COordiNated CommuNication, Education, and Care Transitions After Acute Kidney Injury (CONNECT-AKI)- A Pilot Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AKI Discharge Summary Template, Chat-Based Educational Messaging Program.
- Who it may be relevant to
- Registry conditions: Acute Kidney Injury, Acute Kidney Injury (AKI). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
CONNECT-AKI: COordiNated CommuNication, Education, and Care Transitions After Acute Kidney Injury - A Pilot Randomized Controlled Trial
Overview
The goal of this clinical trial is to learn whether different ways of providing information and follow-up support after acute kidney injury, also called AKI, can improve care transitions for adults being discharged from the hospital. AKI is a sudden decrease in kidney function that can occur during a hospital stay. The main questions this study aims to answer are: * Does an AKI discharge summary template improve communication about AKI after hospital discharge? * Does a chat-based educational messaging program improve patient understanding of AKI and support follow-up care after hospital discharge? * Researchers will compare usual care, an AKI discharge summary template, a chat-based educational messaging program, and the combination of the discharge summary template plus chat-based messaging. Researchers will compare four groups: * Usual care * An AKI discharge summary template * A chat-based educational messaging program * Both the AKI discharge summary template and the chat-based educational messaging program Participants will complete questionnaires at the start of the study and about 4 weeks after hospital discharge. Participants will also receive a brief phone call about 3 months after discharge, and the research team will review their medical record for information about follow-up care, lab testing, emergency department visits, and hospital readmissions.
Detailed description
Acute kidney injury, also called AKI, is a common complication during hospitalization and is associated with increased risk of poor outcomes after discharge, including incomplete kidney recovery, medication-related safety concerns, emergency department visits, and hospital readmissions. Despite these risks, information about AKI and recommended follow-up care may not always be communicated clearly to patients or outpatient clinicians during the transition from hospital to home.
This pilot randomized clinical trial will evaluate the feasibility and preliminary effects of two care transition strategies for adults hospitalized with AKI. The strategies include an AKI discharge summary template designed to improve communication with outpatient clinicians, and a chat-based educational messaging program designed to provide patients with AKI-related information after discharge.
Participants will be assigned to one of four study groups: usual care, the AKI discharge summary template, the chat-based educational messaging program, or both the discharge summary template and chat-based messaging. The study will assess whether these strategies are feasible to deliver and acceptable to participants, and whether they improve patient knowledge, perceived preparedness, communication about AKI, and completion of recommended follow-up care after hospital discharge.
Participants will complete study questionnaires and allow the research team to review their medical records for information related to kidney function monitoring, follow-up care, emergency department visits, and hospital readmissions. The results of this pilot study will help inform the design of a larger future trial to improve care transitions for patients recovering from AKI.
Interventions
- Behavioral AKI Discharge Summary Template
The AKI discharge summary template provides structured AKI-related information for the hospital discharge summary, including information about the AKI episode and recommended follow-up care. The template is intended to improve communication during the transition from hospital to outpatient care. - Behavioral Chat-Based Educational Messaging Program
The chat-based educational messaging program provides AKI-related educational messages after hospital discharge. Messages are delivered through a secure web-based chat-style interface and are designed to support patient understanding of AKI, post-discharge follow-up, and kidney-related care after hospitalization.
Primary outcome measures
- Feasibility: Eligible patient enrollment [Time frame: Enrollment period]
- Feasibility: Participant retention [Time frame: Baseline to 3 months after discharge]
- Feasibility: Successful delivery of assigned intervention components [Time frame: Hospital discharge through 4 weeks after discharge]
Secondary outcome measures (5)
- AKI Knowledge Score [Time frame: 4 weeks after hospital discharge]
- Patient experience during care transitions [Time frame: 4 weeks after hospital discharge]
- Self-management behaviors related to kidney health [Time frame: 4 weeks after hospital discharge]
- Adherence to outpatient follow-up appointments [Time frame: 4 weeks after hospital discharge, and 3 months after hospital discharge]
- Patient-reported discussion of AKI with outpatient provider [Time frame: 4 weeks after hospital discharge]
Eligibility criteria
Inclusion criteria
- Age 18 years or older
- Hospitalized with Stage 2 or Stage 3 acute kidney injury
- Kidney function has not returned to baseline at the time of hospital discharge
- Able to communicate in English
- Able to provide informed consent
- Willing and able to participate in study procedures independently or with assistance from a patient-designated care partner
Exclusion criteria
- Acute kidney injury requiring ongoing dialysis at the time of hospital discharge
- End-stage kidney disease
- Kidney transplant recipient
- Currently pregnant
- Documented cognitive impairment that precludes informed consent
- Receiving hospice or comfort-focused end-of-life care
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Wright JA, Wallston KA, Elasy TA, Ikizler TA, Cavanaugh KL. Development and results of a kidney disease knowledge survey given to patients with CKD. Am J Kidney Dis. 2011 Mar;57(3):387-95. doi: 10.1053/j.ajkd.2010.09.018. Epub 2010 Dec 18. PMID 21168943
- Coleman EA, Mahoney E, Parry C. Assessing the quality of preparation for posthospital care from the patient's perspective: the care transitions measure. Med Care. 2005 Mar;43(3):246-55. doi: 10.1097/00005650-200503000-00007. PMID 15725981
- Piette JD, Striplin D, Marinec N, Chen J, Trivedi RB, Aron DC, Fisher L, Aikens JE. A Mobile Health Intervention Supporting Heart Failure Patients and Their Informal Caregivers: A Randomized Comparative Effectiveness Trial. J Med Internet Res. 2015 Jun 10;17(6):e142. doi: 10.2196/jmir.4550. PMID 26063161
- Li WY, Chiu FC, Zeng JK, Li YW, Huang SH, Yeh HC, Cheng BW, Yang FJ. Mobile Health App With Social Media to Support Self-Management for Patients With Chronic Kidney Disease: Prospective Randomized Controlled Study. J Med Internet Res. 2020 Dec 15;22(12):e19452. doi: 10.2196/19452. PMID 33320101
- Hall AK, Cole-Lewis H, Bernhardt JM. Mobile text messaging for health: a systematic review of reviews. Annu Rev Public Health. 2015 Mar 18;36:393-415. doi: 10.1146/annurev-publhealth-031914-122855. PMID 25785892
- Lopez-Vargas PA, Tong A, Howell M, Craig JC. Educational Interventions for Patients With CKD: A Systematic Review. Am J Kidney Dis. 2016 Sep;68(3):353-70. doi: 10.1053/j.ajkd.2016.01.022. Epub 2016 Mar 26. PMID 27020884
- Robelia PM, Kashiwagi DT, Jenkins SM, Newman JS, Sorita A. Information Transfer and the Hospital Discharge Summary: National Primary Care Provider Perspectives of Challenges and Opportunities. J Am Board Fam Med. 2017 Nov-Dec;30(6):758-765. doi: 10.3122/jabfm.2017.06.170194. PMID 29180550
- Howard SJ, Elvey R, Ohrnberger J, Turner AJ, Anselmi L, Martindale AM, Blakeman T. Post-discharge care following acute kidney injury: quality improvement in primary care. BMJ Open Qual. 2020 Dec;9(4):e000891. doi: 10.1136/bmjoq-2019-000891. PMID 33328317
Identifiers
NCT: NCT07626268 · 26-0133 · K23DK132459