NCT03380351

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 21, 2017

Completed
1.7 years until next milestone

Study Start

First participant enrolled

August 26, 2019

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

4.5 years

First QC Date

November 20, 2017

Last Update Submit

May 6, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Interventions

The research team will characterize the intervention components and their implementation strategies.

SCDIC interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Related Publications (3)

  • Nwosu C, Khan H, Masese R, Nocek JM, Gollan S, Varughese T, Bourne S, Clesca C, Jacobs SR, Baumann A, Klesges LM, Shah N, Hankins JS, Smeltzer MP. Recruitment Strategies in the Integration of Mobile Health Into Sickle Cell Disease Care to Increase Hydroxyurea Utilization Study (meSH): Multicenter Survey Study. JMIR Form Res. 2024 Apr 16;8:e48767. doi: 10.2196/48767.

  • 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.

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Ana Baumann, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2017

First Posted

December 21, 2017

Study Start

August 26, 2019

Primary Completion

March 1, 2024

Study Completion

March 30, 2024

Last Updated

May 8, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
data will be available in two years for the remaining of the 2 years of the consortium.
Access Criteria
Assess will be given to all participants via the Consortium's webpage
More information

Locations