Clinical trial NCT03253211: Disseminating NIH Evidence Based Sickle Cell Recommendations in North Carolina
Official title: Disseminating NIH Evidence Based Sickle Cell Recommendations in North Carolina
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sickle Cell Disease
Keywords: Co-management model of care
Primary Care
Specialty Care
Decision support tools
Emergency Department Clinicians
Co-management
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2017-08-17
Enrollment: 4392
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

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

Primary outcomes:
measure: HU refills
timeFrame: 12 months
measure: Co-management visits
timeFrame: 12 months
Secondary outcomes:
measure: ED visits
timeFrame: 12 months
measure: In-patient hospitalizations
timeFrame: 12 months
measure: Re-admission to hospital within 30 days
timeFrame: 12 months
measure: Primary care visits
timeFrame: 12 months
measure: Specialty visits
timeFrame: 12 months
measure: Transcranial doppler screening
timeFrame: 12 months
measure: Opioid prescription fills
timeFrame: 12 months
Other outcomes:
Locations:
city: Raleigh
country: United States
facility: Community Care of North Carolina
state: North Carolina
Study officials:
affiliation: Duke University
name: Paula Tanabe, PhD
role: PRINCIPAL_INVESTIGATOR
References: