Use of a Patient Preferences Shared Decision-Making Encounter Tool in Clinical Practice for Patients With DLBCL and FL

Not Applicable

Completed

• Conditions: Diffuse Large B Cell Lymphoma; Follicular Lymphoma

• Registration Number: NCT04160442
• Lead Sponsor: Carevive Systems, Inc.

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.

Study Timeline

• Study Start: 2009-01-16
• Study First Submitted: 2019-11-01
• Study First Submitted QC: 2019-11-12
• Study First Posted: 2019-11-13
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-10
• Last Update Posted: 2020-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Satisfaction of using the Carevive treatment planning system in shared decision making will be collected from both patient and provider perspectives: questionnaires	3 months	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

Name	Time	Method
Evaluation of patient satisfaction and perceived shared decision making utilizing surveys at each clinic visit	3 months	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.

Trial Locations

Locations (1)

University of Alabama Birmingham; 🇺🇸 Birmingham, Alabama, United States