Patient Activation to Address Chronic Pain and Opioid Management in Primary Care
Phase: NA
Conditions: Chronic Pain
Sponsor: Kaiser Permanente

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Prescription Opioid Management in Chronic Pain Patients:  
A Patient-Centered Activation Intervention 
 
PI: Cynthia Campbell, PhD 
PCORI Contract: IHS-1310-08734 
Clinical Trials.gov Protocol ID: NCT02290223 
Last updated: January 16, 2018 
ABSTRACT 
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 compared 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.  With our stakeholder group of patient, clinical, and operational advisors, we conducted a 
pragmatic, randomized trial to examine the effectiveness of a group-based PA intervention in two large 
primary care clinics in an integrated health system. We randomized 376 PWCP to either the PA+UC arm 
or UC only arm. The curriculum covers 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 online patient portal.  We developed the study questions, intervention 
curriculum, outcome measures, and dissemination plan with our stakeholder groups. We examined 
effects over 12 months using follow-up patient interviews combined with electronic health records 
(EHR) and a mixed effects modeling approach. Patient outcomes included patient-reported activation, 
quality of life, prescription opioid use, pain severity and function, patient-provider communication, 
patient satisfaction, self-care, including use of health information technology, and service utilization. 
RESEARCH QUESTION 
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? 
AIMS 
Aim 1: Refine and finalize a patient-driven intervention curriculum and patient-centered outcomes, 
developed with a stakeholder group. 

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Aim 2: Compare the effectiveness of Patient Activation + Usual Care (PA+UC) versus Usual Care (UC) on 
patient-centered outcomes.  
Will patients in the PA+UC arm:  
a. Have greater improvement in patient activation, patient satisfaction, pain and function 
scores, quality of life and provider communication over time? 
b. Be more likely to engage in self-management strategies? 
c. Be more likely to actively use primary care, and decrease use of acute care services? 
Aim 3: To compare the effectiveness of PA+UC versus UC on prescription opioid use. Will patients in the 
PA+UC arm be more likely to reach their goal for prescription opioid use and/or decrease their use over 
time? 
SIGNIFICANCE 
Chronic non-cancer pain is widespread and debilitating, often involving multiple chronic health 
conditions, and is a burden on patients, their families, and health systems. The Institute of Medicine’s 
2011 report, “Relieving Pain in America” estimated that roughly 100 million adult Americans suffer from 
chronic pain, a number which only stands to increase due to an aging population and increasing chronic 
disease. It is one of the most common complaints presenting in primary care, and costs the U.S. 
between $560-635 billion annually in health care and lost productivity. We focused on chronic non-
cancer pain, since clinical considerations differ for individuals with a terminal condition. 
Patients with chronic pain (PWCP) can have considerable work and social disability, compromised 
quality of life, loss of function, and isolation from family and friends. PWCP suffer from social stigma as 
well, and frequently from depression. The impact on patients’ family members and community is also 
considerable, as we learned in our prior surveys and recent qualitative work with PWCP.  
Prescription opioids are the most common medication used to treat pain, and their use has increased 
dramatically in recent years. However, long-term use, or chronic opioid therapy (COT), remains 
controversial; and evidence supporting COT for long-term pain and functional outcomes is mixed. There 
is considerable evidence and concern over associated harms. Increases in adverse events such as opioid 
abuse, falls, overdose and deaths associated with COT has led to what has been called a prescription 
opioid epidemic. The overdose rate in 2008 was nearly four times the rate in 1999, with 14,800 
prescription opioid overdose deaths.  Hospitalizations for prescription opioid poisoning doubled from 
1999 to 2006. From 2004 to 2009, emergency room visits involving prescription opioids nearly doubled. 
From 1999 to 2009, drug abuse treatment admissions rates for non-heroin opiates grew over 400%. In 
2010, 11.1% of persons age 18-25 used prescription opioids non-medically, and 1.4% were prescription 
opioid dependent. Patients may be unaware of long-term risks. 
Federal agencies and health systems are responding to the increased rates of mortality and overdose 
with new initiatives related to opioid prescribing. The Food and Drug Administration (FDA) has issued 
Risk Evaluation and Mitigation Strategies (REMS) for training and education materials for prescribers of 

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long-acting opioids, and for manufacturers to obtain new drug approvals. Hydrocodone (e.g. Vicodin) 
has recently been reclassified as a Schedule II medication, and the FDA recently ordered new patient 
information labels on prescription bottles. Health systems have also initiated programs to reduce opioid 
prescribing, and dosages. For example, Group Health Cooperative (now Kaiser Permanente Washington) 
implemented an initiative to standardize prescribing practices and lower dosages to reduce risks 
associated with opioid use. It was a multi-faceted, primary care approach, designed with input from a 
variety of departments including “leaders in primary care, physical and rehabilitation medicine, clinical 
improvement, pharmacy, legal affairs, and other relevant departments to define new care processes 
that could be implemented”. Although ultimately intended to improve patient safety, it is not clear how 
patient-centered these types of initiatives are.  
There is a unique tension in the experience of patients and providers with prescription opioids. 
Providers are reluctant to prescribe them because they are concerned both about scrutiny of their 
prescribing practices, about patients abusing them and other adverse events, and also feel frustration 
with this population. PWCP are often viewed as among the most difficult patients, because clinicians 
often feel they do not know how to help them. Patients, on the other hand, often have poor pain 
control, are afraid of losing access to their medication, and can find it difficult to talk with their provider. 
They do not want to be seen as the “difficult patient.” They often experience stigma from using 
prescription opioids, and feel they are treated with mistrust. They also may not feel “heard” by their 
physicians, and feel they are just being prescribed a pill. It is often easy to lose sight of the fact that 
patients and providers have the same goal: to reduce pain, and improve the functioning and quality of 
life of the patient.  
Whom to talk with and how to get care is confusing for patients, particularly those with chronic illness.  
If they have more than one provider, they may not know which one is appropriate. In a pilot study of 
complex patients with multiple conditions, we found that those with pain frequently seek care at the 
emergency room. Health information technology (IT) can make it easier to communicate with and 
navigate the health system, but we have found pain patients often have not taken advantage of these 
resources, (e.g., not registering to email their physician).  As part of Centers for Medicare and Medicaid 
Services (CMS) Stage 2 “meaningful use criteria”, web-based patient portals will be available to most 
health plans and federally qualified health centers (FQHC), but patients may need help to engage in use 
of these tools. 
METHODS 
This was a randomized clinical trial in Adult Medicine, which compared a behavioral patient activation 
and pain self-management intervention to usual care for chronic pain patients using opioid pain 
medication. 
Study Site and Patients. The study was located at the Santa Clara and San Jose Medical Centers of Kaiser 
Permanente Northern California, and led by a research team from the Kaiser Permanente Northern 
California Division of Research.  The team included strong clinical research partnerships with the Chiefs 

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of Medicine at each site, Dr. Sheryl Sun at Santa Clara and Dr. Michael Matsumoto at San Jose. The study 
sites were large primary care medical centers reflecting the diversity of the service area.  
Study Design. The design was a pragmatic, randomized controlled trial with the patient as the unit of 
randomization. Eligible patients were those who used prescription opioids for a minimum of 3 days a 
week for the past 3+ months. We compared patient reported outcomes (see below) as well as health 
services use and prescription opioid use for those in the intervention arm to those who received usual 
care only (comparator group). We choose “usual care only” as the comparator group to best inform the 
intervention’s potential to enhance current practice. Usual care was determined by patients’ individual 
providers, according to practice guidelines related to specific conditions. 
Data Sources. Patient-centered outcomes are reported from patient survey data at baseline, 6 and 12 
months post recruitment. Pain is an individual experience, affected by individual factors, and patients 
and providers often have different definitions of treatment success. We assessed multiple domains to 
capture the patient experience. The EHR was the data source for patient clinical characteristics, patient 
portal use, prescription opioid use, and health services utilization.  
Primary Outcome Measures 
Patient Activation. Measured by Patient Activation Measure (PAM), a 13-item instrument for measuring 
patient beliefs, knowledge and confidence for engaging in a wide range of health behaviors.  
Self-Efficacy. The 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. 
Quality of Life. Measured by two dimensions of the PROMIS Global Health Scale- Physical Health and 
Mental Health.  
Depression. Measured by the Patient Health Questionnaire-9 (PHQ-9), one of the most commonly used 
validated screening tools used to measure depression severity.  
Pain Coping. Pain coping strategies and measures of functioning were assessed with the Chronic Pain 
Coping Inventory -42.  
Pain Severity and Functional Status. 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 is used in raw form. We also assessed the 
respondent’s satisfaction with his/her overall sex life using the PROMIS Global Satisfaction with Sex Life.  
In addition, the survey asks questions about source and quality of pain (not part of the PROMIS-29). 

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Patient Satisfaction. Measured by patients' overall satisfaction with their overall health care, and their 
primary care doctor on a scale of "0" to "10," where "0" is the worst possible care and "10" is the best 
possible care. 
Patient Provider Communication. 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) was used to measure patients' self-efficacy in obtaining 
medical information and attention to their medical concerns from physicians. 
Prescription Opioid Use. Pharmacy data on opioid dispensations were extracted and summarized from 
the EHR. We asked about patients’ long-term goals for prescription opioid use among 4 categories: stay 
the same, increase, decrease, and stopping. Progress toward goals was assessed at 6 and 12 month 
follow-ups. 
Pain Management. The survey asks questions about non-pharmaceutical pain management strategies.  
Opioid Misuse. The Screener and Opioid Assessment for Patients in Pain (SOAPP) and Current Opioid 
Misuse Measure (COMM) were used to identify aberrant behaviors related to long-term opioid 
treatment. 
Other (non-opioid) Substance Use. Drug, alcohol and tobacco use were collected from patient survey 
data.  
Health Care Utilization and Engagement. Primary care services (number of non-urgent outpatient visits) 
and acute care services (number of emergency room visits and inpatient stays) within KPNC were 
extracted from the EHR. Questions on services received outside KPNC were included in the patient 
survey. Use of Kaiser’s patient portal and health education programs were extracted from EHR and 
assessed by self-report. 
Patient Activation Group Intervention Sessions Curriculum. The intervention consists of 4 group 
sessions, one meeting per week, led by a licensed psychologist trained in pain management.  
Session 1: “Taking a Leading Role”. This session focused on empowering patients to take a leading role in 
their pain management and overall healthcare. It provides patients with information about how pain 
manifests in the brain and the body via the Gate Control Theory of Pain, the long-term risks and side 
effects of prescription opioid use and how neuroplasticity can cause pain to become chronic in nature 
and render pain medications less effective, ineffective, or possibly even harmful over time. Patients 
were introduced to why mind, body, and behavioral methods of pain control are part of a 
comprehensive pain management package.  
Session 2:  “Lifestyle and Balance”. This session discussed importance of healthy behaviors (e.g. exercise, 
sleep, caffeine, nutrition, alcohol, tobacco, and emotional health), and how they are related to chronic 
pain. This session provided interactive education on the stress response of the autonomic nervous 
system and how pain activates the stress response, thereby providing rationale for why learning how to 

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reduce sympathetic nervous system activity is crucial for a comprehensive pain management package. 
Patients had an opportunity to learn and practice several new pain management skills.   
Session 3: “Navigating the health care system”. This session’s goal was to meet patients’ individual 
needs via active use of the KP online portal via smart phones or computers. The session included hands-
on practice navigating kp.org, exploring Kaiser’s healthy lifestyle resources, as well as resources outside 
of KP. 
Session 4: “Partnership and Prevention”. The last session focused on increasing patients’ confidence in 
discussing pain and self-management strategies with their primary care team, with a focus on assertive 
communication strategies. 
SAMPLE SIZE  
To power our main patient outcomes, we planned to recruit 324 patients. With a conservative sample 
retention rate of 80%, we estimated a final sample size of approximately 260 patients at the 12 month 
follow-up, which would provide power of .80 or higher for the proposed analyses.  We surpassed our 
enrollment goal and our final sample size was 376. With a 90% retention rate, our final sample size of 
patients at the 12 month follow up was 342, allowing sufficient sample to power to test all research 
hypotheses.  
We illustrate power calculations for hypothesis testing based on our original proposed estimates, using 
worst case scenarios for each type of model used in the research aims, and assuming a Type 1 error rate 
of α=.05.  As an example of a continuous outcome, we consider the difference in activation scores 
between the Patient Activation (PA) + Usual Care (UC) and UC only groups. The cross-sectional analyses 
modeled by multivariate regression analyses will have a power of .80 to detect a conventionally small 
effect size of 0.07 with 12 independent covariates including the treatment group indicator, with a 
sample size of 260. We then examine the longitudinal analyses modeled by linear mixed-effects models. 
Assuming the worst case scenario of a correlation between the three repeated measures (baseline, 6 
and 12 month questionnaires) to be 0.3 (analyses of prior studies indicate correlations of < 0.3), the 
power to detect a 24% difference in standard deviation units will be .80 with a sample size of 230. As an 
example of power calculation for a binary response, we present statistical power for the likelihood of 
portal use between the PA+UC and UC groups. We will first examine the cross-sectional analyses 
modeled by multivariate logistic regression models. Based on results from an internally funded pilot 
study of complex patients, we expect an overall rate of portal use of 61%. The test of significance for an 
odds ratio of 2.5 for the coefficient of the indicator variable for treatment group (=1 if PA+UC, 0=UC), 
will have a power of .80 with a sample size of 166. In longitudinal analyses modeled by mixed-effects 
logistic models, using 3 repeated measures, for a  worst case correlation of 30% between successive 
measurements, we will be able to detect a 12% difference between the PA+UC and UC groups with a 
power of .80 and sample size of 126 patients in each arm (n=252). Given that our final sample size 
exceeded our original estimate, we have adequate power to examine main study questions. 
CONFIDENTIALITY 

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In accordance with long-standing policy, all data collected as part of this study is being held in strict 
confidence. Only study staff has access to the data collected as part of the study, and all employees who 
come in contact with these records sign an agreement to maintain confidentiality.  All study participant 
materials are stored electronically on a password protected, secure Kaiser Permanente Division of 
Research server.  A Certificate of Confidentiality from NIH was obtained for the study. 
All names are removed from research records; no identifying information is used in any report or 
publication that is produced from this study. Data will only be presented in the aggregate.  
PARTICIPATION RECRUITMENT 
Inclusion and Exclusion Criteria. Our target population was all eligible adult primary care patients 
receiving care at the Santa Clara or San Jose Medical Centers, who were regularly taking prescription 
opioids at time of enrollment.  
Inclusion criteria. (1) adult patients aged 18+ who received primary care at one of the study clinics and 
used prescription opioids for pain at least three days per week over the previous three months.  
Exclusion criteria. Potential participants were excluded if they: (1) had any serious comorbidity other 
than their pain (e.g., terminal illness, active cancer, severe mental health issues such as psychosis), or 
any condition that would impair their ability to engage with the intervention; (2) were currently being 
treated in a pain clinic; (3) were in chemical dependency treatment; (4) had stopped or were planning to 
stop taking opioids before the intervention started; (5) had a relative or close friend participating in the 
study; or (6) did not read or understand English.  
Recruitment. We used a multi-method approach to recruitment found to be very successful in previous 
studies.  It included the following methods of making potential participants aware of the opportunity to 
participate in the study:  
Identification via EHR. We identified potentially eligible patients through the EHR. With the approval of 
the patients' primary care physician, we sent eligible patients an IRB-approved recruitment letter with 
an invitation to participate.  After 10 days, the research staff telephoned patients to determine if they 
were interested in participating in the study. Using an IRB-approved telephone screening script. the 
research staff screened and recruited eligible patients based on the study inclusion criteria. 
 
KPNC clinician referral. Providers received instruction regarding the study and identification of eligible 
patients, as well as a referral script. Providers explained the study to potentially eligible patients, and 
provided a flyer to the patients so that they could contact study staff if interested.  
Patients who were interested in the study, but not yet willing or interested in being contacted directly, 
were given a “Participant Information Sheet”, which contained contact information for the Principal 
Investigator and research staff. 
Self-referral. Fliers advertising the study were available in the clinic lobby. Interested patients could 
respond to the information on the study flier by calling a designated study phone number.  The research 

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staff telephoned interested patients, using an IRB-approved telephone screening script, conducted a 
brief screening survey and invited eligible patients to participate. 
Informed consent and baseline appointment. For patients who were eligible and agreed to participate, 
the research staff scheduled a one-hour, in-person appointment at the medical center at the patient’s 
convenience. At the appointment, the research staff explained the study, invited the patient to 
participate, and obtained informed consent, using an IRB-approved recruiting script. Informed consent 
included access to patient medical records for research, including pharmacy and utilization of medical, 
mental health and chemical dependency services.  The Research Associate answered all questions by the 
patient about the study, and reviewed the study consent form with the patients.   If the participant 
stated that they understood the purpose of the study, and agreed to participate, the participant’s 
signature was obtained.  The research staff also clearly explained the HIPAA authorization form, and 
obtained the participant’s signature. 
After signing the consent form, the patient was asked to complete the online baseline survey, using a 
study laptop. The survey took about 45-60 minutes to complete. 
Randomization. Randomization was conducted independently, using a block randomization approach 
and a SAS random-number generator.  Assignments were pre-determined and placed in sealed opaque 
envelopes. As each eligible patient provided informed consent, the research staff opened an envelope 
to identify the treatment group to which the patient was assigned. Assignments were concealed from 
study staff until opened in front of patient. 
Participants assigned to the intervention arm were required to attend their first session within 3 months 
of completing the baseline survey. In situations where this was difficult, participants were offered the 
option to re-do the baseline survey or forgo the group sessions and proceed with the remainder of the 
study (the 6 and 12 month follow up telephone interviews), which aligned with the planned intent-to-
treat analysis of the study. 
Follow-up appointments. Patients were interviewed by telephone at 6 and 12 months post intake. 
Trained DOR interviewers conducted follow up interviews (approximately 45 minutes) using 
standardized scripts and procedures. For patients who were difficult to reach by phone, we sent contact 
letters to let them know we were trying to reach them, and provided a telephone number to contact us. 
The Kaiser EHR was utilized for locating updated contact information. Multiple attempts were made to 
contact patients over 4-6 week time period. 
 
COMPENSATION 
Patients were offered $50 Target gift cards for completion of the baseline assessment to compensate 
them for their time. Patients were offered $50 Target gift cards for completion of the 6-month and 12-
month telephone assessment ($150 possible total for all assessments). 
VULNERABLE POPULATIONS 

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We did not specifically exclude patients identified as vulnerable populations (e.g. educationally or 
economically disadvantaged patients). This was a low-risk behavioral study that did not include the use 
of any pharmaceuticals prescribed by the study.  Participation in the study was completely voluntary, 
and patients could refuse. It was possible that some KP employees could be recruited. However, there 
was no coercion to participate and participation in the study had no impact on employment status or 
treatment. 
 
RISKS AND BENEFITS 
This study entailed no physical procedures and imparted no physical risk. However, because materials 
for the study entailed disclosure about sensitive information, there were risks to confidentiality. 
Participants may have felt uncomfortable disclosing information about their chronic pain. In addition, it 
was expected that some individuals could receive a more effective treatment than others. Specifically, 
those assigned to the usual care group condition may not have experienced as much improvement in 
study outcomes as those assigned the experimental behavioral health intervention.  
The experimental treatment in this study was a behavioral health intervention and was considered a 
low-risk treatment method. The intervention was conducted at the same treatment location where 
patients received usual care.  Dr. Campbell and Dr. Weisner carefully monitored delivery of the 
intervention and took steps to ensure participant safety.  Finally, all participants (participants in both 
treatment arms) received the same ongoing medical care in the KPNC health plan they would have 
received if they were not part of the study.  
Safety monitoring plan and reporting mechanisms.  In addition to the data security measures 
discussed, we utilized an Independent Safety Monitor (ISM) who periodically examined aggregate 
reports of adverse events generated by the primary data analyst. Risk to patients was extremely low 
relative to biomedical randomized controlled trials. The ISM did not have any personal or professional 
interest in the outcome of the trial.  
The role of the ISM was to (1) monitor and evaluate the safety of study participants, (2) monitor the 
performance of the study, and (3) assure that the data safety and monitoring plan, including the 
reporting of any adverse events (AEs) and serious adverse events (SAEs) was adhered to.  
We did not anticipate any injuries in the course of the study. For any potential injury, patients were 
eligible for services based on their usual KPNC health plan coverage. The PIs monitored the safety and 
efficacy of the study by compiling a data and safety monitoring report twice yearly and submitting it for 
review to the ISM. The report included a summary of all serious and non-serious adverse events, 
relationship to the intervention and recommendation for action.  
Study-specific potential adverse events. There were no physical procedures to patients and risk of 
study-specific adverse events was very low. The study team members were trained to identify adverse 

