- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Florida
-
Gainesville, Florida, Förenta staterna, 32607
- Family Medicine at Hampton Oaks
-
Gainesville, Florida, Förenta staterna, 32608
- Family Medicine at Haile Plantation
-
Gainesville, Florida, Förenta staterna, 32641
- Eastside Community Practice
-
Gainesville, Florida, Förenta staterna, 32669
- Family Medicine at Jonesville
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv 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.
|
Sham Comparator: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Provider Satisfaction Survey
Tidsram: 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.
|
Up to 15 months
|
Patient Satisfaction Survey
Tidsram: 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.
|
Up to 15 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Hospital Readmission Rates
Tidsram: 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.
|
Up to 5 years
|
Lab Orders and Results
Tidsram: 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
|
Up to 5 years
|
Prescribed and Dispensed Medications
Tidsram: 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
Tidsram: 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.
|
Up to 5 years
|
Medical Costs
Tidsram: Up to 5 years
|
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
|
Health Care Utilization
Tidsram: 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
Tidsram: Up to 5 years
|
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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Christopher A Harle, PhD, University of Florida
- Huvudutredare: Robert W Hurley, MD, PhD, University of Florida
- Huvudutredare: Nicole Marlow, PhD, University of Florida
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- IRB201300433
- 8578749 (Annat bidrag/finansieringsnummer: Pfizer, Inc.)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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