Clinical trial NCT03743402: Strategies to Improve Pain and Enjoy Life
Official title: Randomized Trial of Telephonic Pain Self-management to Promote Opioid Tapering
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: long-term opioid therapy
chronic pain self-management
primary care prescribing guidance
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Kaiser Permanente
name: National Institute on Drug Abuse (NIDA)
First posted: 2018-11-16
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Daily Opioid Morphine Milligram Equivalents (MME)
timeFrame: 12 months after randomization
measure: Pain, Enjoyment of Life, and General Activity (PEG) Score
timeFrame: 12 months after randomization
Secondary outcomes:
measure: Daily Opioid Morphine Milligram Equivalents (MME)
timeFrame: 6 months after randomization
measure: Pain, Enjoyment of Life, and General Activity (PEG) Score
timeFrame: 6 months after randomization
measure: Pain Self-Efficacy Questionnaire (PSEQ) Score
timeFrame: 6 months after randomization
measure: Pain Self-Efficacy Questionnaire (PSEQ) Score
timeFrame: 12 months after randomization
measure: Patient Health Questionnaire-8 (PHQ-8) Score
timeFrame: 6 months after randomization
measure: Patient Health Questionnaire-8 (PHQ-8) Score
timeFrame: 12 months after randomization
measure: Generalized Anxiety Disorders-7 (GAD-7) Score
timeFrame: 6 months after randomization
measure: Generalized Anxiety Disorders-7 (GAD-7) Score
timeFrame: 12 months after randomization
measure: Patient Global Impression of Change (PGIC) Score
timeFrame: 6 months after randomization
measure: Patient Global Impression of Change (PGIC) Score
timeFrame: 12 months after randomization
measure: Prescription Opioid Misuse Index (POMI) Score
timeFrame: 6 months after randomization
measure: Prescription Opioid Misuse Index (POMI) Score
timeFrame: 12 months after randomization
measure: Prescription Opioid Difficulties Scale (PODS) Score
timeFrame: 6 months after randomization
measure: Prescription Opioid Difficulties Scale (PODS) Score
timeFrame: 12 months after randomization
measure: Opioid Craving Score
timeFrame: 6 months after randomization
measure: Opioid Craving Score
timeFrame: 12 months after randomization
measure: At Least 30% Reduction in Daily Opioid Dose
timeFrame: 6 months after randomization
measure: At Least 30% Reduction in Daily Opioid Dose
timeFrame: 12 months after randomization
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Kaiser Permanente Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Mark D Sullivan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sullivan MD, Turner JA, DiLodovico C, D'Appollonio A, Stephens K, Chan YF. Prescription Opioid Taper Support for Outpatients With Chronic Pain: A Randomized Controlled Trial. J Pain. 2017 Mar;18(3):308-318. doi: 10.1016/j.jpain.2016.11.003. Epub 2016 Nov 28.
citation: Wartko PD, Boudreau DM, Turner JA, Cook AJ, Wellman RD, Fujii MM, Garcia RC, Moser KA, Sullivan MD. STRategies to Improve Pain and Enjoy life (STRIPE): Protocol for a pragmatic randomized trial of pain coping skills training and opioid medication taper guidance for patients on long-term opioid therapy. Contemp Clin Trials. 2021 Nov;110:106499. doi: 10.1016/j.cct.2021.106499. Epub 2021 Jul 2.