Recruitment and Engagement in Care to Impact Practice Enhancement (RECIPE) for Sickle Cell Disease
ConditionSickle Cell Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRTI International
About this trial
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?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Individuals with Sickle Celle Disease (SCD) who are unaffiliated from SCD care specialists
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Linkage Coordinator
BehavioralThe 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.
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: Individuals diagnosed with Sickle Cell Disease (SCD) but not receiving care from an SCD specialist.1 intervention
Trial outcomes
Primary outcomes
1
Identification of unaffiliated patients
Identification of patients through hospital, surveillance, and community-based pathways.
Time frame
Beginning of enrollment - end of study (up to 5 years)2
Affiliation with a Sickle cell disease (SCD)-specific care with SCD specialist
Rate of affiliation of participants previously unaffiliated with SCD-specific care with an SCD specialist who are now connected to a linkage coordinator and an SCD-specific care with SCD specialist.
Time frame
Beginning of enrollment - end of study (up to 5 years)Secondary outcomes
1
Scale Out to Other SCD Centers - Implementation in at least 2 other SCD Center study sites
Once investigators optimize methods for finding and engaging unaffiliated patients with SCD, it is necessary to expand efforts to other SCD sites. The study will expand to include 2 additional sites and begin to assess rate of affiliation of participants previously unaffiliated with SCD-specific care with an SCD specialist who are now connected to a linkage coordinator and an SCD-specific care with SCD specialist.
Time frame
After methods are optimized - end of study (up to 5 years)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov