- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02527915
Mental Health eConsults
The Effects of Mental Health eConsults: A Clinic-level Randomized Trial
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
This study assesses the effects of electronic consultations (eConsults) between primary care providers and psychiatrists as a way to support the delivery of mental health services in primary care settings. The setting for the study are the primary care clinics of Allina Health.
The study uses a randomized rollout design. Across 45 primary care clinics, half of the clinics will be randomly assigned to receive access to eConsults at the start of the study. The other half of the clinics will provide care-as-usual for nine months, at which point they will also gain access to eConsults. Stratified randomization will be used, with stratification on whether primary care clinics have co-located specialty mental health services.
For primary care clinics that are given access to eConsults, the primary care providers in those clinics will have the option of ordering an eConsult on behalf of their patients, which will include specific questions about a particular patient's care. The request is routed to the service region's psychiatry pool, and the psychiatrists have the option of responding. If they choose to respond, the psychiatrist responds with their recommendations within one business day, and the PCP proceeds with care accordingly. The psychiatrist receives 0.75 work relative value units (wRVUs) for providing this service. All communications for the eConsult are routed through Allina's Epic system. Although patients will not be billed for eConsults over the course of the proposed research, some insurance plans do cover it and evidence of eConsult effectiveness may impel other insurers to cover the service.
The study will have two components. First, the investigators will collect web survey data from the primary care providers to assess how access to eConsults affects providers' perceptions of their support and skill for delivering mental health services to their patients. Second, the investigators will assess the effects of receiving eConsults at the patient level, by using data from the Electronic Medical Record system.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Minnesota
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Minneapolis, Minnesota, Stati Uniti, 55407
- Allina Health
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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:
- For the provider surveys, we will recruit all of the primary care providers who work in Allina's primary care clinics to participate in the surveys
- For the patient-level analysis, we will examine data from all patients seen in Allina's primary care clinics during the study period. We will include children and adults.
Exclusion Criteria:
- We will exclude patients from the patient-level analysis who have opted that their secondary data not be used by Allina for research purposes.
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)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Mental Health eConsults
Primary care clinics that will receive the eConsults intervention at the start of the study.
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Providers in primary care clinics who receive the intervention will be able to use electronic consultations (eConsults) with psychiatrists.
If a primary care provider wishes to use eConsults, he/she will enter a specific question about a patient in the electronic medical record system and submit as an eConsult.
A psychiatrist will review the question and the patient's record, and send a response back to the primary care provider within one business day.
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|
Comparatore attivo: Usual care
Primary care clinics that will deliver care as usual for nine months, and will receive the eConsults intervention nine months subsequent to the eConsults "intervention" clinics.
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Providers in primary care clinics will deliver care as usual to their patients.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Use of eConsults
Lasso di tempo: Within one day of a primary care clinic visit
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Whether an eConsult was actually ordered in a primary care visit for a mental health issue.
Data will be extracted from the electronic medical record system.
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Within one day of a primary care clinic visit
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Frequency of specialist consultation
Lasso di tempo: Baseline and 6 months
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Primary care providers report how often in the past 6 months they consult with a mental health specialist for help with a patient's mental health issues at the baseline web survey questionnaire and the 6-month followup survey.
Survey data will be collected from up to 400 primary care providers.
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Baseline and 6 months
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How easy to consult with specialist
Lasso di tempo: Baseline and 6 months
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Primary care providers report how easy it is in the past 6 months to consult with a mental health specialist for help with a patient's mental health issues at the baseline web survey questionnaire and the 6-month followup survey.
Survey data will be collected from up to 400 primary care providers.
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Baseline and 6 months
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Patient contact with a specialist, 1 month
Lasso di tempo: 1-month
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Whether patients see a mental health specialist within a month after a primary care visit.
Data will be extracted from the electronic medical record system.
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1-month
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Patient contact with a specialist, 3 months
Lasso di tempo: 3-month
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Whether patients see a mental health specialist within 3 months after a primary care visit.
Data will be extracted from the electronic medical record system.
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3-month
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Patient contact with a specialist, 6 months
Lasso di tempo: 6-month
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Whether patients see a mental health specialist within 6 months after a primary care visit.
