Depression, Acute Pain, Chronic Pain
Conditions
Keywords
Pharmacogenetic, CYP2D6, CYP2C19
Brief summary
This is a Master Protocol Screening record. This study is comprised of three separate pharmacogenetic trials grouped into a single protocol due to similarities in the intervention, the hypotheses, and the trial design. The three trials are the Acute Pain Trial, the Chronic Pain Trial, and the Depression Trial. Participants can enroll in only one of the three trials. Each trial is listed individually on clinicaltrials.gov and includes "PRO00104948" within the Unique Protocol ID: PRO00104948\_A - Acute Pain Trial - NCT05966129 PRO00104948\_B - Chronic Pain Trial - NCT05966142 PRO00104948\_C - Depression Trial - NCT05966155 Acute Pain Trial: A prospective, multicenter, two arm randomized pragmatic trial. Participants meeting eligibility criteria will be randomly assigned to either immediate pharmacogenetic testing and genotype-guided post-surgical opioid therapy (Intervention arm) or standard care and pharmacogenetic testing after 6 months (Control arm). The investigators will test the hypothesis that pharmacogenetic testing and genotype guided pain management therapy improves pain control after surgery in participants who's body processes some pain medicines slower than normal. Chronic Pain Trial: A prospective, multicenter, two arm randomized pragmatic trial. Participants meeting eligibility criteria will be randomly assigned to either immediate pharmacogenetic testing and genotype-guided opioid therapy (Intervention arm) or standard care with 6-month delayed pharmacogenetic testing (Control arm). The investigators will test the hypothesis that pharmacogenetic testing and genotype guided pain therapy improves pain control after surgery in participants who's body processes some pain medicines slower than normal. Depression: A prospective, multicenter, two arm randomized pragmatic trial. Participants meeting eligibility criteria will be randomly assigned to either immediate pharmacogenetic testing and genotype-guided anti-depressant therapy (Intervention arm) or standard care with 6-month delayed pharmacogenetic testing (Control arm). The investigators will test the hypothesis that pharmacogenetic testing and genotype-guided anti-depressant therapy will reduce depression symptoms in participants who's body processes some anti-depressants faster or slower than normal.
Detailed description
Pain and depression are conditions that impact substantial proportions of the US population. Finding safe and effective drug therapies for both conditions is challenging. In the case of treatment for acute and chronic pain, the challenge is finding effective therapy while minimizing adverse effects or opioid addiction (and the ensuing consequences). For depression, there are few clinically relevant predictors of successful treatment leading to multiple trials of inadequate therapy for some patients. Both opioid and antidepressant prescriptions can be guided by pharmacogenetics (PGx) data based on existing guidelines from the Clinical Pharmacogenetics Implementation Consortium (CPIC). This study is designed to evaluate the impact of pharmacogenetic testing and genotype-guided pain or anti-depressant therapy on pain control or depression symptoms in a pragmatic setting. The rationale for examining a genotype-guided approach to acute and chronic pain management is based on the importance of CYP2D6 for the bioactivation of tramadol, codeine, and hydrocodone and data from a pilot study supporting improved pain control in intermediate and poor CYP2D6 metabolizers in the genotype-guided arm who are taking these drugs at baseline. Similarly, the rationale for examining a genotype-guided approach to depression medication therapy is based on the demonstrated role of CYP2D6 in the bio inactivation and CYP2C19 oxidation of select, commonly used SSRIs. Secondly, data from industry sponsored trials support the hypothesis of improved depression symptom control in a genotype-guided arm. Study objectives: Acute Pain Trial: Determine if a genotype-guided approach to acute post-surgical pain therapy leads to improved pain control compared to usual care, as defined by a decrease in the SIA score. Secondarily, The investigators will evaluate whether this approach leads to reduced use of DEA Schedule II opioids and reduced pain intensity. Chronic Pain Trial: Determine if a genotype-guided approach to pain therapy in participants with at least 3 months of chronic pain leads to improved pain control compared to usual care. Depression Trial: Determine if genotype-guided dosing or selection of antidepressants among participants with at least 3 months of depressive symptoms who require new or revised antidepressant therapy leads to improved control of depression, compared to usual care.
Interventions
Genetic testing of CYP2D6 and CYP2C19
Prescribing recommendations to the provider based on the pharmacogenetic testing results
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Immediate vs. delayed pharmacogenetic testing and genotype-guided pain or depression therapy
Eligibility
Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Acute Pain * Age ≥ 8 years * English speaking or Spanish speaking * Elective/planned surgery types with planned or anticipated to be treated with tramadol, hydrocodone, or codeine pain management at an enrolling site, which may include orthopedic surgeries (e.g. arthroplasty, spine, etc.), open abdominal surgery, or cardiothoracic surgery and others Chronic Pain * Age ≥ 18 years * English speaking or Spanish speaking * Seen at primary care clinics (such as, but not limited to, Internal Medicine, Family Medicine or Pediatrics) or patients seen in pain-relevant specialty clinics * History of pain for at least the last 3 months * Currently treated or being considered for treatment with tramadol, hydrocodone, or codeine to improve pain management Depression * Age ≥ 8 years * English speaking or Spanish speaking * Patients followed at psychiatry clinics or primary care clinics at an enrolling site (such as, but not limited to, Internal Medicine, Family Medicine, or Pediatrics) * Documentation of depression and/or provider report of depression * Evidence of depressive symptoms for at least 3 months based on patient interview or documentation in electronic health records * Recent initiation of SSRI therapy, recent revised SSRI therapy, or anticipated need for revised or new SSRI therapy per health care provider
Exclusion criteria
Trial-wide: * Life expectancy less than 12 months * Are too cognitively impaired to provide informed consent and/or complete study protocol * Are institutionalized or too ill to participate (i.e. mental or nursing home facility or incarcerated) * Have a history of allogeneic stem cell transplant or liver transplant * People with prior clinical pharmacogenetic test results for genes relevant for the study in which they will enroll (CYP2D6 for the pain studies and CYP2D6 or CYP2C19 for depression) or already enrolled in an ADOPT PGx trial Acute Pain * Undergoing a laparoscopic surgery * Receiving chronic opioid therapy, defined as use of opioids on most days for \>3 months Chronic Pain * Plan to move out of the area within 6 months of enrollment * Undergoing treatment for an active cancer diagnosis * Currently taking daily opioids other than tramadol, codeine or hydrocodone Depression * Plan to move out of the area within 6 months of enrollment * Have active psychosis or diagnosed psychotic disorders (schizophrenia, schizoaffective disorder, delusional disorder, psychotic depression, substance induced psychosis, schizophreniform disorder) * Have dementia or other neurocognitive disorders due to any cause, such as Alzheimer's disease, vascular/subcortical, lewy body disease, frontotemporal lobar degeneration * Have cognitive developmental delay and/or cognitive disability, including autism spectrum disorders (Note: ADHD is not an
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Individuals Identified as Potential Participants Through EHR (Electronic Health Record) | Up to 3 years | Potential participants identified for the Acute Pain, Chronic Pain, and Depression Trials through EHR. |
| Number of Individuals Who Were Screened to the Acute Pain, Chronic Pain, and Depression Trials | Up to 3 years | Individuals who were screened to be in the Acute Pain, Chronic Pain and Depression Trials. |
| Number of Participants Who Were Randomized to the Acute Pain, Chronic Pain, and Depression Trials | Up to 3 years | Individuals who were randomized to be in the Acute Pain, Chronic Pain and Depression Trials. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Interference as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 6 months | The 6-item PROMIS 43 subscale for pain interference assesses the extent to which participants experience interference with daily activities over the past 7 days using a 5-point Likert scale. The pain interference subscale provides a raw score ranging from 6 to 30. Raw scores are converted to T-scores using the PROMIS conversion tables, T-scores range from 41.1 to 76.3. Higher scores reflect greater pain interference. |
| Physical Function as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 6 months | The 6-item PROMIS 43 subscale for physical functioning assesses a participants physical functioning over the past 7 days using a 5-point Likert scale. The physical functioning sub scale provides a raw score ranging from 6 to 30. Raw scores are converted to T-scores using the PROMIS conversion tables. T-scores range from 21.0 to 59.0. Higher T-scores reflect higher levels of physical functioning. |
| Sleep Disturbance as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 6 months | The 6-item PROMIS 43 subscale for sleep disturbance assesses the extent to which participants experience sleep disturbance related symptoms sleep over the past 7 days using a 5-point Likert scale. The sleep disturbance subscale provides a raw score ranging from 6 to 30. Raw scores are converted to T-scores using the PROMNIS conversion tables, ranging from 31.7 to 76.1. Higher scores reflect higher levels of sleep disturbance. |
| Ability to Participant in Social Roles and Activities as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 6 months | The 6-item PROMIS 43 subscale for ability to participate in social roles and activities assesses the extent to which participants are able to participant in different social roles and activities over the past 7 days using a 5-point Likert scale. The ability to participant in social roles and activities subscale provides a raw score ranging from 6 to 30. Raw scores are converted to T-scores using the PROMIS conversion tables, T-scores range from 26.7 to 65.0 with higher values corresponding to a higher ability to participant in social roles and activities. |
| Fatigue as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 6 months | The 6-item PROMIS 43 subscale for fatigue assesses the extent to which participants experience fatigue-related symptoms over the past 7 days using a 5-point Likert scale. The fatigue subscale provides a raw score ranging from 6 to 30. Raw scores are converted to T-scores using the PROMIS conversion tables, T-scores range from 33.4 to 76.8. Higher T-scores reflect greater fatigue symptoms. |
| Anxiety as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 6 months | The 6-item PROMIS subscale for anxiety assesses the extent to which participants experience anxiety symptoms over the past 7 days using a 5-point Likert scale. The anxiety subscale provides a raw score, ranging from 6 to 30. Raw scores are converted to T-scores using the PROMIS conversion tables, T-scores range from 33.4 to 76.8. Higher T-scores reflect greater anxiety. |
| Depression as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 6 months | The 6-item PROMIS 43 subscale for depression assesses the extent to which participants experience depressive symptoms over the past 7 days using a 5-point Likert scale. The depression subscale provides a raw sore ranging from 6 to 30. Raw scores are converted to T-scores using the PROMIS conversion tables, T-scores range from 38.4 to 80.3. Higher T-scores reflect greater depression. |
| Overall Wellbeing as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 6 months | Overall wellbeing is the sum of the PROMIS 43 subdomain T-scores, with physical function and ability to participate in social roles scores reversed such that higher values within each subscale correspond with poorer health. Overall wellbeing ranges from 259.7 to 541.2, higher scores correspond to worse wellbeing. |
| Number of Participants With Pharmacogenetic Drug-Gene Concordance | 10 days for Acute Pain; 3 months for Chronic Pain and Depression | Concordance between PGx phenotypes and opioid (Acute Pain and Chronic Pain) and SSRI (Depression) medications. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORHrishikesh Chakraborty
Duke University
Participant flow
Recruitment details
This record is for the overall master study protocol for the ADOPT PGx trial. The results for the individual trials are reported in separate records.
Pre-assignment details
There were 4284 participants consented into the overall trial. Of the 4284, 174 consented participants were not randomized into the trial and were not assigned to a treatment arm. The remaining 4110 consented participants were randomized and assigned into the treatment arms. The 4110 randomized participants will be described moving forward.
Participants by arm
| Arm | Count |
|---|---|
| Acute Pain, Chronic Pain, and Depression Trial Participants Acute Pain Trial: A prospective, multicenter, two arm randomized pragmatic trial. Participants meeting eligibility criteria will be randomly assigned to either immediate pharmacogenetic testing and genotype-guided post-surgical opioid therapy (Intervention arm) or standard care and pharmacogenetic testing after 6 months (Control arm).
Chronic Pain Trial: A prospective, multicenter, two arm randomized pragmatic trial. Participants meeting eligibility criteria will be randomly assigned to either immediate pharmacogenetic testing and genotype-guided opioid therapy (Intervention arm) or standard care with 6-month delayed pharmacogenetic testing (Control arm).
