Disseminating NIH Evidence Based Sickle Cell Recommendati... | NCT03253211

Studies
Disseminating NIH Evidence Based Sickle Cell Recommendations in North Carolina

NCT03253211

Sponsor

Duke University

Status

Completed

Last Update Posted

Mar 27, 2020Actual

Enrollment

4,392Actual

Phase

Not provided

Conditions

Sickle Cell Disease

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 6, 2018Actual

Primary Completion Date

Dec 15, 2019Actual

Completion Date

Dec 15, 2019Actual

First Submitted Date

Aug 2, 2017

First Submission Date that Met QC Criteria

Aug 15, 2017

First Posted Date

Aug 17, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2020

Last Update Posted Date

Mar 27, 2020Actual

Name	Class
Agency for Healthcare Research and Quality (AHRQ)	FED

Description Module

Brief Summary

This project will improve the efficiency and quality of healthcare for persons with sickle cell disease, an under-served and at risk population by implementing a co-management model of care. Many patients with sickle cell disease (SCD) receive care primarily from specialty physicians and emergency departments (ED), thus resulting in a lack of primary care and a high number of ED visits and hospitalizations. The goal is to improve PCP and SCD specialist co-management. The overall purpose of this dissemination project is to evaluate utilization data, as well as patient and provider reported outcomes associated with the dissemination of a toolbox of decision support tools to PCP's and ED providers across NC and SC.

Detailed Description

The investigators will achieve the goals stated above through three aims.

Examine the effects of decision support tools on study outcomes during the 12 months prior to project start and across the 3.5 years of the project in NC and SC. The investigators will also determine which patient and practice level characteristics predict study outcomes.
Evaluate individual provider-reported awareness, use and preference of health maintenance tables and algorithms amongst PCPs and ED providers in NC and SC at project start and yearly across the project. Additionally, the investigators will explore patient reported awareness of and satisfaction with co-management model of care in NC and SC.
The investigators will conduct an exploratory cost analysis of the dissemination and implementation of the SCD co-management model and its effect on healthcare resource utilization.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

4,392Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
State		North Carolina
SCD Patients
Providers		Primary care and emergency department clinicians
Year		Baseline, year 2, year 3

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HU refills	number of hydroxyurea prescription refills per patient	12 months
Co-management visits	number of co-management visits per patient	12 months

Secondary Outcomes

Measure	Description	Time Frame
ED visits	number of visits to the emergency department per patient	12 months
In-patient hospitalizations	number of in-patient hospitalizations per patient

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patient with diagnosis of sickle cell disease, emergency department clinician, or primary care clinician in the state of NC or part of SC

Exclusion Criteria:

Non-English speaking, non-resident of NC or SC

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with a diagnosis of sickle cell disease (not trait) are eligible for inclusion. Additionally, we will survey primary care and emergency department clinicians. Patients must be from North Carolina or Georgetown, SC. Clinicians must practice in NC or SC.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Paula Tanabe, PhD	Duke University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Community Care of North Carolina		Raleigh	North Carolina	27607	United States

Condition Browse Module

MeSH Terms

ID	Term
D000755	Anemia, Sickle Cell

Ancestor Terms

ID	Term
D000745	Anemia, Hemolytic, Congenital
D000743	Anemia, Hemolytic
D000740	Anemia
D006402	Hematologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided