Veterans' Pain Care Organizational Improvement Comparative Effectiveness Study
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Chronic Pain, Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 11/2/2017 |
| Start Date: | October 19, 2017 |
| End Date: | October 2020 |
Comparative Effectiveness of Patient-Centered Strategies to Improve Pain Management and Opioid Safety for Veterans
Background and significance: Treatment with opioid pain medications (like hydrocodone and
morphine) is common for severe pain, but studies show these medications may not always help
and can cause serious problems. High daily doses of opioids can be especially unsafe. To help
patients with chronic pain have better quality of life and avoid medication toxicity, health
care teams need to manage pain while helping patients reduce opioid medication doses to safer
levels.
morphine) is common for severe pain, but studies show these medications may not always help
and can cause serious problems. High daily doses of opioids can be especially unsafe. To help
patients with chronic pain have better quality of life and avoid medication toxicity, health
care teams need to manage pain while helping patients reduce opioid medication doses to safer
levels.
Study aims: This study will test which of two pain treatment strategies is better for
managing pain and helping patients improve safety of opioid medication. For patients on high
opioid doses who want to reduce, this study will also test whether offering an extra option
for tapering (buprenorphine-naloxone) helps them succeed. Finally, the study will examine
patients' and clinicians' experiences with the interventions.
Study description: The study will compare two treatment strategies among patients with pain
who are taking long-term opioid pain medications prescribed by VA healthcare facilities
across the country. Patients who wish to enter the study will be assigned by chance to
telecare collaborative management (TCM) or integrated pain team (IPT). TCM involves a
pharmacist and supervising physician working together to find the best medication options for
each individual patient. In IPT, a team of clinicians focuses on non-medication pain
management options, in addition to pain medication.
All participants will be asked to stay in the study for 12 months. Patients for whom it would
be unsafe to participate will not be invited to join. With either treatment strategy, TCM or
IPT, participants will have individualized pain care tailored to their needs and preferences.
Participants on high opioid medication doses who want to reduce their opioid medication dose
will be assigned by chance to get either a regular step-wise taper or a choice between a
regular taper or switching to a different medication (buprenorphine-naloxone).
At the end of the study, the two treatment strategies will be compared to see which worked
better to (1) decrease pain severity and (2) reduce opioid medication dose. Other outcomes
important to patients will also be tracked. These include quality of life, sleep, fatigue,
depression, anxiety, and side effects.
managing pain and helping patients improve safety of opioid medication. For patients on high
opioid doses who want to reduce, this study will also test whether offering an extra option
for tapering (buprenorphine-naloxone) helps them succeed. Finally, the study will examine
patients' and clinicians' experiences with the interventions.
Study description: The study will compare two treatment strategies among patients with pain
who are taking long-term opioid pain medications prescribed by VA healthcare facilities
across the country. Patients who wish to enter the study will be assigned by chance to
telecare collaborative management (TCM) or integrated pain team (IPT). TCM involves a
pharmacist and supervising physician working together to find the best medication options for
each individual patient. In IPT, a team of clinicians focuses on non-medication pain
management options, in addition to pain medication.
All participants will be asked to stay in the study for 12 months. Patients for whom it would
be unsafe to participate will not be invited to join. With either treatment strategy, TCM or
IPT, participants will have individualized pain care tailored to their needs and preferences.
Participants on high opioid medication doses who want to reduce their opioid medication dose
will be assigned by chance to get either a regular step-wise taper or a choice between a
regular taper or switching to a different medication (buprenorphine-naloxone).
At the end of the study, the two treatment strategies will be compared to see which worked
better to (1) decrease pain severity and (2) reduce opioid medication dose. Other outcomes
important to patients will also be tracked. These include quality of life, sleep, fatigue,
depression, anxiety, and side effects.
Inclusion Criteria:
- Moderate or high-dose long-term opioid therapy (≥ 50 ME mg daily for at least 3
months) for chronic pain
- Chronic pain of at least moderate severity (defined as pain that is present every or
nearly every day for ≥ 6 months and with a score on the PEG 3-item pain measure of ≥
5)
Exclusion Criteria:
- Dementia diagnosis or moderate-severe cognitive impairment, defined as ≥2 errors on
six-item cognitive screener
- Unstable or severe untreated psychiatric disorder, including severe untreated
substance use disorder or active suicidal ideation
- Unstable or end-stage medical disease that would interfere with participation,
including cancer requiring active treatment and life expectancy < 12 months
- Documentation of suspected controlled substance diversion
- Inability to communicate by telephone
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