Patient Initiated Note About Goals (PING)
Primary Purpose
Chronic Disease
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PING
Sponsored by
About this trial
This is an interventional health services research trial for Chronic Disease
Eligibility Criteria
Inclusion Criteria: Patient referred for Annual Wellness Visit at participating clinic Exclusion Criteria: Non-English speaking
Sites / Locations
- Duke HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment
Control
Arm Description
Patients receive PING administered by RN
Usual care
Outcomes
Primary Outcome Measures
Number of participants with subsequent goals of care conversation
Conversation documented in EHR (electronic health record)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05637489
Brief Title
Patient Initiated Note About Goals
Acronym
PING
Official Title
Patient Initiated Note About Goals
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
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
This is a randomized controlled trial of the Patient-Initiated Note about Goals (PING).
Detailed Description
The PING is a brief survey designed to elicit patients' goals, preferences, and preferred surrogate decision-maker. In the PING study, patients will be assigned to receive either a nurse-administered PING or usual care. Outcomes include PING completion, subsequent goals of care conversations with providers, and healthcare utilization.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel RCT
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Patients receive PING administered by RN
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Behavioral
Intervention Name(s)
PING
Intervention Description
Brief survey of goals and preferences
Primary Outcome Measure Information:
Title
Number of participants with subsequent goals of care conversation
Description
Conversation documented in EHR (electronic health record)
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient referred for Annual Wellness Visit at participating clinic
Exclusion Criteria:
Non-English speaking
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David J Casarett, MD
Phone
9196687215
Email
david.casarett@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David J Casarett, MD
Organizational Affiliation
Duke Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Health
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David J Casarett, MD
Phone
919-668-7215
Email
david.casarett@duke.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Patient Initiated Note About Goals
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