Depression: A prospective, multicenter, two arm randomized pragmatic trial. Participants meeting eligibility criteria will be randomly assigned to either immediate pharmacogenetic testing and genotype-guided anti-depressant therapy (Intervention arm) or standard care with 6-month delayed pharmacogenetic testing (Control arm). | 4,110 |
| Total | 4,110 |
Baseline characteristics
| Characteristic | Acute Pain, Chronic Pain, and Depression Trial Participants |
|---|---|
| Age, Customized Age, Categorical 18 to 65 years | 2529 Participants |
| Age, Customized Age, Categorical <=18 years | 264 Participants |
| Age, Customized Age, Categorical >=65 years | 1317 Participants |
| Age, Customized Age, Categorical Unknown or Not Reported | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 381 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3679 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 50 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 29 Participants |
| Race (NIH/OMB) Asian | 71 Participants |
| Race (NIH/OMB) Black or African American | 865 Participants |
| Race (NIH/OMB) More than one race | 99 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 15 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 360 Participants |
| Race (NIH/OMB) White | 2671 Participants |
| Region of Enrollment United States | 4110 Participants |
| Sex/Gender, Customized Gender Do not identify as female, male, or transgender | 28 Participants |
| Sex/Gender, Customized Gender Female | 2782 Participants |
| Sex/Gender, Customized Gender Male | 1276 Participants |
| Sex/Gender, Customized Gender Prefer not to answer | 10 Participants |
| Sex/Gender, Customized Gender Transgender | 12 Participants |
| Sex/Gender, Customized Gender Unknown | 2 Participants |
| Sex/Gender, Customized Sex Female | 2827 Participants |
| Sex/Gender, Customized Sex Male | 1280 Participants |
| Sex/Gender, Customized Sex Unknown or Not Reported | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 5 / 2,055 | 7 / 2,055 |
| other Total, other adverse events | 1 / 2,550 | 0 / 2,550 |
| serious Total, serious adverse events | 0 / 2,550 | 0 / 2,550 |
Outcome results
Primary
Number of Individuals Identified as Potential Participants Through EHR (Electronic Health Record)
Potential participants identified for the Acute Pain, Chronic Pain, and Depression Trials through EHR.
Time frame: Up to 3 years
Population: Individuals who were prescreened.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Individuals Identified as Potential Participants Through EHR | Number of Individuals Identified as Potential Participants Through EHR (Electronic Health Record) | 17,496 Participants |
Primary
Number of Individuals Who Were Screened to the Acute Pain, Chronic Pain, and Depression Trials
Individuals who were screened to be in the Acute Pain, Chronic Pain and Depression Trials.
Time frame: Up to 3 years
Population: Individuals who were screened for the Acute Pain, Chronic Pain, and Depression Trials.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Individuals Identified as Potential Participants Through EHR | Number of Individuals Who Were Screened to the Acute Pain, Chronic Pain, and Depression Trials | 4,285 Participants |
Primary
Number of Participants Who Were Randomized to the Acute Pain, Chronic Pain, and Depression Trials
Individuals who were randomized to be in the Acute Pain, Chronic Pain and Depression Trials.
Time frame: Up to 3 years
Population: Participants who were consented to the Acute Pain, Chronic Pain, and Depression Trials.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Individuals Identified as Potential Participants Through EHR | Number of Participants Who Were Randomized to the Acute Pain, Chronic Pain, and Depression Trials | 4110 Participants |
Secondary
Ability to Participant in Social Roles and Activities as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
The 6-item PROMIS 43 subscale for ability to participate in social roles and activities assesses the extent to which participants are able to participant in different social roles and activities over the past 7 days using a 5-point Likert scale. The ability to participant in social roles and activities subscale provides a raw score ranging from 6 to 30. Raw scores are converted to T-scores using the PROMIS conversion tables, T-scores range from 26.7 to 65.0 with higher values corresponding to a higher ability to participant in social roles and activities.
Time frame: 6 months
Population: Randomized population with completed 6 month survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individuals Identified as Potential Participants Through EHR | Ability to Participant in Social Roles and Activities as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 53.4 T-score | Standard Deviation 10.3 |
| Acute Pain - Delayed PGx Testing | Ability to Participant in Social Roles and Activities as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 53.5 T-score | Standard Deviation 10.3 |
| Chronic Pain - Immediate PGx Testing | Ability to Participant in Social Roles and Activities as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 44.2 T-score | Standard Deviation 9.5 |
| Chronic Pain - Delayed PGx Testing | Ability to Participant in Social Roles and Activities as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 44.9 T-score | Standard Deviation 9.8 |
| Depression - Immediate PGx Testing | Ability to Participant in Social Roles and Activities as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 49.4 T-score | Standard Deviation 10 |
| Depression - Delayed PGx Testing | Ability to Participant in Social Roles and Activities as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 48.3 T-score | Standard Deviation 10.3 |
p-value: 0.6971Wilcoxon (Mann-Whitney)
p-value: 0.2309Wilcoxon (Mann-Whitney)
p-value: 0.0441Wilcoxon (Mann-Whitney)
Secondary
Anxiety as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
The 6-item PROMIS subscale for anxiety assesses the extent to which participants experience anxiety symptoms over the past 7 days using a 5-point Likert scale. The anxiety subscale provides a raw score, ranging from 6 to 30. Raw scores are converted to T-scores using the PROMIS conversion tables, T-scores range from 33.4 to 76.8. Higher T-scores reflect greater anxiety.
Time frame: 6 months
Population: Randomized population with completed 6 month survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individuals Identified as Potential Participants Through EHR | Anxiety as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 45.5 T-score | Standard Deviation 9 |
| Acute Pain - Delayed PGx Testing | Anxiety as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 45.2 T-score | Standard Deviation 9 |
| Chronic Pain - Immediate PGx Testing | Anxiety as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 52.7 T-score | Standard Deviation 11.2 |
| Chronic Pain - Delayed PGx Testing | Anxiety as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 51.9 T-score | Standard Deviation 11.2 |
| Depression - Immediate PGx Testing | Anxiety as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 57.5 T-score | Standard Deviation 9.3 |
| Depression - Delayed PGx Testing | Anxiety as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 58.4 T-score | Standard Deviation 9.9 |
p-value: 0.521Wilcoxon (Mann-Whitney)
p-value: 0.2348Wilcoxon (Mann-Whitney)
p-value: 0.0517Wilcoxon (Mann-Whitney)
Secondary
Depression as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
The 6-item PROMIS 43 subscale for depression assesses the extent to which participants experience depressive symptoms over the past 7 days using a 5-point Likert scale. The depression subscale provides a raw sore ranging from 6 to 30. Raw scores are converted to T-scores using the PROMIS conversion tables, T-scores range from 38.4 to 80.3. Higher T-scores reflect greater depression.
Time frame: 6 months
Population: Randomized population with completed 6 month survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individuals Identified as Potential Participants Through EHR | Depression as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 44.0 T-score | Standard Deviation 8.2 |
| Acute Pain - Delayed PGx Testing | Depression as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 43.7 T-score | Standard Deviation 7.9 |
| Chronic Pain - Immediate PGx Testing | Depression as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 51.2 T-score | Standard Deviation 10.5 |
| Chronic Pain - Delayed PGx Testing | Depression as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 49.7 T-score | Standard Deviation 10.6 |
| Depression - Immediate PGx Testing | Depression as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 55.0 T-score | Standard Deviation 9.6 |
| Depression - Delayed PGx Testing | Depression as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 56.6 T-score | Standard Deviation 9.9 |
p-value: 0.6835Wilcoxon (Mann-Whitney)
p-value: 0.0205Wilcoxon (Mann-Whitney)
p-value: 0.0036Wilcoxon (Mann-Whitney)
Secondary
Fatigue as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
The 6-item PROMIS 43 subscale for fatigue assesses the extent to which participants experience fatigue-related symptoms over the past 7 days using a 5-point Likert scale. The fatigue subscale provides a raw score ranging from 6 to 30. Raw scores are converted to T-scores using the PROMIS conversion tables, T-scores range from 33.4 to 76.8. Higher T-scores reflect greater fatigue symptoms.
Time frame: 6 months
Population: Randomized population with completed 6 month survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individuals Identified as Potential Participants Through EHR | Fatigue as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 46.7 T-score | Standard Deviation 10.2 |
| Acute Pain - Delayed PGx Testing | Fatigue as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 46.6 T-score | Standard Deviation 10.3 |
| Chronic Pain - Immediate PGx Testing | Fatigue as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 56.0 T-score | Standard Deviation 10.8 |
| Chronic Pain - Delayed PGx Testing | Fatigue as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 54.7 T-score | Standard Deviation 10.7 |
| Depression - Immediate PGx Testing | Fatigue as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 55.4 T-score | Standard Deviation 9.8 |
| Depression - Delayed PGx Testing | Fatigue as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 57.0 T-score | Standard Deviation 10.7 |
p-value: 0.7988Wilcoxon (Mann-Whitney)
p-value: 0.0483Wilcoxon (Mann-Whitney)
p-value: 0.0104Wilcoxon (Mann-Whitney)
Secondary
Number of Participants With Pharmacogenetic Drug-Gene Concordance
Concordance between PGx phenotypes and opioid (Acute Pain and Chronic Pain) and SSRI (Depression) medications.
Time frame: 10 days for Acute Pain; 3 months for Chronic Pain and Depression
Population: Randomized population with completed 6 month survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Individuals Identified as Potential Participants Through EHR | Number of Participants With Pharmacogenetic Drug-Gene Concordance | 642 Participants |
| Acute Pain - Delayed PGx Testing | Number of Participants With Pharmacogenetic Drug-Gene Concordance | 548 Participants |
| Chronic Pain - Immediate PGx Testing | Number of Participants With Pharmacogenetic Drug-Gene Concordance | 371 Participants |
| Chronic Pain - Delayed PGx Testing | Number of Participants With Pharmacogenetic Drug-Gene Concordance | 362 Participants |
| Depression - Immediate PGx Testing | Number of Participants With Pharmacogenetic Drug-Gene Concordance | 609 Participants |
| Depression - Delayed PGx Testing | Number of Participants With Pharmacogenetic Drug-Gene Concordance | 579 Participants |
p-value: <0.0001Chi-squared
p-value: 0.5973Chi-squared
p-value: 0.0046Chi-squared
Secondary
Overall Wellbeing as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
Overall wellbeing is the sum of the PROMIS 43 subdomain T-scores, with physical function and ability to participate in social roles scores reversed such that higher values within each subscale correspond with poorer health. Overall wellbeing ranges from 259.7 to 541.2, higher scores correspond to worse wellbeing.
Time frame: 6 months
Population: Randomized population with completed 6 month survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individuals Identified as Potential Participants Through EHR | Overall Wellbeing as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 337.4 score on a scale | Standard Deviation 51.3 |
| Acute Pain - Delayed PGx Testing | Overall Wellbeing as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 336.2 score on a scale | Standard Deviation 51.2 |
| Chronic Pain - Immediate PGx Testing | Overall Wellbeing as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 397.6 score on a scale | Standard Deviation 50.5 |
| Chronic Pain - Delayed PGx Testing | Overall Wellbeing as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 392.1 score on a scale | Standard Deviation 50.7 |
| Depression - Immediate PGx Testing | Overall Wellbeing as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 376.8 score on a scale | Standard Deviation 51.8 |
| Depression - Delayed PGx Testing | Overall Wellbeing as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 383.6 score on a scale | Standard Deviation 53.5 |
p-value: 0.5878Wilcoxon (Mann-Whitney)
p-value: 0.1051Wilcoxon (Mann-Whitney)
p-value: 0.0292Wilcoxon (Mann-Whitney)
Secondary
Pain Interference as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
The 6-item PROMIS 43 subscale for pain interference assesses the extent to which participants experience interference with daily activities over the past 7 days using a 5-point Likert scale. The pain interference subscale provides a raw score ranging from 6 to 30. Raw scores are converted to T-scores using the PROMIS conversion tables, T-scores range from 41.1 to 76.3. Higher scores reflect greater pain interference.
