COordiNated CommuNication, Education, and Care Transitions After Acute Kidney Injury (CONNECT-AKI)- A Pilot Randomized Controlled Trial

Официальное название

CONNECT-AKI: COordiNated CommuNication, Education, and Care Transitions After Acute Kidney Injury - A Pilot Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• Feasibility: Eligible patient enrollment [Срок оценки: Enrollment period]
• Feasibility: Participant retention [Срок оценки: Baseline to 3 months after discharge]
• Feasibility: Successful delivery of assigned intervention components [Срок оценки: Hospital discharge through 4 weeks after discharge]

Вторичные конечные точки (5)

• AKI Knowledge Score [Срок оценки: 4 weeks after hospital discharge]
• Patient experience during care transitions [Срок оценки: 4 weeks after hospital discharge]
• Self-management behaviors related to kidney health [Срок оценки: 4 weeks after hospital discharge]
• Adherence to outpatient follow-up appointments [Срок оценки: 4 weeks after hospital discharge, and 3 months after hospital discharge]
• Patient-reported discussion of AKI with outpatient provider [Срок оценки: 4 weeks after hospital discharge]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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

Идентификаторы

NCT: NCT07626268 · 26-0133 · K23DK132459

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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