Ignite Creation Date:
2024-05-06 @ 11:11 AM
Last Modification Date:
2024-10-26 @ 12:41 PM
Study NCT ID:
NCT03454555
Status:
COMPLETED
Last Update Posted:
2024-04-11
First Post:
2018-02-27
Brief Title:
Integrated Services for Pain Interventions to Reduce Pain Effectively
Sponsor:
RTI International
Organization:
RTI International
Study Overview
Official Title:
Integrated Health Services to Reduce Opioid Use While Managing Chronic Pain
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INSPIRE
Brief Summary:
What is the research about
Long-term pain -or pain that lasts for months or years-is one of the most common health problems in the United States Clinicians often treat long-term pain with opioids Opioids can help ease pain in the short term but evidence does not support their effectiveness in the long term For some people long-term opioid use can lead to addiction and overdose People need effective options and support to help improve their function and enjoy life as much as possible
What is the research team doing
This study that compared two programs for helping people living with long-term pain to improve their function while managing their pain People with long-term pain who had been taking opioid medicines for 3 or more months could be in the study This study was done at primary care and pain care clinics at 3 health systems in North Carolina and Tennessee
The study team assigned people by chance to one of two study programs 1 Shared Decision Making SDM or 2 Cognitive Behavioral Therapy and Motivational Interviewing CBTMI Both programs went by clinical guidelines for opioid prescribing
In the SDM program the patient and clinician worked together to make decisions that were best for the patient In the CBTMI program the patient learned strategies to better cope with chronic pain
The study team compared the two programs by looking at changes in opioid dose physical functioning and pain interference over time They collected information on prescribed opioid dose from electronic health records People did surveys at the start of the study and at 6 and 12 months
Study data collection is over and the study team is analyzing data Results are forthcoming
The study team worked with an advisory group that included patients advocates clinicians and pain experts The advisory group met with the study team two to three times per year to provide input on the study
Long-term pain -or pain that lasts for months or years-is one of the most common health problems in the United States Clinicians often treat long-term pain with opioids Opioids can help ease pain in the short term but evidence does not support their effectiveness in the long term For some people long-term opioid use can lead to addiction and overdose People need effective options and support to help improve their function and enjoy life as much as possible
What is the research team doing
This study that compared two programs for helping people living with long-term pain to improve their function while managing their pain People with long-term pain who had been taking opioid medicines for 3 or more months could be in the study This study was done at primary care and pain care clinics at 3 health systems in North Carolina and Tennessee
The study team assigned people by chance to one of two study programs 1 Shared Decision Making SDM or 2 Cognitive Behavioral Therapy and Motivational Interviewing CBTMI Both programs went by clinical guidelines for opioid prescribing
In the SDM program the patient and clinician worked together to make decisions that were best for the patient In the CBTMI program the patient learned strategies to better cope with chronic pain
The study team compared the two programs by looking at changes in opioid dose physical functioning and pain interference over time They collected information on prescribed opioid dose from electronic health records People did surveys at the start of the study and at 6 and 12 months
Study data collection is over and the study team is analyzing data Results are forthcoming
The study team worked with an advisory group that included patients advocates clinicians and pain experts The advisory group met with the study team two to three times per year to provide input on the study
Detailed Description:
Rationale
Up to one-third of Americans suffer from chronic non-cancer pain CNCP Opioids are often used to treat CNCP Once on chronic opioid therapy COT individuals often continue with this class of medication for years Evidence for the effectiveness of COT to treat CNCP is limited exposing individuals to known risks Modified or novel pharmacological and nonpharmacological strategies are needed to improve pain management and promote informed decision making regarding possible opioid dose reduction
Study Design and Approach
This is a large-scale pragmatic randomized controlled trial implementing pharmacotherapy guidelines and behavioral interventions in real-world settings A pragmatic trial is a study designed to evaluate the effectiveness of interventions in broad patient groups in routine clinical practice This differs from an explanatory trial which is designed to evaluate efficacy under ideal conditions
In this trial the researchers will examine the comparative effectiveness of two approaches to reducing opioid dose for CNCP who are on COT shared decision making SDM and guideline-concordant pharmacotherapy SDM Arm versus motivational interviewing plus cognitive behavioral therapy for chronic pain MICBT-CP and guideline-concordant pharmacotherapy MICBT-CP Arm
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 educate 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 SDM as compared with MICBT-CP
Primary Objective
To assess if the interventions result in opioid dose reduction and to 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 Participant recruitment occurred from June 2019 to March 2022 Delivery of the intervention occurred on a rolling basis through March 2023
Recruitment Screening Enrollment and Randomization
The study enrolled 526 participants from primary care and pain clinics at three medical centers in North Carolina and Tennessee The researchers identified patients who are potentially eligible through electronic health records and contacted these patients with an invitation to participate A Research Coordinator contacted patients to complete screening enrollment and randomization The researchers randomized enrolled participants to either the SDM Arm or MICBT-CP Arm of the intervention
Interventions
In the SDM arm patients and clinicians engaged in SDM In the MICBT-CP Arm patients participated in MICBT-CP Patients in both study arms received guideline-concordant pharmacotherapy treatment based on clinical guidelines for opioid therapy for CNCP
Data Collection
The researchers employed a comprehensive multi-mode data collection method that included collecting patient-reported outcomes through Web-based and phone-based surveys and leveraging existing harmonized electronic health record EHR data The researchers will use validated measures to measure the impact of the interventions
The researchers will assess the primary outcome change in opioid dose from baseline using EHR data at 6 timepoints 3 months 6 months 9 months 12 months 15 months and 18 months Change from baseline in average daily opioid dose will be measured as prescribed morphine equivalent dose MED The researchers will measure the secondary outcomes physical functioning and pain interference via participant survey at three 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 the 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
The researchers will evaluate clinical outcomes and patient-reported outcomes using cross-sectional and longitudinal intent-to-treat analyses These analyses will use mixed effects models to compare opioid dose between the two study arms over an 18-month period The 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 history of substance abuse Qualitative research methods have been used to obtain participant input on their experiences
Up to one-third of Americans suffer from chronic non-cancer pain CNCP Opioids are often used to treat CNCP Once on chronic opioid therapy COT individuals often continue with this class of medication for years Evidence for the effectiveness of COT to treat CNCP is limited exposing individuals to known risks Modified or novel pharmacological and nonpharmacological strategies are needed to improve pain management and promote informed decision making regarding possible opioid dose reduction
Study Design and Approach
This is a large-scale pragmatic randomized controlled trial implementing pharmacotherapy guidelines and behavioral interventions in real-world settings A pragmatic trial is a study designed to evaluate the effectiveness of interventions in broad patient groups in routine clinical practice This differs from an explanatory trial which is designed to evaluate efficacy under ideal conditions
In this trial the researchers will examine the comparative effectiveness of two approaches to reducing opioid dose for CNCP who are on COT shared decision making SDM and guideline-concordant pharmacotherapy SDM Arm versus motivational interviewing plus cognitive behavioral therapy for chronic pain MICBT-CP and guideline-concordant pharmacotherapy MICBT-CP Arm
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 educate 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 SDM as compared with MICBT-CP
Primary Objective
To assess if the interventions result in opioid dose reduction and to 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 Participant recruitment occurred from June 2019 to March 2022 Delivery of the intervention occurred on a rolling basis through March 2023
Recruitment Screening Enrollment and Randomization
The study enrolled 526 participants from primary care and pain clinics at three medical centers in North Carolina and Tennessee The researchers identified patients who are potentially eligible through electronic health records and contacted these patients with an invitation to participate A Research Coordinator contacted patients to complete screening enrollment and randomization The researchers randomized enrolled participants to either the SDM Arm or MICBT-CP Arm of the intervention
Interventions
In the SDM arm patients and clinicians engaged in SDM In the MICBT-CP Arm patients participated in MICBT-CP Patients in both study arms received guideline-concordant pharmacotherapy treatment based on clinical guidelines for opioid therapy for CNCP
Data Collection
The researchers employed a comprehensive multi-mode data collection method that included collecting patient-reported outcomes through Web-based and phone-based surveys and leveraging existing harmonized electronic health record EHR data The researchers will use validated measures to measure the impact of the interventions
The researchers will assess the primary outcome change in opioid dose from baseline using EHR data at 6 timepoints 3 months 6 months 9 months 12 months 15 months and 18 months Change from baseline in average daily opioid dose will be measured as prescribed morphine equivalent dose MED The researchers will measure the secondary outcomes physical functioning and pain interference via participant survey at three 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 the 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
The researchers will evaluate clinical outcomes and patient-reported outcomes using cross-sectional and longitudinal intent-to-treat analyses These analyses will use mixed effects models to compare opioid dose between the two study arms over an 18-month period The 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 history of substance abuse Qualitative research methods have been used to obtain participant input on their experiences
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None