INSPIRE: Integrated Services for Pain: Interventions to Reduce Pain Effectively

  • STATUS
    Recruiting
  • End date
    Sep 30, 2022
  • participants needed
    1060
  • sponsor
    RTI International
Updated on 23 January 2021
analgesics
morphine
opioid
cancer
behavior therapy
chronic pain
drug abuse
cancer pain
narcotic use
cognitive therapy
pain relieving

Summary

Up to one-third of Americans suffer from chronic noncancer pain (CNCP)(Institute of Medicine, 2011). Opioids are often used to treat CNCP. Once on chronic opioid therapy (COT), individuals often continue for months or years(Martin et al., 2011; Vanderlip et al., 2014). Evidence for the effectiveness of COT to treat CNCP is insufficient, exposing individuals to known risk. Strategies are needed to reduce/eliminate COT in patients who are not benefiting from opioids while ensuring access for those who are.

The researchers will employ a multisite pragmatic trial using real-time randomization to examine the comparative effectiveness of 2 approaches: a guideline-concordant pharmacotherapy approach integrated with shared decision making (SDM) (Arm 1) compared with a guideline-concordant pharmacotherapy approach integrated with motivational interviewing (MI) and cognitive behavioral therapy for chronic pain (CBT-CP) (Arm 2).

The researchers will examine the impact of the 2 approaches on several outcomes. The study will examine which set of patients have greater opioid dose reduction, improved functioning, and/or lower pain scores. Clinical outcomes will be assessed using electronic health record data at 4 timepoints: baseline, 6 months, 12 months, and 18 months. Patient-reported outcomes, including physical functioning and level of pain, will be measured via patient survey at 3 timepoints: baseline, 6 months, and 12 months.

The study will include patients from North Carolina and Tennessee. The researchers will enroll 530 patients in each study arm for a total enrollment of 1,060. This sample size will provide robust power to detect clinically important differences in reduction of opioid use between the two study arms.

Analyses will include longitudinal (mixed effects) models to compare the change in outcomes from baseline to each timepoint between the two study arms. The project team will explore differences in the intervention effect according to participant characteristics such as age, sex, baseline pain level, baseline opioid dose, physical comorbidities, mental health comorbidities, and a history of substance abuse. Qualitative research methods will be used to obtain patient input on their experiences.

Description

Study Design and Approach This is a large-scale randomized pragmatic trial implementing pharmacotherapy guidelines and behavioral interventions in real-world settings.

In this trial, the researchers will examine the comparative effectiveness of two approaches to reducing opioid dosages for chronic non-cancer patients (CNCP) who are on chronic opioid therapy (COT): shared decision making (SDM) and guideline-concordant pharmacotherapy (Arm 1) compared with cognitive behavioral therapy for chronic pain and motivational interviewing (CBT-CP+MI) and guideline-concordant pharmacotherapy (Arm 2).

Rationale
  • Up to one-third of Americans suffer from chronic noncancer pain (CNCP) (Institute of Medicine, 2011).
  • Opioids are often used to treat CNCP. Once on chronic opioid therapy (COT), individuals often continue with this class of medication for years (Martin et al., 2011; Vanderlip et al., 2014).
  • Evidence for the effectiveness of COT to treat CNCP is limited, exposing individuals to known risks (Chou et al., 2014).
  • Modified or novel pharmacological and nonpharmacological strategies are needed to improve pain management and promote informed decision making regarding possible opioid dose reduction.
  • This project will evaluate two nonpharmacologic approaches to pain management and opioid reduction in primary care and specialty pain clinics.
  • The approaches are designed to educate medical care providers and patients currently being treated for CNCP, help patients address pain and pain coping skills, and enhance patient motivation to reduce or discontinue opioid use
  • This study will determine the feasibility, effectiveness and potential scalability of these interventions in reducing opioid use in patients who are using 20 morphine equivalent doses [MED]).
  • The study will also assess patient acceptability of the interventions including involvement in their implementation and willingness to incur out-of-pocket costs associated with the visits.
Objectives

To conduct a multisite pragmatic trial of two active interventions: shared decision making (SDM) as compared with cognitive behavioral therapy for chronic pain with motivational interviewing (MI+CBT-CP).

