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Implementing Genomics in Practice (IGNITE) Proof of Concept Study: Genotyping in Family Medicine Clinics (IGNITE)

5. juni 2019 opdateret af: University of Florida
This study will examine the effect of having genotype information on pain management and pain control for patients treated in family medicine clinics. This study will also examine physician-perceived usefulness of genotype information. Patients will be enrolled from family medicine clinics serving as either implementation sites or control sites. Patients from implementation sites will undergo genotyping, while those from control sites will not by genotyped.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Codeine and tramadol are opioid analgesics that depend on cytochrome P450 2D6 (CYP2D6) for bioactivation to morphine and O-desmethyltramadol, respectively. Morphine and O-desmethyltramadol have much greater affinity for the opioid receptor and thus are more powerful analgesics.

Individuals with genotypes associated with low CYP2D6 activity (poor metabolizers) are unable to convert sufficient amounts of codeine or tramadol to their active metabolites and may fail to derive sufficient pain relief. At the opposite extreme, individuals with genotypes associated with increased CYP2D6 activity (ultra-rapid metabolizers) are at risk for serious toxicity with usual codeine or tramadol doses.

The CYP2D6 genotype also has implications for response to other drugs, such as tricyclic antidepressants (TCAs), which are commonly used for neuropathic pain.

Patients will be recruited from family medicine clinics, serving as either implementation sites or control sites. Patients from implementation sites will undergo CYP2D6 genotyping, with results placed in the medical record to assist with prescribing of pain medications. Pain medications prescribed from baseline to 3 months will be assessed through medical record review. A pain assessment questionnaire will be administered to patients enrolled from both sites at baseline and 3 months.

At the end of the study, a 20-item survey will be administered to physicians at the implementation sites. We will assess whether having CYP2D6 genotype results is useful to inform prescribing decisions for pain medication from the physician's perspective.

We will also assess medicines prescribed to patients enrolled from both sites over the 12-month period after enrollment from medical record review and determine the number of patients who were prescribed a medication that has genetic information in its FDA-approved label.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

505

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Florida
      • Archer, Florida, Forenede Stater, 32618
        • Archer Family Health Care
      • Gainesville, Florida, Forenede Stater, 32606
        • UF Health Spring Hill Pain Management
      • Gainesville, Florida, Forenede Stater, 32607
        • UF Health Family Medicine: Hampton Oaks
      • Gainesville, Florida, Forenede Stater, 32607
        • UF Health Internal Medicine - Tower Hill
      • Gainesville, Florida, Forenede Stater, 32608
        • UF Health Family Medicine: Haile Plantation
      • Gainesville, Florida, Forenede Stater, 32609'
        • UF Health Family Medicine: Main Street
      • Gainesville, Florida, Forenede Stater, 32610
        • UF Health Internal Medicine-Medical Plaza
      • Gainesville, Florida, Forenede Stater, 32641
        • UF Health Family Medicine: Eastside
      • Old Town, Florida, Forenede Stater, 32680
        • UF Health Family Medicine - Old Town
      • Oviedo, Florida, Forenede Stater, 32765
        • Oviedo Family Health Center
      • Saint Cloud, Florida, Forenede Stater, 34769
        • ProHealth Family Physicians

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 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients will be enrolled from family medicine clinics serving as either implementation sites or control sites for pain mangement.

Beskrivelse

Inclusion Criteria:

  • Treated in family medicine clinic
  • History of pain for at least 3 months
  • Prescribed medication for pain relief

Exclusion Criteria:

  • Pain for less than 3 months
  • Not currently prescribed any medication for pain

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Control
Patients will continue to receive their current pain management therapy. In addition, a pain assessment questionnaire will be administered at baseline and 3 months.
Andet: Pain assessment questionnaire
A pain assessment questionnaire will be administered at baseline and 3 months.
Andre navne:
  • PROMIS questionnaire
Implementation
Patients will undergo CYP2D6 genotyping, with results entered into the medical record to assist the physician with prescribing pain medication. In addition, a pain assessment questionnaire will be administered at baseline and 3 months.
Andet: Pain assessment questionnaire
A pain assessment questionnaire will be administered at baseline and 3 months.
Andre navne:
  • PROMIS questionnaire
Genetisk: CYP2D6 genotyping
CYP2D6 genotype results and an interpretive report will be placed in the electronic medical record to assist the physician with prescribing medication for pain management.
Physician assessment
At the end of the study, a 20-item survey will be administered to physicians who treated patients enrolled in the study. The survey will assess whether having CYP2D6 genotype results is useful to inform prescribing decisions for pain medication from the physician's perspective.
Andet: Physician assessment
20-item survey administered to physicians treating patients enrolled in the study

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in overall pain score (Patient Reported Outcomes Measurement Information System (PROMIS)
Tidsramme: Change from baseline to 3 months
Patient Reported Outcomes Measurement Information System (PROMIS) measures will be used to assess pain intensity, physical functioning, and emotional functioning. There are 10 subscales on the PROMIS questionnaire that address the domains of pain, pain functioning, and emotional functioning. At least 4 (and up to 30) items are used to derive a score for each subscale. A computer adaptive version of the questionnaire based on item response theory will be used to administer the survey. A score of 0 to 100 based on survey responses will be resulted for each subscale.
Change from baseline to 3 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in pain medication
Tidsramme: Change from baseline to 3 months
Change in pain medication will be evaluated in several manners: change in the opiate prescribed, change from an opiate to a non-opiate; and change in dose of the opiate prescribed
Change from baseline to 3 months
Change in pain score of pain intensity (Patient Reported Outcomes Measurement Information System (PROMIS) subscale)
Tidsramme: Change from baseline to 3 months
Patient Reported Outcomes Measurement Information System (PROMIS) subscale for pain intensity, with the score ranging from 0 to 100 resulting.
Change from baseline to 3 months
Change in pain score of physical functioning (Patient Reported Outcomes Measurement Information System (PROMIS) subscale)
Tidsramme: Change from baseline to 3 months
Patient Reported Outcomes Measurement Information System (PROMIS) subscales for physical functioning include pain function, pain interference, pain behavior, sleep disturbance, and sleep-related impairment. A score of 0 to 100 based on survey responses will be resulted for each subscale.
Change from baseline to 3 months
Change in pain score of emotional functioning
Tidsramme: Change from baseline to 3 months
Patient Reported Outcomes Measurement Information System (PROMIS) subscales for emotional functioning include fatigue, anxiety, depression, and anger. A score of 0 to 100 based on survey responses will be resulted for each subscale.
Change from baseline to 3 months
Physician perceived usefulness of genetic information (survey)
Tidsramme: 3 months
Survey will be administered to physicians with patients in the study to assess the effect of having genotype information on their prescribing decisions.
3 months
Medications prescribed with pharmacogenetic implications (Percent of patients with at least one other drug (besides an opioid) where genotype information might be useful for prescribing)
Tidsramme: 12 months
Percent of patients with at least one other drug (besides an opioid) where genotype information might be useful for prescribing
12 months

Samarbejdspartnere og efterforskere

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

Sponsor

University of Florida

Samarbejdspartnere

National Human Genome Research Institute (NHGRI)

Efterforskere

  • Ledende efterforsker: Larisa Cavallari, PharmD, University of Florida

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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 (Faktiske)

1. juni 2015

Primær færdiggørelse (Faktiske)

12. juni 2017

Studieafslutning (Faktiske)

25. oktober 2017

Datoer for studieregistrering

Først indsendt

7. januar 2015

Først indsendt, der opfyldte QC-kriterier

8. januar 2015

Først opslået (Skøn)

9. januar 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. juni 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. juni 2019

Sidst verificeret

1. juni 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • IRB201400501 - N
  • U01HG007269-02 (U.S. NIH-bevilling/kontrakt)
  • OCR14741 (Anden identifikator: Universiy of Florida)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

The consent form has an addendum for NIH dbGaP. Participants who agree will have their deidentified results shared to dbGaP. Those who do not agree will not have their results shared.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Smerte

Kliniske forsøg med Pain assessment questionnaire

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