- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02585557
Heart Health NOW (Previously Known as FAST PACE NC) (HHN)
Heart Health NOW (Previously Known as Facilitation, Spread, and Translation of Patient-Centered Evidence in North Carolina Practices)
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
The burden of cardiovascular disease in North Carolina remains large. The latest data available show an annual cardiovascular death rate of 263 per 100,000 explaining almost one-third of deaths in the state. Disease progression is largely determined by several risk factors including elevated blood pressure or cholesterol, not using aspirin for prevention, and tobacco use. Primary care practices as currently organized have been unable to get more than half these patients to achieve recommended targets for risk factor reduction. Small independent practices, in particular, lack resources for enhanced practice support to improve cardiovascular care.
This study will enroll 300 primary care practices to evaluate the effect of primary care support on evidence-based cardiovascular disease (CVD) prevention and organizational change process measures. Each practice will start the trial as a control, receive the intervention at a randomized time point, and then enter a maintenance period 12 months after starting the intervention. All practices will receive 12 months of the intense intervention including onsite quality improvement (QI) facilitation, academic detailing, electronic health record (EHR) support, and, through the North Carolina Health Information Exchange (HIE), a shared statewide utility providing whole population analytics, care gap identification, benchmarking, and an external reporting mechanism which otherwise would not be available to independent practices.
A successful intervention would prove that practice facilitation supported by effective informatics tools is an effective method of translating PCOR findings into practice. Discernible reductions in cardiovascular risk in 300 practices covering over an estimated 900,000 adult patients would likely lead to prevention of thousands of cardiovascular events within 10 years.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Primary care practice in North Carolina with 10 or fewer providers in a single location
- must have implemented an EHR and either be connected to or have agreed to connect to the HIE.
Exclusion Criteria:
- practices with more than 10 providers in a single location
- practices receiving practice facilitation services beyond the usual support provided by Area Health Education Centers (AHEC) or the Community Care of North Carolina (CCNC) program through their parent organization.
- practices without an EHR
- practices where the central practice organization either bars the practice from our program or provides onsite facilitation services equal to or greater than the 4-6 hour standard contact with a QI coach
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Cluster A
50 practices randomly assigned to start intervention at month 9. Assigned Intervention: Primary Care Practice Support.
The intervention consists of practice facilitation, academic detailing, and regional learning collaboratives.
|
The intervention consists of practice facilitation, academic detailing, and regional learning collaboratives.
|
Experimental: Cluster B
50 practices randomly assigned to start intervention at month 11.
Assigned Intervention: Primary Care Practice Support.
The intervention consists of practice facilitation, academic detailing, and regional learning collaboratives.
|
The intervention consists of practice facilitation, academic detailing, and regional learning collaboratives.
|
Experimental: Cluster C
50 practices randomly assigned to start intervention at month 12. Assigned Intervention: Primary Care Practice Support.
The intervention consists of practice facilitation, academic detailing, and regional learning collaboratives.
|
The intervention consists of practice facilitation, academic detailing, and regional learning collaboratives.
|
Experimental: Cluster D
50 practices randomly assigned to start intervention at month 14.
Assigned Intervention: Primary Care Practice Support.
The intervention consists of practice facilitation, academic detailing, and regional learning collaboratives.
|
The intervention consists of practice facilitation, academic detailing, and regional learning collaboratives.
|
Experimental: Cluster E
50 practices randomly assigned to start intervention at month 16.
Assigned Intervention: Primary Care Practice Support.
The intervention consists of practice facilitation, academic detailing, and regional learning collaboratives.
|
The intervention consists of practice facilitation, academic detailing, and regional learning collaboratives.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Measurable reduction in arteriosclerotic cardiovascular disease (ASCVD) risk
Zeitfenster: 18 months
|
By comparing EHR data at baseline and post-intervention, determine whether practice support resulted in discernible reduction in CVD risk.
|
18 months
|
Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Sam Cykert, MD, UNC Chapel Hill
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 15-0479
- 1R18HS023912-01 (US-AHRQ-Zuschuss/Vertrag)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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