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Empowering Veterans to Communicate With Healthcare Providers

Primary Purpose

Chronic Kidney Disease Stage 3

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CKD-Question Prompt Sheet
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Kidney Disease Stage 3 focused on measuring communication, patient activation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adult (age 18+) English-speaking CKD patients stage 3 (eGFR = 30-70 mL/min) who are scheduled for a clinic visit will be eligible for participation.

    1. Up to 60 will receive the QPS and all data collection activities
    2. Up to 10 will be audio recorded only
  2. Nephrologists (or Nurse Practitioners or Physician Assistants) seeing CKD patients in routine clinic visits will be eligible for participation at Hines, VA.

Exclusion Criteria:

1. CKD patients who are non-English speaking, blind, hard of hearing or deaf, unable to read, and/or who are cognitively impaired will not be eligible for participation.

Sites / Locations

  • Jesse Brown Veterans Affairs Medical Center
  • Edward Hines, Jr. VA Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CKD-Question Prompt Sheet

Control

Arm Description

Study participants will receive the CKD-QPS.

Individuals will not receive any intervention or surveys.

Outcomes

Primary Outcome Measures

Perceived efficacy in patient-physician interaction (PEPPI)
This measure, the full name of which is provided above, assesses patients' perceived self-efficacy or confidence in interacting with physicians. It includes 5 items, each of which is anchored by 1 (not at all confident) and 5 (very confident). Scores range from 5 to 25, which higher scores indicating greater confidence.

Secondary Outcome Measures

# Question Prompt Sheet (QPS) Questions Asked
Number of questions from the QPS that were asked during the clinic encounter.
Short-form patient satisfaction questionnaire (PSQ-18)
This measure assesses patients' perceptions of satisfaction in interacting with healthcare providers. It includes 18 items, each of which is anchored by 1 (strongly agree) and 5 (strongly disagree). Scores range from 18 to 90, which lower scores indicating greater satisfaction with medical care.

Full Information

First Posted
April 20, 2018
Last Updated
March 3, 2022
Sponsor
Northwestern University
Collaborators
Edward Hines Jr. VA Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03529071
Brief Title
Empowering Veterans to Communicate With Healthcare Providers
Official Title
Empowering Veterans to Communicate With Healthcare Providers to Improve CKD Care
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
Unable to recruit enough participants due to limited grant funding.
Study Start Date
September 17, 2018 (Actual)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
Edward Hines Jr. VA Hospital

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 VA Innovation Seed project is to test the best approach for the delivery, feasibility, and usability of a patient-centered CKD-QPS to facilitate better Veteran understanding and engagement in their CKD-care in nephrology clinics at two geographically distinct VA hospitals (Chicago and Dallas) through on-going user feedback in real time.
Detailed Description
The goal of this VA Innovation Seed project is to test the best approach for the delivery, feasibility, and usability of a patient-centered CKD-QPS to facilitate better Veteran understanding and engagement in their CKD-care in nephrology clinics at two geographically distinct VA hospitals (Chicago and Dallas) through on-going user feedback in real time. Specifically, the pilot goals are to: Test the process of delivering the CKD-QPS into clinical workflow to optimize patient and provider use of the QPS. We will rely on user (patient and provider) feedback about the feasibility of using the QPS in a real world VA environment (e.g., time required for visits using the QPS, impact on clinical workflow, patient and providers' preferences for delivering the QPS to Veterans with CKD) to adjust delivery throughout the project period. Obtain continuous provider and patient feedback during the project period about QPS feasibility, use, patient participation, and provider information-giving and encouragement of question-asking during outpatient clinic visits. Test how well iterative adjustments to delivery can help improve CKD-QPS patient-reported outcome measures (e.g., satisfaction with provider). The multi-site study will take place at Hines, VA, and at VA North Texas Health System, in Dallas, TX. The intervention entails providing the CKD-Question Prompt Sheet to patients to use during patient-nephrologist (or Nurse Practitioner or Physician Assistant) clinic visits. The CKD-QPS is a 31-item list of questions about treatment options for CKD. The QPS is designed to empower patients to ask questions by reminding them of questions that they may consider asking. Data collection entails pre-post clinic visit surveys among CKD patients, a post-clinic interview with CKD patients and nephrologists (separately), and audio-recording the clinic visit. The knowledge gained from this study may improve other patients' satisfaction with care and communication with providers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease Stage 3
Keywords
communication, patient activation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be provided with a Question Prompt Sheet to use at their nephrology clinic visit.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CKD-Question Prompt Sheet
Arm Type
Experimental
Arm Description
Study participants will receive the CKD-QPS.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Individuals will not receive any intervention or surveys.
Intervention Type
Behavioral
Intervention Name(s)
CKD-Question Prompt Sheet
Intervention Description
The CKD-QPS is a list of 31 questions specific to CKD stage 3 patients about treatment options and self-care management designed to activate patient communication with their providers and question-asking.
Primary Outcome Measure Information:
Title
Perceived efficacy in patient-physician interaction (PEPPI)
Description
This measure, the full name of which is provided above, assesses patients' perceived self-efficacy or confidence in interacting with physicians. It includes 5 items, each of which is anchored by 1 (not at all confident) and 5 (very confident). Scores range from 5 to 25, which higher scores indicating greater confidence.
Time Frame
up to 2 days
Secondary Outcome Measure Information:
Title
# Question Prompt Sheet (QPS) Questions Asked
Description
Number of questions from the QPS that were asked during the clinic encounter.
Time Frame
1 day
Title
Short-form patient satisfaction questionnaire (PSQ-18)
Description
This measure assesses patients' perceptions of satisfaction in interacting with healthcare providers. It includes 18 items, each of which is anchored by 1 (strongly agree) and 5 (strongly disagree). Scores range from 18 to 90, which lower scores indicating greater satisfaction with medical care.
Time Frame
up to 2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult (age 18+) English-speaking CKD patients stage 3 (eGFR = 30-70 mL/min) who are scheduled for a clinic visit will be eligible for participation. Up to 60 will receive the QPS and all data collection activities Up to 10 will be audio recorded only Nephrologists (or Nurse Practitioners or Physician Assistants) seeing CKD patients in routine clinic visits will be eligible for participation at Hines, VA. Exclusion Criteria: 1. CKD patients who are non-English speaking, blind, hard of hearing or deaf, unable to read, and/or who are cognitively impaired will not be eligible for participation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisa J Gordon, PhD, MPH
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jesse Brown Veterans Affairs Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Edward Hines, Jr. VA Hospital
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60141
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27760524
Citation
Lederer S, Fischer MJ, Gordon HS, Wadhwa A, Popli S, Gordon EJ. A question prompt sheet for adult patients with chronic kidney disease. BMC Nephrol. 2016 Oct 19;17(1):155. doi: 10.1186/s12882-016-0362-z.
Results Reference
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Empowering Veterans to Communicate With Healthcare Providers

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