Educational Intervention to Increase Select Guideline-recommended Cardioprotective Medications in Patients With Diabetes
Improving Outcomes in Patients With Comorbid T2DM and ASCVD: Population Health Management Interventions Supporting Guideline-recommended SGLT2i and GLP-1 RA Medications
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Tipo di studio
Iscrizione (Effettivo)
Iscrizione
Fase
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Kentucky
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Louisville, Kentucky, Stati Uniti, 40202
- Humana
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Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
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Comparatore attivo: 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.
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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.
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Nessun intervento: Control
Patients and primary care providers randomly selected and assigned to the control arm will not receive any of the educational outreach communications.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Percentage of individuals who initiate guideline-based SGLT2i or GLP-1 RA medications with cardiovascular benefit, excluding combination products, based on administrative claims data
Lasso di tempo: 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
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6-months
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Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Percentage of individuals who initiate guideline-based SGLT2i or GLP-1 RA medications with cardiovascular benefit, excluding combination products, based on administrative claims data
Lasso di tempo: 12-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
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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
Lasso di tempo: 6-months
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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
Lasso di tempo: 6-months
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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
|
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Percentage of individuals who initiate guideline-based SGLT2i or GLP-1 RA medications with cardiovascular benefit, including combination products, based on administrative claims data
Lasso di tempo: 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
Lasso di tempo: 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
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Collaboratori e investigatori
Sponsor
Sponsor
Collaboratori
Collaboratori
Investigatori
Investigatori
- Investigatore principale: Alexjandro Daviano, DN, DrPH, Humana Inc.
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Inizio studio
Completamento primario (Effettivo)
Completamento primario
Completamento dello studio (Anticipato)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- 1236
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