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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03454555
Recruitment Status : Recruiting
First Posted : March 6, 2018
Last Update Posted : January 7, 2020
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
University of North Carolina Health Care System
Duke University Health System
Vanderbilt University Health System
Information provided by (Responsible Party):
RTI International

Tracking Information
First Submitted Date  ICMJE February 27, 2018
First Posted Date  ICMJE March 6, 2018
Last Update Posted Date January 7, 2020
Actual Study Start Date  ICMJE June 21, 2019
Estimated Primary Completion Date September 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2019)
  • Reduction of opioid use [ Time Frame: Baseline ]
    Average daily opioid dose in milligrams of morphine equivalent. Briefly, total morphine equivalents for each prescription will be calculated by multiplying the quantity of each prescription by the strength of the prescription (milligrams of opioid per unit dispensed). The quantity-strength product is then multiplied by conversion factors derived from published sources to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription. The total average dose in morphine equivalents per day supplied is calculated by summing the morphine equivalents for each prescription filled during a given period, and dividing by the number of days supplied. Prescribing data are derived from electronic health records (EHRs).
  • Reduction of opioid use [ Time Frame: 6 months ]
    Average daily opioid dose in milligrams of morphine equivalent. Briefly, total morphine equivalents for each prescription will be calculated by multiplying the quantity of each prescription by the strength of the prescription (milligrams of opioid per unit dispensed). The quantity-strength product is then multiplied by conversion factors derived from published sources to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription. The total average dose in morphine equivalents per day supplied is calculated by summing the morphine equivalents for each prescription filled during a given period, and dividing by the number of days supplied. Prescribing data are derived from electronic health records (EHRs).
  • Reduction of opioid use [ Time Frame: 12 months ]
    Average daily opioid dose in milligrams of morphine equivalent. Briefly, total morphine equivalents for each prescription will be calculated by multiplying the quantity of each prescription by the strength of the prescription (milligrams of opioid per unit dispensed). The quantity-strength product is then multiplied by conversion factors derived from published sources to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription. The total average dose in morphine equivalents per day supplied is calculated by summing the morphine equivalents for each prescription filled during a given period, and dividing by the number of days supplied. Prescribing data are derived from electronic health records (EHRs).
  • Reduction of opioid use [ Time Frame: 18 months ]
    Average daily opioid dose in milligrams of morphine equivalent. Briefly, total morphine equivalents for each prescription will be calculated by multiplying the quantity of each prescription by the strength of the prescription (milligrams of opioid per unit dispensed). The quantity-strength product is then multiplied by conversion factors derived from published sources to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription. The total average dose in morphine equivalents per day supplied is calculated by summing the morphine equivalents for each prescription filled during a given period, and dividing by the number of days supplied. Prescribing data are derived from electronic health records (EHRs).
Original Primary Outcome Measures  ICMJE
 (submitted: March 2, 2018)
  • Reduction of opioid use [ Time Frame: Baseline ]
    Average daily opioid dose in milligrams of morphine equivalent. Briefly, total morphine equivalents for each prescription will be calculated by multiplying the quantity of each prescription by the strength of the prescription (milligrams of opioid per unit dispensed). The quantity-strength product is then multiplied by conversion factors derived from published sources to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription. The total average dose in morphine equivalents per day supplied is calculated by summing the morphine equivalents for each prescription filled during a given period, and dividing by the number of days supplied. Prescribing data are derived from electronic health records (EHRs).
  • Reduction of opioid use [ Time Frame: 6 months ]
    Average daily opioid dose in milligrams of morphine equivalent. Briefly, total morphine equivalents for each prescription will be calculated by multiplying the quantity of each prescription by the strength of the prescription (milligrams of opioid per unit dispensed). The quantity-strength product is then multiplied by conversion factors derived from published sources to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription. The total average dose in morphine equivalents per day supplied is calculated by summing the morphine equivalents for each prescription filled during a given period, and dividing by the number of days supplied. Prescribing data are derived from electronic health records (EHRs).
  • Reduction of opioid use [ Time Frame: 12 months ]
    Average daily opioid dose in milligrams of morphine equivalent. Briefly, total morphine equivalents for each prescription will be calculated by multiplying the quantity of each prescription by the strength of the prescription (milligrams of opioid per unit dispensed). The quantity-strength product is then multiplied by conversion factors derived from published sources to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription. The total average dose in morphine equivalents per day supplied is calculated by summing the morphine equivalents for each prescription filled during a given period, and dividing by the number of days supplied. Prescribing data are derived from electronic health records (EHRs).
  • Reduction of opioid use [ Time Frame: 18 months ]
    Average daily opioid dose in milligrams of morphine equivalent. Briefly, total morphine equivalents for each prescription will be calculated by multiplying the quantity of each prescription by the strength of the prescription (milligrams of opioid per unit dispensed). The quantity-strength product is then multiplied by conversion factors derived from published sources to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription. The total average dose in morphine equivalents per day supplied is calculated by summing the morphine equivalents for each prescription filled during a given period, and dividing by the number of days supplied. Prescribing data are derived from electronic health records (EHRs).
  • Time to discontinuation of opioid use [ Time Frame: Baseline ]
    Discontinuation will be defined as the first day of a minimum 90-day period with no opioid prescriptions and will be assessed at four timepoints. Data are derived from EHRs.
  • Time to discontinuation of opioid use [ Time Frame: 6 months ]
    Time to discontinuation will be defined as the first day of a minimum 90-day period with no opioid prescriptions and will be assessed at four timepoints.. Data are derived from EHRs.
  • Time to discontinuation of opioid use [ Time Frame: 12 months ]
    Discontinuation will be defined as the first day of a minimum 90-day period with no opioid prescriptions and will be assessed at four timepoints.. Data are derived from EHRs.
  • Time to discontinuation of opioid use [ Time Frame: 18 months ]
    Discontinuation will be defined as the first day of a minimum 90-day period with no opioid prescriptions and will be assessed at four timepoints. Data are derived from EHRs.
Change History Complete list of historical versions of study NCT03454555 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2019)
  • Physical functioning [ Time Frame: Baseline ]
    PROMIS-PF (Patient-Reported Outcomes Measurement Information System Physical functioning). Assesses self-reported capability rather than actual performance of physical activities. Patient-reported outcome.
  • Physical functioning [ Time Frame: 6 months ]
    PROMIS-PF (Patient-Reported Outcomes Measurement Information System Physical functioning). Assesses self-reported capability rather than actual performance of physical activities. Patient-reported outcome.
  • Physical functioning [ Time Frame: 12 months ]
    PROMIS-PF (Patient-Reported Outcomes Measurement Information System Physical functioning). Assesses self-reported capability rather than actual performance of physical activities. Patient-reported outcome.
  • Pain interference on functioning [ Time Frame: Baseline ]
    PROMIS-PI (Pain Interference), 8-item Short Form. Assesses extent to which pain interferes with daily functioning. Items measured on 5-point Likert scale. Patient-reported outcome.
  • Pain interference on functioning [ Time Frame: 6 months ]
    PROMIS-PI (Pain Interference), 8-item Short Form. Assesses extent to which pain interferes with daily functioning. Items measured on 5-point Likert scale. Patient-reported outcome.
  • Pain interference on functioning [ Time Frame: 12 months ]
    PROMIS-PI (Pain Interference), 8-item Short Form. Assesses extent to which pain interferes with daily functioning. Items measured on 5-point Likert scale. Patient-reported outcome.
  • Pain Intensity [ Time Frame: Baseline ]
    PROMIS Pain Intensity Short Form, 3 items. Assesses intensity of pain over the past 7 days. Patient-reported outcome.
  • Pain Intensity [ Time Frame: 6 months ]
    PROMIS Pain Intensity Short Form, 3 items. Assesses intensity of pain over the past 7 days. Patient-reported outcome.
  • Pain Intensity [ Time Frame: 12 months ]
    PROMIS Pain Intensity Short Form, 3 items. Assesses intensity of pain over the past 7 days. Patient-reported outcome.
  • Emotional distress [ Time Frame: Baseline ]
    PROMIS Emotional Distress - Anxiety, 4-items Short Form. Assesses generalized anxiety/distress over the past 7 days. Items measured on 5-point Likert scale. Patient-reported outcome.
  • Emotional distress [ Time Frame: 6 months ]
    PROMIS Emotional Distress - Anxiety, 4-items Short Form. Assesses generalized anxiety/distress over the past 7 days. Items measured on 5-point Likert scale. Patient-reported outcome.
  • Emotional distress [ Time Frame: 12 months ]
    PROMIS Emotional Distress - Anxiety, 4-items Short Form. Assesses generalized anxiety/distress over the past 7 days. Items measured on 5-point Likert scale. Patient-reported outcome.
  • Depressive symptoms [ Time Frame: Baseline ]
    PROMIS Emotional Distress - Depression, 4-item Short Form. Assesses depressive symptoms over the past 7 days. Items measured on 5-point Likert scale. Patient-reported outcome.
  • Depressive symptoms [ Time Frame: 6 months ]
    PROMIS Emotional Distress - Depression, 4-item Short Form. Assesses depressive symptoms over the past 7 days. Items measured on 5-point Likert scale. Patient-reported outcome.
  • Depressive symptoms [ Time Frame: 12 months ]
    PROMIS Emotional Distress - Depression, 4-item Short Form. Assesses depressive symptoms over the past 7 days. Items measured on 5-point Likert scale. Patient-reported outcome.
  • Satisfaction with pain care [ Time Frame: Baseline ]
    Assesses current satisfaction with pain management, 1 item. Patient-reported outcome.
  • Satisfaction with pain care [ Time Frame: 6 months ]
    Assesses current satisfaction with pain management, 1 item. Patient-reported outcome.
  • Satisfaction with pain care [ Time Frame: 12 months ]
    Assesses current satisfaction with pain management, 1 item. Patient-reported outcome.
  • Brief Pain Inventory [ Time Frame: Baseline ]
    Brief Pain Inventory (BPI) short form, 11 items. Asks for numeric ratings of pain intensity and pain interference. Patient-reported outcome.
  • Brief Pain Inventory [ Time Frame: 6 months ]
    Brief Pain Inventory (BPI) short form, 11 items. Asks for numeric ratings of pain intensity and pain interference. Patient-reported outcome.
  • Brief Pain Inventory [ Time Frame: 12 months ]
    Brief Pain Inventory (BPI) short form, 11 items. Asks for numeric ratings of pain intensity and pain interference. Patient-reported outcome.
  • Satisfaction with study health information [ Time Frame: 6 months ]
    Assesses satisfaction with and use of study intervention materials. 3 items. Patient-reported outcome.
  • Satisfaction with study health information [ Time Frame: 12 months ]
    Assesses satisfaction with and use of study intervention materials. 3 items. Patient-reported outcome.
  • Non-opioid treatments [ Time Frame: Baseline ]
    Assesses treatments used to manage physical pain, 18 items. Patient-reported outcome.
  • Non-opioid treatments [ Time Frame: 6 months ]
    Assesses treatments used to manage physical pain, 18 items. Patient-reported outcome.
  • Non-opioid treatments [ Time Frame: 12 months ]
    Assesses treatments used to manage physical pain, 18 items. Patient-reported outcome.
  • Intent to taper [ Time Frame: Baseline ]
    Assesses intent to reduce the amount of opioids taken, 2 items. Patient-reported outcome.
  • Intent to taper [ Time Frame: 6 months ]
    Assesses intent to reduce the amount of opioids taken, 2 items. Patient-reported outcome.
  • Intent to taper [ Time Frame: 12 months ]
    Assesses intent to reduce the amount of opioids taken, 2 items. Patient-reported outcome.
  • Relative opioid use [ Time Frame: 6 months ]
    Assesses overall use of opioids relative to baseline. 1 item. Patient-reported outcome.
  • Relative opioid use [ Time Frame: 12 months ]
    Assesses overall use of opioids relative to baseline. 1 item. Patient-reported outcome.
  • Patient-Centered Communication [ Time Frame: Baseline ]
    Patient-Centered Communication in Cancer Care, short form, 6 items (PCC-CA-6). Assesses patients' experiences with doctors and other health professionals in 6 domains. Patient-reported outcome.
  • Patient-Centered Communication [ Time Frame: 6 months ]
    Patient-Centered Communication in Cancer Care, short form, 6 items (PCC-CA-6). Assesses patients' experiences with doctors and other health professionals in 6 domains. Patient-reported outcome.
  • Patient-Centered Communication [ Time Frame: 12 months ]
    Patient-Centered Communication in Cancer Care, short form, 6 items (PCC-CA-6). Assesses patients' experiences with doctors and other health professionals in 6 domains. Patient-reported outcome.
  • Hospitalization [ Time Frame: 6 months ]
    Assesses hospitalization and emergency department visits related to overdose, withdrawal, or self-harm. Patient-reported outcome.
  • Hospitalization [ Time Frame: 12 months ]
    Assesses hospitalization and emergency department visits related to overdose, withdrawal, or self-harm. Patient-reported outcome.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2018)
  • Physical functioning [ Time Frame: Baseline ]
    PROMIS-PF (Patient-Reported Outcomes Measurement Information System Physical functioning). Assesses self-reported capability rather than actual performance of physical activities. Patient-reported outcome.
  • Physical functioning [ Time Frame: 3 months ]
    PROMIS-PF (Patient-Reported Outcomes Measurement Information System Physical functioning). Assesses self-reported capability rather than actual performance of physical activities. Patient-reported outcome.
  • Physical functioning [ Time Frame: 12 months ]
    PROMIS-PF (Patient-Reported Outcomes Measurement Information System Physical functioning). Assesses self-reported capability rather than actual performance of physical activities. Patient-reported outcome.
  • Pain interference on functioning [ Time Frame: Baseline ]
    PROMIS-PI (Pain Interference), 8-item Short Form. Assesses extent to which pain interferes with daily functioning. Items measured on 5-point Likert scale. Patient-reported outcome.
  • Pain interference on functioning [ Time Frame: 3 months ]
    PROMIS-PI (Pain Interference), 8-item Short Form. Assesses extent to which pain interferes with daily functioning. Items measured on 5-point Likert scale. Patient-reported outcome.
  • Pain interference on functioning [ Time Frame: 12 months ]
    PROMIS-PI (Pain Interference), 8-item Short Form. Assesses extent to which pain interferes with daily functioning. Items measured on 5-point Likert scale. Patient-reported outcome.
  • Pain status [ Time Frame: Baseline ]
    PROMIS Pain Intensity Short Form, 3 items. Assesses intensity of pain over the past 7 days. Patient-reported outcome.
  • Pain status [ Time Frame: 3 months ]
    PROMIS Pain Intensity Short Form, 3 items. Assesses intensity of pain over the past 7 days. Patient-reported outcome.
  • Pain status [ Time Frame: 12 months ]
    PROMIS Pain Intensity Short Form, 3 items. Assesses intensity of pain over the past 7 days. Patient-reported outcome.
  • Emotional distress [ Time Frame: Baseline ]
    PROMIS anxiety, 4-items Short Form. Assesses generalized anxiety/distress over the past 7 days. Items measured on 5-point Likert scale. Patient-reported outcome.
  • Emotional distress [ Time Frame: 3 months ]
    PROMIS anxiety, 4-items Short Form. Assesses generalized anxiety/distress over the past 7 days. Items measured on 5-point Likert scale. Patient-reported outcome.
  • Emotional distress [ Time Frame: 12 months ]
    PROMIS anxiety, 4-items Short Form. Assesses generalized anxiety/distress over the past 7 days. Items measured on 5-point Likert scale. Patient-reported outcome.
  • Depressive symptoms [ Time Frame: Baseline ]
    PROMIS depression, 4-item Short Form. Assesses depressive symptoms over the past 7 days. Items measured on 5-point Likert scale. Patient-reported outcome.
  • Depressive symptoms [ Time Frame: 3 months ]
    PROMIS depression, 4-item Short Form. Assesses depressive symptoms over the past 7 days. Items measured on 5-point Likert scale. Patient-reported outcome.
  • Depressive symptoms [ Time Frame: 12 months ]
    PROMIS depression, 4-item Short Form. Assesses depressive symptoms over the past 7 days. Items measured on 5-point Likert scale. Patient-reported outcome.
  • Self-efficacy to manage and cope with pain [ Time Frame: Baseline ]
    Selected items from the Chronic Pain Self-Efficacy Scale. Assesses self-efficacy in managing/coping with pain using a 3-factor scale. Items measured on 5-pt Likert scale. Patient-reported outcome.
