Enhanced Kidney Follow-up for AKI Survivors in Care Transitions

Enhanced Kidney Follow-up for AKI Survivors in Care Transitions (The ACT Study): Impact on Patient Reported Outcomes

The purpose of this study is to assess the ability of education and outpatient kidney care follow-up in order to improve patient knowledge about acute kidney injury (AKI).

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Behavioral: Education; Behavioral: Education and follow-up

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

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:

• KDIGO Stage 3 AKI
• Primary care provider at Mayo Rochester.

Exclusion Criteria:

• Patient with need for dialysis at discharge from hospital or hospice.
• Enrolled in the Primary Care Transition Program.
• Non-English speaking.
• Cognitive impairment.
• Dementia.
• Mini-Cog score of less than 3.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care
Active Comparator: Education alone	Behavioral: Education; Kidney health education will be delivered prior to discharge by trained nurse educators.
Active Comparator: Education and follow-up	Behavioral: Education and follow-up; In patients allocated to the education and follow-up arm, education along with a a post-discharge healthcare visit from a multidisciplinary care team will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Kidney Knowledge Survey (mKIKS)	Assesses participants' objective knowledge about AKI causes, risk factors, and management. The minimum score is 0, maximum score is 15, higher scores indicate greater knowledge.	14-days after last study contact

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brief health literacy screen	A 4-item tool to assess health literacy. Minimum score of 0, maximum score 20, higher scores indicate higher health literacy	30-days post hospitalization
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health 10	Based on the provided responses, an overall summary score, and two subset scores - Global health physical and Global health mental can be calculated. Raw summed score are converted into T-scores. Higher scores indicate better health.	30-days post hospitalization

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Erin F Barreto, PharmD, RPh, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2020
• Primary Completion (Actual): December 21, 2021
• Study Completion (Actual): December 21, 2021

Study Registration Dates

• First Submitted: August 4, 2020
• First Submitted That Met QC Criteria: August 6, 2020
• First Posted (Actual): August 10, 2020

Study Record Updates

• Last Update Posted (Actual): January 5, 2022
• Last Update Submitted That Met QC Criteria: January 3, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: chronic kidney disease; acute kidney injury; transitions of care; education; patient reported outcomes
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: 20-004204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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