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Integrated Health Services to Reduce Opioid Use While Managing Chronic Pain

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ClinicalTrials.gov Identifier: NCT03454555
Recruitment Status : Not yet recruiting
First Posted : March 6, 2018
Last Update Posted : March 6, 2018
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

Brief Summary:

Up to one-third of Americans suffer from chronic noncancer pain (CNCP). Opioids are often used to treat CNCP. Once on chronic opioid therapy (COT), individuals often continue for months or years. 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, greater rates of opioid discontinuation, improved functioning, and/or lower pain scores. Clinical outcomes (opioid dose reduction and time to discontinuation) 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, 3 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.


Condition or disease Intervention/treatment Phase
Chronic Pain Behavioral: Shared Decision Making Behavioral: Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1060 participants
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
Official Title: Integrated Health Services to Reduce Opioid Use While Managing Chronic Pain
Estimated Study Start Date : January 31, 2019
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
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.
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. Patients randomized to Arm 1 will have their study visits and opioid use managed by the one or two SDM-trained clinicians at their practice.

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.
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, including MI to enhance motivation for opioid dose reduction or cessation and CBT-CP for pain coping skills enhancement. We anticipate 2 MI sessions that will focus on engaging, focusing, evoking, and planning. We anticipate 8 sessions of CBT-CP, as is standard, delivered in a group setting.




Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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.

  6. 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.

  7. 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.

  8. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Pain status [ Time Frame: Baseline ]
    PROMIS Pain Intensity Short Form, 3 items. Assesses intensity of pain over the past 7 days. Patient-reported outcome.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants will be patients at participating primary care or specialty pain management clinics at study sites
  • Patients will be 18-75 years,
  • Patients will have used opioids at the level of ≥50 mg daily MED for 90 or more days (based on EHR data).
  • Patients will not have a terminal cancer diagnosis
  • Patients will not currently be in psychotherapy (based on self-report).

Exclusion Criteria:

  • Patients whose providers refuse permission will not be eligible.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03454555


Contacts
Contact: Laura Wagner, MPH 919-316-3802 lwagner@rti.org

Locations
United States, North Carolina
University of North Carolina Health Care System Not yet recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Audrina Bunton, MA, LPCS    919-843-3084    audrina_bunton@unc.edu   
Principal Investigator: Paul Chelminski, MD,MPH,FACP         
Sub-Investigator: Timothy Ives, PharmD,CPP,MPH         
Sub-Investigator: Maryam Jowza, MD         
Duke University Health System Not yet recruiting
Durham, North Carolina, United States, 27701
Contact: Jasmin Carmona, PhD, LMFT    919-668-0622    jasmin.carmona@duke.edu   
Principal Investigator: Li-Tzy Wu, RN, ScD, MA         
Sub-Investigator: Rowena Dolor, MD, MHS         
Sub-Investigator: Lynn Bowlby, MD         
United States, Tennessee
Vanderbilt University Health System Not yet recruiting
Nashville, Tennessee, United States, 27232
Contact: Claudia Davidson, MPH    615-936-4056    claudia.davidson@vanderbilt.edu   
Principal Investigator: Kristin A Swygert, PhD, DPT         
Sub-Investigator: Gurjeet Birdee, MD, MPH         
Sub-Investigator: Rogelio Coronado, PT, PhD         
Sponsors and Collaborators
RTI International
Patient-Centered Outcomes Research Institute
University of North Carolina Health Care System
Duke University Health System
Vanderbilt University Health System
Investigators
Principal Investigator: Lauren McCormack, PhD, MSPH RTI International

Publications:
Bernet AC; Willens DE; Bauer MS. Effectiveness -implementation hybrid designes: implications for quality improvement science. Implement Sci. 2013;8(Suppl 1):S2. doi: 10.1186/1748-5908-8-s!-s2.
Bandura A. Social learning theory. Englewood Cliffs, NJ: Prentice Hall; 1977
Bandura A.Social foundations of thought and action: A social cognitive theory: Prentice-Hall, Inc.; 1986
Agency Medical Directors' Group. Interagency guideline on opioid dosing for chronic non-cancer pain (CNP)::2010 update. 2010

Responsible Party: RTI International
ClinicalTrials.gov Identifier: NCT03454555     History of Changes
Other Study ID Numbers: PCORI-OPD-1610-37006
First Posted: March 6, 2018    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by RTI International:
Pragmatic Clinical Trial
Comparative Effectiveness Research
Analgesics, Opioid
Decision Making, Shared
Motivational Interviewing
Cognitive Therapy
Patient Reported Outcome Measures

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents