Brief Summary
This study proposes to pilot test an intervention to facilitate opioid pain reliever (OPR) tapering in primary care. The intervention will incorporate a clinician embedded within primary care to follow tapering dose schedules to support providers as well to deliver a psychosocial curriculum to support and engage patients. In a pilot randomized controlled trial (RCT), the study will examine the preliminary efficacy and feasibility of the manualized, protocol-based tapering intervention ("TapPro") compared to usual care. As there is no standard definition or outcome for tapering, the primary efficacy outcome is a decrease in OPR dose over six months. Separately, the study proposes a clinically meaningful dose reduction (greater than or equal to 30 percent) as a secondary outcome. The central hypotheses' are that a tapering intervention with patient and provider support is feasible in a primary care setting and can result in greater dose reduction when compared to usual care.
Brief Title
Developing and Pilot Testing an Opioid Tapering Protocol
Detailed Description
In a 12-week randomized controlled trial based in a primary care outpatient clinic, the study will recruit 60 patients on moderate to high dose chronic opioid therapy for whom providers recommend opioid tapering and randomize 1:1 to an opioid tapering protocolized intervention (TapPro) or to usual care. Over three months, participants in the TapPro arm will visit with a clinician on the telephone on a biweekly basis in order to facilitate opioid prescribing and tapering and a pain self-care and coping curriculum. In the control arm, participants will see their primary care providers as per usual and decisions on opioid prescribing and tapering will be made by the primary care providers. Participants will be assessed throughout the study with questionnaires, urine drug screens, prescription database review, and medical record review.
Completion Date
Completion Date Type
Actual
Conditions
Chronic Pain
Opioid Use
Analgesia
Eligibility Criteria
Inclusion Criteria:
1. age ≥ 18
2. chronic prescription opioid use (\>3 monthly prescriptions from the clinic within prior 6 months)
3. morphine milligram equivalents (MME) ≥50
4. poorly controlled pain (PEG pain score ≥ 5/10)
5. providers considering opioid taper but no reductions in opioid dose over the past 6 months.
Exclusion Criteria:
1. Active cancer or other serious progressive illness, by medical review and by self-report
2. Moderate or severe opioid use disorder, as per DSM-V
3. Inability to give informed consent
4. Active suicidal ideation.
1. age ≥ 18
2. chronic prescription opioid use (\>3 monthly prescriptions from the clinic within prior 6 months)
3. morphine milligram equivalents (MME) ≥50
4. poorly controlled pain (PEG pain score ≥ 5/10)
5. providers considering opioid taper but no reductions in opioid dose over the past 6 months.
Exclusion Criteria:
1. Active cancer or other serious progressive illness, by medical review and by self-report
2. Moderate or severe opioid use disorder, as per DSM-V
3. Inability to give informed consent
4. Active suicidal ideation.
Inclusion Criteria
Inclusion Criteria:
1. age ≥ 18
2. chronic prescription opioid use (\>3 monthly prescriptions from the clinic within prior 6 months)
3. morphine milligram equivalents (MME) ≥50
4. poorly controlled pain (PEG pain score ≥ 5/10)
5. providers considering opioid taper but no reductions in opioid dose over the past 6 months.
1. age ≥ 18
2. chronic prescription opioid use (\>3 monthly prescriptions from the clinic within prior 6 months)
3. morphine milligram equivalents (MME) ≥50
4. poorly controlled pain (PEG pain score ≥ 5/10)
5. providers considering opioid taper but no reductions in opioid dose over the past 6 months.
