Strategies to Improve Pain and Enjoy Life

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-04

Study Completion Date

2022-01-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Brief Intervention for Patients on Opioids for Acute Pain

NCT05658926

Acute Pain

COMPLETED NA

Cessation of Long-term Opioid Therapy in Chronic Pain Patients

NCT02132221

Chronic Pain

TERMINATED NA

Evaluate the Safety and Pharmacokinetic Profile of ETR028 and ETR029 in Healthy Adult Subjects

NCT05572190

Acute Pain

UNKNOWN PHASE1

Attenuation of Pain in Men and Women

NCT01220414

Pain

COMPLETED NA

Reduced Opioid Analgesic Requirements Via Improved Endogenous Opioid Function

NCT02469077

Chronic Pain

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Outcomes assessment will be conducted by Kaiser survey team which will be blind to treatment assignment.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Pain self-management training

Intervention Type BEHAVIORAL

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.

video education, motivational interviewing

Intervention Type BEHAVIORAL

web-based video of successfully tapered patients with motivational interviewing debriefing

voluntary self-paced opioid taper

Intervention Type BEHAVIORAL

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.

prescribing guidance for primary care provider

Intervention Type BEHAVIORAL

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

Patients randomized to usual care will continue to receive care as usual from their Kaiser primary care provider.

Group Type ACTIVE_COMPARATOR

usual care

Intervention Type OTHER

Usual care will consist of any and all regular care that may be offered by primary care for chronic pain and related illnesses

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

video education, motivational interviewing

web-based video of successfully tapered patients with motivational interviewing debriefing

Intervention Type BEHAVIORAL

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 will negotiate details with their primary care provider.

Intervention Type BEHAVIORAL

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. All prescriptions will be written by the primary care provider.

Intervention Type BEHAVIORAL

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

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

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No