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Comparative effectiveness of patient-centered strategies to improve pain management and opioid safety for veterans
Investigator (PI): Krebs, Erin
Performing Organization (PO): (Current): University of Minnesota, Medical School, Department of Medicine / (612) 625-3654
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2016
Final Year: 2023
Record Source/Award ID: PCORI/OPD-1511-33052
Funding: Total Award Amount: $12,147,779
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Background and significance: Treatment with opioid pain medications (e.g., hydrocodone and morphine) is common for severe pain, but studies show these medications may not always help reduce pain and can cause serious problems, especially when taken at high doses. To help patients with chronic pain have better quality of life and avoid medication toxicity, health care teams need to find ways to reduce opioid medication doses to safer levels while also helping patients manage their pain. Patients told us that to help bring down opioid pain medication doses, our focus should be on finding better pain care strategies first and dropping doses second, only if the patient is ready. Study aims: We will test which of two pain-treatment strategies is better for managing pain and helping patients reduce opioid medication doses. For patients on high opioid doses who want to reduce, we will also test whether offering an extra option for tapering down helps them succeed. Finally, we want to look at patients' and providers' experiences in the study, so that if these treatments work, we will know the best ways to implement them more broadly. Study description: We will compare two treatment strategies among patients with pain who are taking long-term opioid pain medications prescribed by Veterans Affairs health care 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; IPT uses a team approach, delivered by a physician, psychologist, and physical therapist. IPT uses medications but focuses most on nonmedication pain management options (e.g., exercise or talk therapies) to address not only the physical aspects of pain but also the emotional and social aspects. 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. Patients who do join the study are free to withdraw at any time. With either the TCM or IPT treatment strategy, participants will have individualized pain care tailored to their wants and needs. 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 a different medication. At the end of the study, we will compare which treatment strategy, TCM versus ITP, worked better to 1) decrease pain severity and 2) reduce opioid pain medication dose. We will also track other outcomes that are important to patients. These include overall quality of life, sleep, fatigue, depression, anxiety, and side effects. We will also test whether participants with certain conditions responded better to each strategy than others so we can learn how to best treat patients in an individualized way.
MeSH Terms:
  • Analgesics, Opioid /*therapeutic use
  • Anxiety /complications
  • Chronic Pain /drug therapy
  • Comparative Effectiveness Research
  • Depression /complications
  • Drug Administration Schedule
  • Fatigue /complications
  • Hospitals, Veterans
  • Humans
  • Hydrocodone /therapeutic use
  • Morphine /therapeutic use
  • Pain Management /*methods
  • * Patient Safety
  • Patient-Centered Care
  • Quality of Life
  • Sleep
  • United States
  • United States Department of Veterans Affairs
  • Veterans
Country: United States
State: Minnesota
Zip Code: 55455
UI: 20164146
CTgovId: NCT03026790
Project Status: Ongoing
Record History: ('2019: Project extended to 2023',)