Recruitment and Engagement in Care to Impact Practice Enhancement (RECIPE) for Sickle Cell Disease

NCT ID: NCT06385886

Last Updated: 2025-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-08

Study Completion Date

2027-12-31

Brief Summary

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The goal of this observational study is to help us understand more about the best ways to help individuals living with Sickle Cell Disease (SCD) get the best care. The main question it aims to answer is: How to find individuals unaffiliated from SCD specialist care use three distinct pathways? Once unaffiliated individuals are found using the pathways, Investigators will employ linkage coordinators (trained staff) to engage these patients in care. Participants will be asked to fill out an assessment survey which will cover areas such as previous and current treatment, clinic and hospital experience, pain, and quality of life. Participants will also be given the option of participation in a 1-hour long interview how they feel about treatment for sickle cell disease including clinic experience, pain, and quality of life?

Detailed Description

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The goal of RECIPE (Recruitment and Engagement in Care to Impact Practice Enhancement) for Sickle Cell Disease is to find unaffiliated patients with SCD using three distinct pathways (Community, Hospital, Surveillance) engage them in care using linkage coordinators (LCs; a successful method adapted from HIV care), and understand the contextual factors and implementation support needed to ensure these methodologies can be further scaled up at a national level. This study is significant because information about unaffiliated patients with SCD who are not actively engaged in the health system has not been systematically collected and studied in the past. Information comes only from experienced clinicians, community groups, patient advocates, and word of mouth. The lack of data about this population is problematic because current implementation studies focus on the barriers related to affiliated patients, with no known strategies identified to engage unaffiliated patients. No previous studies have evaluated the best methods for locating and then engaging and maintaining unaffiliated patients in specialty SCD care. This study will contribute to the literature by optimizing different pathways for finding unaffiliated patients, as well as providing evidence on what may work best in different clinical care settings and among different patients to address barriers to care in hard-to-reach populations.

Conditions

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Sickle Cell Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Individuals diagnosed with Sickle Cell Disease (SCD) but not receiving care from an SCD specialist.

Individuals diagnosed with Sickle Cell Disease (SCD) but unaffiliated from SCD specialist care. These individuals will be connected to a linkage coordinator (trained staff) to provide a patient-centered approach to engagement with SCD specialist care.

Linkage Coordinator

Intervention Type BEHAVIORAL

The Linkage Coordinator (LC) will be the initial contact with unaffiliated SCD patients to establish a relationship, champion preventative services, and support them in engaging with an SCD specialist by helping patients address barriers to care. Study staff will provide initial and ongoing training to the LC to ensure they have adequate support to effectively engage with patients.

Interventions

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Linkage Coordinator

The Linkage Coordinator (LC) will be the initial contact with unaffiliated SCD patients to establish a relationship, champion preventative services, and support them in engaging with an SCD specialist by helping patients address barriers to care. Study staff will provide initial and ongoing training to the LC to ensure they have adequate support to effectively engage with patients.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Persons must be \>/= 18 years of age
* Persons must have confirmed SCD
* Persons not seen by a SCD specialist \> 1 year +/- 3 months
* Literacy in English will be required of the consenting patient or parent/guardian

Exclusion Criteria

* Persons \< 18 years of age
* Persons that are unable to provide informed consent and do not have a designated care-giver that can consent on his/her behalf
* Persons with sickle cell trait (as per hemoglobin electrophoresis)
* Persons seen by a SCD specialist \< 1 year +/1 3 months
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RTI International

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julie Kanter, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama, Birmingham (UAB)

Locations

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University of Alabama, Birmingham (UAB)

Birmingham, Alabama, United States

Site Status RECRUITING

Phoenix Children's Hospital

Phoenix, Arizona, United States

Site Status RECRUITING

University of California, San Francisco (UCSF)

Oakland, California, United States

Site Status RECRUITING

Augusta University

Augusta, Georgia, United States

Site Status RECRUITING

University of Illinois

Chicago, Illinois, United States

Site Status RECRUITING

Cleveland Clinic

Cleveland, Ohio, United States

Site Status RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

University of Tennessee at Memphis

Memphis, Tennessee, United States

Site Status RECRUITING

University of Texas at Houston

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lisa A Cox, MS

Role: CONTACT

770-407-4908

Sara Jacobs, PhD

Role: CONTACT

770-407-4951

Facility Contacts

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Julie Kanter, MD

Role: primary

(205) 934-0435

Sanjay Shah

Role: primary

602-933-0920

Marsha Treadwell, PhD

Role: primary

(510) 428-3356

Robert Gibson, PhD

Role: primary

(706) 721-1005

Lewis Hsu, MD, PhD

Role: primary

312-355-5019

Ravi Talati

Role: primary

216.444.5437

Nadia Ali

Role: primary

215-615-6555

Ugochi Ogu

Role: primary

901.545.8535

Modupe Idowu

Role: primary

(713) 486-5660

Other Identifiers

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1R01HL158807-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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