Strategies to Improve Pain and Enjoy Life (STRIPE)

• ClinicalTrials.gov Identifier: NCT03743402
• Recruitment Status: Active, not recruiting
• First Posted: November 16, 2018
• Last Update Posted: December 14, 2021
• Sponsor: University of Washington
• Collaborators: Kaiser Permanente; National Institute on Drug Abuse (NIDA)
• Information provided by (Responsible Party): Mark Sullivan, University of Washington

Study Description

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.

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	Not Applicable

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 (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 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 153 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
• Actual Study Start Date: April 4, 2019
• Actual Primary Completion Date: July 11, 2021
• Estimated Study Completion Date: January 11, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Pain self-management; 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.	Behavioral: Pain self-management training; 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.; 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.	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; Other Name: standard opioid therapy for chronic pain

Outcome Measures

Primary Outcome Measures :

1. mean daily opioid dose [ Time Frame: over following 30 days, assessed at 6 and 12 (primary) 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 6 and 12 (primary) months after randomization ]
   mean 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)

Eligibility Criteria

• 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 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
• 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

Contacts and Locations

Locations

United States, Washington

Kaiser Permanente Washington

Seattle, Washington, United States, 98112

Sponsors and Collaborators

University of Washington

Kaiser Permanente

National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Mark D Sullivan, MD, PhD; University of Washington

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Mark Sullivan, Professor of Psychiatry and Behavioral Sciences, University of Washington
• ClinicalTrials.gov Identifier: NCT03743402
• Other Study ID Numbers: SITE00000193; R01DA044970-01 ( U.S. NIH Grant/Contract )
• First Posted: November 16, 2018
• Last Update Posted: December 14, 2021
• Last Verified: December 2021

• 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; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents