- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04862858
Educational Intervention to Increase Select Guideline-recommended Cardioprotective Medications in Patients With Diabetes
13 maj 2022 uppdaterad av: Alexjandro Daviano, Humana Inc.
Improving Outcomes in Patients With Comorbid T2DM and ASCVD: Population Health Management Interventions Supporting Guideline-recommended SGLT2i and GLP-1 RA Medications
This is an educational outreach to patients with type 2 diabetes mellitus (T2DM) and atherosclerotic cardiovascular disease (ASCVD) and their primary care and specialist providers to improve use of guideline-recommended treatments, specifically sodium-glucose cotransporter 2 inhibitor (SGLT2i) and glucagon-like peptide-1 receptor agonist (GLP-1 RA) medications.
Studieöversikt
Status
Aktiv, inte rekryterande
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Patients with type 2 diabetes mellitus, a history of atherosclerotic cardiovascular disease, without use of select guideline-recommended medications in the previous year will be identified from administrative claims.
Primary care providers will be identified, randomly selected and randomized to the intervention arm or control arm.
All eligible patients for that provider will be included.
The patient's specialist providers (cardiologist and/or endocrinologist, as applicable) will be identified and contacted.
The intervention will include a multi-faceted strategy to support providers in the care of their patients by sharing recent guideline-based treatment recommendations and provide patients with information regarding ways to reduce their cardiovascular risk.
Outreach will occur for all patients and providers randomized for the intervention - there will be no active enrollment or recruitment.
Studietyp
Interventionell
Inskrivning (Faktisk)
4197
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Kentucky
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Louisville, Kentucky, Förenta staterna, 40202
- Humana
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 85 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
Patient
- Patients with T2DM defined as ≥2 outpatient diagnoses of T2DM in any position on separate days; OR ≥1 inpatient diagnosis T2DM in any position; OR ≥1 outpatient diagnosis in any position AND ≥1 medication claim for T2DM
- ≥1 diagnosis code for ASCVD (coronary artery disease diagnoses or procedures, cerebrovascular disease, peripheral artery disease of atherosclerotic origin) on any claim type in any position within the 24-month period prior to identification
- Enrolled in a Humana Medicare Advantage Prescription Drug plan with ≥12 months pre-identification continuous enrollment (no more than a 31 day gap) as of the identification date and currently enrolled as of the identification date
- Age 18-85 years at time of identification
- Patients residing in Kentucky (KY), West Virginia (WV), Pennsylvania (PA), and 6 counties in south New Jersey (NJ) (Burlington, Camden, Cumberland, Gloucester, Mercer, Salem) (United States)
Provider
- Primary care providers of the identified patients
Exclusion Criteria:
Patients
- ≥1 diagnosis or procedure code for end-stage kidney disease, renal transplant, dialysis or kidney failure
- Any hospice or long-term care residence
- ≥1 code for pregnancy/childbirth
- Patients with any use of SGLT2i or GLP-1 RA medications in the pre-identification period
- Patients without an attributed primary care provider
- Patients on do not contact lists
- Patients without valid addresses and telephone numbers
- Patients with ≥1 diagnosis for type 1 diabetes pre-identification
Primary care providers
- Providers on do not contact lists
- Providers without valid fax/mailing address and phone number
- Providers with <3 or >50 eligible patients
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Intervention
The educational outreach intervention will entail a multi-faced strategy to provide patients resources to learn more about reducing their risk for heart disease and supporting providers in the care of their patients by sharing recent guideline-recommended treatments for these high-risk individuals.
|
The educational intervention will involve guideline-based treatment recommendation information for providers via fax/mail and phone and provide resources via mail and phone for patients to learn more about ways to reduce their cardiovascular risk.
|
|
Inget ingripande: Control
Patients and primary care providers randomly selected and assigned to the control arm will not receive any of the educational outreach communications.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage of individuals who initiate guideline-based SGLT2i or GLP-1 RA medications with cardiovascular benefit, excluding combination products, based on administrative claims data
Tidsram: 6-months
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Percentage of individuals with T2D & ASCVD who have ≥1 pharmacy claim for SGLT2i or GLP-1 RA medications with cardiovascular benefit, excluding combination products
|
6-months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage of individuals who initiate guideline-based SGLT2i or GLP-1 RA medications with cardiovascular benefit, excluding combination products, based on administrative claims data
Tidsram: 12-months
|
Percentage of individuals with T2D & ASCVD who have ≥1 pharmacy claim for SGLT2i or GLP-1 RA medications with cardiovascular benefit, excluding combination products
|
12-months
|
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Percentage of individuals adherent to guideline-based SGLT2i or GLP-1 RA medications with cardiovascular benefit, excluding combination products, based on administrative claims data
Tidsram: 6-months
|
Adherence to guideline-based SGLT2i or GLP-1 RA medications with cardiovascular benefit, excluding combination products, measured by proportion of days covered based on days' supply of medications from pharmacy claims
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6-months
|
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Percentage of individuals persistent to guideline-based SGLT2i or GLP-1 RA medications with cardiovascular benefit, excluding combination products, based on administrative claims data
Tidsram: 6-months
|
Persistence to guideline-based SGLT2i or GLP-1 RA medications with cardiovascular benefit, excluding combination products, measured by <90 day gap in treatment based on pharmacy claims
|
6-months
|
|
Percentage of individuals who initiate guideline-based SGLT2i or GLP-1 RA medications with cardiovascular benefit, including combination products, based on administrative claims data
Tidsram: 6-months
|
Percentage of individuals with T2D & ASCVD who have ≥1 pharmacy claim for SGLT2i or GLP-1 RA medications with cardiovascular benefit, including combination products
|
6-months
|
|
Percentage of individuals who initiate guideline-based SGLT2i or GLP-1 RA medications with cardiovascular benefit, including combination products, based on administrative claims data
Tidsram: 12-months
|
Percentage of individuals with T2D & ASCVD who have ≥1 pharmacy claim for SGLT2i or GLP-1 RA medications with cardiovascular benefit, including combination products
|
12-months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Alexjandro Daviano, DN, DrPH, Humana Inc.
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- American Diabetes Association. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes-2021. Diabetes Care. 2021 Jan;44(Suppl 1):S111-S124. doi: 10.2337/dc21-S009.
- American Diabetes Association. 10. Cardiovascular Disease and Risk Management: Standards of Medical Care in Diabetes-2021. Diabetes Care. 2021 Jan;44(Suppl 1):S125-S150. doi: 10.2337/dc21-S010. Erratum In: Diabetes Care. 2021 Sep;44(9):2183-2185.
- Das SR, Everett BM, Birtcher KK, Brown JM, Januzzi JL Jr, Kalyani RR, Kosiborod M, Magwire M, Morris PB, Neumiller JJ, Sperling LS. 2020 Expert Consensus Decision Pathway on Novel Therapies for Cardiovascular Risk Reduction in Patients With Type 2 Diabetes: A Report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. 2020 Sep 1;76(9):1117-1145. doi: 10.1016/j.jacc.2020.05.037. Epub 2020 Aug 5. No abstract available.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
18 augusti 2021
Primärt slutförande (Faktisk)
30 november 2021
Avslutad studie (Förväntat)
16 augusti 2022
Studieregistreringsdatum
Först inskickad
12 april 2021
Först inskickad som uppfyllde QC-kriterierna
23 april 2021
Första postat (Faktisk)
28 april 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
20 maj 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
13 maj 2022
Senast verifierad
1 maj 2022
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1236
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