- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02188667
Integrating Patient Reported Outcomes (I-PRO) Study for Multidisciplinary Pain Care (I-PRO)
An Integrative and Sustainable Approach to Pain Management in Primary Care
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
The initiative has three components to aid clinicians' care of patients with chronic noncancer pain: (1) education, (2) standardized patient reported outcomes data collection, and (3) evidence-based brief treatment reminders. Practices will be randomized to either receive the three novel components (treatment group) or continue with usual care (control group).
Providers in the treatment group will be asked (a) to complete a series of six online education modules in pain care, (b) will be given access to new patient reported outcomes questionnaire data collected from patients within the electronic health record, (c) asked to review this data and related care recommendations during the patient visit, and (d) asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain.
Providers in the control group will provide care as usual to patients and will be asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain.
Primary study outcomes include comparison of treatment and control group provider and patient satisfaction surveys. Secondary outcome measures include provider referral rates, patient outcomes, patient treatments recommended/ordered, and patient service utilization/costs.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Florida
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Gainesville, Florida, Stati Uniti, 32607
- Family Medicine at Hampton Oaks
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Gainesville, Florida, Stati Uniti, 32608
- Family Medicine at Haile Plantation
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Gainesville, Florida, Stati Uniti, 32641
- Eastside Community Practice
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Gainesville, Florida, Stati Uniti, 32669
- Family Medicine at Jonesville
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Providers at one of six active Community Health and Family Medicine locations in the University of Florida Health system Gainesville service area (Hampton Oaks, Eastside, Jonesville, and Haile) between May 1, 2014 and September 1, 2015
- Doctor of Medicine (MD), Doctor of Osteopathic Medicine (DO), Advanced Registered Nurse Practitioner (ARNP), Physician Assistant (PA) or other faculty professional providing primary care services
Exclusion Criteria:
- Residents or other trainees at one of four active Community Health and Family Medicine locations in the University of Florida Health system Gainesville service area (Hampton Oaks, Eastside, Jonesville, and Haile) between May 1, 2014 and September 1, 2015
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Comparatore attivo: Providers of Novel Care
Providers in the treatment group will be asked (1) to complete a series of six online education modules in pain care, (2) will be given access to new patient reported outcomes questionnaire data collected from patients within the electronic health record, (3) asked to review this data and related care recommendations during the patient visit, and (4) asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain.
|
Providers in the treatment group will be asked (1) to complete a series of six online education modules in pain care, (2) will be given access to new patient reported outcomes questionnaire data collected from patients within the electronic health record, (3) asked to review this data and related care recommendations during the patient visit, and (4) asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain.
|
Comparatore fittizio: Providers of Usual Care
Providers in the control group will provide care as usual to patients and will be asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain.
|
Providers in the control group will provide care as usual to patients and will be asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Provider Satisfaction Survey
Lasso di tempo: Up to 15 months
|
This is a 16 item web based questionnaire about general experiences and satisfaction with providing care to patients with chronic noncancer pain.
Data will be collected at baseline (June 2014) and monthly thereafter through the end of the study period (July 2014 - September 2015).
Provider satisfaction data for both the treatment and control groups will be compared.
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Up to 15 months
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Patient Satisfaction Survey
Lasso di tempo: Up to 15 months
|
This is a four to five question phone survey (depending on whether patient is seeing a provider in a treatment or control group) about general and pain-specific satisfaction with visit.
Data will be collected after each visit for chronic noncancer pain through the study period (July 2014 - September 2015).
Patient satisfaction data for both the treatment and control groups will be compared.
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Up to 15 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Hospital Readmission Rates
Lasso di tempo: Up to 5 years
|
The data will be collected retrospectively for a history of hospital readmission rates (June 2011 - June 2014).
Once the new care model starts for the clinicians, data will be collected at baseline (July 2014) and at the end of the study period (September 2015) for an indication of trends.
Data for both the treatment and control groups will be compared.
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Up to 5 years
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Lab Orders and Results
Lasso di tempo: Up to 5 years
|
The data will be collected retrospectively for a history of lab orders and results (June 2011 - June 2014).
Once the new care model starts for the clinicians, data will be collected at baseline (July 2014) and at the end of the study period (September 2015) for an indication of trends.
Data will be
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Up to 5 years
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Prescribed and Dispensed Medications
Lasso di tempo: Up to 5 years
|
The data will be collected retrospectively for a history of prescribed and dispensed medications (June 2011 - June 2015).
Once the new care model starts for the clinicians, data will be collected at baseline (July 2014) and at the end of the study period (September 2015) for an indication of trends.
Data for both the treatment and control groups will be compared.
|
Up to 5 years
|
Pain Intensity
Lasso di tempo: Up to 5 years
|
The data will be collected retrospectively for a history of pain intensity (June 2011 - June 2014).
Once the new care model starts for the clinicians, data will be collected at baseline (July 2014) and at the end of the study period (September 2015) for an indication of trends.
Data for both the treatment and control groups will be compared.
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Up to 5 years
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Medical Costs
Lasso di tempo: Up to 5 years
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The data will be collected retrospectively for a history of medical costs (June 2011 - June 2014).
Once the new care model starts for the clinicians, data will be collected at baseline (July 2014) and at the end of the study period (September 2015) for an indication of trends.This will include cost of pain related care for charge amounts and billed amounts for specialist services, hospital services, and utilization of non-physician services (e.g., pharmacy, physical therapy, etc.).
Data for both the treatment and control groups will be compared.
|
Up to 5 years
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Health Care Utilization
Lasso di tempo: Up to 5 years
|
The data will be collected retrospectively for a history of health care utilization (June 2011 - June 2014).
Once the new care model starts for the clinicians, data will be collected at baseline (July 2014) and at the end of the study period (September 2015) for an indication of trends.
This will include utilization of specialist services, hospital services, and utilization of non-physician services (e.g., pharmacy, physical therapy, etc.).
Data for both the treatment and control groups will be compared.
|
Up to 5 years
|
Pain Specialist Referral Rates
Lasso di tempo: Up to 5 years
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The data will be collected retrospectively for a history of pain specialist referral rates (June 2011 - June 2014).
Once the new care model starts for the clinicians, data will be collected at baseline (July 2014) and at the end of the study period (September 2015) for an indication of trends.
Data for both the treatment and control groups will be compared.
|
Up to 5 years
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Christopher A Harle, PhD, University of Florida
- Investigatore principale: Robert W Hurley, MD, PhD, University of Florida
- Investigatore principale: Nicole Marlow, PhD, University of Florida
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
Parole chiave
Altri numeri di identificazione dello studio
- IRB201300433
- 8578749 (Altro numero di sovvenzione/finanziamento: Pfizer, Inc.)
Piano per i dati dei singoli partecipanti (IPD)
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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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