- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00793260
Deep Dive Randomized Control Trial
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Maine
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Portland, Maine, Stati Uniti, 04101
- Health Dialog Analytic Solutions, Inc
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- All employees, dependents and retirees in one of seven large employer groups, including a state university system, a state employee group, two manufacturing companies, a natural resource extraction company, a public educational service agency, and a nonprofit multiple employer association for independent colleges were eligible for inclusion.
Exclusion Criteria:
- no financial information was available from their facility and professional claims;
- they were in an employer sub-group ineligible for care support services;
- they asked not be to contacted or were deceased;
- gender information was missing from their eligibility files;
- their claims data from the year prior to the start of the study indicated diagnoses of HIV, AIDS, end-stage renal disease (ESRD), organ transplants, or necrotizing fasciitis (intended to improve the likelihood of a balanced distribution of costs and conditions); OR
- they were in an employer sub-group with less than four months of enrollment prior to the study start date (resulting in too little information for stratification).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore attivo: Usual Support Group
Predictive models in the Usual-Support Group were aimed at identifying individuals through medical claims and administrative data (such as hospitalization notification).
The output of the predictive models is a rank-ordered, or stratified, list of individuals who have support needs.
These lists were then used to generate outbound mail, interactive voice response (IVR) calls or calls by health coaches.
|
Predictive models in the Usual-Support Group were aimed at identifying individuals through medical claims and administrative data (such as hospitalization notification).
The output of the predictive models is a rank-ordered, or stratified, list of individuals who have support needs.
These lists were then used to generate outbound mail, interactive voice response (IVR) calls or calls by health coaches.
|
|
Sperimentale: Enhanced Support Group
The Enhanced-Support Group intervention used more sophisticated predictive models, more extensive outreach to engage individuals, and provided tighter feedback loops to inform the care support process.
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The Enhanced-Support Group program used lower risk thresholds for targeted outreach of individuals with chronic illness and for those likely to face discrete surgical interventions. Individuals at high financial risk but without one of the five chronic conditions were included in the Enhanced-Support Group. The Enhanced-Support Group received up to five initial reach attempts while the Usual-Support Group received up to three attempts. The Enhanced-Support Group used a 'tight loop' management structure including detailed, timely coach level feedback reports on efficiency and effectiveness. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
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The primary outcome measure was total medical costs (capped at $200,000 per individual per year) and pharmacy costs.
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Misure di risultato secondarie
Misura del risultato |
|---|
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Secondary measures included utilization of selected services.
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: David E Wennberg, MD, MPH, Health Dialog
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- DeepDive
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .