Use of a Patient Preferences Shared Decision-Making Encounter Tool in Clinical Practice for Patients With DLBCL and FL
Primary Purpose
Diffuse Large B Cell Lymphoma, Follicular Lymphoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Carevive CarePlanning System
Sponsored by
About this trial
This is an interventional health services research trial for Diffuse Large B Cell Lymphoma
Eligibility Criteria
Inclusion Criteria:
- All participants must be 18 years of age or older.
- Patient participants must have a diagnosis of new or recurrent DLBCL or FL
- All participants must be able to understand English.
Exclusion Criteria:
- Any patient who cannot understand written or spoken English.
- Any prisoner and/or other vulnerable persons as defined by NIH (45 CFR 46, Subpart B, C and D).
Sites / Locations
- University of Alabama Birmingham
Outcomes
Primary Outcome Measures
Satisfaction of using the Carevive treatment planning system in shared decision making will be collected from both patient and provider perspectives: questionnaires
patient and providers will complete questionnaires at each clinic visit. These questions will determine their satisfaction with the treatment care planning system.
Secondary Outcome Measures
Evaluation of patient satisfaction and perceived shared decision making utilizing surveys at each clinic visit
Questionnaires answering questions regarding patient satisfaction with the treatment decision, patient activation, and patient perceived achievement of desired role in shared decision making following the technology-facilitated SDM intervention and compare differences in scores between the enrolled subjects. These surveys are part of the Carevive treatment planning platform and collect the information at each clinic visit.
Full Information
NCT ID
NCT04160442
First Posted
November 1, 2019
Last Updated
December 10, 2020
Sponsor
Carevive Systems, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04160442
Brief Title
Use of a Patient Preferences Shared Decision-Making Encounter Tool in Clinical Practice for Patients With DLBCL and FL
Official Title
Use of a Patient Preferences Shared Decision-Making Encounter Tool in Clinical Practice for Patients With DLBCL and FL
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
January 16, 2009 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carevive Systems, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this project is to test the feasibility of a Patient Preferences in Shared Decision-Making encounter tool (PPSDM) in the clinical context of Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL). This project will evaluate the feasibility of a shared decision-making (SDM) model that employs an "encounter tool"1 to facilitate SDM at the point of a treatment decision for patients with DLBCL and FL.
Detailed Description
This project is a single-arm pilot project conducted with 90 patients with newly diagnosed or recurrent DLBCL or FL and their providers at three medical oncology practices. Utilizing the PPSDM tool in the Carevive electronic platform, patients will report their needs, preferences, values and goal prior to the treatment decision-making focused clinical encounter. The treating provider will receive the patient results prior to the visit and can use these to facilitate SDM in treatment selection during the clinical encounter. Post-encounter, patients and providers will complete measures designed to assess feasibility and utility of SDM intervention. Patients will also complete measures to assess patient satisfaction with the treatment decision, patient activation, and patient perceived achievement of desired role in shared decision making and satisfaction with care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B Cell Lymphoma, Follicular Lymphoma
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
46 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Carevive CarePlanning System
Intervention Description
Subject will complete brief survey prior to seeing provider in clinic. Utilizing the CarePlanning System, the provider will review the subject's responses directing the conversation and treatment decision will be made. A treatment careplan will be developed and given to the subject.
Primary Outcome Measure Information:
Title
Satisfaction of using the Carevive treatment planning system in shared decision making will be collected from both patient and provider perspectives: questionnaires
Description
patient and providers will complete questionnaires at each clinic visit. These questions will determine their satisfaction with the treatment care planning system.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Evaluation of patient satisfaction and perceived shared decision making utilizing surveys at each clinic visit
Description
Questionnaires answering questions regarding patient satisfaction with the treatment decision, patient activation, and patient perceived achievement of desired role in shared decision making following the technology-facilitated SDM intervention and compare differences in scores between the enrolled subjects. These surveys are part of the Carevive treatment planning platform and collect the information at each clinic visit.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All participants must be 18 years of age or older.
Patient participants must have a diagnosis of new or recurrent DLBCL or FL
All participants must be able to understand English.
Exclusion Criteria:
Any patient who cannot understand written or spoken English.
Any prisoner and/or other vulnerable persons as defined by NIH (45 CFR 46, Subpart B, C and D).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Debbie Wujcik, PhD,RN
Organizational Affiliation
Carevive Systems, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Use of a Patient Preferences Shared Decision-Making Encounter Tool in Clinical Practice for Patients With DLBCL and FL
We'll reach out to this number within 24 hrs