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Empowering Veterans to Communicate With Healthcare Providers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03529071
Recruitment Status : Completed
First Posted : May 18, 2018
Last Update Posted : August 28, 2019
Sponsor:
Collaborator:
Edward Hines Jr. VA Hospital
Information provided by (Responsible Party):
Elisa Gordon, Northwestern University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Stage 3 Behavioral: CKD-Question Prompt Sheet Not Applicable

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:

  1. 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.
  2. 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.
  3. 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be provided with a Question Prompt Sheet to use at their nephrology clinic visit.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Empowering Veterans to Communicate With Healthcare Providers to Improve CKD Care
Actual Study Start Date : September 17, 2018
Actual Primary Completion Date : September 30, 2018
Actual Study Completion Date : September 30, 2018
Arms and Interventions
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Arm Intervention/treatment
Experimental: CKD-Question Prompt Sheet
Study participants will receive the CKD-QPS.
 Behavioral: CKD-Question Prompt Sheet
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.
No Intervention: Control
Individuals will not receive any intervention or surveys.


Outcome Measures
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Primary Outcome Measures :
  1. Perceived efficacy in patient-physician interaction (PEPPI) [ Time Frame: up to 2 days ]
    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 :
  1. # Question Prompt Sheet (QPS) Questions Asked [ Time Frame: 1 day ]
    Number of questions from the QPS that were asked during the clinic encounter.

  2. Short-form patient satisfaction questionnaire (PSQ-18) [ Time Frame: up to 2 days ]

    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.



Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03529071


Locations
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United States, Illinois
Jesse Brown Veterans Affairs Medical Center
Chicago, Illinois, United States, 60611
Edward Hines, Jr. VA Hospital
Maywood, Illinois, United States, 60141
Sponsors and Collaborators
Northwestern University
Edward Hines Jr. VA Hospital
Investigators
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Principal Investigator: Elisa J Gordon, PhD, MPH Northwestern University
More Information
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Publications:

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Responsible Party: Elisa Gordon, Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT03529071    
Other Study ID Numbers: 1212869-1
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elisa Gordon, Northwestern University:
communication
patient activation
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency