Patient ReadmissionNCT02689076
Regional Data Exchange to Improve Care for Veterans After Non-VA Hospitalization
A study testing HIE Notification and Care transitions intervention in people with Patient Readmission and Adverse Drug Event, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
Among older VA patients who have Medicare coverage, 43% use both VA and non-VA (Medicare-covered) services. VA and non-VA providers are often uninformed about encounters, treatments and test results provided in the other system. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Patient Readmission, Adverse Drug Event, Cost
- What is being tested?
- HIE Notification and Care transitions intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 796 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Mar 2016to 5 Apr 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- established patient in a Bronx VA or Indianapolis VA geriatrics or primary care clinic
- 65 years or older
- be consented in the local health information exchange
- have utilized any non-VA services in the previous two years, including:
- nursing
- lab
Show all 9Show fewer
- physician
- pharmacy
- and/or hospital services
Who cannot join
- Refusal to sign informed consent or consent to access local health information exchange
- Enrolled in hospice at baseline
- Enrolled in Geriatric Resources and Care for Elders (GRACE) program (Indianapolis) at baseline
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, 46202-2884
James J. Peters VA Medical Center, Bronx, NY
The Bronx, New York, 10468-3904
About this study
Among older VA patients who have Medicare coverage, 43% use both VA and non-VA (Medicare-covered) services. VA and non-VA providers are often uninformed about encounters, treatments and test results provided in the other system. The overall objective of this project is to examine the impact of VA provider notification of non-VA hospitalization or emergency department (ED) visit using electronic health information exchange (HIE), along with provision of post-hospital care coordination services. The investigators will examine the impact of these approaches on preventing hospital readmission, increasing provider follow-up, improving patient's self-knowledge, and preventing medication errors. The investigators will also examine the effect of these approaches on VA and non-VA costs. Finally the investigators will examine the acceptance of these approaches among VA and non-VA providers. The study sample will consist of Veterans followed in geriatrics or primary care clinics at the Bronx and Indianapolis VAs who are older than 65. The investigators will monitor patients for non-VA hospital admission or ED visit using technology provided by health information exchange organizations. Patients will be assigned to enhanced or control treatment groups. For both groups the VA provider will receive an electronic notification of a non-VA hospital admission or ED visit if it occurs. For the enhanced group, a care transitions coordinator will deliver post-hospital coordination services during a home and/or VA facility visit and follow-up phone calls over 1 month. The investigators' analyses will compare effects of notification-plus-coordination versus notification-only on health care outcomes. The investigators will conduct interviews with intervention team members, patients, VA and non-VA staff, and other stakeholders to ascertain the barriers and facilitators to implementation of these approaches.
Read the detailed description
Background: Among older VA patients who have Medicare coverage, 43% use both VA and non-VA (Medicare-covered) services. VA and non-VA providers are often uninformed about encounters, treatments and test results provided in the other system. In particular, the absent or delayed notification of a non-VA hospital encounter is a missed opportunity for the VA to provide post-hospital transitional care services that have been shown to be effective in preventing adverse events and hospital readmission after hospital discharge. Objectives: The overall objective of this project is to examine the effectiveness, cost, and implementation acceptance of VA provider notification of non-VA hospitalization or emergency department (ED) visit using electronic health information exchange (HIE), with or without provision of evidence-based post-hospital transitional care services. Specific Aim 1 is to examine the impact of these approaches on preventing hospital admission or readmission as the primary outcome, and, as secondary outcomes, increasing provider follow-up, improving patient's condition self-knowledge, and preventing medication errors after discharge. been shown to be effective in preventing adverse events and hospital readmission after hospital discharge.
Specific Aim 2 is to examine the effect of these approaches on VA and non-VA costs. Specific Aim 3 is to examine the acceptance of these approaches among VA and non-VA stakeholders.
