NCT03529071

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 18, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

September 17, 2018

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

March 18, 2022

Status Verified

March 1, 2022

Enrollment Period

13 days

First QC Date

April 20, 2018

Last Update Submit

March 3, 2022

Conditions

Keywords

communicationpatient activation

Outcome Measures

Primary Outcomes (1)

  • 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.

    up to 2 days

Secondary Outcomes (2)

  • # Question Prompt Sheet (QPS) Questions Asked

    1 day

  • Short-form patient satisfaction questionnaire (PSQ-18)

    up to 2 days

Study Arms (2)

CKD-Question Prompt Sheet

EXPERIMENTAL

Study participants will receive the CKD-QPS.

Behavioral: CKD-Question Prompt Sheet

Control

NO INTERVENTION

Individuals will not receive any intervention or surveys.

Interventions

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.

CKD-Question Prompt Sheet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jesse Brown Veterans Affairs Medical Center

Chicago, Illinois, 60611, United States

Location

Edward Hines, Jr. VA Hospital

Maywood, Illinois, 60141, United States

Location

Related Publications (1)

  • 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.

    PMID: 27760524BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, ChronicCommunicationPatient Participation

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehaviorPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Study Officials

  • Elisa J Gordon, PhD, MPH

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Participants will be provided with a Question Prompt Sheet to use at their nephrology clinic visit.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 20, 2018

First Posted

May 18, 2018

Study Start

September 17, 2018

Primary Completion

September 30, 2018

Study Completion

September 30, 2018

Last Updated

March 18, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations