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Virtual Consults for Cardio-Renal-Metabolic Conditions (IMPLEMENT-CRM Trial)

Q: Are there any available vacancies in this clinical trial?

<p>Affirmative. Per the clinicaltrials.gov database, this medical trial which was launched on June 9th 2023 is currently recruiting patients. 200 participants are required from a single location for successful enrolment in the study.</p>

Q: How many participants are being recruited for this research initiative?

<p>Affirmative. According to the information accessible on clinicaltrials.gov, this study began on June 9th of 2023 and was last updated September 1st of that same year. With a need for 200 participants at one location, recruitment is still in progress.</p>

N/A

Recruiting

Led By Stephen J Greene

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Hospitalized adults age ≥ 18 years with diagnosis of HF (any ejection fraction), CKD with estimated GFR ≥ 20 mL/min/1.73m2, or T2DM (by clinical history or hemoglobin A1c)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up hospital discharge (up to approximately 14 days), 30 days post-discharge (approximately 6 weeks)

Awards & highlights

IMPLEMENT-CRM Trial Summary

This trial will study 200 patients hospitalized with heart failure, CKD, and/or type 2 diabetes to see if virtual consults improve medication use. Patients' clinician teams will be assigned at random to receive the consult or not.

Who is the study for?

This trial is for hospitalized adults over 18 with heart failure, chronic kidney disease (with specific kidney function levels), or type 2 diabetes. It's not for those on dialysis, pregnant or breastfeeding women, patients listed for a heart transplant, active cancer cases (except certain localized cancers), hospice care enrollees, or those with certain heart devices.Check my eligibility

What is being tested?

The study tests if a virtual consult can increase the use of recommended cardio-renal-metabolic medications in the hospital setting. Specifically focusing on SGLT2 inhibitor therapy among about 200 eligible patients who will be randomly assigned to either receive this intervention or not.See study design

What are the potential side effects?

Since the intervention involves medication optimization through consultation rather than direct drug administration, side effects are related to changes in medication regimens which could include typical reactions to new cardio-renal-metabolic drugs like dizziness, gastrointestinal issues, and potential changes in blood sugar levels.

IMPLEMENT-CRM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am an adult hospitalized with heart failure, chronic kidney disease, or type 2 diabetes.

IMPLEMENT-CRM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ hospital discharge (up to approximately 14 days), 30 days post-discharge (approximately 6 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~hospital discharge (up to approximately 14 days), 30 days post-discharge (approximately 6 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and hospital discharge (up to approximately 14 days), 30 days post-discharge (approximately 6 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of patients prescribed SGLT2i (sodium glucose co-transporter-2 inhibitors)

Other outcome measures

Composite medication score at discharge based on the use of ≥ 50% target dosing of ACEI/ARB/ARNI and beta-blocker, any MRA dose, and any SGLT2i dose (for patients with heart failure and ejection fraction </=40% only).

Number of participants with ACEI/ARB therapy among patients with heart failure or chronic kidney disease

Number of participants with ARNI for heart failure

+6 more

IMPLEMENT-CRM Trial Design

2Treatment groups

Active Control

Group I: Virtual Consult InterventionActive Control1 Intervention

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.

Group II: Usual CareActive Control1 Intervention

Usual care

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor

2,364 Previous Clinical Trials

3,420,442 Total Patients Enrolled

Boehringer IngelheimIndustry Sponsor

2,507 Previous Clinical Trials

11,340,707 Total Patients Enrolled

Stephen J GreenePrincipal InvestigatorDuke University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies in this clinical trial?

"Affirmative. Per the clinicaltrials.gov database, this medical trial which was launched on June 9th 2023 is currently recruiting patients. 200 participants are required from a single location for successful enrolment in the study."

Answered by AI

How many participants are being recruited for this research initiative?

"Affirmative. According to the information accessible on clinicaltrials.gov, this study began on June 9th of 2023 and was last updated September 1st of that same year. With a need for 200 participants at one location, recruitment is still in progress."

Answered by AI