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Randomized Trial of Telephonic Pain Self-management to Promote Opioid Tapering (PSMOT)

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ClinicalTrials.gov Identifier: NCT03743402
Recruitment Status : Not yet recruiting
First Posted : November 16, 2018
Last Update Posted : November 16, 2018
Sponsor:
Collaborator:
Kaiser Permanente
Information provided by (Responsible Party):
Mark Sullivan, University of Washington

Brief Summary:
In the Pain Self-Management Training for Opioid Taper (PSMOT) 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 (≥ 50 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.

Condition or disease Intervention/treatment Phase
Chronic Pain Behavioral: Pain self-management training Behavioral: video education, motivational interviewing Drug: voluntary self-paced opioid taper Drug: prescribing guidance for primary care provider Other: usual care Phase 4

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: Pain Self-Management Training for Opioid Taper (PSMOT). Specifically, the effectiveness of this intervention will be tested, compared with usual care, on opioid dose and pain outcomes among patients on high dose (≥ 50 mg 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 (PSMOT). 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 PSMOT intervention on: a) opioid outcomes: daily opioid dose (primary outcome), percent dose reduction from baseline, problem opioid use (interview, questionnaire, and electronic health record text indicators), and patient-reported opioid problems; and b) pain-related outcomes: PEG (self-report of Pain intensity, Enjoyment of life interference, General activity interference; primary outcome), pain self-efficacy, and depression symptoms. Hypotheses pertaining to opioid use: Patients receiving LtOT for chronic non-cancer pain (CNCP) randomized to the PSMOT 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, and lower levels of patient-reported opioid-related problems at 6 and 12 months after randomization. Hypotheses pertaining to pain outcomes: Patients receiving LtOT for CNCP randomized to the PSMOT intervention, as compared with those randomized to usual care, will have lower PEG scores, higher levels of pain self-efficacy, and lower levels of 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 higher-dose long-term opioid therapy patients without increasing pain levels or activity interference. If this trial is successful, then prescribers and patients may be able to pursue supported opioid taper without fear of escalating pain.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
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)
Masking Description: Outcomes assessment will be conducted by Kaiser survey team which will be blind to treatment assignment.
Primary Purpose: Treatment
Official Title: Randomized Trial of Telephonic Pain Self-management to Promote Opioid Tapering
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: Pain self-management

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.
Behavioral: Pain 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.
Other Name: phone cognitive-behavioral pain self-management training

Behavioral: video education, motivational interviewing
web-based video of successfully tapered patients with motivational interviewing debriefing
Other Name: exposure to successfully tapered patients with debriefing

Drug: voluntary 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 may modify it as wished.
Other Name: opioid daily dose reduction

Drug: prescribing 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
Other Name: medication initiation and adjustment suggestions to optimize control of pain and psychiatric comorbidity

Active Comparator: usual care
Patients randomized to usual care will continue to receive care as usual from their Kaiser primary care provider. The only restriction is buprenorphine treatment is not allowed.
Other: usual care
Usual care will consist of any and all regular care that may be offered by primary care for chronic pain and related illnesses, excluding only use of buprenorphine.
Other Name: standard opioid therapy for chronic pain




Primary Outcome Measures :
  1. mean daily opioid dose [ Time Frame: over past 30 days, assessed at 12 months after randomization ]
    mean daily opioid dose in mg morphine equivalent dose (MED)

  2. PEG score (Pain, Enjoyment interference, General activity interference) [ Time Frame: past week, assessed at 12 months after randomization ]
    sum of 0-10 ratings of Pain severity, General activity interference, Enjoyment of life interference.


Secondary Outcome Measures :
  1. Prescription Opioid Misuse Index (POMI) [ Time Frame: lifetime, assessed at 6 and 12 months after randomization ]
    6-item self-report of aberrant opioid use behaviors, Y vs N, range 0 (better) -6 (worse)

  2. Prescription Opioid Difficulties Scale (PODS) [ Time Frame: past 2 weeks, assessed at 6 and 12 months after randomization ]
    Self-report measure with two 8-item subscales assessing psychosocial problems attributed to opioids and opioid control concerns, items scored 0 (good)-4 (bad), range 0-32 for each scale, subscales not summed

  3. Patient Health Questionnaire-8 (PHQ-8) [ Time Frame: past 2 weeks, assessed at 6 and 12 months after randomization ]
    eight item self report measure assessing depressive symptom severity, range 0 (good) -24 (bad)

  4. Generalized Anxiety Disorders-7 (GAD-7) [ Time Frame: past 2 weeks, assessed at 6 and 12 months after randomization ]
    seven item self-report measure assessing anxiety symptom severity, range 0 (good) -21 (bad)

  5. Pain Self-Efficacy Questionnaire (PSEQ) [ Time Frame: current, assessed at 6 and 12 months after randomization ]
    10 item self-report measure assessing confidence in ability to do activities despite pain, scored 0-6, range 0 (bad) to 60 (good)

  6. Opioid craving [ Time Frame: past week, assessed at 6 and 12 months after randomization ]
    0-10 numerical scale for self-report of opioid craving, single item, range 0 (good) -10 (bad)

  7. Patient Global Impression of Change Scale (PGIC) [ Time Frame: during time in trial, assessed at 6 and 12 months after randomization ]
    single 7-point scale assessing global improvement with treatment, range 0 (bad) - 7 (good)

  8. Concurrent pain and psychotropic medication use [ Time Frame: during trial, assessed at 6 and 12 months after randomization ]
    all prescribed pain and psychotropic medications during trial

  9. concurrent non-medication pain treatment use [ Time Frame: during trial, assessed at 6 and 12 months after randomization ]
    non-medication pain treatment received during trial



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 18-80 years
  • receiving care at a Kaiser Western 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 50 mg MED or greater in the past 30 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 a year 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 month of parenteral, transdermal, or transmucosal opioids
  • residing in nursing home or assisted living
  • using any implanted device for pain control
  • American Psychiatric Association Diagnostic and Statistical Manual 5th edition (DSM-5) Opioid Use Disorder (OUD) according to International Classification Diseases OUD diagnoses in the Electronic Health Record
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03743402


Contacts
Contact: Mark D Sullivan, MD, PhD 2066853184 sullimar@uw.edu
Contact: Denise Boudreau, PhD 2062872067 denise.m.boudreau@kp.org

Sponsors and Collaborators
University of Washington
Kaiser Permanente

Responsible Party: Mark Sullivan, Professor of Psychiatry and Behavioral Sciences, University of Washington
ClinicalTrials.gov Identifier: NCT03743402     History of Changes
Other Study ID Numbers: 1135070-1
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mark Sullivan, University of Washington:
long-term opioid therapy
chronic pain self-management
primary care prescribing guidance

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents