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Integrating Patient Reported Outcomes (I-PRO) Study for Multidisciplinary Pain Care (I-PRO)

29. marts 2016 opdateret af: University of Florida

An Integrative and Sustainable Approach to Pain Management in Primary Care

The purpose of this study is to assess the impact of clinician education, electronic health record integrated patient reported outcomes, and electronic health record integrated decision support on pain-related care quality, outcomes, and service utilization.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

21

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Florida
      • Gainesville, Florida, Forenede Stater, 32607
        • Family Medicine at Hampton Oaks
      • Gainesville, Florida, Forenede Stater, 32608
        • Family Medicine at Haile Plantation
      • Gainesville, Florida, Forenede Stater, 32641
        • Eastside Community Practice
      • Gainesville, Florida, Forenede Stater, 32669
        • Family Medicine at Jonesville

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 89 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / 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.
Andet: 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.
Sham-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.
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Provider Satisfaction Survey
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Hospital Readmission Rates
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Florida

Samarbejdspartnere

Pfizer

Efterforskere

  • Ledende efterforsker: Christopher A Harle, PhD, University of Florida
  • Ledende efterforsker: Robert W Hurley, MD, PhD, University of Florida
  • Ledende efterforsker: Nicole Marlow, PhD, University of Florida

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2014

Primær færdiggørelse (Faktiske)

1. marts 2016

Studieafslutning (Faktiske)

1. marts 2016

Datoer for studieregistrering

Først indsendt

7. juli 2014

Først indsendt, der opfyldte QC-kriterier

9. juli 2014

Først opslået (Skøn)

11. juli 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

30. marts 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. marts 2016

Sidst verificeret

1. marts 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • IRB201300433
  • 8578749 (Andet bevillings-/finansieringsnummer: Pfizer, Inc.)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

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Placeringer

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