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
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain||Behavioral: Behavioral Based Treatment Model||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||377 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|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|
|Principal Investigator:||Cynthia I Campbell, PhD||Kaiser Permanente|