Time frame: 6 months
Population: Randomized population with completed 6 month survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individuals Identified as Potential Participants Through EHR | Pain Interference as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 51.0 T-score | Standard Deviation 9.4 |
| Acute Pain - Delayed PGx Testing | Pain Interference as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 50.9 T-score | Standard Deviation 9.6 |
| Chronic Pain - Immediate PGx Testing | Pain Interference as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 62.4 T-score | Standard Deviation 8.4 |
| Chronic Pain - Delayed PGx Testing | Pain Interference as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 62.2 T-score | Standard Deviation 8.6 |
| Depression - Immediate PGx Testing | Pain Interference as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 51.7 T-score | Standard Deviation 10.9 |
| Depression - Delayed PGx Testing | Pain Interference as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 51.6 T-score | Standard Deviation 11.2 |
p-value: 0.7195Wilcoxon (Mann-Whitney)
p-value: 0.8054Wilcoxon (Mann-Whitney)
p-value: 0.861Wilcoxon (Mann-Whitney)
Secondary
Physical Function as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
The 6-item PROMIS 43 subscale for physical functioning assesses a participants physical functioning over the past 7 days using a 5-point Likert scale. The physical functioning sub scale provides a raw score ranging from 6 to 30. Raw scores are converted to T-scores using the PROMIS conversion tables. T-scores range from 21.0 to 59.0. Higher T-scores reflect higher levels of physical functioning.
Time frame: 6 months
Population: Randomized population with completed 6 month survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individuals Identified as Potential Participants Through EHR | Physical Function as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 44.9 T-score | Standard Deviation 9.7 |
| Acute Pain - Delayed PGx Testing | Physical Function as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 45.3 T-score | Standard Deviation 9.6 |
| Chronic Pain - Immediate PGx Testing | Physical Function as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 36.0 T-score | Standard Deviation 7.5 |
| Chronic Pain - Delayed PGx Testing | Physical Function as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 36.2 T-score | Standard Deviation 7.5 |
| Depression - Immediate PGx Testing | Physical Function as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 47.2 T-score | Standard Deviation 9.7 |
| Depression - Delayed PGx Testing | Physical Function as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 46.8 T-score | Standard Deviation 10.3 |
p-value: 0.4385Wilcoxon (Mann-Whitney)
p-value: 0.7185Wilcoxon (Mann-Whitney)
p-value: 0.431Wilcoxon (Mann-Whitney)
Secondary
Sleep Disturbance as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
The 6-item PROMIS 43 subscale for sleep disturbance assesses the extent to which participants experience sleep disturbance related symptoms sleep over the past 7 days using a 5-point Likert scale. The sleep disturbance subscale provides a raw score ranging from 6 to 30. Raw scores are converted to T-scores using the PROMNIS conversion tables, ranging from 31.7 to 76.1. Higher scores reflect higher levels of sleep disturbance.
Time frame: 6 months
Population: Randomized population with completed 6 month survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individuals Identified as Potential Participants Through EHR | Sleep Disturbance as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 48.5 T-score | Standard Deviation 9.5 |
| Acute Pain - Delayed PGx Testing | Sleep Disturbance as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 48.5 T-score | Standard Deviation 9.5 |
| Chronic Pain - Immediate PGx Testing | Sleep Disturbance as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 55.3 T-score | Standard Deviation 9.5 |
| Chronic Pain - Delayed PGx Testing | Sleep Disturbance as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 54.6 T-score | Standard Deviation 9.6 |
| Depression - Immediate PGx Testing | Sleep Disturbance as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 53.8 T-score | Standard Deviation 8.9 |
| Depression - Delayed PGx Testing | Sleep Disturbance as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 55.0 T-score | Standard Deviation 8.8 |
p-value: 0.9222Wilcoxon (Mann-Whitney)
p-value: 0.1918Wilcoxon (Mann-Whitney)
p-value: 0.0119Wilcoxon (Mann-Whitney)