Clinical trial NCT03529071: Empowering Veterans to Communicate With Healthcare Providers
Official title: Empowering Veterans to Communicate With Healthcare Providers to Improve CKD Care
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Kidney Disease Stage 3
Keywords: communication
patient activation
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Edward Hines Jr. VA Hospital
First posted: 2018-05-18
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be provided with a Question Prompt Sheet to use at their nephrology clinic visit.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Perceived efficacy in patient-physician interaction (PEPPI)
timeFrame: up to 2 days
Secondary outcomes:
measure: # Question Prompt Sheet (QPS) Questions Asked
timeFrame: 1 day
measure: Short-form patient satisfaction questionnaire (PSQ-18)
timeFrame: up to 2 days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Jesse Brown Veterans Affairs Medical Center
state: Illinois
city: Maywood
country: United States
facility: Edward Hines, Jr. VA Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: Elisa J Gordon, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.