A Quality Improvement Approach to the Management of Chronic Lymphocytic Leukemia (Med-IQ CLL)
Primary Purpose
Chronic Lymphocytic Leukemia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Education Intervention
Sponsored by
About this trial
This is an interventional health services research trial for Chronic Lymphocytic Leukemia
Eligibility Criteria
Inclusion Criteria: Clinician
- Participant must be a hematologist, oncologist, nurse practitioner, or physician assistant who practices medicine in the Duke Cancer Network
- Participant treats patients with CLL
- Participant is willing to participate in the educational component of this project
Inclusion Criteria: Patient
- Patient has a diagnosis of Chronic Lymphocytic Leukemia
- Patient is over the age of 18
- Patient is being treated at a Duke Cancer Network affiliate site,
- Patient is expected to see their physician or another member of their care team at least 3 times annually.
- Signed informed consent
Exclusion Criteria: Clinician
- None
Exclusion Criteria: Patient
- Patient is Non-English speaking
- Patient diagnosed with CLL < 60 days ago
Sites / Locations
- Duke Cancer Network
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Clinician education
Arm Description
Outcomes
Primary Outcome Measures
Change in provider knowledge with management of Quality of Life Concerns for CLL patients, as measured by survey
Change in provider confidence with management of Quality of Life Concerns for CLL patients, as measured by survey
Secondary Outcome Measures
Full Information
NCT ID
NCT02619604
First Posted
November 30, 2015
Last Updated
February 14, 2017
Sponsor
Duke University
Collaborators
Med-IQ, Gilead Sciences, Genentech, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02619604
Brief Title
A Quality Improvement Approach to the Management of Chronic Lymphocytic Leukemia
Acronym
Med-IQ CLL
Official Title
A Quality Improvement Approach to the Management of Chronic Lymphocytic Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Med-IQ, Gilead Sciences, Genentech, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This project addresses the need to improve physician knowledge and clinical practice patterns related to quality of life (QoL) concerns for patients with chronic lymphocytic leukemia (CLL).
Detailed Description
This multifaceted initiative will include evaluating patient perspectives on their QoL, evaluating provider perspectives on managing QoL, and providing education to the whole CLL care team (hematologists/oncologists, nurse practitioners, physician assistants, and nurses) on contemporary approaches for individualized, patient-centered management of CLL. Providers, including physicians, nurse practitioners, and physician assistants will participate in educational initiatives geared towards enhancing their knowledge and confidence with managing QoL concerns for patients with CLL. Pre and post surveys will be conducted with providers to evaluate change in these areas. The project aims to train this team on how to enhance communication with patients and caregivers as a means to increase patient engagement in care and QoL in this population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Clinician education
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Education Intervention
Intervention Description
Education interventions will be delivered sporadically within the 6-month window between the time the clinician completes the pre-survey and when he/she completes the post-survey. Interventions consist of e-brief publications, teleconferences with project faculty, and evidence based resources.
Primary Outcome Measure Information:
Title
Change in provider knowledge with management of Quality of Life Concerns for CLL patients, as measured by survey
Time Frame
Baseline, 6 months
Title
Change in provider confidence with management of Quality of Life Concerns for CLL patients, as measured by survey
Time Frame
Baseline, 6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinician
Participant must be a hematologist, oncologist, nurse practitioner, or physician assistant who practices medicine in the Duke Cancer Network
Participant treats patients with CLL
Participant is willing to participate in the educational component of this project
Inclusion Criteria: Patient
Patient has a diagnosis of Chronic Lymphocytic Leukemia
Patient is over the age of 18
Patient is being treated at a Duke Cancer Network affiliate site,
Patient is expected to see their physician or another member of their care team at least 3 times annually.
Signed informed consent
Exclusion Criteria: Clinician
None
Exclusion Criteria: Patient
Patient is Non-English speaking
Patient diagnosed with CLL < 60 days ago
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda Sutton, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Cancer Network
City
Durham
State/Province
North Carolina
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Quality Improvement Approach to the Management of Chronic Lymphocytic Leukemia
We'll reach out to this number within 24 hrs