Understanding the Role of Patient Behavior Change in Improving AKI Outcomes (Change AKI)

Understanding the Role of Patient Behavior Change in Improving AKI Outcomes (Change AKI Study)

This study is looking to improve the safety of patients with acute kidney injury via education provided on a mobile tablet. This study will additionally examine if electronic tools, such as mobile tablets, can help.

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Other: mHealth tool

Detailed Description

Acute kidney injury (AKI) is an increasingly common complication of acute hospitalizations. Hospital-related AKI, commonly caused by hemodynamic changes or contrast exposure, carries a threat of adverse outcomes that persists following hospital discharge, with an independent and graded association with long-term mortality. It is estimated that, approximately 13% of individuals with acute coronary syndrome (ACS) will develop some degree of AKI during their hospitalization. Survivors of AKI consume significantly greater health resources than the general population, and suffer exceedingly poor renal outcomes, including persistent loss of kidney function, progression to end stage renal disease (ESRD), and increased risk of recurrent AKI. It is estimated that 25% of individuals with an AKI-related hospitalization will be readmitted with recurrent AKI within 12 months of discharge, highlighting a critical need to address ongoing AKI risk once the acute hospitalization is complete. Patient-centered educational interventions that intensify awareness of potentially hazardous situations may reduce AKI recurrence. For example, commonly prescribed therapies such as diuretics or ACE inhibitors may threaten the renal safety of individuals at high risk of recurrent AKI if taken when significantly volume deplete, such as during an acute gastroenteritis, and in most cases should be held until one can eat and drink normally; Nonsteroidal Anti-inflammatory Drugs (NSAIDs) may exacerbate AKI risk if taken in combination with diuretics or ACE inhibitors even when volume replete and should be completely avoided. Tailored educational curricula surrounding these and other topics pertinent to AKI survivors may reduce recurrent hospitalizations and lower healthcare costs. In the absence of a patient centered outpatient approach to AKI education, the development of effective and sustainable AKI prevention strategies remains unlikely.

Our long-term goal is to develop patient-centered educational materials to reduce AKI recurrence. We hypothesize that a tailored educational curriculum will improve patient awareness of potential hazards and reduce AKI recurrence among hospital-based AKI survivors. Therefore, our overall objective for this proposal is to pilot test and evaluate the feasibility of a patient-centered mobile health (mHealth) educational curriculum for hospitalized AKI survivors at Duke Medical Center.

Aim 1: To test the feasibility and acceptance of a mHealth patient safety curriculum in hospitalized AKI survivors.

Hypothesis 1: Patient safety risk awareness at 1 month will be higher in the educational intervention arm than the usual care arm.

Aim 2: To determine if a mHealth educational curriculum improves patient safety behaviors in AKI survivors.

Hypothesis 2: High-risk safety behaviors will be reduced at 1 month in AKI survivors receiving the educational intervention, but not in the usual care arm.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of acute kidney injury as diagnosed by renal care team
• On medical or surgical services
• Over 18 year of age
• Ability to read and speak English

Exclusion Criteria:

• Legal blindness or deafness
• Pregnant
• Cognitive impairment that limits ability to consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Care; Complete a survey asking about kidney function and participant demographics.; Receive a one-month follow-up call (one month after hospital discharge date) and complete a phone survey about patient kidney function after discharge
Experimental: mHealth Tool; Complete a survey asking about kidney function and participant demographics.; Review a 15-20 minute educational tool on a tablet about kidney health; Receive a one-month follow-up call (one month after hospital discharge date) and complete a phone survey about patient kidney function after discharge	Other: mHealth tool; The curriculum in the mHealth tool was derived in consultation with patient safety, informatics and adult educational curricula experts, and is comprised of clinical vignettes describing the post-hospital discharge stories of two hypothetical AKI survivors. opics of emphasis included NSAID risk awareness and avoidance of volume depletion when ill ("Sick Day Protocol").

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Patient Safety-Related Knowledge (Patient safety risk awareness)	mHealth tool and how knowledge changes pre/post intervention	Baseline, 1 month
Change in Patient Safety Behavior and Risk awareness	Survey assessing patient safety behavior and risk awareness	Baseline, 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
User Satisfaction	Satisfaction of mHealth tool	5 minutes

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Clarissa J Diamantidis, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2017
• Primary Completion (Actual): August 27, 2018
• Study Completion (Actual): August 27, 2018

Study Registration Dates

• First Submitted: April 11, 2017
• First Submitted That Met QC Criteria: April 13, 2017
• First Posted (Actual): April 14, 2017

Study Record Updates

• Last Update Posted (Actual): December 13, 2018
• Last Update Submitted That Met QC Criteria: December 12, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: Pro00080287

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We are not sharing IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No