Methods: The study sample consists of Veterans followed in geriatrics or primary care clinics at the Bronx and Indianapolis VAs who are older than 65. The investigators will monitor patients for non-VA hospital admission or ED visit using technology provided by regional HIE organizations (i.e., the Bronx Regional Health Information Organization and the Indiana Health Information Exchange). Patients will be cluster-randomized 1:1 to notification-plus-coordination or notification-only groups by PACT team, stratified by facility. For both groups the PACT provider will receive real-time notification of a non-VA hospital admission or ED visit if it occurs. For the notification-plus-coordination group, a care transitions coordinator will deliver coordination activities during a home and/or VA facility visit and via follow-up phone calls over 1 month. Coordination activities will consist of: reconciliation of and counseling on the patient's VA and non-VA medications, education on signs of condition worsening, coordination of VA and non-VA follow-up appointments, and counseling on communicating with VA and non-VA providers, using structured protocols. All information-gathering by the transitions coordinator will include the HIE as an information source. The notification-only group will receive usual care after the notification. Multivariable regression models will be estimated to compare effects of notification-plus-coordination versus notification-only on primary and secondary outcomes and costs (Aims 1 and 2). The investigators will conduct interviews with intervention team members, patients, VA and non-VA staff, and other stakeholders to ascertain the barriers and facilitators to implementation of these approaches (Aim 3).
- Conditions
- Patient Readmission, Adverse Drug Event, Cost
- Being tested
- HIE Notification, Care transitions intervention
- Keywords
- Patient transfer, Patient care management, Health information exchange
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIE NotificationOther
VA provider notification of non-VA hospitalization or ED visit via electronic health information exchange
Care transitions interventionOther
Post-hospital geriatrics care transitions coordinator provides home visit and telephone support for 30 days after hospital discharge
| Study group | Role | What they receive |
|---|---|---|
| HIE Notification plus Care Coordination | Experimental | VA provider notification of non-VA hospitalization via electronic health information exchange (HIE) plus post-hospital geriatric care transitions intervention Receives: Other: HIE Notification; Other: Care transitions intervention |
| HIE Notification alone | Active comparator | VA provider notification of non-VA hospitalization via electronic health information exchange (HIE) followed by usual post-hospital care Receives: Other: HIE Notification |
| Usual Care (No HIE Notification and No Care Coordination) | No intervention | Absence of VA provider notification of non-VA hospitalization via HIE plus Absence of post-hospital geriatric care transitions intervention [Usual Care] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Hospital Readmission
Percentage of patients with VA and non-VA hospital admission or readmission 90 days after non-VA hospital or ED discharge (or, if the patient is not discharged home, 90 days after discharge home from a rehabilitation facility)
Measured: 90 days
Secondary outcomes (3)
Number of Participants With Scheduled Follow-up
VA follow-up visit with a VA provider (physician or nurse practitioner) within 30 days of non-VA hospital discharge or ED visit.
Measured: 30 days
Number of High-risk Medication Discrepancies
The number of discrepancies in medications classified as high risk for hospitalized older adults, including opioid analgesics, insulin, non-steroidal anti-inflammatory drugs, digoxin, antipsychotics, sedatives/hypnotics, and anticoagulants based on medical record review and patient or caregiver interview 30 days after non-VA hospital discharge.
Measured: 30 days
Care Transitions Measure Score
A measure of condition self-knowledge and transitional care quality from the patient's perspective is ascertained by patient or caregiver interview 30 days after non-VA hospital discharge. The investigators will use an adapted 3-item version which includes items such as: "After I left the hospital, I had all the information I needed to be able to take care of myself" with the response options strongly agree, agree, disagree, strongly disagree, and don't know. The investigators chose to use the 3-item rather than a 15-item version as the shorter instrument demonstrates excellent correlation with the longer version but with lower respondent burden. Unabbreviated scale title is "3-Item Care Transitions Measure" and minimum value is 1 and maximum value is 12. Higher scores mean a better transition/outcome.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study start14 Mar 2016
- Primary completion5 Apr 2020
- Study completion5 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Patient ReadmissionStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 796 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Kenneth S Boockvar, MD MS, Principal investigator, James J. Peters Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02689076
- Sponsor's protocol ID
- IIR 14-049
- Status last verified
- Jul 2023
- First submitted
- 18 Feb 2016
- Last updated
- 27 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dixon BE, Boockvar KS. Event Notification in Support of Population Health: The Promise and Challenges from a Randomized Controlled Trial. Stud Health Technol Inform. 2017;245:1357.
PubMed 29295436Dixon BE, Schwartzkopf AL, Guerrero VM, May J, Koufacos NS, Bean AM, Penrod JD, Schubert CC, Boockvar KS. Regional data exchange to improve care for veterans after non-VA hospitalization: a randomized controlled trial. BMC Med Inform Decis Mak. 2019 Jul 4;19(1):125. doi: 10.1186/s12911-019-0849-1.
