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

Sponsor
Carevive Systems, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04160442
Collaborator
(none)
46
1
137.4
0.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Carevive CarePlanning System
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
46 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Use of a Patient Preferences Shared Decision-Making Encounter Tool in Clinical Practice for Patients With DLBCL and FL
Actual Study Start Date :
Jan 16, 2009
Actual Primary Completion Date :
Jun 30, 2020
Actual Study Completion Date :
Jun 30, 2020

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alabama Birmingham Birmingham Alabama United States 35294

Sponsors and Collaborators

  • Carevive Systems, Inc.

Investigators

  • Principal Investigator: Debbie Wujcik, PhD,RN, Carevive Systems, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Carevive Systems, Inc.
ClinicalTrials.gov Identifier:
NCT04160442
Other Study ID Numbers:
  • 419 NHL SDM
First Posted:
Nov 13, 2019
Last Update Posted:
Dec 11, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 11, 2020