Gender
All
Gender Based
false
Keywords
opioid
tapering
chronic pain
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04257695
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2019-10910
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Developing and Pilot Testing an Intervention to Increase Opioid Tapering in Primary Care
Primary Outcomes
Outcome Description
Repeated measure analysis of opioid dosage over six months
Outcome Measure
Change in opioid dose over six months
Outcome Time Frame
Up to six months
Secondary Ids
Secondary Id
K23DA044327
Secondary Outcomes
Outcome Description
Dichotomous outcome assessing whether participant reached a thirty percent or greater opioid dose reduction
Outcome Time Frame
Up to six months
Outcome Measure
Opioid dose reduction
Outcome Description
Repeated measure analysis of pain severity, as per the PEG pain screening tool. The PEG is a 3 item scale that assesses pain intensity and interference on a 0 to 10 scale where 0 equals "no pain" and 10 is "pain as bad as you can imagine"
Outcome Time Frame
Up to six months
Outcome Measure
Patient reported pain score
Outcome Description
Repeated measures analysis of pain interference, as per the Brief Pain Inventory (BPI) pain interference subscale. The BPI pain interference subscale is scored as the mean of 7 interference items, scored from 0 (does not interfere) to 10 (completely interferes).
Outcome Time Frame
Up to six months
Outcome Measure
Pain interference
Outcome Description
Repeated measures analysis of pain related self-efficacy, as per the Pain Self-Efficacy Scale. The Pain Self-Efficacy scale consists of 10 questions that assess a patient's confidence in performing tasks in spite of pain. It is scored from 0 (not at all confident) to 6 (completely confident). Higher scores are better.
Outcome Time Frame
Up to six months
Outcome Measure
Pain related self-efficacy
Outcome Description
Repeated measures analysis of two different quality of life scores, as per the EQ-5D and the Assessment of Quality of Life 8-item scale (AQoL-8D). The EQ-5D measures quality of life in 5 different domains in 5 questions. The AQoL-8D measures quality of life in 8 different domains in 35 questions. Higher scores denote greater quality of life.
Outcome Time Frame
Up to six months
Outcome Measure
Change in Quality of life score
Outcome Description
Repeated measures analysis of depression scores, as per the Center for Epidemiologic Studies Depression Scale (CES-D). This is a 20 item questionnaire that assesses the frequency of several depressive symptoms, rated from 0 (rarely or none of the time) to 3 (most or all of the time). Lower scores mean fewer depressive symptoms.
Outcome Time Frame
Up to six months
Outcome Measure
Depressive symptoms
Outcome Description
Repeated measures analysis of anxiety scores, as per the Brief symptom anxiety subscale. This is a 40 item questionnaire that assesses the frequency of symptoms of anxiety. It is scored from 1 (almost never) to 4 (almost always). Lower scores mean less anxiety.
Outcome Time Frame
Up to six months
Outcome Measure
Anxiety symptoms
Outcome Description
Repeated measures analysis of the Pain Catastrophizing Scale. This is a 13 item scale scored from 0 (not at all) to 4 (all the time) about symptoms associated with pain catastrophizing. Lower scores denote less pain catastrophizing.
Outcome Time Frame
Up to six months
Outcome Measure
Pain catastrophizing
Outcome Description
Repeated measures analysis of sleep quality, as per the Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-ME) Sleep Impact Short Form. This is a 5 item survey of sleep symptoms, scored from 1 (always) to 5 (never), with higher scores meaning more problems with sleep.
Outcome Time Frame
Up to six months
Outcome Measure
Sleep quality
Outcome Description
Repeated measures analysis of opioid misuse, as per the Current Opioid Misuse Measure (COMM) score. It is a 17 item survey, rated from 0 (never) to 4 (very often), assessing behaviors associated with opioid misuse. Higher scores are associated with greater opioid misuse.
Outcome Time Frame
Up to six months
Outcome Measure
Opioid Misuse
Outcome Description
Change in Opioid Knowledge score, as per the Survey for Pain Attitudes, Knowledge, and Beliefs (SOPA+KB). This is an 18 question survey that assesses agreement with several pain statements, rated from 1 (do not agree) to 4 (completely agree). Higher scores denote better knowledge.
Outcome Time Frame
Up to six months
Outcome Measure
Opioid Knowledge
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Hector Perez
Investigator Email
heperez@montefiore.org