Chronic Pain
Conditions
Keywords
long-term opioid therapy, chronic pain self-management, primary care prescribing guidance
Brief summary
In the Strategies to Improve Pain and Enjoy Life (STRIPE) study, the effectiveness of a multicomponent intervention will be tested, compared with usual care, on opioid dose and pain outcomes among patients on high dose (≥ 40 mg morphine equivalent dose) long-term opioid therapy in a randomized controlled trial. This intervention will have 4 components: a) telephone-delivered evidence-based pain self-management training, b) web-based video of successfully tapered patients with motivational interviewing debriefing, c) a voluntary, self-paced opioid taper, and d) opioid and non-opioid prescribing guidance for the patient's primary care provider.
Detailed description
In a National Institute on Drug Abuse-funded R34 pilot study of pain self-management training for prescription opioid taper support, it was demonstrated that 22 weeks of opioid taper support promotes opioid dose reduction more effectively than usual care (43% vs 19% dose reduction from baseline) with no increase in pain intensity and significantly reduced activity interference. This intervention will now be adapted and tested in a large integrated primary care system. To address patients' fears of opioid taper that limited recruitment into this pilot study, subjects will be randomized to pain self-management training and then offered the option of self-paced opioid taper. Specifically, the effectiveness of this intervention will be tested, compared with usual care, on opioid dose and pain outcomes among patients on moderate-high dose (≥ 40mg morphine equivalent dose) long-term opioid therapy (LtOT) in a randomized controlled trial. This intervention will have 4 components: a) telephone-delivered evidence-based pain self-management training, b) web-based video of successfully tapered patients with motivational interviewing debriefing, c) a voluntary, self-paced opioid taper, and d) opioid and non-opioid prescribing guidance for the patient's primary care provider. Specific Aim 1: To adapt a previously developed prescription opioid taper support intervention into a telephone-delivered pain self-management training that provides the option for supported opioid taper. This will be delivered in multiple primary care clinics by a nurse interventionist trained and supervised by a pain psychologist and will include guidance in opioid and non-opioid medication prescribing. Specific Aim 2: To test in a randomized trial the effects of this intervention on: a) opioid outcomes: daily opioid dose (primary outcome), percent dose reduction from baseline, problem opioid use (questionnaire and electronic health record text indicators), and patient-reported opioid difficulties; and b) pain-related outcomes: PEG (self-report of Pain intensity, Enjoyment of life interference, General activity interference; primary outcome), pain self-efficacy, and anxiety and depression symptoms. Hypotheses pertaining to opioid use: Patients receiving LtOT for chronic non-cancer pain (CNCP) randomized to the STRIPE intervention, as compared with those randomized to usual care, will have lower opioid doses, greater percent reduction of opioid dose, lower proportions with problem opioid use, lower opioid craving, and lower levels of patient-reported opioid-related difficulties at 6 and 12 months after randomization. Hypotheses pertaining to pain outcomes: Patients receiving LtOT for CNCP randomized to the STRIPE intervention, as compared with those randomized to usual care, will have lower PEG scores, higher levels of pain self-efficacy, higher global impression of change, and lower levels of anxiety and depressive symptoms at 6 and 12 months after randomization. The proposed trial will determine whether pain self-management training can promote prescription opioid taper in moderate-higher-dose long-term opioid therapy patients without increasing pain level or activity and enjoyment interference. If this trial is successful, then prescribers and patients may be able to pursue supported opioid taper without fear of escalating pain.
Interventions
BEHAVIORALPain self-management training
This intervention will have 4 components: 1. telephone-delivered evidence-based pain self-management training, 2. web-based video of successfully tapered patients with motivational interviewing debriefing, 3. a voluntary, self-paced opioid taper 4. opioid and non-opioid prescribing guidance for the patient's primary care provider.
BEHAVIORALvideo education, motivational interviewing
web-based video of successfully tapered patients with motivational interviewing debriefing
BEHAVIORALvoluntary self-paced opioid taper
Voluntary self-paced opioid taper where patient chooses whether, when and how much to taper opioids. Taper schedule and strategy will be proposed to patients, but they will negotiate details with their primary care provider.
BEHAVIORALprescribing guidance for primary care provider
Based upon review of medications and diagnoses in the electronic medical record, the principal investigator will offer guidance on opioid taper rate and strategy. He will also offer suggestions to adjust or initiate other psychotropic medications to treat pain or psychiatric comorbid illness that may be unmasked through opioid taper. All prescriptions will be written by the primary care provider.
OTHERusual care
Usual care will consist of any and all regular care that may be offered by primary care for chronic pain and related illnesses
Sponsors
Kaiser Permanente
National Institute on Drug Abuse (NIDA)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes assessment will be conducted by Kaiser survey team which will be blind to treatment assignment.
Intervention model description
Patients are individually randomized to pain self-management training for opioid taper or usual care. Those randomized to pain self-management training will be offered assistance with opioid taper during approximately the fourth session of pain self-management training.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* age 18-80 years * receiving care at a Kaiser Washington primary care clinic; * Chronic Non-Cancer Pain, defined as patient-reported pain on more than half the days in the past 6 months; * currently on higher-dose long-term opioid therapy, defined as \>90 days' supply in the past 180 days with a mean daily dose of 40 mg MED or greater in the past 90 days, as first identified via Kaiser's pharmacy dispensing data and subsequently validated by patient self-report during screening for the trial * consent to participate in the study arm to which they are randomly assigned * able to read, speak, and write English adequate for outcome measures * enrollment in Kaiser for at least 6 months prior and no plans to disenroll over the next year.
Exclusion criteria
* receiving treatment for cancer * enrollment in palliative or hospice care * use in past year of parenteral, transdermal, or transmucosal opioids * residing in nursing home or assisted living * using any implanted device for pain control * psychotic symptoms, psychiatric hospitalization or suicide attempts in the past year * current suicidal ideation with plan or intent * dementia diagnosis in Electronic Health Record * Patients on buprenorphine for any reason, or methadone or naltrexone for treatment of Opioid Use Disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily Opioid Morphine Milligram Equivalents (MME) | 12 months after randomization | Average over the prior 30 days of the prescribed daily morphine milligram equivalents (MME). |
| Pain, Enjoyment of Life, and General Activity (PEG) Score | 12 months after randomization | A 3-item, self-report measure reflecting average pain intensity, pain interference with general activity, and pain interference with enjoyment of life in the past week. It is scored on a scale of 0 to 10; higher scores indicate worse pain intensity and interference with life and enjoyment of activities. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Self-Efficacy Questionnaire (PSEQ) Score | 6 months after randomization | Score from a 10-item questionnaire about pain self-efficacy that range between 0 and 60; higher scores indicate higher confidence in ability to do activities despite pain. |
| Patient Health Questionnaire-8 (PHQ-8) Score | 6 months after randomization | An 8-item questionnaire used to assess depression with scores between 0 and 24; higher scores indicate greater depression severity. |
| Generalized Anxiety Disorders-7 (GAD-7) Score | 6 months after randomization | A 7-item questionnaire used to assess anxiety with scores between 0 and 21; higher scores indicate greater anxiety severity. |
| Patient Global Impression of Change (PGIC) Score | 6 months after randomization | Single 7-point scale assessing global improvement with treatment, range 0 (bad) - 7 (good) |
| Daily Opioid Morphine Milligram Equivalents (MME) | 6 months after randomization | Average over the prior 30 days of the prescribed daily morphine milligram equivalents (MME). |
| Prescription Opioid Difficulties Scale (PODS) Score | 6 months after randomization | A 15-item questionnaire used to assess patient-perceived difficulties and concerns attributed to the use of opioid medication with scores between 0 and 60; higher scores indicate greater difficulties and concerns. |
| Opioid Craving Score | 6 months after randomization | A single-item questionnaire used to assess opioid craving in the past week with scores between 0 and 10; higher scores indicate greater craving. |
| At Least 30% Reduction in Daily Opioid Dose | 6 months after randomization | Indication of at least 30% reduction from baseline in the prior 30-day average prescribed morphine milligram equivalents (MME). |
