Improving the health of veterans with chronic kidney disease
| ISRCTN | ISRCTN12374636 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12374636 |
- Submission date
- 25/02/2022
- Registration date
- 15/03/2022
- Last edited
- 23/02/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims:
Sodium glucose co-transport 2 inhibitors (SGLT2i) are a class of drugs approved for the treatment of type 2 diabetes. Numerous studies have been published showing SGLT2i improves outcomes in chronic kidney disease (CKD) patients. CKD means your kidneys are damaged and can't filter blood the way they should. The main risk factors for developing kidney disease are diabetes, high blood pressure, heart disease, and a family history of kidney failure. The aim of this study is to improve the health of veterans with CKD by evaluating the effectiveness of a targeted pharmacy intervention in improving the rate of SGLT2i initiation among eligible patients.
Who can participate?
Veterans with chronic kidney disease who are candidates for SGLT2i therapy. These patients will be identified through an existing dashboard created by the VA.
What does the study involve?
Eligible patients will be mailed a letter outlining the benefits of starting SGLT2i therapy. Then, a care team member will contact the patient and offer a pharmacy consultation to initiate the medication. After reviewing criteria and discussing the risks and benefits with the Veteran, the pharmacist will initiate the appropriate dose of SGLT2i. Notification of the drug change will be sent to the patient’s primary care provider. The pharmacist will schedule follow up labs 3 months after drug initiation and provide a phone number to Veterans to contact the pharmacist for future questions or to report adverse events. Labs at 3 months will be reviewed by the program’s medical assistant. The Veteran will be contacted by letter with a summary of their lab results (sent by medical assistant) and reminded of the contact number. Any issues with labs will be flagged to the pharmacist to be addressed with the Veteran.
What are the possible benefits and risks of participating?
Benefits include improved CKD, cardiovascular, and other health outcomes, as well as decreased mortality. In trials, the incidence of hypoglycemia or other adverse events did not differ between SGLT2i treatment and control arms. Risks include any potential adverse events to SGLT2i, such as diabetic ketoacidosis, urinary tract infections, etc.
Where is the study run from?
The Minneapolis VA Health Care System (USA)
When is the study starting and how long is it expected to run for?
February 2022 to May 2024
Who is funding the study?
US Veterans Association (USA)
Who is the main contact?
Areef Ishani, MD, Areef.Ishani@va.gov
Contact information
Principal Investigator
1 Veterans Dr
Minneapolis
55417
United States of America
| Phone | +1 612-467-4431 |
|---|---|
| Areef.Ishani@va.gov |
Public
1 Veterans Dr
Minneapolis
55417
United States of America
| Phone | +1 612-467-4431 |
|---|---|
| Areef.Ishani@va.gov |
Scientific
1 Veterans Dr
Minneapolis
55417
United States of America
| Phone | +1 612-467-4431 |
|---|---|
| Areef.Ishani@va.gov |
Study information
| Study design | Multicenter interventional non randomised study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | GP practice |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Evaluating the implementation of targeted pharmacy services to enhance the uptake of SGLT2i among veterans with chronic kidney disease (CKD) |
| Study objectives | Patients that receive a targeted pharmacy intervention will have higher rates of SGLT2i initiation than those receiving usual care |
| Ethics approval(s) | Approved 26/01/2022, Minneapolis VA Health Care System (1 Veterans Dr, Minneapolis, MN, 55417, USA; +1 612-467-5655; julie.toth@va.gov), ref: n/a |
| Health condition(s) or problem(s) studied | Chronic kidney disease |
| Intervention | Using an established VA dashboard that identifies chronic kidney disease patients that are candidates for SGLT2i therapy, half of eligible patients will be sent a letter informing them of the benefits of this medication (the letter will be sent to patients whose social security number ends with an odd digit). A medical assistant will then reach out to those patients and offer to schedule a consultation with one of two intervention pharmacists. The pharmacist will review the patients’ charts and ensure they meet necessary criteria for initiating the drug and no exclusion criteria exist. After reviewing criteria and discussing the risks and benefits with the Veteran, the pharmacist will initiate the appropriate dose of SGLT2i. Notification of the drug change will be sent to the patient’s primary care provider. The pharmacist will schedule follow up labs 3 months after drug initiation and provide a phone number to Veterans to contact the pharmacist for future questions or to report adverse events. Labs at 3 months will be reviewed by the program’s medical assistant. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | SGLT2 inhibitors |
| Primary outcome measure | SGLT2i initiation will be tracked quarterly by assessing the presence of SGLT2 inhibitors on active medication lists in the electronic health record |
| Secondary outcome measures | 1. Reach: Proportion of eligible patients being reached in each intervention assessed quarterly by data collected through the tracking app that has been developed to monitor patient outreach 2. Fidelity: Measured using an intervention tracking app assessed quarterly by data collected through the tracking app that has been developed to monitor patient outreach 3. Acceptability: Patient perception of starting the medication will be measured at the end of year one and the end of year two through semi-structured one-on-one qualitative interviews with patients |
| Overall study start date | 01/02/2022 |
| Completion date | 01/01/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 4000 |
| Key inclusion criteria | 1. CKD (defined as eGFR >=25 and eGFR <60 x2) 2. Type 2 Diabetes (defined as either ICD9/10 code of Type 2 DM or most recent A1c >=7) 3. Must have active Metformin or (not on Metformin and has a Metformin allergy) |
| Key exclusion criteria | 1. Type 1 diabetes 2. Taking SGLT-2 or GLP-1 3. SGLT2 allergy 4. On dialysis 5. Have a diagnosis of Pancreatic Cancer or Pancreatitis |
| Date of first enrolment | 01/03/2022 |
| Date of final enrolment | 01/01/2025 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Minneapolis
55417
United States of America
Sponsor information
Hospital/treatment centre
1 Veterans Dr
Minneapolis
55417
United States of America
| Phone | +1 612-467-5655 |
|---|---|
| Julie.Toth@va.gov | |
| Website | http://www.minneapolis.va.gov/ |
"ROR" |
https://ror.org/02ry60714 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Department of Veterans Affairs, United States Department of Veterans Affairs, US Department of Veterans Affairs, U.S. Dept. of Veterans Affairs, Veterans Affairs, Veterans Affairs Department, VA, USDVA
- Location
- United States of America
Results and Publications
| Intention to publish date | 01/06/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 05/01/2024 | 08/01/2024 | Yes | No |
Editorial Notes
23/02/2024: The following changes were made:
1. The recruitment end date was changed from 01/02/2024 to 01/01/2025.
2. The overall study end date was changed from 01/05/2024 to 01/01/2026.
3. The intention to publish date was changed from 01/08/2024 to 01/06/2026.
08/01/2024: Publication reference added.
07/03/2022: Trial's existence confirmed by Department of Veterans Affairs
