- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Florida
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Gainesville, Florida, Stany Zjednoczone, 32607
- Family Medicine at Hampton Oaks
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Gainesville, Florida, Stany Zjednoczone, 32608
- Family Medicine at Haile Plantation
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Gainesville, Florida, Stany Zjednoczone, 32641
- Eastside Community Practice
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Gainesville, Florida, Stany Zjednoczone, 32669
- Family Medicine at Jonesville
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
---|---|
Aktywny komparator: 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.
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Pozorny komparator: 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.
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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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Provider Satisfaction Survey
Ramy czasowe: Up to 15 months
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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
Ramy czasowe: Up to 15 months
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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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Hospital Readmission Rates
Ramy czasowe: Up to 5 years
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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
Ramy czasowe: Up to 5 years
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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
Ramy czasowe: Up to 5 years
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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.
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Up to 5 years
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Pain Intensity
Ramy czasowe: Up to 5 years
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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
Ramy czasowe: 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.
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Up to 5 years
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Health Care Utilization
Ramy czasowe: Up to 5 years
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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.
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Up to 5 years
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Pain Specialist Referral Rates
Ramy czasowe: 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.
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Up to 5 years
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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Christopher A Harle, PhD, University of Florida
- Główny śledczy: Robert W Hurley, MD, PhD, University of Florida
- Główny śledczy: Nicole Marlow, PhD, University of Florida
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- IRB201300433
- 8578749 (Inny numer grantu/finansowania: Pfizer, Inc.)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
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