A Quality Improvement Approach to the Management of Chronic Lymphocytic Leukemia (Med-IQ CLL)

February 14, 2017 updated by: Duke University
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States
        • Duke Cancer Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Clinician education
Other: Education Intervention
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in provider knowledge with management of Quality of Life Concerns for CLL patients, as measured by survey
Time Frame: Baseline, 6 months
Baseline, 6 months
Change in provider confidence with management of Quality of Life Concerns for CLL patients, as measured by survey
Time Frame: Baseline, 6 months
Baseline, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Gilead Sciences
Genentech, Inc.
Med-IQ

Investigators

  • Principal Investigator: Linda Sutton, MD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

November 30, 2015

First Submitted That Met QC Criteria

November 30, 2015

First Posted (Estimate)

December 2, 2015

Study Record Updates

Last Update Posted (Actual)

February 15, 2017

Last Update Submitted That Met QC Criteria

February 14, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00063975

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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