N/A
N=850
Pain Program for Active Coping & Training
Chronic Non-malignant Pain
Bottom Line
View on ClinicalTrials.gov: NCT02113592 ↗Enrolled (actual)
850
Serious AEs
24.2%
Results posted
May 2022
Primary outcome: Primary: Pain Impact Assessed Using the 4-Item Version of Brief Pain Inventory-Short Form ("PEGS") — 6.485; 6.645; 5.486; 6.210 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Interdisciplinary pain program (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kaiser Permanente
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Impact Assessed Using the 4-Item Version of Brief Pain Inventory-Short Form ("PEGS") |
6.485; 6.645; 5.486; 6.210; 5.516; 6.197 | — |
| SECONDARY Pain-related Disability |
0.672; 0.692; 0.612; 0.675; 0.609; 0.678 | — |
| SECONDARY Average Daily Dose of Opioids |
47.458; 55.252; 46.641; 56.695; 45.606; 55.563 | — |
| SECONDARY Patient Satisfaction |
4.263; 4.237; 4.240; 3.984; 3.658; 3.581 | — |
| SECONDARY Health Care Costs |
21,372; 25,648; 9,395; 11,343 | — |
| SECONDARY Count of Health Care Encounters by Type (Health Care Utilization) |
20.85; 21.59; 10.42; 10.11; 24.04; 23.18 | — |
| SECONDARY Inpatient Hospital Days (Health Care Utilization) |
0.86; 0.22 | — |
| SECONDARY Total Pharmacy Dispenses (Health Care Utilization) |
50.45; 52.22 | — |
Summary
The overall aim of this study is to adopt an integrative rehabilitation approach for helping patients adopt self-management skills for managing chronic pain, limiting use of opioid medications, and identifying exacerbating factors amenable to treatment (e.g., depression, sleep problems) that is feasible and sustainable within the primary care setting.
Eligibility Criteria
Patient inclusion criteria are:
- Adult (18 years of age or older) Kaiser Permanente (KP) health plan members from the KP Northwest, KP Georgia, and KP Hawaii regions who receive their primary care services from participating primary care providers
- Kaiser Permanente health plan membership of at least 180 days duration
- Long term opioid use defined by: 90+ day supply of short acting opioid spanning at least 120 days or 2 or more long acting opioid dispense in the past 180 days
- Pain diagnosis within the past year (based on ICD-9 or ICD-10 diagnostic codes)
- English speaking
Patient exclusion criteria are:
- Currently enrolled in intensive addiction medicine services or evidence of active substance dependence
- Cognitive impairment severe enough to preclude patient's participation in a behavioral/lifestyle change program
- Current malignant cancer diagnosis
- Having received hospice or other end-of-life palliative care within past year
Data sourced from ClinicalTrials.gov (NCT02113592). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.