Heart FailureIMPLEMENT-CRMNCT05781334
Optimizing In-hospital Use of Evidence-based Therapies for Patients With Cardio-Renal-Metabolic Disease
A study testing Virtual Consult Intervention in people with Heart Failure and Type 2 Diabetes, run by Duke University at 1 site in United States.
Trial summary
This study will be a prospective randomized implementation trial for patients hospitalized with heart failure, chronic kidney disease, and/or type 2 diabetes mellitus within Duke University Medical Center. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Type 2 Diabetes, Chronic Kidney Diseases
- What is being tested?
- Virtual Consult Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2023to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Hospitalized adults age ≥ 18 years with ≥1 of the following diagnoses, as defined by the medical record:
- HF (any ejection fraction)
- CKD with estimated GFR ≥ 20 mL/min/1.73m2 *
- T2DM (by clinical history or hemoglobin A1c)
Who cannot join
- End-stage stage renal disease on dialysis or eGFR <20 mL/kg/1.73m2.
- Pre-menopausal woman who are either breast-feeding or pregnant
- History of heart transplant or actively listed for heart transplant
- Implanted left ventricular assist device or implant anticipated within 3 months.
- Enrolled in or planning to enroll in hospice care.
- Active cancer (except localized prostate, breast, or non-melanoma skin cancers)
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27707
About this study
Official title: Identifying Barriers to and optiMizing In-hosPitaL usE of Evidenced-based Medical thErapies for patieNTs With Cardio-Renal-Metabolic Disease
This study will be a prospective randomized implementation trial for patients hospitalized with heart failure, chronic kidney disease, and/or type 2 diabetes mellitus within Duke University Medical Center. The primary hypothesis is that a virtual quality improvement-based consult intervention will improve the rate of in-hospital evidence-based cardio-renal-metabolic medication use, particularly SGLT2 inhibitor therapy. Approximately 200 patients meeting eligibility criteria will be included in the study. Patients will be assigned into study groups, as defined by randomization of their treating clinician team to receiving the virtual consult versus not.
- Conditions
- Heart Failure, Type 2 Diabetes, Chronic Kidney Diseases
- Being tested
- Virtual Consult Intervention
- Keywords
- heart failure, type 2 diabetes, chronic kidney disease, implementation, hospitalization
- Medical subject headings
- Heart Failure, Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Consult InterventionOther
The intervention will consist of a quality improvement (QI)-based virtual consult designed by a multi-disciplinary team that will aim to address provider-level, patient-level, and system-level barriers to cardio-renal-metabolic disease medications
| Study group | Role | What they receive |
|---|---|---|
| Virtual Consult Intervention | Active comparator | The intervention will consist of a quality improvement (QI)-based virtual consult designed by a multi-disciplinary team that will aim to address provider-level, patient-level, and system-level barriers to cardio-renal-metabolic disease medications. Receives: Other: Virtual Consult Intervention |
| Usual Care | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients prescribed SGLT2i (sodium glucose co-transporter-2 inhibitors)
Measured: hospital discharge (up to approximately 14 days)
Proportion of patients prescribed SGLT2i (sodium glucose co-transporter-2 inhibitors)
Measured: 30 days post-discharge (approximately 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start9 Jun 2023
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
- Investigators
- Stephen J Greene, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05781334
- Sponsor's protocol ID
- Pro00112465
- Acronym
- IMPLEMENT-CRM
- Status last verified
- Sep 2024
- First submitted
- 16 Feb 2023
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Barriers to and optiMizing In-hosPitaL usE of Evidenced-based Medical thErapies for patieNTs With Cardio-Renal-Metabolic Disease
- ClinicalTrials.gov ID
- NCT05781334
- Acronym / sponsor ID
- IMPLEMENT-CRM / Pro00112465
- Conditions
- Heart Failure, Type 2 Diabetes, Chronic Kidney Diseases
- Keywords
- heart failure, type 2 diabetes, chronic kidney disease, implementation, hospitalization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- 9 Jun 2023 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 23 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be a prospective randomized implementation trial for patients hospitalized with heart failure, chronic kidney disease, and/or type 2 diabetes mellitus within Duke University Medical Center. The primary hypothesis is that a virtual quality improvement-based consult intervention will improve the rate of in-hospital evidence-based cardio-renal-metabolic medication use, particularly SGLT2 inhibitor therapy. Approximately 200 patients meeting eligibility criteria will be included in the study. Patients will be assigned into study groups, as defined by randomization of their treating clinician team to receiving the virtual consult versus not.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Consult Intervention | Active comparator | Other: Virtual Consult InterventionThe intervention will consist of a quality improvement (QI)-based virtual consult designed by a multi-disciplinary team that will aim to address provider-level, patient-level, and system-level barriers to cardio-renal-metabolic disease medications. |
| Usual Care | No intervention | –Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Hospitalized adults age ≥ 18 years with ≥1 of the following diagnoses, as defined by the medical record:
- HF (any ejection fraction)
- CKD with estimated GFR ≥ 20 mL/min/1.73m2 *
- T2DM (by clinical history or hemoglobin A1c)
Key exclusion criteria (6 listed)
- End-stage stage renal disease on dialysis or eGFR <20 mL/kg/1.73m2.
- Pre-menopausal woman who are either breast-feeding or pregnant
- History of heart transplant or actively listed for heart transplant
- Implanted left ventricular assist device or implant anticipated within 3 months.
- Enrolled in or planning to enroll in hospice care.
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 |
|---|---|---|
| Virtual Consult InterventionThe intervention will consist of a quality improvement (QI)-based virtual consult designed by a multi-disciplinary team that will aim to address provider-level, patient-level, and system-level barriers to cardio-renal-metabolic disease medications | Other | Virtual Consult Intervention |
Primary outcome
Proportion of patients prescribed SGLT2i (sodium glucose co-transporter-2 inhibitors)
Time frame: hospital discharge (up to approximately 14 days)
Proportion of patients prescribed SGLT2i (sodium glucose co-transporter-2 inhibitors)
Time frame: 30 days post-discharge (approximately 6 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Stephen J Greene principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Consult Intervention in people with Heart Failure and Type 2 Diabetes, run by Duke University at 1 site 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 4 inclusion and 6 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 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of patients prescribed SGLT2i (sodium glucose co-transporter-2 inhibitors) (time frame: hospital discharge (up to approximately 14 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Sep 2024.