PubMed 31272427Franzosa E, Traylor MH, Aquino VG, Judon K, Schwartzkopf A, Dixon BE, Boockvar K. Care Team Members' Perceptions of an Informatics Intervention to Improve Geriatric Care Across Multiple sites. [Abstract]. Innovation in aging. 2020 Dec 16; 4(Supplement_1):519.
Franzosa E, Traylor M, Judon KM, Guerrero Aquino V, Schwartzkopf AL, Boockvar KS, Dixon BE. Perceptions of event notification following discharge to improve geriatric care: qualitative interviews of care team members from a 2-site cluster randomized trial. J Am Med Inform Assoc. 2021 Jul 30;28(8):1728-1735. doi: 10.1093/jamia/ocab074.
PubMed 33997903Kartje R, Dixon BE, Schwartzkopf AL, Guerrero V, Judon KM, Yi JC, Boockvar K. Characteristics of Veterans With Non-VA Encounters Enrolled in a Trial of Standards-Based, Interoperable Event Notification and Care Coordination. J Am Board Fam Med. 2021 Mar-Apr;34(2):301-308. doi: 10.3122/jabfm.2021.02.200251.
PubMed 33832998Koufacos NS, May J, Judon KM, Franzosa E, Dixon BE, Schubert CC, Schwartzkopf AL, Guerrero VM, Traylor M, Boockvar KS. Improving Patient Activation among Older Veterans: Results from a Social Worker-Led Care Transitions Intervention. J Gerontol Soc Work. 2022 Jan;65(1):63-77. doi: 10.1080/01634372.2021.1932003. Epub 2021 May 30.
PubMed 34053407Dixon BE, Judon KM, Schwartzkopf AL, Guerrero VM, Koufacos NS, May J, Schubert CC, Boockvar KS. Impact of event notification services on timely follow-up and rehospitalization among primary care patients at two Veterans Affairs Medical Centers. J Am Med Inform Assoc. 2021 Nov 25;28(12):2593-2600. doi: 10.1093/jamia/ocab189.
PubMed 34597411Boockvar KS, Koufacos NS, May J, Schwartzkopf AL, Guerrero VM, Judon KM, Schubert CC, Franzosa E, Dixon BE. Effect of Health Information Exchange Plus a Care Transitions Intervention on Post-Hospital Outcomes Among VA Primary Care Patients: a Randomized Clinical Trial. J Gen Intern Med. 2022 Dec;37(16):4054-4061. doi: 10.1007/s11606-022-07397-5. Epub 2022 Feb 23.
PubMed 35199262
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Data Exchange to Improve Care for Veterans After Non-VA Hospitalization
- ClinicalTrials.gov ID
- NCT02689076
- Acronym / sponsor ID
- IIR 14-049
- Conditions
- Patient Readmission, Adverse Drug Event, Cost
- Keywords
- Patient transfer, Patient care management, Health information exchange
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 796 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 14 Mar 2016 (actual)
- Primary completion
- 5 Apr 2020 (actual)
- Study completion
- 5 Apr 2020 (actual)
- First posted
- 23 Feb 2016 (estimated)
- Results
- Posted 24 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Among older VA patients who have Medicare coverage, 43% use both VA and non-VA (Medicare-covered) services. VA and non-VA providers are often uninformed about encounters, treatments and test results provided in the other system. The overall objective of this project is to examine the impact of VA provider notification of non-VA hospitalization or emergency department (ED) visit using electronic health information exchange (HIE), along with provision of post-hospital care coordination services. The investigators will examine the impact of these approaches on preventing hospital readmission, increasing provider follow-up, improving patient's self-knowledge, and preventing medication errors. The investigators will also examine the effect of these approaches on VA and non-VA costs. Finally the investigators will examine the acceptance of these approaches among VA and non-VA providers. The study sample will consist of Veterans followed in geriatrics or primary care clinics at the Bronx and Indianapolis VAs who are older than 65. The investigators will monitor patients for non-VA hospital admission or ED visit using technology provided by health information exchange organizations. Patients will be assigned to enhanced or control treatment groups. For both groups the VA provider will receive an electronic notification of a non-VA hospital admission or ED visit if it occurs. For the enhanced group, a care transitions coordinator will deliver post-hospital coordination services during a home and/or VA facility visit and follow-up phone calls over 1 month. The investigators' analyses will compare effects of notification-plus-coordination versus notification-only on health care outcomes. The investigators will conduct interviews with intervention team members, patients, VA and non-VA staff, and other stakeholders to ascertain the barriers and facilitators to implementation of these approaches.
