Chronic Pain, Opioid Dependence
Conditions
Brief summary
This pilot study evaluates a collaborative care program to assist with opioid tapering in patients with chronic pain. Patients will be randomized to receive the intervention or usual care.
Interventions
BEHAVIORALTelecare Intervention
Patients will meet with a care coordinator to discuss current opioid use pattern and potential reduction strategies. Participants will fill out baseline measures. A 6 week positive psychology intervention will also be introduced in which patients will practice different techniques each week over 6 weeks, and will then practice incorporating a single technique into daily practice for the remaining 6 weeks. During the first 6 weeks, patients will have weekly check in meetings with a care manager to report on any withdrawal symptoms. These meetings will space to ever other week during the remaining 6 weeks. Possible treatment adjustments will be discussed between the care coordinator and primary investigator at weekly meetings. At the completion of the 12 week study, patients will complete outcome measures.
Sponsors
National Center for Advancing Translational Sciences (NCATS)
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Chronic pain for at least 6 months * Receiving daily opioid treatment
Exclusion criteria
* Not speaking English * Significant psychiatric impairment including severe cognitive impairment, suicidality, schizophrenia, or bipolar disorder * Known life expectancy of less than 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Dose Change | 12 weeks | Percentage change in daily opioid morphine milligram equivalent (MME) dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in PROMIS Pain Interference | 12 weeks | The Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.1 - Pain Interference 8a is an 8-item scale from the PROMIS item bank which assesses self-reported consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. Each item has a 5-point Likert response, with total scores ranging from 8 - 40, with higher numbers corresponding to worse pain interference outcomes. For this outcome, the score at baseline was subtracted from the score at 12 weeks to determine the change score, with negative change scores demonstrating symptom improvement (i.e. less pain interference). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Arm Patients will receive the telecare intervention.
Telecare Intervention: Patients will meet with a care coordinator to discuss current opioid use pattern and potential reduction strategies. Participants will fill out baseline measures. A 6 week positive psychology intervention will also be introduced in which patients will practice different techniques each week over 6 weeks, and will then practice incorporating a single technique into daily practice for the remaining 6 weeks. During the first 6 weeks, patients will have weekly check in meetings with a care manager to report on any withdrawal symptoms. These meetings will space to ever other week during the remaining 6 weeks. Possible treatment adjustments will be discussed between the care coordinator and primary investigator at weekly meetings. At the completion of the 12 week study, patients will complete outcome measures. | 2 |
| Usual Care Arm Patients will receive usual care. | 4 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 3 |
Baseline characteristics
| Characteristic | Intervention Arm | Usual Care Arm | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 3 Participants | 5 Participants |
| Age, Continuous | 49.0 years STANDARD_DEVIATION 12.7 | 61.0 years STANDARD_DEVIATION 6.8 | 57.0 years STANDARD_DEVIATION 9.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 3 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Opioid Dose | 35.0 Morphine Milligram Equivalents STANDARD_DEVIATION 35.4 | 27.5 Morphine Milligram Equivalents STANDARD_DEVIATION 21.8 | 30 Morphine Milligram Equivalents STANDARD_DEVIATION 23.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 2 Participants | 3 Participants | 5 Participants |
| Region of Enrollment United States | 2 Participants | 4 Participants | 6 Participants |
| Sex: Female, Male Female | 1 Participants | 4 Participants | 5 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 4 |
| other Total, other adverse events | 1 / 2 | 0 / 4 |
| serious Total, serious adverse events | 0 / 2 | 0 / 4 |
Outcome results
Primary
Opioid Dose Change
Percentage change in daily opioid morphine milligram equivalent (MME) dose
Time frame: 12 weeks
Population: Participants who completed the 12 week survey were included for analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Arm | Opioid Dose Change | 62.5 percentage of MME reduction |
| Usual Care Arm | Opioid Dose Change | 50 percentage of MME reduction |
Secondary
Change in PROMIS Pain Interference
The Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.1 - Pain Interference 8a is an 8-item scale from the PROMIS item bank which assesses self-reported consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. Each item has a 5-point Likert response, with total scores ranging from 8 - 40, with higher numbers corresponding to worse pain interference outcomes. For this outcome, the score at baseline was subtracted from the score at 12 weeks to determine the change score, with negative change scores demonstrating symptom improvement (i.e. less pain interference).
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Arm | Change in PROMIS Pain Interference | -0.25 scores on a scale |
| Usual Care Arm | Change in PROMIS Pain Interference | -0.63 scores on a scale |