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.
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.
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.
web-based video of successfully tapered patients with motivational interviewing debriefing
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.
Kaiser Permanente Washington
Seattle, Washington, United States
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
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
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
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
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
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.
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Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
153
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.
Usual care will consist of any and all regular care that may be offered by primary care for chronic pain and related illnesses
Time frame: 12 months after randomization
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
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
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
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
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
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
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
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
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
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
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
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
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
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