Strategies to Improve Pain and Enjoy Life
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional

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.
    

Intervention name(s): Pain self-management training; video education, motivational interviewing; voluntary self-paced opioid taper; prescribing guidance for primary care provider; usual care
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Other
Intervention description(s): This intervention will have 4 components:
telephone-delivered evidence-based pain self-management training,
web-based video of successfully tapered patients with motivational interviewing debriefing,
a voluntary, self-paced opioid taper
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.; 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
Other intervention name(s): phone cognitive-behavioral pain self-management training; exposure to successfully tapered patients with debriefing; opioid daily dose reduction; medication initiation and adjustment suggestions to optimize control of pain and psychiatric comorbidity; standard opioid therapy for chronic pain
Intervention MeSH terms: Analgesics, Opioid
Allocation: Randomized
Intervention model: Parallel 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.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: long-term opioid therapy; chronic pain self-management; primary care prescribing guidance