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

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ClinicalTrials.gov Identifier: NCT02290223
Recruitment Status : Active, not recruiting
First Posted : November 14, 2014
Last Update Posted : September 7, 2017
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Kaiser Permanente

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?

Condition or disease Intervention/treatment Phase
Chronic Pain Behavioral: Behavioral Based Treatment Model Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 377 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Patient Activation to Address Chronic Pain and Opioid Management in Primary Care
Study Start Date : June 2015
Actual Primary Completion Date : August 6, 2017
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: Patient Activation Group Intervention
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: 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
Usual care is determined by patients' individual providers, according to practice guidelines related to specific conditions.



Primary Outcome Measures :
  1. Patient Activation [ Time Frame: 6 and 12 months post randomization ]
    Patient Activation Measure (PAM) is a 13-item instrument for measuring patient beliefs, knowledge and confidence for engaging in a wide range of health behaviors. It has a 1-100 scale.


Secondary Outcome Measures :
  1. Satisfaction with care [ Time Frame: 6 and 12 months post randomization ]
    Using a scale of "0" to "10," where "0" is the worst possible care and "10" is the best possible care. Change will be measured between three time points, baseline, 6 and 12 months.

  2. Patterns of opioid use and long-term goals for opioid use [ Time Frame: 6 and 12 months post randomization ]
    Questions will be asked about frequency and patterns of opioid use, source and quality of pain, and pain management strategies. Patients will be asked their long-term goal for prescription opioid use among 4 categories: stay the same, increase, decrease, and stopping. Progress toward goals will be assessed at 6 and 12 month follow up.

  3. Opioid Misuse [ Time Frame: 6 and 12 months post randomization ]
    The Screener and Opioid Assessment for Patients in Pain (SOAPP) and Current Opioid Misuse Measure (COMM) are used to identify aberrant behaviors related to long-term opioid treatment.

  4. Pain coping [ Time Frame: 6 and 12 months post randomization ]
    Pain coping strategies and measures of functioning are assessed with the Chronic Pain Coping Inventory -42.

  5. Health Care Utilization [ Time Frame: 6 and 12 months post randomization ]
    Primary care services (number of non-urgent outpatient visits) and acute care services (number of emergency room (ER) visits and inpatient stays) within KPNC will be extracted from the EHR. Questions on services received outside KPNC will be included in the patient survey. Use of Kaiser's patient portal and health education programs will be extracted from EHR and assessed by self-report.

  6. Self-Efficacy [ Time Frame: 6 and 12 months post randomization ]
    Pain Self-Efficacy Questionnaire (PSEQ) is an established 10-item measure of pain self-efficacy that is widely used in clinical settings to assess confidence in one's ability to work and lead a normal life despite pain.

  7. Pain Severity and Functional Status. [ Time Frame: 6 and 12 months post randomization ]
    Measured with the Patient-Reported Outcome Measurement Information System 29-item Health Profile (PROMIS-29) instrument. PROMIS is a system of highly reliable, precise and easy to implement measures of patient-reported outcomes in physical and mental health and social well-being, which can be used as primary or secondary endpoints in clinical studies of treatment effectiveness. The single pain-intensity item will be used in raw form. We will also assess the respondent's satisfaction with his/her overall sex life using the PROMIS Global Satisfaction with Sex Life.

  8. Quality of Life [ Time Frame: 6 and 12 months post randomization ]
    Measured by the Patient Health Questionnaire-9 (PHQ-9), one of the most commonly used generic questionnaires to measure health-related quality of life, and the PROMIS Global Health Scale.