Primary Objective

To assess if the interventions result in opioid dose reduction and compare their effectiveness.

Secondary Objectives

  • To examine the impact of the interventions on physical function.
  • To examine the impact of the interventions on pain interference.
    Timeline

The project commenced in February 2018. Study recruitment began in June 2019.

Recruitment, Screening, Enrollment, and Randomization:

The proposed study will enroll 530 participants in each arm, from primary care and pain clinics at three medical centers. Participants must be receiving high-dose COT for chronic non-cancer pain (CNCP) as evidenced by current or most recent prescription of an average daily morphine-equivalent dose (MED) of 20 mg or greater for CNCP.

Patient recruitment will occur on a rolling basis beginning in June 2019 and will last for up to 26 months. Delivery of the intervention will also occur on a rolling basis with the recruitment process. Patients who are potentially eligible will be identified through electronic health records (EHRs) and contacted with an invitation to participate. Interested patients will be met at their next clinic visit by a Research Coordinator to complete screening, enrollment, and randomization.

The study will use real-time randomization to limit participant loss prior to treatment. Eligible patients will be randomized using a stratified, permuted-block design, as this constrained randomization approach ensures balance between treatment groups within each of the 3 clinical institutions (our only stratification factor) at the completion of each block. Patients will be provided study information based on their treatment assignment.

Interventions

In Arm 1, patients and clinicians will engage in Shared Decision Making (SDM). In Arm 2, patients will participate in cognitive behavioral therapy for chronic pain (CBT-CP) and motivational interviewing (MI).

Patients in both study arms will receive guideline-concordant pharmacotherapy treatment, based on clinical guidelines for opioid therapy for CNCP.

Data Collection We will employ a comprehensive, multi-mode data collection method that includes the collection of patient-reported outcomes through Web-based and phone-based surveys, and that leverages existing harmonized EHR data. We will use validated measures to measure the impact of the interventions.

We will assess our primary outcomes using EHR data from 4 timepoints: baseline, 6 months, 12 months, and 18 months. Reduction of opioid use will be measured as prescribed milligrams of daily morphine equivalent.

We will measure our secondary outcomes using patient-reported outcomes. Patient-reported outcomes, including physical functioning and level of pain, will be measured via patient survey at 3 timepoints: baseline, 6 months, and 12 months.

Data Analysis and Reporting:

In a large pragmatic trial such as the one planned, the probability is small that the groups will have imbalance by age, sex, health behaviors, or other measured or unmeasured possible confounding factors. Nevertheless, researchers will assess whether randomization has successfully created comparable groups by descriptively comparing their baseline demographic characteristics and potential confounders, including baseline pain score, comorbidities, opioid dosage, and number and type of CNCP conditions.

Researchers will evaluate clinical outcomes and patient-reported outcomes using longitudinal analyses. Analyses will use longitudinal (mixed effects) models to compare opioid dose over 18 months between the two study arms. Researchers also will explore differences in the intervention effect according to participant characteristics, such as age, sex, baseline pain level, baseline opioid dose, and the presence of physical comorbidities, mental health comorbidities, or a history of substance abuse.

Details
Condition Pain, Chronic Pain, Post-Surgical Pain, Pain (Pediatric), chronic pains
Treatment Shared Decision Making, Shared Decision Making, Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain
Clinical Study IdentifierNCT03454555
SponsorRTI International
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 85 yrs?
Gender: Male or Female
Do you have any of these conditions: Pain (Pediatric) or Pain or Post-Surgical Pain or Chronic Pain?
Do you have any of these conditions: Post-Surgical Pain or Pain (Pediatric) or Pain or Chronic Pain or chronic pains?
Opioid use is for pain directly related to an active cancer diagnosis
Opioid use is for maintenance treatment of an opioid use disorder (OUD)
Suicide attempt within the past 3 years
Active suicidal ideation
Currently receiving CBT
Non-English speaking
Other reason at the discretion of the investigator
Clear my responses

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