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reactions. A study participant could be withdrawn from the study intervention if the investigator 
determined that it was the best decision in order to protect the safety of the member  
Procedures in case of clinical escalation during the study follow-up period.  Participants in the study 
had resources available to them through primary care as well as specialty care clinics within KPNC. All 
study participants were members of the KPNC health plan and were able to access services directly. 
Study interviewers were well trained and had KPNC and public telephone numbers and resources 
available in order to effectively link participants with clinical and emergency services if such need 
became apparent during course of the study. The investigators took all necessary steps to ensure 
patient safety, ensuring that participants received clinical attention and that participants were quickly 
evaluated by a provider in primary care, if these steps were needed. All participants received ongoing 
usual clinical care from primary care services.  
QUALITATIVE INTERVIEWS 
Over the course of the study, we interviewed 13 primary care physicians about their experience caring 
for patients on prescription opioids. Through a series of open-ended questions, we solicited feedback on 
the current prescribing environment and how it has affected provides’ relationships with patients, and 
the quality of care provided. The interviews were conducted by the study research clinician. All 
interviews were conducted during lunch hours at the primary care clinic, and were recorded. Audio files 
were transcribed, and summaries were drafted of each interview. Data will be used to supplement main 
quantitative findings.  
 
STAKEHOLDER ENGAGEMENT  
We engaged an extensive panel of patient and clinical stakeholders in all aspects of the research from 
formulation of research questions and study aims, development of recruitment, and data collection 
materials, refinement of the intervention curriculum, monitoring study progress, interpretation of study 
findings, and development of presentations and manuscripts. The stakeholder panel included clinical 
and operational leaders with significant professional experience in treating pain with prescription 
opioids. There were seven KPNC clinicians with expertise in primary care (Sheryl Sun, MD), psychiatry 
(Mason Turner, MD), addiction medicine (Murtuza Ghadiali, MD), emergency medicine (Steve 
Offerman, MD), psychology/chronic pain (Karen Peters, PhD), pharmacy (George Shea, R.Ph, MBA), and 
anesthesiology and pain management (Andrea Rubinstein, MD). We also had two family practice 
physicians specializing in chronic pain treatment from Contra Costa Medical Center (CCMC), Ken Saffier, 
MD and Karen Burt-Imara, MD, and a psychiatrist/bioethics researcher from academia (Mark Sullivan 
MD). Lastly our stakeholder panel was complemented by the director of a nationally renowned chronic 
pain advocacy organization, American Chronic Pain Association, Penney Cowan. 
There were four patient stakeholders, two from within Kaiser and two from Contra Costa Medical 
Center (CCMC), a local Federally Qualified Health Center (FQHC). The two Kaiser patients, Ben Gonzalez 
and Georgie Hunter, were invited to participate as stakeholders while attending the KP Santa Clara Pain 

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Management Rehabilitation Program (PMRP). The two FQHC patients, Kristie Mathews and Sylvia 
Turner, were recruited from the Pain and Wellness Group at the CCMC.  
Patient and clinical stakeholders met separately for the first year, and subsequently as one group. 
Training was provided to clinical stakeholders and research staff on the principles of patient 
engagement and patient-centered outcomes research. Meetings were held quarterly and there was 
regular communication via email, and phone.  
RESEARCH TEAM 
Cynthia Campbell, PhD, MPH, Principal Investigator (PI). Dr. Campbell was responsible for the scientific 
and technical aspect of the grant activities at the Kaiser Permanente, Northern California (KPNC) Division 
of Research (DOR). She led the overall direction of the project, including ensuring that the project stayed 
patient centered through the close participation of the multidisciplinary patient and stakeholder 
advisory groups.  Additionally, she was responsible for the development of the data collection tools, 
curriculum development, protocol implementation at the clinic, analytic plan, data extraction and 
analysis, manuscript preparation, and dissemination of study findings to the professional community 
through presentations, manuscripts, and working with state and national workgroups.  
 
Constance Weisner, DrPH, LCSW, Principal Investigator. Dr. Weisner was responsible for the scientific 
and administrative direction of the study, in coordination with Dr. Campbell at DOR. Her responsibilities 
included finalizing the study design and data collection tools, partnering with Dr. Campbell to work with 
the stakeholder groups, monitoring the data collection and analysis, interpreting study data, preparing 
manuscripts, and disseminate findings.  
 
Andrea Rubinstein, MD, Co-Investigator. Dr. Rubinstein was responsible for bringing clinical knowledge 
of chronic pain etiology and symptomology in addition to expertise regarding prescription opioid use 
and other pain management practices, guidelines and protocols. She was an active member of the study 
team focusing on clinical issues regarding chronic pain management, KPNC clinical policy, a member of 
the stakeholder group, and contributed to the finalization of study tools, data interpretation, and writing 
manuscripts and disseminating study results 
Catherine Marino, PsyD, functions as the Behavioral Health Clinician.  She was responsible for 
executing the clinical activities required in the patient activation study arm, which consisted of four 
group sessions. She is a licensed clinical psychologists with specialization in pain management and 
patient activation (such as stages of change model, motivational interviewing, and cognitive behavioral 
therapy).  Dr. Marino has a highly successful track record working with patients with complex and 
chronic conditions in primary care, chemical dependency, and psychiatry.   
 
Monique Does, MPH, worked closely with Dr. Campbell as the Project Manager. She was a resource for 
the scientific leadership, clinical staff, and study participants. She managed the training and assisted 
clinical staff with study methodology and ensured the baseline, 6-month, and 12-month questionnaires 
were translated into efficient data collection tools. She built relationships with clinicians and staff, acted 

12 
 
as a liaison between the clinics and the research team, provided technical and hands-on assistance, 
assessment and feedback, coaching, and team-building. She was the primary contact for the patient and 
clinical stakeholders, and was responsible for engaging the stakeholders throughout the research 
process. In addition to these operational necessities, she ensured that the IRB requirements were 
current; she provided support for the weekly study team meetings, the stakeholder group meetings, and 
assisted in tracking methodology decisions made during the course of the study.  
Nancy Charvat-Aguilar, MPH, Research Assistant, partnered with the Behavioral Health Clinician during 
the first two years of the project to ensure the recruitment, baseline, 6-month and 12-month interviews 
were completed.  Specifically, she assisted in recruitment and informed consent activities and helped to 
pilot interview instruments and  create and maintain participant databases.  
Andrea Kline-Simon, MS , Data Analyst. Ms. Kline-Simon’s primary roles were defining study 
population, identifying potentially eligible candidates in the EHR, finalizing data collection protocols, 
developing an analytic plan, and helping to develop the patient tracking system. Andrea also provided 
consultation on recruitment and data collection issues, and assisted with monitoring adverse events, 
running enrollment reports and drafting manuscripts for publication.  
Sara Adams, MPH, Data Analyst. Ms. Adams primary responsibilities on the study were compiling 
final study results, and drafting methods and results for final research report and manuscripts. She 
cleaned survey data, retrieved relevant data from EHR and compiled final data tables. She created 
summary statistics for outcome variables, and compared differences between treatment groups on 
outcome measures at 6 and 12 months. She ran cross-sectional multivariate models to examine 
relationships between the outcomes and the two treatment arms at the 6-month and 12-month 
follow-ups, and used a repeated measures mixed effects framework to examine differences in 
outcomes by treatment arm over time.