| Prescription Opioid Misuse Index (POMI) Score | 6 months after randomization | A 6-item questionnaire used to assess problem opioid use with scores between 0 and 6; higher scores indicate a greater likelihood of having opioid use disorder. |
| Pain, Enjoyment of Life, and General Activity (PEG) Score | 6 months after randomization | A 3-item, self-report measure reflecting average pain intensity, pain interference with general activity, and pain interference with enjoyment of life in the past week. It is scored on a scale of 0 to 10; higher scores indicate worse pain intensity and interference with life and enjoyment of activities. |
Countries
United States
Participant flow
Pre-assignment details
Using electronic health records and claims data, 1381 individuals fulfilled a subset of study inclusion criteria and were contacted to assess further inclusion criteria. 170 of these individuals fulfilled all inclusion criteria, as determined using two phone screenings and were contacted to participate in the study. 153 of these individuals returned a baseline questionnaire and were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Pain Self-Management This arm includes patients randomized to Pain Self-Management Training. This intervention has 4 components:
1. telephone-delivered evidence-based pain self-management training,
2. web-based video of successfully tapered patients with motivational interviewing debriefing,
3. a voluntary, self-paced opioid taper, and
4. opioid and non-opioid prescribing guidance for the patient's primary care provider. | 79 |
| Usual Care Patients randomized to usual care will continue to receive care as usual from their Kaiser primary care provider. | 74 |
| Total | 153 |
Baseline characteristics
| Characteristic | Usual Care | Pain Self-Management | Total |
|---|---|---|---|
| Age, Continuous | 60.7 years STANDARD_DEVIATION 10.6 | 60.7 years STANDARD_DEVIATION 10.7 | 60.7 years STANDARD_DEVIATION 10.6 |
| Daily Opioid Morphine Milligram Equivalents (MME) | 72.8 MME/day STANDARD_DEVIATION 30.3 | 77.1 MME/day STANDARD_DEVIATION 67.9 | 75.0 MME/day STANDARD_DEVIATION 53 |
| Generalized Anxiety Disorder-7 (GAD-7) Score | 5.3 score on a scale STANDARD_DEVIATION 4.5 | 4.7 score on a scale STANDARD_DEVIATION 4.8 | 5.0 score on a scale STANDARD_DEVIATION 4.6 |
| Opioid Craving Score | 1.5 score on a scale STANDARD_DEVIATION 2.8 | 1.0 score on a scale STANDARD_DEVIATION 2.1 | 1.3 score on a scale STANDARD_DEVIATION 2.5 |
| Pain, Enjoyment of Life, and General Activity (PEG) Score | 6.6 score on a scale STANDARD_DEVIATION 1.8 | 6.5 score on a scale STANDARD_DEVIATION 1.8 | 6.6 score on a scale STANDARD_DEVIATION 1.8 |
| Pain Self-Efficacy Questionnaire (PSEQ) Score | 27.7 score on a scale STANDARD_DEVIATION 13 | 29.9 score on a scale STANDARD_DEVIATION 10.4 | 28.8 score on a scale STANDARD_DEVIATION 11.8 |
| Patient Health Questionnaire-8 (PHQ-8) Score | 8.8 score on a scale STANDARD_DEVIATION 4.7 | 8.1 score on a scale STANDARD_DEVIATION 5.1 | 8.5 score on a scale STANDARD_DEVIATION 4.9 |
| Prescribed Opioids Difficulties Scale (PODS) Score | 10.5 score on a scale STANDARD_DEVIATION 8.1 | 9.3 score on a scale STANDARD_DEVIATION 7.5 | 9.9 score on a scale STANDARD_DEVIATION 7.8 |
| Prescription Opioid Misuse Index (POMI) Score | 0.8 score on a scale STANDARD_DEVIATION 0.9 | 0.7 score on a scale STANDARD_DEVIATION 0.9 | 0.7 score on a scale STANDARD_DEVIATION 0.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 1 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 6 Participants | 9 Participants |
| Race (NIH/OMB) White | 62 Participants | 64 Participants | 126 Participants |
| Region of Enrollment United States | 74 participants | 79 participants | 153 participants |
| Sex: Female, Male Female | 45 Participants | 53 Participants | 98 Participants |
| Sex: Female, Male Male | 29 Participants | 26 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 79 | 0 / 74 |
| other Total, other adverse events | 8 / 79 | 0 / 74 |
| serious Total, serious adverse events | 0 / 79 | 0 / 74 |
Outcome results
Primary
Daily Opioid Morphine Milligram Equivalents (MME)
Average over the prior 30 days of the prescribed daily morphine milligram equivalents (MME).
Time frame: 12 months after randomization
Population: Randomized individuals with complete electronic prescription records available during the 6- and/or 12-month post-randomization assessment period with non-missing baseline data used for adjustment in regression models.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pain Self-Management | Daily Opioid Morphine Milligram Equivalents (MME) | 65.17 MME/day |
| Usual Care | Daily Opioid Morphine Milligram Equivalents (MME) | 67.51 MME/day |
Comparison: A priori power calculations indicated 90% power to detect an average 24 MME/day difference between arms.p-value: 0.5895% CI: [-10.55, 5.88]Regression, Linear
Primary
Pain, Enjoyment of Life, and General Activity (PEG) Score
A 3-item, self-report measure reflecting average pain intensity, pain interference with general activity, and pain interference with enjoyment of life in the past week. It is scored on a scale of 0 to 10; higher scores indicate worse pain intensity and interference with life and enjoyment of activities.
Time frame: 12 months after randomization
Population: Randomized individuals who completed the 6-month and/or 12-month PEG questionnaire and with complete baseline data used for adjustment in regression models.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pain Self-Management | Pain, Enjoyment of Life, and General Activity (PEG) Score | 6.14 score on a scale |
| Usual Care | Pain, Enjoyment of Life, and General Activity (PEG) Score | 6.14 score on a scale |
Comparison: A priori power calculations indicated 90% power to detect a 1.2-point average difference in PEG score between arms.p-value: 0.9895% CI: [-0.51, 0.52]Regression, Linear
Secondary
At Least 30% Reduction in Daily Opioid Dose
Indication of at least 30% reduction from baseline in the prior 30-day average prescribed morphine milligram equivalents (MME).
Time frame: 12 months after randomization
Population: Randomized individuals with complete electronic pharmacy records during the 6- and/or 12-month post-randomization assessment period with non-missing baseline data used for adjustment in regression models.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pain Self-Management | At Least 30% Reduction in Daily Opioid Dose | 10 participants |
| Usual Care | At Least 30% Reduction in Daily Opioid Dose | 7 participants |
p-value: 0.5395% CI: [0.54, 3.32]Regression, Poison
Secondary
At Least 30% Reduction in Daily Opioid Dose
Indication of at least 30% reduction from baseline in the prior 30-day average prescribed morphine milligram equivalents (MME).
Time frame: 6 months after randomization
Population: Randomized individuals with complete electronic pharmacy records during the 6- and/or 12-month post-randomization assessment period with non-missing baseline data used for adjustment in regression models.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pain Self-Management | At Least 30% Reduction in Daily Opioid Dose | 9 participants |
| Usual Care | At Least 30% Reduction in Daily Opioid Dose | 4 participants |
p-value: 0.295% CI: [0.68, 6.53]Regression, Poison
Secondary
Daily Opioid Morphine Milligram Equivalents (MME)
Average over the prior 30 days of the prescribed daily morphine milligram equivalents (MME).
Time frame: 6 months after randomization
Population: Randomized individuals with complete electronic prescription records available during the 6- and/or 12-month post-randomization assessment period with non-missing baseline data used for adjustment in regression models.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pain Self-Management | Daily Opioid Morphine Milligram Equivalents (MME) | 73.03 MME/day |
| Usual Care | Daily Opioid Morphine Milligram Equivalents (MME) | 71.74 MME/day |
p-value: 0.7295% CI: [-5.69, 8.29]Regression, Linear
Secondary
Generalized Anxiety Disorders-7 (GAD-7) Score
A 7-item questionnaire used to assess anxiety with scores between 0 and 21; higher scores indicate greater anxiety severity.
Time frame: 6 months after randomization
Population: Randomized individuals with completed GAD-7 questionnaires at 6- and/or 12-months post-randomization with non-missing baseline data used for adjustment in regression models.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pain Self-Management | Generalized Anxiety Disorders-7 (GAD-7) Score | 4.89 score on a scale |
| Usual Care | Generalized Anxiety Disorders-7 (GAD-7) Score | 5.14 score on a scale |
p-value: 0.6495% CI: [-1.31, 0.81]Regression, Linear
Secondary
Generalized Anxiety Disorders-7 (GAD-7) Score
A 7-item questionnaire used to assess anxiety with scores between 0 and 21; higher scores indicate greater anxiety severity.
Time frame: 12 months after randomization
Population: Randomized individuals with completed GAD-7 questionnaires at 6- and/or 12-months post-randomization with non-missing baseline data used for adjustment in regression models.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pain Self-Management | Generalized Anxiety Disorders-7 (GAD-7) Score | 5.20 score on a scale |
| Usual Care | Generalized Anxiety Disorders-7 (GAD-7) Score | 4.91 score on a scale |
p-value: 0.6595% CI: [-0.94, 1.51]Regression, Linear
Secondary
Opioid Craving Score
A single-item questionnaire used to assess opioid craving in the past week with scores between 0 and 10; higher scores indicate greater craving.
Time frame: 6 months after randomization
Population: Randomized individuals with completed opioid craving questionnaires at 6- and/or 12-months post-randomization with non-missing baseline data used for adjustment in regression models.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pain Self-Management | Opioid Craving Score | 1.36 score on a scale |
| Usual Care | Opioid Craving Score | 1.40 score on a scale |
p-value: 0.995% CI: [-0.66, 0.57]Regression, Linear
Secondary
Opioid Craving Score
A single-item questionnaire used to assess opioid craving in the past week with scores between 0 and 10; higher scores indicate greater craving.
Time frame: 12 months after randomization
Population: Randomized individuals with completed opioid craving questionnaires at 6- and/or 12-months post-randomization with non-missing baseline data used for adjustment in regression models.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pain Self-Management | Opioid Craving Score | 0.97 score on a scale |
| Usual Care | Opioid Craving Score | 1.33 score on a scale |
p-value: 0.395% CI: [-1.03, 0.32]Regression, Linear
Secondary
Pain, Enjoyment of Life, and General Activity (PEG) Score
A 3-item, self-report measure reflecting average pain intensity, pain interference with general activity, and pain interference with enjoyment of life in the past week. It is scored on a scale of 0 to 10; higher scores indicate worse pain intensity and interference with life and enjoyment of activities.
Time frame: 6 months after randomization
Population: Randomized individuals who completed the 6-month and/or 12-month PEG questionnaire and with complete baseline data used for adjustment in regression models.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pain Self-Management | Pain, Enjoyment of Life, and General Activity (PEG) Score | 6.06 score on a scale |
| Usual Care | Pain, Enjoyment of Life, and General Activity (PEG) Score | 6.59 score on a scale |
p-value: 0.0795% CI: [-1.11, 0.05]Regression, Linear
Secondary
Pain Self-Efficacy Questionnaire (PSEQ) Score
Score from a 10-item questionnaire about pain self-efficacy that range between 0 and 60; higher scores indicate higher confidence in ability to do activities despite pain.
Time frame: 12 months after randomization
Population: Randomized individuals with completed PSEQ questionnaires at 6- and/or 12-months post-randomization with non-missing baseline data used for adjustment in regression models.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pain Self-Management | Pain Self-Efficacy Questionnaire (PSEQ) Score | 31.97 score on a scale |
| Usual Care | Pain Self-Efficacy Questionnaire (PSEQ) Score | 27.65 score on a scale |
p-value: 0.0295% CI: [0.56, 8.09]Regression, Linear
Secondary
Pain Self-Efficacy Questionnaire (PSEQ) Score
Score from a 10-item questionnaire about pain self-efficacy that range between 0 and 60; higher scores indicate higher confidence in ability to do activities despite pain.
Time frame: 6 months after randomization
Population: Randomized individuals with completed PSEQ questionnaires at 6- and/or 12-months post-randomization with non-missing baseline data used for adjustment in regression models.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pain Self-Management | Pain Self-Efficacy Questionnaire (PSEQ) Score | 32.31 score on a scale |
| Usual Care | Pain Self-Efficacy Questionnaire (PSEQ) Score | 30.21 score on a scale |
p-value: 0.895% CI: [-13.83, 18.04]Regression, Linear
Secondary
Patient Global Impression of Change (PGIC) Score
Single 7-point scale assessing global improvement with treatment, range 0 (bad) - 7 (good)
Time frame: 12 months after randomization
Population: Randomized individuals with completed PGIC questionnaires at 6- and/or 12-months post-randomization with non-missing baseline data used for adjustment in regression models.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pain Self-Management | Patient Global Impression of Change (PGIC) Score | 3.71 score on a scale |
| Usual Care | Patient Global Impression of Change (PGIC) Score | 2.38 score on a scale |
p-value: <0.0195% CI: [0.77, 1.88]Regression, Linear
Secondary
Patient Global Impression of Change (PGIC) Score
Single 7-point scale assessing global improvement with treatment, range 0 (bad) - 7 (good)
Time frame: 6 months after randomization
Population: Randomized individuals with completed PGIC questionnaires at 6- and/or 12-months post-randomization with non-missing baseline data used for adjustment in regression models.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pain Self-Management | Patient Global Impression of Change (PGIC) Score | 3.12 score on a scale |
| Usual Care | Patient Global Impression of Change (PGIC) Score | 2.51 score on a scale |
p-value: 0.0295% CI: [0.12, 1.1]Regression, Linear
Secondary
Patient Health Questionnaire-8 (PHQ-8) Score
An 8-item questionnaire used to assess depression with scores between 0 and 24; higher scores indicate greater depression severity.
