Overview

This trial is active, not recruiting.

Condition chronic pain
Treatment behavioral based treatment model
Sponsor Kaiser Permanente
Collaborator Patient-Centered Outcomes Research Institute
Start date June 2015
End date August 2017
Trial size 377 participants
Trial identifier NCT02290223, CN-14-1928-H

Summary

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?

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week plus usual care which is is determined by patients' individual providers, according to practice guidelines related to specific conditions.
behavioral based treatment model
The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week.
(No Intervention)
Usual care is determined by patients' individual providers, according to practice guidelines related to specific conditions.

Primary Outcomes

Measure
Patient Activation
time frame: 6 and 12 months post randomization

Secondary Outcomes

Measure
Satisfaction with care
time frame: 6 and 12 months post randomization
Patterns of opioid use and long-term goals for opioid use
time frame: 6 and 12 months post randomization
Opioid Misuse
time frame: 6 and 12 months post randomization
Pain coping
time frame: 6 and 12 months post randomization
Health Care Utilization
time frame: 6 and 12 months post randomization
Self-Efficacy
time frame: 6 and 12 months post randomization
Pain Severity and Functional Status.
time frame: 6 and 12 months post randomization
Quality of Life
time frame: 6 and 12 months post randomization
Patient Provider Communication
time frame: 6 and 12 months post randomization

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Patient Activation to Address Chronic Pain and Opioid Management in Primary Care
Principal investigator Cynthia I Campbell, PhD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Kaiser Permanente.