  9. Patient Provider Communication [ Time Frame: 6 and 12 months post randomization ]
    Measured by the Communication Assessment Tool (CAT), a 14-item instrument, the CAT asks respondents to rate different dimensions of the communication and interpersonal skills of their physician using a 5-point rating scale. The Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI) will also be used to measure patients' self-efficacy in obtaining medical information and attention to their medical concerns from physicians.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02290223


Locations
United States, California
Kaiser Permanente, San Jose Medical Center
San Jose, California, United States, 95119
Kaiser Permanente, Santa Clara Medical Center
Santa Clara, California, United States, 95051
Sponsors and Collaborators
Kaiser Permanente
Patient-Centered Outcomes Research Institute
Investigators
Principal Investigator: Cynthia I Campbell, PhD Kaiser Permanente

Publications of Results:
Other Publications:
Substance Abuse and Mental Health Services Administration, Office of Applied Studies. The DAWN Report: Trends in Emergency Department visits involving nonmedical use of narcotic pain relievers. Rockville, MD. June 18, 2010. http://www.samhsa.gov/data/2k10/DAWN016/OpioidED.htm. Accessed January 19, 2012.
Substance Abuse and Mental Health Services Administration. Table 1.1a. Admissions aged 12 and older, by primary substance of abuse: 1999-2009. Treatment Episode Dataset (TEDS) 1999-2009. National Admissions to Substance Abuse Treatment Services. 2010. http://www.samhsa.gov/data/DASIS/teds09/TEDS2k9NTbl1.1a.htm. Accessed January 19, 2014.
U. S. Food and Drug Administration. Questions and answers: FDA approves a Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release and Long-Acting (ER/LA) opioid analgesics. Drugs. 2012. http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm309742.htm. Updated March 1, 2013. Accessed January 17, 2014.
U. S. Food and Drug Administration. Background on opioid REMS. Drugs. 2012. http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm187975.htm. Updated April 22, 2013. Accessed January 17, 2014.
Putre L. Caring for health care's costliest patients: Aligning Forces for Equality & Robert Wood Johnson Foundation. 2014. http://www.rwjf.org/content/dam/farm/reports/issue_briefs/2014/rwjf409911. Accessed January 17, 2014
Brumder T, Wood SB. Strategies to improve linkages between primary care and substance abuse treatment. Treatment Research Center Conference on Clinical Innovations in Substance Abuse Treatment May 19, 2012; University of California San Francisco, CA
Weisner C, Parthasarathy S, Chi F, et al. Integrating alcohol and drug treatment with primary care: a medical home model. Treatment Research Center Conference on Clinical Innovations in Substance Abuse Treatment May 19, 2012; University of California San Francisco, CA
Office of the National Coordinator for Health Information Technology. Policymaking, regulation, & strategy. Meaningful use. HealthIT.gov. 2013. http://www.healthit.gov/policy-researchers-implementers/meaningful-use. Accessed January 19, 2014
Driessen E, Hollon S. Motivational interviewing from a cognitive behavioral perspective. Cogn Behav Pract. 2011;18:70-73
Miller WR, Rollnick S, eds. Motivational Interviewing : Preparing People for Change. 2nd ed. New York: Guildord Press; 2002
National Research Council. Health Literacy: A Prescription to End Confusion. Washington, DC: The National Academies Press; 2004. http://www.nap.edu/catalog.php?record_id=10883. Accessed January 19, 2014
Pain Survey Executive Summary. Massachusetts Pain Initiative. 2010. http://www.masspaininitiative.org/files/MassPI%20Pain%20Survey%20-%20Executive%20Summary%20v3.pdf. Updated August 15, 2013. Accessed January 18, 2014.
Cohen J. Statistical Power Analysis for the Behavioral Sciences. 2nd ed. Hillsdale, NJ: Lawrence Erlbaum Associates; 1988
PROMIS Network Center. PROMIS (Patient Reported Outcome Measurement Information System). USA.gov. http://www.nihpromis.org/?AspxAutoDetectCookieSupport=1#3. Accessed January 18, 2014

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT02290223     History of Changes
Other Study ID Numbers: CN-14-1928-H
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: September 7, 2017
Last Verified: September 2017

Keywords provided by Kaiser Permanente:
Chronic pain
Analgesics, Opioid
Cognitive Therapy
Behavior Therapy
Mindfulness
Psychophysiology
Biofeedback, Psychology

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents