Disseminating NIH Evidence Based Sickle Cell Recommendations in North Carolina

Sickle Cell Disease Clinical Trial

Official title:

Disseminating NIH Evidence Based Sickle Cell Recommendations in North Carolina

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03253211
• Other study ID #: PRO00076048
• Status: Completed
• Start date: November 6, 2018
• Est. completion date: December 15, 2019

Study information

• Verified date: March 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4392
• Est. completion date: December 15, 2019
• Est. primary completion date: December 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Locations

Country	Name	City	State
United States	Community Care of North Carolina	Raleigh	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HU refills	number of hydroxyurea prescription refills per patient	12 months
Primary	Co-management visits	number of co-management visits per patient	12 months
Secondary	ED visits	number of visits to the emergency department per patient	12 months
Secondary	In-patient hospitalizations	number of in-patient hospitalizations per patient	12 months
Secondary	Re-admission to hospital within 30 days	number of re-admissions per patient over the course of one year	12 months
Secondary	Primary care visits	number of visits to primary care provider per patient	12 months
Secondary	Specialty visits	number of specialty care visits per patient	12 months
Secondary	Transcranial doppler screening	number of transcranial doppler screenings per patient	12 months
Secondary	Opioid prescription fills	number of opioid prescription fill days per patient	12 months