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

Sponsor

Duke University (Other)

Overall Status

Completed

CT.gov ID

NCT03037021

Collaborator

National Institutes of Health (NIH) (NIH), National Heart, Lung, and Blood Institute (NHLBI) (NIH)

213

Enrollment

Location

6.2

Actual Duration (Months)

34.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Actual Enrollment :

213 participants

Observational Model:

Other

Time Perspective:

Prospective

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

Actual Study Start Date :

May 31, 2017

Actual Primary Completion Date :

Dec 7, 2017

Actual Study Completion Date :

Dec 7, 2017

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University	Durham	North Carolina	United States	27710

Sponsors and Collaborators

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

Investigators

Principal Investigator: Paula Tanabe, PhD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Duke University

ClinicalTrials.gov Identifier:

NCT03037021

Other Study ID Numbers:

Pro00073506
1U01HL133964-01

First Posted:

Jan 31, 2017

Last Update Posted:

Aug 8, 2018

Last Verified:

Aug 1, 2018

Keywords provided by Duke University

Additional relevant MeSH terms:

Anemia, Sickle Cell

Study Results

No Results Posted as of Aug 8, 2018