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

NCT03037021 | Completed

• 2 other identifiers: Pro000735061U01HL133964-01
• Study Type: observational
• Target: 213
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sickle Cell Disease

Keywords

Sickle Cell Disease; Needs Assessment; Barriers to care; Access to care; Primary care

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (4)

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

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• \- 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

You may not qualify if:

• Non-English speaking

Sponsors & Collaborators

• Duke University: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Paula Tanabe, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: January 31, 2017
• Study Start: May 31, 2017
• Primary Completion: December 7, 2017
• Study Completion: December 7, 2017
• Last Updated: November 1, 2023

Record last verified: 2018-08

Locations

US (1)