Disseminating NIH Evidence Based Sickle Cell Recommendations in North Carolina

Completed

• Conditions: Sickle Cell Disease

• Registration Number: NCT03253211
• Lead Sponsor: Duke University

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.

1. 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.

2. 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.

3. 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.

Study Timeline

• Study First Submitted: 2017-08-02
• Study First Submitted QC: 2017-08-15
• Study First Posted: 2017-08-17
• Study Start: 2018-11-06
• Primary Completion: 2019-12-15
• Study Completion: 2019-12-15
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-25
• Last Update Posted: 2020-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4392

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HU refills	12 months	number of hydroxyurea prescription refills per patient
Co-management visits	12 months	number of co-management visits per patient

Secondary Outcome Measures

Name	Time	Method
Re-admission to hospital within 30 days	12 months	number of re-admissions per patient over the course of one year
Primary care visits	12 months	number of visits to primary care provider per patient
In-patient hospitalizations	12 months	number of in-patient hospitalizations per patient
ED visits	12 months	number of visits to the emergency department per patient
Specialty visits	12 months	number of specialty care visits per patient
Transcranial doppler screening	12 months	number of transcranial doppler screenings per patient
Opioid prescription fills	12 months	number of opioid prescription fill days per patient

Trial Locations

Locations (1)

Community Care of North Carolina; 🇺🇸 Raleigh, North Carolina, United States