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

Sickle Cell Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03037021
• Other study ID #: Pro00073506
• Secondary ID: 1U01HL133964-01
• Status: Completed
• Start date: May 31, 2017
• Est. completion date: December 7, 2017

Study information

• Verified date: August 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: December 7, 2017
• Est. primary completion date: December 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 45 Years

Eligibility

Inclusion Criteria:

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

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

and

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

Exclusion Criteria:

• Non-English speaking

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Barriers to primary care as measured by Survey	Descriptive statistics will be used to summarize the survey data.	Approximately 30-45 minutes
Primary	Barriers to specialty care as measured by Survey	Descriptive statistics will be used to summarize the survey data.	Approximately 30-45 minutes
Primary	Barriers to ED care as measured by Survey	Descriptive statistics will be used to summarize the survey data.	Approximately 30-45 minutes