Equitable Implement Cascade Screening in Individuals With Familial Hypercholesterolemia
Study Details
Study Description
Brief Summary
Design, refine, and pilot the two implementation approaches using behavioral economics and then seek further feedback prior to the proposed clinical trial, consistent with these recommendations.
Aim 1. Co-design both implementation strategies using behavioral economics in partnership with the Family Heart Foundation and key partners from diverse backgrounds.
Aim 2. Pilot strategies with 20 patients with high cholesterol and/or with familial hypercholesterolemia (FH) to ascertain feasibility, acceptability, appropriateness.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Aim 1. engage in interviews with patients with high cholesterol and/or FH, family members, and clinicians to identify common barriers and facilitators for individuals to engage in cascade screening. These activities will occur in the first 6 months and will serve as inputs into the design of the implementation strategies to ensure that strategies address determinants identified in the interviews.
Aim 2. To maximize success, pilot test the implementation strategies and the planned data collection approaches.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Qualitative Interviews Conduct 20 interviews (10 with patients diagnosed with FH, 10 with family members of patients diagnosed with FH). Interviews will be 30-60 minutes in length and will focus on how individuals understand cascade screening, barriers to engagement including reasons why individuals do and do not share health information with family members, and preferred approaches to engaging family members, with a focus on acceptability, appropriateness, and feasibility of the planned implementation strategies. Interviewers will also attend to structural factors such as medical mistrust and experiences of racism in health care, and ask about preferences and logistics to incorporate preference into the future clinical trial design. |
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| Penn-mediated implementation strategy The Penn-mediated implementation strategy will be designed and then iterated upon during mini-pilots. As part of this strategy, the patients would receive text messages containing information about FH and cascade screening from Penn Medicine. This would include a request for the patient to identify first-degree biological relatives. They would be given a choice of either contacting their family members directly or sharing their contact information so someone from Penn Medicine can contact them. If the patient wanted Penn Medicine to reach out, they can choose the format and the perceived sender. At any time, they could elect to schedule a call with a Penn Medicine health representative. Family members would be offered FH screening at no cost either by blood lipid panel or genetic test. The patients and/or family members would be able to contact a member of the research team at any time with questions. |
Other: Cascade Screening
FH is a genetic condition that causes high LDL cholesterol since birth. When one individual with FH is diagnosed, it is important that biological family members are also screened as well since there is a 50% chance that each of your family members may have also inherited FH. This process is known as cascade screening.
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| Family Heart Foundation-mediated implementation strategy The Family Heart Foundation (FHF)-mediated implementation strategy will be designed and then iterated upon during mini-pilots. As part of this strategy, the patient would be contacted by a FHF patient navigator. The patient navigator would ask to set up a time to talk to the patient to talk about options for contacting family members, introduce them to the services they can provide to the patient and/or family members and obtain some details about the patient's family. The patient would come up with a plan to either contact their family members directly or have the patient navigator contact them. Just like in Penn-mediated implementation strategy, the patient will make decisions about each component of cascade screening. Family members will be offered FH screening at no cost either by blood lipid panel or genetic test. The patient and/or family members will be able to contact the patient navigator at any time with questions. |
Other: Cascade Screening
FH is a genetic condition that causes high LDL cholesterol since birth. When one individual with FH is diagnosed, it is important that biological family members are also screened as well since there is a 50% chance that each of your family members may have also inherited FH. This process is known as cascade screening.
|
Outcome Measures
Primary Outcome Measures
- Qualitative Interview Outcome: perspectives on cascade screening [1 time interview to last 1 hour]
To learn about the perspectives on cascade screening
- Mini-Pilot #1 Outcome: Feasibility [one week]
Feasibility is defined as the extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. It will be measured using the validated 4-item "Feasibility of Intervention Measure".
- Mini-Pilot #2 Outcome: Feasibility [one week]
Feasibility is defined as the extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. It will be measured using the validated 4-item "Feasibility of Intervention Measure".
- Mini-Pilot #3 Outcome: Feasibility [one week]
Feasibility is defined as the extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. It will be measured using the validated 4-item "Feasibility of Intervention Measure".
- Mini-Pilot #4 Outcome: Feasibility [one week]
Feasibility is defined as the extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. It will be measured using the validated 4-item "Feasibility of Intervention Measure".
- Mini-Pilot #5 Outcome: Feasibility [one week]
Feasibility is defined as the extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. It will be measured using the validated 4-item "Feasibility of Intervention Measure".
- Mini-Pilot #1 Outcome: Acceptability [one week]
Acceptability is the perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory. Lack of acceptability has long been noted as a challenge in implementation. It will be measured using the validated 4-item "Acceptability of Intervention Measure".
- Mini-Pilot #2 Outcome: Acceptability [one week]
Acceptability is the perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory. Lack of acceptability has long been noted as a challenge in implementation. It will be measured using the validated 4-item "Acceptability of Intervention Measure".
- Mini-Pilot #3 Outcome: Acceptability [one week]
Acceptability is the perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory. Lack of acceptability has long been noted as a challenge in implementation. It will be measured using the validated 4-item "Acceptability of Intervention Measure".
- Mini-Pilot #4 Outcome: Acceptability [one week]
Acceptability is the perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory. Lack of acceptability has long been noted as a challenge in implementation. It will be measured using the validated 4-item "Acceptability of Intervention Measure".
- Mini-Pilot #5 Outcome: Acceptability [one week]
Acceptability is the perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory. Lack of acceptability has long been noted as a challenge in implementation. It will be measured using the validated 4-item "Acceptability of Intervention Measure".
- Mini-Pilot #1 Outcome: Appropriateness [one week]
Appropriateness is the perceived fit, relevance, or compatibility of the innovation or evidence based practice for a given practice setting, provider, or consumer; and/or perceived fit of the innovation to address a particular issue or problem. It will be measured using the validated 4-item "Intervention Appropriateness Measure".
- Mini-Pilot #2 Outcome: Appropriateness [one week]
Appropriateness is the perceived fit, relevance, or compatibility of the innovation or evidence based practice for a given practice setting, provider, or consumer; and/or perceived fit of the innovation to address a particular issue or problem. It will be measured using the validated 4-item "Intervention Appropriateness Measure".
- Mini-Pilot #3 Outcome: Appropriateness [one week]
Appropriateness is the perceived fit, relevance, or compatibility of the innovation or evidence based practice for a given practice setting, provider, or consumer; and/or perceived fit of the innovation to address a particular issue or problem. It will be measured using the validated 4-item "Intervention Appropriateness Measure".
- Mini-Pilot #4 Outcome: Appropriateness [one week]
Appropriateness is the perceived fit, relevance, or compatibility of the innovation or evidence based practice for a given practice setting, provider, or consumer; and/or perceived fit of the innovation to address a particular issue or problem. It will be measured using the validated 4-item "Intervention Appropriateness Measure".
- Mini-Pilot #5 Outcome: Appropriateness [one week]
Appropriateness is the perceived fit, relevance, or compatibility of the innovation or evidence based practice for a given practice setting, provider, or consumer; and/or perceived fit of the innovation to address a particular issue or problem. It will be measured using the validated 4-item "Intervention Appropriateness Measure".
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with high cholesterol and/or FH (Aims 1 Interviews and Aim 2 Pilot Testing Strategies). Adults aged 18 and older with clinically diagnosed FH who are treated within Penn Medicine
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Family Members (Aim 1 interviews). Adults aged 18 and older who have a family member who has been identified as a patient with high cholesterol and/or FH who is treated within Penn Medicine
Exclusion Criteria:
- none
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Pennsylvania
- Family Heart Foundation
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- 851061