Empowering Veterans to Communicate With Healthcare Providers

NCT ID: NCT03529071

Last Updated: 2022-03-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-17
• Study Completion Date: 2018-09-30

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:

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.

Conditions

Chronic Kidney Disease Stage 3

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

CKD-Question Prompt Sheet

Study participants will receive the CKD-QPS.

Group Type: EXPERIMENTAL

CKD-Question Prompt Sheet

Intervention Type: BEHAVIORAL

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.

Control

Individuals will not receive any intervention or surveys.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Edward Hines Jr. VA Hospital

FED

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Elisa Gordon

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elisa J Gordon, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Jesse Brown Veterans Affairs Medical Center

Chicago, Illinois, United States

Edward Hines, Jr. VA Hospital

Maywood, Illinois, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 27760524 (View on PubMed)

Other Identifiers

1212869-1

Identifier Type: -

Identifier Source: org_study_id