COordiNated CommuNication, Education, and Care Transitions After Acute Kidney Injury (CONNECT-AKI)- A Pilot Randomized Controlled Trial (CONNECT-AKI)
29 maja 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Jeszcze nie rekrutacja
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Szacowany)
160
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Jia Hwei Ng, MD, MSCE
- Numer telefonu: 516-465-8200
- E-mail: jng10@northwell.edu
Kopia zapasowa kontaktu do badania
- Nazwa: Farwa Batool, MPH
- E-mail: fbatool@northwell.edu
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Brak interwencji: 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.
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Eksperymentalny: 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.
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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.
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Eksperymentalny: 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.
|
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Eksperymentalny: 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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Feasibility: Eligible patient enrollment
Ramy czasowe: Enrollment period
|
Percentage of eligible patients enrolled among those approached.
|
Enrollment period
|
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Feasibility: Participant retention
Ramy czasowe: Baseline to 3 months after discharge
|
Percentage of enrolled participants who complete the follow-up assessment.
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Baseline to 3 months after discharge
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Feasibility: Successful delivery of assigned intervention components
Ramy czasowe: Hospital discharge through 4 weeks after discharge
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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.
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Hospital discharge through 4 weeks after discharge
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
AKI Knowledge Score
Ramy czasowe: 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
Ramy czasowe: 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.
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4 weeks after hospital discharge
|
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Self-management behaviors related to kidney health
Ramy czasowe: 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
|
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Adherence to outpatient follow-up appointments
Ramy czasowe: 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.
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4 weeks after hospital discharge, and 3 months after hospital discharge
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Patient-reported discussion of AKI with outpatient provider
Ramy czasowe: 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
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Hospital readmission
Ramy czasowe: Within 4 weeks and within 3 months after hospital discharge
|
Percentage of participants readmitted to the hospital after discharge from the index hospitalization.
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Within 4 weeks and within 3 months after hospital discharge
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Kidney function trajectory after discharge
Ramy czasowe: 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.
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Within 4 weeks and within 3 months after hospital discharge
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Główny śledczy: Jia Hwei Ng, MD, MSCE, Northwell Health
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- 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.
- 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.
- Hoste EA, Bagshaw SM, Bellomo R, Cely CM, Colman R, Cruz DN, Edipidis K, Forni LG, Gomersall CD, Govil D, Honore PM, Joannes-Boyau O, Joannidis M, Korhonen AM, Lavrentieva A, Mehta RL, Palevsky P, Roessler E, Ronco C, Uchino S, Vazquez JA, Vidal Andrade E, Webb S, Kellum JA. Epidemiology of acute kidney injury in critically ill patients: the multinational AKI-EPI study. Intensive Care Med. 2015 Aug;41(8):1411-23. doi: 10.1007/s00134-015-3934-7. Epub 2015 Jul 11.
- Coca SG, Singanamala S, Parikh CR. Chronic kidney disease after acute kidney injury: a systematic review and meta-analysis. Kidney Int. 2012 Mar;81(5):442-8. doi: 10.1038/ki.2011.379. Epub 2011 Nov 23.
- Heung M, Steffick DE, Zivin K, Gillespie BW, Banerjee T, Hsu CY, Powe NR, Pavkov ME, Williams DE, Saran R, Shahinian VB; Centers for Disease Control and Prevention CKD Surveillance Team. Acute Kidney Injury Recovery Pattern and Subsequent Risk of CKD: An Analysis of Veterans Health Administration Data. Am J Kidney Dis. 2016 May;67(5):742-52. doi: 10.1053/j.ajkd.2015.10.019. Epub 2015 Dec 12.
- 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.
- Zeng X, McMahon GM, Brunelli SM, Bates DW, Waikar SS. Incidence, outcomes, and comparisons across definitions of AKI in hospitalized individuals. Clin J Am Soc Nephrol. 2014 Jan;9(1):12-20. doi: 10.2215/CJN.02730313. Epub 2013 Oct 31.
- 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.
- 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.
- Silver SA, Saragosa M, Adhikari NK, Bell CM, Harel Z, Harvey A, Kitchlu A, Neyra JA, Wald R, Jeffs L. What insights do patients and caregivers have on acute kidney injury and posthospitalisation care? A single-centre qualitative study from Toronto, Canada. BMJ Open. 2018 Jun 15;8(6):e021418. doi: 10.1136/bmjopen-2017-021418.
- 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.
- Silver SA, Chertow GM. The Economic Consequences of Acute Kidney Injury. Nephron. 2017;137(4):297-301. doi: 10.1159/000475607. Epub 2017 Jun 9.
- Ikizler TA, Parikh CR, Himmelfarb J, Chinchilli VM, Liu KD, Coca SG, Garg AX, Hsu CY, Siew ED, Wurfel MM, Ware LB, Faulkner GB, Tan TC, Kaufman JS, Kimmel PL, Go AS; ASSESS-AKI Study Investigators. A prospective cohort study of acute kidney injury and kidney outcomes, cardiovascular events, and death. Kidney Int. 2021 Feb;99(2):456-465. doi: 10.1016/j.kint.2020.06.032. Epub 2020 Jul 22.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
1 czerwca 2026
Zakończenie podstawowe (Szacowany)
31 grudnia 2026
Ukończenie studiów (Szacowany)
30 października 2027
Daty rejestracji na studia
Pierwszy przesłany
29 maja 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
29 maja 2026
Pierwszy wysłany (Rzeczywisty)
4 czerwca 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
4 czerwca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
29 maja 2026
Ostatnia weryfikacja
1 maja 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 26-0133
- K23DK132459 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Opis planu 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.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
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