N/A N=376 Randomized Treatment

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

Chronic Pain

Bottom Line

View on ClinicalTrials.gov: NCT02290223 ↗

Enrolled (actual)

376

Serious AEs

11.2%

Results posted

Oct 2019

Primary outcome: Primary: Patient Activation — 65.8; 65.2; 67.3; 67.7 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Behavioral Based Treatment Model (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Kaiser Permanente
Primary completion: Sep 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Patient Activation	65.8; 65.2; 67.3; 67.7; 67.7; 66.6	—
SECONDARY Quality of Life: Physical Health	38.3; 38.2; 40.2; 39.9; 40.9; 39.0	—
SECONDARY Quality of Life: Mental Health	45.8; 45.1; 47.4; 46.9; 47.8; 46.2	—
SECONDARY Overall Health	2.7; 2.6; 2.8; 2.5; 2.7; 2.4	—
SECONDARY PHQ-9 Depression	6.7; 7.0; 5.6; 6.2; 5.5; 6.2	—
SECONDARY Satisfaction With Care	8.6; 8.6; 8.5; 8.6; 8.7; 8.5	—
SECONDARY Opioid Misuse SOAPP	48; 59; 28; 28; 25; 23	—
SECONDARY Opioid Misuse COMM	57; 68; 22; 25; 14; 22	—
SECONDARY Pain Coping	3.6; 3.7; 3.4; 3.6; 4.3; 3.9	—
SECONDARY Self-Efficacy	34.1; 35.7; 40.2; 39.6; 42.3; 40.0	—
SECONDARY Pain Intensity	6.7; 6.7; 5.9; 5.9; 5.8; 6.1	—
SECONDARY Function: Everyday Physical Activities	3.4; 3.3; 3.4; 3.4; 3.6; 3.3	—
SECONDARY Function: Social Activities and Roles	3.3; 3.1; 3.3; 3.3; 3.3; 3.1	—
SECONDARY Patient Provider Communication	4.3; 4.2; 4.2; 4.2; 4.3; 4.2	—
SECONDARY Patient Provider Interactions	43.4; 43.3; 44.9; 44.7; 45.6; 45.9	—
SECONDARY Health Care Utilization Service Visits (EHR)	2.9; 2.7; 1.2; 1.2; 2.9; 2.7	—
SECONDARY Health Care Utilization Portal Use (EHR)	168; 157; 164; 152; 160; 156	—
SECONDARY Use of Online Health and Wellness Resources (Self-reported)	47; 42; 68; 50; 76; 50	—
SECONDARY Attendance at Health Education Classes (Self-reported)	113; 108; 22; 20; 22; 18	—
SECONDARY Prescription Opioid Use (EHR)	35.8; 32.1; 30.4; 28.2; 28.0; 25.3	—
SECONDARY Pain Management Strategies- Mindfulness, Meditation and Relaxation	64; 50; 75; 45; 61; 34	—
SECONDARY Pain Management Strategies- Exercise, Stretching or Physical Therapy	108; 95; 120; 123; 127; 100	—
SECONDARY Goals for Opioid Use at Baseline	67; 76; 122; 111	—
SECONDARY Met Baseline Goals for Opioid Use at 6 and 12 Months	131; 132; 42; 49; 0; 0	—
SECONDARY Substance Use	23; 29; 53; 51; 160; 173	—
SECONDARY Alcohol Use	11; 10; 8; 9; 8; 8	—
SECONDARY Tobacco Use	26; 27; 17; 24; 15; 18	—

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?

Eligibility Criteria

Inclusion criteria

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

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
Patients who are already treated in pain clinic
Patients who are already treated in chemical dependency treatment
Patients who do not read and understand English
Patients planning to taper or stop taking prescription opioids in next 30 days

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02290223). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.