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

5 juni 2019 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

505

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 80 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
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.
Övrig: Pain assessment questionnaire
A pain assessment questionnaire will be administered at baseline and 3 months.
Andra namn:
  • 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.
Övrig: Pain assessment questionnaire
A pain assessment questionnaire will be administered at baseline and 3 months.
Andra namn:
  • 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.
Övrig: Physician assessment
20-item survey administered to physicians treating patients enrolled in the study

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in overall pain score (Patient Reported Outcomes Measurement Information System (PROMIS)
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in pain medication
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 12 months
Percent of patients with at least one other drug (besides an opioid) where genotype information might be useful for prescribing
12 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Florida

Samarbetspartners

National Human Genome Research Institute (NHGRI)

Utredare

  • Huvudutredare: Larisa Cavallari, PharmD, University of Florida

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 juni 2015

Primärt slutförande (Faktisk)

12 juni 2017

Avslutad studie (Faktisk)

25 oktober 2017

Studieregistreringsdatum

Först inskickad

7 januari 2015

Först inskickad som uppfyllde QC-kriterierna

8 januari 2015

Första postat (Uppskatta)

9 januari 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 juni 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

5 juni 2019

Senast verifierad

1 juni 2019

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • IRB201400501 - N
  • U01HG007269-02 (U.S.S. NIH-anslag/kontrakt)
  • OCR14741 (Annan identifierare: Universiy of Florida)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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