NCT02335307

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
505

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2015

Typical duration for all trials

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2017

Completed
Last Updated

June 6, 2019

Status Verified

June 1, 2019

Enrollment Period

2 years

First QC Date

January 7, 2015

Last Update Submit

June 5, 2019

Conditions

Pain

Keywords

PainCYP2D6

Outcome Measures

Primary Outcomes (1)

  • Change in overall pain score (Patient Reported Outcomes Measurement Information System (PROMIS)

    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

Secondary Outcomes (6)

  • Change in pain medication

    Change from baseline to 3 months

  • Change in pain score of pain intensity (Patient Reported Outcomes Measurement Information System (PROMIS) subscale)

    Change from baseline to 3 months

  • Change in pain score of physical functioning (Patient Reported Outcomes Measurement Information System (PROMIS) subscale)

    Change from baseline to 3 months

  • Change in pain score of emotional functioning

    Change from baseline to 3 months

  • Physician perceived usefulness of genetic information (survey)

    3 months

  • +1 more secondary outcomes

Study Arms (3)

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.

Other: Pain assessment 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.

Genetic: CYP2D6 genotypingOther: Pain assessment questionnaire

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.

Other: Physician assessment

Interventions

CYP2D6 genotypingGENETIC

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.

Implementation
Pain assessment questionnaireOTHER

A pain assessment questionnaire will be administered at baseline and 3 months.

Also known as: PROMIS questionnaire
ControlImplementation
Physician assessmentOTHER

20-item survey administered to physicians treating patients enrolled in the study

Physician assessment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Archer Family Health Care

Archer, Florida, 32618, United States

Location

UF Health Spring Hill Pain Management

Gainesville, Florida, 32606, United States

Location

UF Health Family Medicine: Hampton Oaks

Gainesville, Florida, 32607, United States

Location

UF Health Internal Medicine - Tower Hill

Gainesville, Florida, 32607, United States

Location

UF Health Family Medicine: Haile Plantation

Gainesville, Florida, 32608, United States

Location

UF Health Family Medicine: Main Street

Gainesville, Florida, 32609', United States

Location

UF Health Internal Medicine-Medical Plaza

Gainesville, Florida, 32610, United States

Location

UF Health Family Medicine: Eastside

Gainesville, Florida, 32641, United States

Location

UF Health Family Medicine - Old Town

Old Town, Florida, 32680, United States

Location

Oviedo Family Health Center

Oviedo, Florida, 32765, United States

Location

ProHealth Family Physicians

Saint Cloud, Florida, 34769, United States

Location

Related Publications (1)

  • Crews KR, Gaedigk A, Dunnenberger HM, Leeder JS, Klein TE, Caudle KE, Haidar CE, Shen DD, Callaghan JT, Sadhasivam S, Prows CA, Kharasch ED, Skaar TC; Clinical Pharmacogenetics Implementation Consortium. Clinical Pharmacogenetics Implementation Consortium guidelines for cytochrome P450 2D6 genotype and codeine therapy: 2014 update. Clin Pharmacol Ther. 2014 Apr;95(4):376-82. doi: 10.1038/clpt.2013.254. Epub 2014 Jan 23.

    PMID: 24458010BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

genotype

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Larisa Cavallari, PharmD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2015

First Posted

January 9, 2015

Study Start

June 1, 2015

Primary Completion

June 12, 2017

Study Completion

October 25, 2017

Last Updated

June 6, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will share

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.

Locations

US(11)