  • Self-efficacy to manage and cope with pain [ Time Frame: 3 months ]
    Selected items from the Chronic Pain Self-Efficacy Scale. Assesses self-efficacy in managing/coping with pain using a 3-factor scale. Items measured on 5-pt Likert scale. Patient-reported outcome.
  • Self-efficacy to manage and cope with pain [ Time Frame: 12 months ]
    Selected items from the Chronic Pain Self-Efficacy Scale. Assesses self-efficacy in managing/coping with pain using a 3-factor scale. Items measured on 5-pt Likert scale. Patient-reported outcome.
  • Satisfaction with pain care [ Time Frame: Baseline ]
    Selected items from the Pain Treatment Satisfaction Scale. Assesses current satisfaction with pain management on 5 domains, measured on a 5-point Likert scale. Patient-reported outcome.
  • Satisfaction with pain care [ Time Frame: 3 months ]
    Selected items from the Pain Treatment Satisfaction Scale. Assesses current satisfaction with pain management on 5 domains, measured on a 5-point Likert scale. Patient-reported outcome.
  • Satisfaction with pain care [ Time Frame: 12 months ]
    Selected items from the Pain Treatment Satisfaction Scale. Assesses current satisfaction with pain management on 5 domains, measured on a 5-point Likert scale. Patient-reported outcome.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE INSPIRE: Integrated Services for Pain: Interventions to Reduce Pain Effectively
Official Title  ICMJE Integrated Health Services to Reduce Opioid Use While Managing Chronic Pain
Brief 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.

Detailed 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 ≥ 40 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 40 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants will be randomly assigned to one of two intervention arms for the duration of the study. 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. Consequently, throughout the trial, the treatment arms will have approximately equal sample sizes both within a site and across the study.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Pain
Intervention  ICMJE
  • Behavioral: Shared Decision Making
    The Shared Decision Making (SDM) intervention is a behavioral intervention to explore and compare treatment options, assess a patient's values and preferences, and reach a shared decision. The intervention will have both clinician and patient components. The content of the clinician component will be based on the AHRQ (Agency for Healthcare Research and Quality) SHARE Approach, which is a 5-step process for shared decision making that includes exploring and comparing the benefits, harms, and risks of each option through meaningful dialogue about what matters most to the patient (Agency for Healthcare Research and Quality, 2017) . Patients randomized to Arm 1 will have their study visits and opioid use managed by an SDM-trained clinician at their practice.
  • Behavioral: Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain
    The Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain intervention is an empirically based behavioral pain management behavioral therapy intervention (Monticone et al., 2015), including MI to enhance motivation for opioid dose reduction or cessation and CBT-CP for pain coping skills enhancement. We anticipate one MI session that will focus on engaging, focusing, evoking, and planning. We anticipate 8 sessions of CBT-CP, as is standard, delivered in a group setting.
Study Arms  ICMJE
  • Active Comparator: Arm 1
    Arm 1 patients will receive guideline-concordant pharmacotherapy based on clinical guidelines for opioid therapy for chronic noncancer pain plus the Shared Decision-Making (SDM) intervention.
    Intervention: Behavioral: Shared Decision Making
  • Active Comparator: Arm 2
    Arm 2 patients will receive the guideline-concordant pharmacotherapy based on clinical guidelines for opioid therapy for chronic noncancer pain plus the Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT+CP) Intervention.
    Intervention: Behavioral: Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 2, 2018)
1060
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2022
Estimated Primary Completion Date September 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged 18 to 85 years
  • History of chronic non-cancer pain (CNCP)
  • 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 40 mg or greater for CNCP.
  • Receiving care at a participating clinic from a participating provider, as evidenced by at least 1 in-person visit within the past 12 months.

Exclusion Criteria:

  • Not meeting the above inclusion criteria
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Laura Wagner, MPH 919-316-3802 lwagner@rti.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03454555
Other Study ID Numbers  ICMJE PCORI-OPD-1610-37006
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party RTI International
Study Sponsor  ICMJE RTI International
Collaborators  ICMJE
  • Patient-Centered Outcomes Research Institute
  • University of North Carolina Health Care System
  • Duke University Health System
  • Vanderbilt University Health System
Investigators  ICMJE
Principal Investigator: Lauren McCormack, PhD, MSPH RTI International
PRS Account RTI International
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP