Improving Sickle Cell Disease (SCD) Care Using Web-based Guidelines

Improving Sickle Cell Disease (SCD) Care Using Web-based Guidelines, Nurse Care Managers and Peer Mentors in Primary Care and Emergency Departments in Central North Carolina

The overall goal of this proposed project is to 1) increase co-management between sickle cell specialists and primary care providers (PCP's); 2) increase the use of hydroxyurea (HU) which prevents Vaso-Occlusive Episode (VOE), EDs and subsequent hospitalizations, and death; 3) identify and link patients not receiving primary or SCD specialty care to care, and 4) shift healthcare use from EDs and hospitalizations to primary and specialty co-management. Many persons with SCD experience a poor quality of life, serious medical complications and frequent painful events that require treatment from SCD specialty care, primary care and emergency department (ED) providers. There are two dominating models of care in the United States; neither are ideal. Many people with SCD have all of their healthcare needs addressed by sickle cell specialists who do not typically provide primary care and are often geographically distant from the patients' home. Other sickle cell patients receive all of their care in EDs. Both models are inadequate and result in an alarmingly high number of ED visits for many patients. Current care models are neither cost efficient nor promoting optimal patient outcomes. To improve outcomes, the investigators will implement a new model of care for SCD using nurse care managers, web based-interactive algorithms, and test if additional patient provided coaching can improve outcomes.

Study Overview

• Status: Completed
• Conditions: Sickle Cell Disease

Detailed Description

To inform the model, the investigators will conduct an initial in-depth multi-level assessment of the barriers to care and implementation of the NHLBI "Evidence-Based Management of Sickle Cell Disease". With barriers and facilitators identified at the patient, provider, healthcare organization and community levels, the investigators will develop another study evaluation interventions that may improve the barriers.

• Study Type: Observational
• Enrollment (Actual): 213

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The target population includes 15-45 year olds with and SCD, parents of 15-20 year olds with SCD and healthcare providers of patients with SCD residing in 31 specified counties in Central North Carolina.

Description

Inclusion Criteria:

- SCD patients in the 31 geographic counties surrounding Duke with genotypes Hemoglobin SS, SC, Sβ° or, Sβ+.

and -Parents of 15-20 year old SCD patients in the 31 geographic counties surrounding Duke with genotypes Hemoglobin SS, SC, Sβ° or Sβ+.

and

-Healthcare providers of sickle cell patients in the 31 geographic counties surrounding Duke

Exclusion Criteria:

• Non-English speaking

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
SCD Adult Patients; Focus group or individual interview and survey
SCD Adolescent Patients; Focus group or individual interview and survey
SCD Healthcare Providers; Focus group or individual interview and survey
Parents of SCD Adolescents; Focus group or individual interview and survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Barriers to primary care as measured by Focus Groups./interviews	Qualitative analysis will be used to analyze interviews and focus groups.	60 Minutes after focus group or interview
Barriers to specialty care as measured by Focus Groups./interviews	Qualitative analysis will be used to analyze interviews and focus groups.	60 Minutes after focus group or interview
Barriers to ED care as measured by Focus Groups./interviews	Qualitative analysis will be used to analyze interviews and focus groups.	60 Minutes after focus group or interview
Barriers to primary care as measured by Survey	Descriptive statistics will be used to summarize the survey data.	Approximately 30-45 minutes
Barriers to specialty care as measured by Survey	Descriptive statistics will be used to summarize the survey data.	Approximately 30-45 minutes
Barriers to ED care as measured by Survey	Descriptive statistics will be used to summarize the survey data.	Approximately 30-45 minutes

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Paula Tanabe, PhD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2017
• Primary Completion (Actual): December 7, 2017
• Study Completion (Actual): December 7, 2017

Study Registration Dates

• First Submitted: December 14, 2016
• First Submitted That Met QC Criteria: January 27, 2017
• First Posted (Estimated): January 31, 2017

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Access to care; Primary care; Sickle Cell Disease; Needs Assessment; Barriers to care
• Additional Relevant MeSH Terms: Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Anemia, Sickle Cell
• Other Study ID Numbers: Pro00073506; 1U01HL133964-01 (U.S. NIH Grant/Contract)