Clinical trial NCT06385886: Recruitment and Engagement in Care to Impact Practice Enhancement (RECIPE) for Sickle Cell Disease
Official title: Recruitment and Engagement in Care to Impact Practice Enhancement (RECIPE) for Sickle Cell Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sickle Cell Disease
Keywords: Sickle Cell Disease Care
Unaffiliated patients
Linkage Coordinator
Lead sponsor: RTI International
Sponsor class: OTHER
First posted: 2024-04-26
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with Sickle Celle Disease (SCD) who are unaffiliated from SCD care specialists

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Identification of unaffiliated patients
timeFrame: Beginning of enrollment - end of study (up to 5 years)
measure: Affiliation with a Sickle cell disease (SCD)-specific care with SCD specialist
timeFrame: Beginning of enrollment - end of study (up to 5 years)
Secondary outcomes:
measure: Scale Out to Other SCD Centers - Implementation in at least 2 other SCD Center study sites
timeFrame: After methods are optimized - end of study (up to 5 years)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama, Birmingham (UAB)
state: Alabama
city: Oakland
country: United States
facility: University of California, San Francisco (UCSF)
state: California
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Chicago
country: United States
facility: University of Illinois
state: Illinois
Study officials:
affiliation: University of Alabama, Birmingham (UAB)
name: Julie Kanter, MD
role: PRINCIPAL_INVESTIGATOR
References: