COordiNated CommuNication, Education, and Care Transitions After Acute Kidney Injury (CONNECT-AKI)- A Pilot Randomized Controlled Trial (CONNECT-AKI)
29 мая 2026 г. обновлено: Northwell Health
CONNECT-AKI: COordiNated CommuNication, Education, and Care Transitions After Acute Kidney Injury - A Pilot Randomized Controlled Trial
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.
Обзор исследования
Статус
Еще не набирают
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.
Тип исследования
Интервенционный
Регистрация (Оцененный)
160
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Jia Hwei Ng, MD, MSCE
- Номер телефона: 516-465-8200
- Электронная почта: jng10@northwell.edu
Учебное резервное копирование контактов
- Имя: Farwa Batool, MPH
- Электронная почта: fbatool@northwell.edu
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Без вмешательства: Usual Care
Participants assigned to this group will receive usual hospital discharge care.
No additional study discharge summary template or chat-based educational messaging program will be provided as part of the intervention.
|
|
|
Экспериментальный: AKI Discharge Summary Template
Participants in this group will receive usual hospital discharge care plus use of an AKI discharge summary template.
The template is designed to support communication of AKI-related information and recommended follow-up care during the transition from hospital to outpatient care.
|
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.
|
|
Экспериментальный: Chat-Based Educational Messaging Program
Participants in this group will receive usual hospital discharge care plus access to a chat-based educational messaging program after hospital discharge.
The program provides plain-language AKI education and follow-up support through a secure web-based chat-style interface.
|
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.
|
|
Экспериментальный: AKI Discharge Summary Template + Chat-Based Educational Messaging Program
Participants in this group will receive usual hospital discharge care plus both study interventions: use of the AKI discharge summary template and access to the chat-based educational messaging program after hospital discharge.
|
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.
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.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Feasibility: Eligible patient enrollment
Временное ограничение: Enrollment period
|
Percentage of eligible patients enrolled among those approached.
|
Enrollment period
|
|
Feasibility: Participant retention
Временное ограничение: Baseline to 3 months after discharge
|
Percentage of enrolled participants who complete the follow-up assessment.
|
Baseline to 3 months after discharge
|
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Feasibility: Successful delivery of assigned intervention components
Временное ограничение: Hospital discharge through 4 weeks after discharge
|
Percentage of participants assigned to an intervention arm who receive the assigned intervention component or components as intended, including the AKI discharge summary template and/or chat-based educational messaging program.
|
Hospital discharge through 4 weeks after discharge
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
AKI Knowledge Score
Временное ограничение: 4 weeks after hospital discharge
|
Participant AKI knowledge score measured using a study questionnaire.
|
4 weeks after hospital discharge
|
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Patient experience during care transitions
Временное ограничение: 4 weeks after hospital discharge
|
Patient-reported care transition experience measured using a validated transition-of-care instrument, such as the Care Transitions Measure-15.
|
4 weeks after hospital discharge
|
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Self-management behaviors related to kidney health
Временное ограничение: 4 weeks after hospital discharge
|
Participant-reported self-management behaviors related to kidney health after hospital discharge, assessed using a study questionnaire.
|
4 weeks after hospital discharge
|
|
Adherence to outpatient follow-up appointments
Временное ограничение: 4 weeks after hospital discharge, and 3 months after hospital discharge
|
Percentage of participants who complete follow-up with a primary care provider or specialist after hospital discharge, assessed by participant report and/or medical record review.
|
4 weeks after hospital discharge, and 3 months after hospital discharge
|
|
Patient-reported discussion of AKI with outpatient provider
Временное ограничение: 4 weeks after hospital discharge
|
Percentage of participants who report discussing AKI or kidney-related follow-up needs with an outpatient provider after hospital discharge.
|
4 weeks after hospital discharge
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Hospital readmission
Временное ограничение: Within 4 weeks and within 3 months after hospital discharge
|
Percentage of participants readmitted to the hospital after discharge from the index hospitalization.
|
Within 4 weeks and within 3 months after hospital discharge
|
|
Kidney function trajectory after discharge
Временное ограничение: Within 4 weeks and within 3 months after hospital discharge
|
Kidney function status after hospital discharge, categorized as improved, stable, worsened, or requiring dialysis, based on available laboratory and clinical data.
|
Within 4 weeks and within 3 months after hospital discharge
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Главный следователь: Jia Hwei Ng, MD, MSCE, Northwell Health
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
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- Newnham H, Barker A, Ritchie E, Hitchcock K, Gibbs H, Holton S. Discharge communication practices and healthcare provider and patient preferences, satisfaction and comprehension: A systematic review. Int J Qual Health Care. 2017 Oct 1;29(6):752-768. doi: 10.1093/intqhc/mzx121.
- 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.
- 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.
- 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.
- 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.
- Chadwick W, Bassett H, Hendrickson S, Slonaker K, Perales S, Pantaleoni J, Srinivas N, Platchek T, Destino L. An Improvement Effort to Optimize Electronically Generated Hospital Discharge Instructions. Hosp Pediatr. 2019 Jul;9(7):523-529. doi: 10.1542/hpeds.2018-0251.
- Nye C, Lake S. Acute kidney injury; improving the communication from secondary to primary care. BMJ Qual Improv Rep. 2017 Jun 23;6(1):u211147.w6661. doi: 10.1136/bmjquality.u211147.w6661. eCollection 2017.
- Silver SA, Goldstein SL, Harel Z, Harvey A, Rompies EJ, Adhikari NK, Acedillo R, Jain AK, Richardson R, Chan CT, Chertow GM, Bell CM, Wald R. Ambulatory care after acute kidney injury: an opportunity to improve patient outcomes. Can J Kidney Health Dis. 2015 Oct 6;2:36. doi: 10.1186/s40697-015-0071-8. eCollection 2015.
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- Siew ED, Parr SK, Wild MG, Levea SL, Mehta KG, Umeukeje EM, Silver SA, Ikizler TA, Cavanaugh KL. Kidney Disease Awareness and Knowledge among Survivors ofAcute Kidney Injury. Am J Nephrol. 2019;49(6):449-459. doi: 10.1159/000499862. Epub 2019 Apr 17.
- Greer RC, Liu Y, Crews DC, Jaar BG, Rabb H, Boulware LE. Hospital discharge communications during care transitions for patients with acute kidney injury: a cross-sectional study. BMC Health Serv Res. 2016 Aug 30;16(1):449. doi: 10.1186/s12913-016-1697-7.
- Hung AM, Siew ED, Wilson OD, Perkins AM, Greevy RA Jr, Horner J, Abdel-Kader K, Parr SK, Roumie CL, Griffin MR, Ikizler TA, Speroff T, Matheny ME. Risk of Hypoglycemia Following Hospital Discharge in Patients With Diabetes and Acute Kidney Injury. Diabetes Care. 2018 Mar;41(3):503-512. doi: 10.2337/dc17-1237. Epub 2018 Jan 11.
- Silver SA, Harel Z, McArthur E, Nash DM, Acedillo R, Kitchlu A, Garg AX, Chertow GM, Bell CM, Wald R. 30-Day Readmissions After an Acute Kidney Injury Hospitalization. Am J Med. 2017 Feb;130(2):163-172.e4. doi: 10.1016/j.amjmed.2016.09.016. Epub 2016 Oct 14.
- Siew ED, Parr SK, Abdel-Kader K, Eden SK, Peterson JF, Bansal N, Hung AM, Fly J, Speroff T, Ikizler TA, Matheny ME. Predictors of Recurrent AKI. J Am Soc Nephrol. 2016 Apr;27(4):1190-200. doi: 10.1681/ASN.2014121218. Epub 2015 Aug 11.
- Siew ED, Abdel-Kader K, Perkins AM, Greevy RA Jr, Parr SK, Horner J, Vincz AJ, Denton J, Wilson OD, Hung AM, Robinson-Cohen C, Matheny ME. Timing of Recovery From Moderate to Severe AKI and the Risk for Future Loss of Kidney Function. Am J Kidney Dis. 2020 Feb;75(2):204-213. doi: 10.1053/j.ajkd.2019.05.031. Epub 2019 Sep 16.
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Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
1 июня 2026 г.
Первичное завершение (Оцененный)
31 декабря 2026 г.
Завершение исследования (Оцененный)
30 октября 2027 г.
Даты регистрации исследования
Первый отправленный
29 мая 2026 г.
Впервые представлено, что соответствует критериям контроля качества
29 мая 2026 г.
Первый опубликованный (Действительный)
4 июня 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
4 июня 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
29 мая 2026 г.
Последняя проверка
1 мая 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 26-0133
- K23DK132459 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Описание плана IPD
Individual participant data will not be shared at this time because this is a pilot feasibility study, and the dataset is expected to be small and potentially identifiable due to the clinical context, recruitment sites, hospitalization timing, and post-discharge care details.
Aggregate study results may be shared through presentations and publications.
The IPD sharing plan may be updated in the future if appropriate approvals, de-identification procedures, and data use agreements are established.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .