Specifying Interventions From the Sickle Cell Disease Implementation Consortium (SCDIC)

The Implementation of Cognitive Screening and Educational Support to Improve Outcomes of Adolescents and Young Adults With Sickle Cell Disease: From Clinic to the Community and Back

The goal of this study is to specify the interventions, implementation strategies and control conditions from the Sickle Cell Disease Implementation Consortium (SCDIC) using a mixed-methods approach to study site materials and conduct semi-structured qualitative interviews with site representatives (N=3 per site). We focused on the Emergency Department Working Group from the SCDIC working groups.

Study Overview

• Status: Completed
• Conditions: Anemia, Sickle Cell
• Intervention / Treatment: Behavioral: SCDIC interventions

Detailed Description

The long-term goal of this line of research is to identify the most effective components of SCD interventions while also identifying effective implementation strategies informed by a systematic and rigorous work done by the members of the SCDIC consortium to improve the quality of life of people with SCD, a life-threatening hematological disorder. This study aims to collect detailed information about the planned interventions, the implementation strategies and the control conditions from each site.

• Study Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University in St. Louis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

This study is focused on gathering data about the interventions planned and delivered from three different stakeholders of each site.

Description

Inclusion Criteria:

• three representatives of each of the SDIC sites: the Principal Investigator, and two people nominated by the PI.

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SCDIC interventions; Careful detail the intervention components and the implementation strategies (i.e., the mechanisms by which the interventions are being delivered in usual care) being developed by the consortium.	Behavioral: SCDIC interventions; The research team will characterize the intervention components and their implementation strategies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SCDIC Framework of Interventions	Detailed descriptions of the interventions being developed by the SCDIC including a) entity, or entities, targeted by the intervention; (b) functional domains targeted by the interventions; and (c) delivery system characteristics	2 years

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Ana Baumann, PhD, Washington University School of Medicine

Publications and helpful links

General Publications

• Baumann AA. Commentary: Adapting and Operationalizing the RE-AIM Framework for Implementation Science in Environmental Health: Clean Fuel Cooking Programs in Low Resource Countries. Front Public Health. 2020 Jun 9;8:218. doi: 10.3389/fpubh.2020.00218. eCollection 2020. No abstract available.
• Baumann AA, Belle SH, James A, King AA; Sickle Cell Disease Implementation Consortium. Specifying sickle cell disease interventions: a study protocol of the Sickle Cell Disease Implementation Consortium (SCDIC). BMC Health Serv Res. 2018 Jun 27;18(1):500. doi: 10.1186/s12913-018-3297-1.

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2019
• Primary Completion (Actual): March 1, 2024
• Study Completion (Actual): March 30, 2024

Study Registration Dates

• First Submitted: November 20, 2017
• First Submitted That Met QC Criteria: December 15, 2017
• First Posted (Actual): December 21, 2017

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Anemia, Sickle Cell
• Other Study ID Numbers: 3U01HL133994-02S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Along the study, we will share the information gathered with participants to check for accuracy. The framework of the interventions will be shared with the participants during the SCDIC Steering Committee calls.
• IPD Sharing Time Frame: data will be available in two years for the remaining of the 2 years of the consortium.
• IPD Sharing Access Criteria: Assess will be given to all participants via the Consortium's webpage
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No