Data will be extracted from the electronic medical record system.
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6-month
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Change in depression symptoms
Lasso di tempo: Baseline office visit to followup within 6 months
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Depressive symptoms, as measured by the PHQ-9 at the office visit and again at a routine PHQ9 measurement within six months.
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Baseline office visit to followup within 6 months
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Total cost of care, 1 month
Lasso di tempo: 1-month
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Total health care spending one month after a primary care visit (including the primary care visit).
Data will be extracted from the electronic medical record system.
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1-month
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Total cost of care, 3 month
Lasso di tempo: 3-month
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Total health care spending three months after a primary care visit (including the primary care visit).
Data will be extracted from the electronic medical record system.
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3-month
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Total cost of care, 6 month
Lasso di tempo: 6-month
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Total health care spending six months after a primary care visit (including the primary care visit).
Data will be extracted from the electronic medical record system.
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6-month
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Providers get needed support for mental health care
Lasso di tempo: Baseline and 6 months
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Providers indicate agreement with whether they have adequate support for delivering five aspects of mental health care at the baseline web survey questionnaire and the 6-month followup survey.
Survey data will be collected from up to 400 primary care providers.
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Baseline and 6 months
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Any mental health service use, 2 week
Lasso di tempo: 2-week
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Whether any mental health services (medication, counseling) were used after a primary care visit.
Data will be extracted from the electronic medical record system.
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2-week
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Any mental health service use, 1 month
Lasso di tempo: 1-month
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Whether any mental health services (medication, counseling) were used after a primary care visit.
Data will be extracted from the electronic medical record system.
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1-month
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Any mental health service use, 3-month
Lasso di tempo: 3-month
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Whether any mental health services (medication, counseling) were used after a primary care visit.
Data will be extracted from the electronic medical record system.
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3-month
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Any mental health service use, 6 month
Lasso di tempo: 6-months
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Whether any mental health services (medication, counseling) were used after a primary care visit.
Data will be extracted from the electronic medical record system.
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6-months
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Provider-perceived patient access
Lasso di tempo: Baseline and six months
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Providers' perceptions of how quickly their patients are able to access needed specialty mental health services at the baseline web survey questionnaire and the 6-month followup survey.
Survey data will be collected from up to 400 primary care providers.
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Baseline and six months
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Emergency department use, 1 month
Lasso di tempo: 1-month
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Whether there was any emergency department use in the months after a primary care visit.
Data will be extracted from the electronic medical record system.
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1-month
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Emergency department use, 3 months
Lasso di tempo: 3-month
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Whether there was any emergency department use in the three months after a primary care visit.
Data will be extracted from the electronic medical record system.
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3-month
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Psychotropic medication use, 1 month
Lasso di tempo: 1-month
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Whether there was any psychotropic drug prescription and use in the month after a primary care visit.
Data will be extracted from the electronic medical record system.
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1-month
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Psychotropic medication use, 3 month
Lasso di tempo: 3-month
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Whether there was any psychotropic drug prescription and use in the three months after a primary care visit.
Data will be extracted from the electronic medical record system.
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3-month
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Inpatient use, 1 month
Lasso di tempo: 1-month
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Whether there was any emergency department use in the month after a primary care visit.
Data will be extracted from the electronic medical record system.
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1-month
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Inpatient use, 3 month
Lasso di tempo: 3-month
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Whether there was any emergency department use in the three months after a primary care visit.
Data will be extracted from the electronic medical record system.
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3-month
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Confidence in depression treatment
Lasso di tempo: Baseline and six months
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Providers are asked about their levels of confidence in five aspects of depression treatment at the baseline web survey questionnaire and the 6-month followup survey.
Survey data will be collected from up to 400 primary care providers.
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Baseline and six months
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Skill in depression treatment
Lasso di tempo: Baseline and six months
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Providers are asked to assess their skill in four aspects of depression treatment at the baseline web survey questionnaire and the 6-month followup survey.
Survey data will be collected from up to 400 primary care providers.
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Baseline and six months
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Ezra Golberstein, Ph.D., University of Minnesota
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 (Effettivo)
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
- 1507S76668
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 .
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