Detailed description
Background: Among older VA patients who have Medicare coverage, 43% use both VA and non-VA (Medicare-covered) services. VA and non-VA providers are often uninformed about encounters, treatments and test results provided in the other system. In particular, the absent or delayed notification of a non-VA hospital encounter is a missed opportunity for the VA to provide post-hospital transitional care services that have been shown to be effective in preventing adverse events and hospital readmission after hospital discharge. Objectives: The overall objective of this project is to examine the effectiveness, cost, and implementation acceptance of VA provider notification of non-VA hospitalization or emergency department (ED) visit using electronic health information exchange (HIE), with or without provision of evidence-based post-hospital transitional care services. Specific Aim 1 is to examine the impact of these approaches on preventing hospital admission or readmission as the primary outcome, and, as secondary outcomes, increasing provider follow-up, improving patient's condition self-knowledge, and preventing medication errors after discharge. been shown to be effective in preventing adverse events and hospital readmission after hospital discharge.
Specific Aim 2 is to examine the effect of these approaches on VA and non-VA costs. Specific Aim 3 is to examine the acceptance of these approaches among VA and non-VA stakeholders.
Methods: The study sample consists of Veterans followed in geriatrics or primary care clinics at the Bronx and Indianapolis VAs who are older than 65. The investigators will monitor patients for non-VA hospital admission or ED visit using technology provided by regional HIE organizations (i.e., the Bronx Regional Health Information Organization and the Indiana Health Information Exchange). Patients will be cluster-randomized 1:1 to notification-plus-coordination or notification-only groups by PACT team, stratified by facility. For both groups the PACT provider will receive real-time notification of a non-VA hospital admission or ED visit if it occurs. For the notification-plus-coordination group, a care transitions coordinator will deliver coordination activities during a home and/or VA facility visit and via follow-up phone calls over 1 month. Coordination activities will consist of: reconciliation of and counseling on the patient's VA and non-VA medications, education on signs of condition worsening, coordination of VA and non-VA follow-up appointments, and counseling on communicating with VA and non-VA providers, using structured protocols. All information-gathering by the transitions coordinator will include the HIE as an information source. The notification-only group will receive usual care after the notification. Multivariable regression models will be estimated to compare effects of notification-plus-coordination versus notification-only on primary and secondary outcomes and costs (Aims 1 and 2). The investigators will conduct interviews with intervention team members, patients, VA and non-VA staff, and other stakeholders to ascertain the barriers and facilitators to implementation of these approaches (Aim 3).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HIE Notification plus Care Coordination | Experimental | Other: HIE Notification, Other: Care transitions interventionVA provider notification of non-VA hospitalization via electronic health information exchange (HIE) plus post-hospital geriatric care transitions intervention |
| HIE Notification alone | Active comparator | Other: HIE NotificationVA provider notification of non-VA hospitalization via electronic health information exchange (HIE) followed by usual post-hospital care |
| Usual Care (No HIE Notification and No Care Coordination) | No intervention | –Absence of VA provider notification of non-VA hospitalization via HIE plus Absence of post-hospital geriatric care transitions intervention [Usual Care] |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- established patient in a Bronx VA or Indianapolis VA geriatrics or primary care clinic
- 65 years or older
- be consented in the local health information exchange
- have utilized any non-VA services in the previous two years, including:
Key exclusion criteria (3 listed)
- Refusal to sign informed consent or consent to access local health information exchange
- Enrolled in hospice at baseline
- Enrolled in Geriatric Resources and Care for Elders (GRACE) program (Indianapolis) at baseline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIE NotificationVA provider notification of non-VA hospitalization or ED visit via electronic health information exchange | Other | HIE Notification alone, HIE Notification plus Care Coordination |
| Care transitions interventionPost-hospital geriatrics care transitions coordinator provides home visit and telephone support for 30 days after hospital discharge | Other | HIE Notification plus Care Coordination |
Primary outcome
Number of Participants With Hospital Readmission
Time frame: 90 days
Percentage of patients with VA and non-VA hospital admission or readmission 90 days after non-VA hospital or ED discharge (or, if the patient is not discharged home, 90 days after discharge home from a rehabilitation facility)
3 secondary outcomes
Number of Participants With Scheduled Follow-up
Time frame: 30 days
Number of High-risk Medication Discrepancies
Time frame: 30 days
Care Transitions Measure Score
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29295436Dixon BE, Boockvar KS. Event Notification in Support of Population Health: The Promise and Challenges from a Randomized Controlled Trial. Stud Health Technol Inform. 2017;245:1357.
- Results publication: PubMed 31272427Dixon BE, Schwartzkopf AL, Guerrero VM, May J, Koufacos NS, Bean AM, Penrod JD, Schubert CC, Boockvar KS. Regional data exchange to improve care for veterans after non-VA hospitalization: a randomized controlled trial. BMC Med Inform Decis Mak. 2019 Jul 4;19(1):125. doi: 10.1186/s12911-019-0849-1.
- Results publicationFranzosa E, Traylor MH, Aquino VG, Judon K, Schwartzkopf A, Dixon BE, Boockvar K. Care Team Members' Perceptions of an Informatics Intervention to Improve Geriatric Care Across Multiple sites. [Abstract]. Innovation in aging. 2020 Dec 16; 4(Supplement_1):519.
- Results publication: PubMed 33997903Franzosa E, Traylor M, Judon KM, Guerrero Aquino V, Schwartzkopf AL, Boockvar KS, Dixon BE. Perceptions of event notification following discharge to improve geriatric care: qualitative interviews of care team members from a 2-site cluster randomized trial. J Am Med Inform Assoc. 2021 Jul 30;28(8):1728-1735. doi: 10.1093/jamia/ocab074.
- Results publication: PubMed 33832998Kartje R, Dixon BE, Schwartzkopf AL, Guerrero V, Judon KM, Yi JC, Boockvar K. Characteristics of Veterans With Non-VA Encounters Enrolled in a Trial of Standards-Based, Interoperable Event Notification and Care Coordination. J Am Board Fam Med. 2021 Mar-Apr;34(2):301-308. doi: 10.3122/jabfm.2021.02.200251.
- Results publication: PubMed 34053407Koufacos NS, May J, Judon KM, Franzosa E, Dixon BE, Schubert CC, Schwartzkopf AL, Guerrero VM, Traylor M, Boockvar KS. Improving Patient Activation among Older Veterans: Results from a Social Worker-Led Care Transitions Intervention. J Gerontol Soc Work. 2022 Jan;65(1):63-77. doi: 10.1080/01634372.2021.1932003. Epub 2021 May 30.
- Results publication: PubMed 34597411Dixon BE, Judon KM, Schwartzkopf AL, Guerrero VM, Koufacos NS, May J, Schubert CC, Boockvar KS. Impact of event notification services on timely follow-up and rehospitalization among primary care patients at two Veterans Affairs Medical Centers. J Am Med Inform Assoc. 2021 Nov 25;28(12):2593-2600. doi: 10.1093/jamia/ocab189.
- Results publication: PubMed 35199262Boockvar KS, Koufacos NS, May J, Schwartzkopf AL, Guerrero VM, Judon KM, Schubert CC, Franzosa E, Dixon BE. Effect of Health Information Exchange Plus a Care Transitions Intervention on Post-Hospital Outcomes Among VA Primary Care Patients: a Randomized Clinical Trial. J Gen Intern Med. 2022 Dec;37(16):4054-4061. doi: 10.1007/s11606-022-07397-5. Epub 2022 Feb 23.
- Individual participant dataSharing planned: No
Related trials for Patient Readmission
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Recruiting
Conducting Wound, Ostomy, and Continence (WOC) Nurse Telephone Follow-up for Post-discharge Ostomy Patients to Reduce Hospital Readmission
Ostomy
Not yet recruiting
EHR Integrated Remote Patient Monitoring to Reduce Readmission for Patients With Bladder Cancer Undergoing Cystectomy
Bladder Carcinoma
Not yet recruiting
A Clinician-Patient Dual Behavior Change Framework to Leverage Informed Digital Nudges to Reduce Hospital Readmissions and Improve Patient Outcomes: A Trial for Scalable Strategy to Reduce Readmissions (PREVENT-R)
Readmission, Readmission Rates
Recruiting
COordiNated CommuNication, Education, and Care Transitions After Acute Kidney Injury (CONNECT-AKI)
Acute Kidney Injury, Acute Kidney Injury (AKI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth S Boockvar, MD MS principal investigator
James J. Peters Veterans Affairs Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIE Notification and Care transitions intervention in people with Patient Readmission and Adverse Drug Event, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Hospital Readmission (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02689076, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.