Time frame: 12 months after randomization
Population: Randomized individuals with completed PSEQ questionnaires at 6- and/or 12-months post-randomization with non-missing baseline data used for adjustment in regression models.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pain Self-Management | Patient Health Questionnaire-8 (PHQ-8) Score | 7.54 score on a scale |
| Usual Care | Patient Health Questionnaire-8 (PHQ-8) Score | 8.04 score on a scale |
p-value: 0.4895% CI: [-1.87, 0.87]Regression, Linear
Secondary
Patient Health Questionnaire-8 (PHQ-8) Score
An 8-item questionnaire used to assess depression with scores between 0 and 24; higher scores indicate greater depression severity.
Time frame: 6 months after randomization
Population: Randomized individuals with completed PHQ-8 questionnaires at 6- and/or 12-months post-randomization with non-missing baseline data used for adjustment in regression models.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pain Self-Management | Patient Health Questionnaire-8 (PHQ-8) Score | 8.25 score on a scale |
| Usual Care | Patient Health Questionnaire-8 (PHQ-8) Score | 8.60 score on a scale |
p-value: 0.7595% CI: [-2.53, 1.82]Regression, Linear
Secondary
Prescription Opioid Difficulties Scale (PODS) Score
A 15-item questionnaire used to assess patient-perceived difficulties and concerns attributed to the use of opioid medication with scores between 0 and 60; higher scores indicate greater difficulties and concerns.
Time frame: 6 months after randomization
Population: Randomized individuals with completed PODS questionnaires at 6- and/or 12-months post-randomization with non-missing baseline data used for adjustment in regression models.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pain Self-Management | Prescription Opioid Difficulties Scale (PODS) Score | 9.03 score on a scale |
| Usual Care | Prescription Opioid Difficulties Scale (PODS) Score | 7.43 score on a scale |
p-value: 0.5495% CI: [-3.47, 6.66]Regression, Linear
Secondary
Prescription Opioid Difficulties Scale (PODS) Score
A 15-item questionnaire used to assess patient-perceived difficulties and concerns attributed to the use of opioid medication with scores between 0 and 60; higher scores indicate greater difficulties and concerns.
Time frame: 12 months after randomization
Population: Randomized individuals with completed PODS questionnaires at 6- and/or 12-months post-randomization with non-missing baseline data used for adjustment in regression models.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pain Self-Management | Prescription Opioid Difficulties Scale (PODS) Score | 8.15 score on a scale |
| Usual Care | Prescription Opioid Difficulties Scale (PODS) Score | 7.68 score on a scale |
p-value: 0.5995% CI: [-1.26, 2.21]Regression, Linear
Secondary
Prescription Opioid Misuse Index (POMI) Score
A 6-item questionnaire used to assess problem opioid use with scores between 0 and 6; higher scores indicate a greater likelihood of having opioid use disorder.
Time frame: 6 months after randomization
Population: Randomized individuals with completed POMI questionnaires at 6- and/or 12-months post-randomization with non-missing baseline data used for adjustment in regression models.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pain Self-Management | Prescription Opioid Misuse Index (POMI) Score | 0.56 score on a scale |
| Usual Care | Prescription Opioid Misuse Index (POMI) Score | 0.47 score on a scale |
p-value: 0.4295% CI: [-0.13, 0.31]Regression, Linear
Secondary
Prescription Opioid Misuse Index (POMI) Score
A 6-item questionnaire used to assess problem opioid use with scores between 0 and 6; higher scores indicate a greater likelihood of having opioid use disorder.
Time frame: 12 months after randomization
Population: Randomized individuals with completed POMI questionnaires at 6- and/or 12-months post-randomization with non-missing baseline data used for adjustment in regression models.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pain Self-Management | Prescription Opioid Misuse Index (POMI) Score | 0.39 score on a scale |
| Usual Care | Prescription Opioid Misuse Index (POMI) Score | 0.26 score on a scale |
p-value: 0.2695% CI: [-0.1, 0.36]Regression, Linear