Patient Activation to Address Chronic Pain and Opioid Management in Primary Care



Status:Recruiting
Conditions:Chronic Pain, Chronic Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - Any
Updated:4/27/2016
Start Date:June 2015
End Date:October 2017
Contact:Monique Does, MPH
Email:monique.does@kp.org
Phone:510-891-3612

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Will a primary care-based behavioral intervention for patient activation and engagement and
self-management, for patients with chronic pain who are taking opioid pain medication,
result in better patient outcomes than Usual Care?

Patients with chronic pain (PWCP) typically have multiple chronic conditions, and many
points of contact with the health system. They can feel disempowered, and experience
fragmented care and poor outcomes. PWCP report concerns about under-treatment of pain,
difficulties in obtaining medication, and stigma. Prescription opioids are a very common,
and controversial, pain treatment. PWCP often lack the skills and knowledge to talk to their
physicians about their pain and opioid use, and to navigate the health care system. The
study's aims compare the effectiveness of an innovative behavioral Patient Activation plus
Usual Care (PA+UC) intervention to Usual Care (UC) only on patient-centered outcomes among
PWCP. While most studies have focused on chronic opioid users, this takes an upstream
approach, focusing on patients as they start regular opioid use. The overarching research
question is: Can patients' increased activation improve their quality of life? With our
stakeholder group of patient, clinical, and operational advisors, we propose a pragmatic,
randomized trial to examine the comparative effectiveness of a group-based PA intervention
in two large primary care clinics in Kaiser Permanente Northern California (KPNC). We will
randomize 324 PWCP to either the PA+UC arm or UC only arm. The curriculum will cover patient
activation and empowerment, how to talk to doctors about prescription opioid use, and
self-management of chronic pain, including how to navigate the health care system and a
patient portal. We will further develop the study questions, intervention curriculum,
outcome measures, and dissemination plan with our stakeholder groups. We will examine
effects over 12 months using follow-up patient interviews combined with electronic health
records and a mixed effects modeling approach. Patient outcomes include patient-reported
activation, quality of life, prescription opioid use, pain severity and function,
patient-provider communication, patient satisfaction, knowledge of opioid use risks and
benefits, self-care, including use of health information technology, and service
utilization.

Inclusion criteria:

1. Patients aged 18+ who receive primary care at the Kaiser Permanente Santa Clara or
San Jose Medical Center study clinic

2. Patients who have been using prescription opioids for pain at least three days per
week over the past three months.47,48,60

Exclusion criteria:

1. Patients who have any other more serious comorbidity than their pain (e.g., terminal
illness, active cancer, high risk for/currently with uncontrolled addictions or
severe mental health issues such as psychosis), or impairing ability to engage with
interventions

2. Patients who are already treated in pain clinic

3. Patients who are already treated in chemical dependency treatment

4. Patients who do not read and understand English

5. Patients planning to taper or stop taking prescription opioids in next 30 days
We found this trial at
2
sites
San Jose, California 95119
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Santa Clara, California 95051
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