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

Completed

• Conditions: Pain
• Interventions: Other: Physician assessment; Other: Pain assessment questionnaire; Genetic: CYP2D6 genotyping

• Registration Number: NCT02335307
• Lead Sponsor: University of Florida

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-01-07
• Study First Submitted QC: 2015-01-08
• Study First Posted: 2015-01-09
• Study Start: 2015-06
• Primary Completion: 2017-06-12
• Study Completion: 2017-10-25
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-05
• Last Update Posted: 2019-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 505

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Physician assessment	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.
Control	Pain assessment questionnaire	Patients will continue to receive their current pain management therapy. In addition, a pain assessment questionnaire will be administered at baseline and 3 months.
Implementation	Pain assessment questionnaire	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.
Implementation	CYP2D6 genotyping	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.

Primary Outcome Measures

Name	Time	Method
Change in overall pain score (Patient Reported Outcomes Measurement Information System (PROMIS)	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.

Secondary Outcome Measures

Name	Time	Method
Physician perceived usefulness of genetic information (survey)	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.
Change in pain score of emotional functioning	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 in pain score of pain intensity (Patient Reported Outcomes Measurement Information System (PROMIS) subscale)	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 in pain medication	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 in pain score of physical functioning (Patient Reported Outcomes Measurement Information System (PROMIS) subscale)	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.
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)	12 months	Percent of patients with at least one other drug (besides an opioid) where genotype information might be useful for prescribing

Trial Locations

Locations (11)

UF Health Family Medicine - Old Town; 🇺🇸 Old Town, Florida, United States

Archer Family Health Care; 🇺🇸 Archer, Florida, United States

Oviedo Family Health Center; 🇺🇸 Oviedo, Florida, United States

ProHealth Family Physicians; 🇺🇸 Saint Cloud, Florida, United States

UF Health Spring Hill Pain Management; 🇺🇸 Gainesville, Florida, United States

UF Health Family Medicine: Hampton Oaks; 🇺🇸 Gainesville, Florida, United States

UF Health Internal Medicine - Tower Hill; 🇺🇸 Gainesville, Florida, United States

UF Health Family Medicine: Haile Plantation; 🇺🇸 Gainesville, Florida, United States

UF Health Family Medicine: Main Street; 🇺🇸 Gainesville, Florida, United States

UF Health Internal Medicine-Medical Plaza; 🇺🇸 Gainesville, Florida, United States

UF Health Family Medicine: Eastside; 🇺🇸 Gainesville, Florida, United States