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

NCT ID: NCT02290223

Last Updated: 2019-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 376 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2017-09-06

Brief 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?

Detailed 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.

Conditions

Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patient Activation Group Intervention

The experimental procedure is a behavioral based treatment model, plus usual care which is is determined by patients' individual providers, according to practice guidelines related to specific conditions.

Group Type: EXPERIMENTAL

Behavioral Based Treatment Model

Intervention Type: BEHAVIORAL

Behavioral based treatment consists of four 90 minute group sessions, one meeting per week. The sessions addressed: empowering patients to take an active role in pain management and overall health; pain management lifestyle practices; use of health information technology resources for active self-care; education on neurobiology of pain and opioids; and improving communication with providers.

Usual Care

Usual care is determined by patients' individual providers, according to practice guidelines related to specific conditions.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Behavioral Based Treatment Model

Behavioral based treatment consists of four 90 minute group sessions, one meeting per week. The sessions addressed: empowering patients to take an active role in pain management and overall health; pain management lifestyle practices; use of health information technology resources for active self-care; education on neurobiology of pain and opioids; and improving communication with providers.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cynthia I Campbell, PhD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

Kaiser Permanente, San Jose Medical Center

San Jose, California, United States

Kaiser Permanente, Santa Clara Medical Center

Santa Clara, California, United States

Countries

United States

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Mertens JR, Flisher AJ, Satre DD, Weisner CM. The role of medical conditions and primary care services in 5-year substance use outcomes among chemical dependency treatment patients. Drug Alcohol Depend. 2008 Nov 1;98(1-2):45-53. doi: 10.1016/j.drugalcdep.2008.04.007. Epub 2008 Jun 20.

Reference Type: BACKGROUND

PMID: 18571875 (View on PubMed)

Von Korff M, Saunders K, Thomas Ray G, Boudreau D, Campbell C, Merrill J, Sullivan MD, Rutter CM, Silverberg MJ, Banta-Green C, Weisner C. De facto long-term opioid therapy for noncancer pain. Clin J Pain. 2008 Jul-Aug;24(6):521-7. doi: 10.1097/AJP.0b013e318169d03b.

Reference Type: BACKGROUND

PMID: 18574361 (View on PubMed)

Bernabeo E, Holmboe ES. Patients, providers, and systems need to acquire a specific set of competencies to achieve truly patient-centered care. Health Aff (Millwood). 2013 Feb;32(2):250-8. doi: 10.1377/hlthaff.2012.1120.

Reference Type: RESULT

PMID: 23381517 (View on PubMed)

Does MB, Adams SR, Kline-Simon AH, Marino C, Charvat-Aguilar N, Weisner CM, Rubinstein AL, Ghadiali M, Cowan P, Young-Wolff KC, Campbell CI. A patient activation intervention in primary care for patients with chronic pain on long term opioid therapy: results from a randomized control trial. BMC Health Serv Res. 2024 Jan 22;24(1):112. doi: 10.1186/s12913-024-10558-3.

Reference Type: DERIVED

PMID: 38254073 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

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Document Type: Study Protocol

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Document Type: Statistical Analysis Plan

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Other Identifiers

CN-14-1928-H

Identifier Type: -

Identifier Source: org_study_id