/2-1-1\] to a family member or friend?
Total number of unmet basic needs 4 months after enrollment -Unmet basic needs include food security, housing, personal safety, neighborhood safety, sufficient money for necessities, childcare (if applicable), and transportation. A questionnaire will be given to participants to identify the number of unmet basic needs the participant has.
Change in general distress scores as measured by the NCCN Distress Thermometer and Problem List Enrollment and 4 months after enrollment Participants will be asked to rate the amount of distress (scale of 0 to 10, 10=extreme distress) that they have experienced in the past week and the amount of distress (scale of 0 to 10) that they attribute to their abnormal cervical cancer screen. The NCCN distress problem list is a 40-item list categorized into five themes-practical, family, emotional, spiritual, and physical problems¬-and leaves room for patients to describe "other".
Providers' satisfaction with intervention Completion of study enrollment (estimated to be 18 months) -Providers are asked after completion of enrollment to indicate their satisfaction with the intervention. They are given 12 statements about the satisfaction of the intervention and are asked to circle responses of 1=completely disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, or 5=completely agree. The higher the score the more satisfied the provider is with the intervention.
Resources needed to sustain intervention Completion of study enrollment (estimated to be 18 months) -Validated questionnaire that will be administered to providers, staff, and community health workers: Self-administered 15-minute online survey that will be completed at the end of the study enrollment period. The survey will ask about specific implementation outcomes using the Acceptability Intervention Measure, the Intervention Appropriateness Measure, and the Feasibility of Intervention Measure.
Likelihood that intervention will become built into usual care Completion of study enrollment (estimated to be 18 months) -Providers are asked after completion of enrollment to indicate the likelihood that the intervention can be built into usual care in their clinic. The responses are either likely, very likely, neutral, unlikely, very unlikely, or unsure.
Intent to use intervention over time Completion of study enrollment (estimated to be 18 months) -Providers are asked after completion of enrollment to indicate on a scale of 1=not committed to 10=fully committed of how committed they are to use the intervention in their clinic.
Trial Locations
- Locations (1)
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States