Empowering patients with persistent pain using an Internet-based self-management program

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Fund (Grant LSDF 08-02, John Roll, PI) Conflict of Interest Disclosure Authors Conflicts of Interest A.

1 Empowering patients with persistent pain using an Internet-based self-management program Marian Wilson, PhD, MPH, RN-BC Acknowledgments John Roll, PhD - Chair Cindy Corbett, PhD, RN Celestina Barbosa-Leiker, PhD Washington State Life Sciences Discovery Fund (Grant LSDF 08-02, John Roll, PI) Conflict of Interest Disclosure Authors Conflicts of Interest A. Marian Wilson, No Conflict of Interest B. John Roll, No Conflict of Interest C. Cindy Corbett, No Conflict of Interest D. Celestina Barbosa-Leiker, No Conflict of Interest 1

Objectives Understand how gaps in current pain care can be addressed using self-management programs. Understand how Internet-based programs can be used to address gaps in care.

2 Objectives Understand how gaps in current pain care can be addressed using self-management programs. Understand how Internet-based programs can be used to address gaps in care. Identify expected outcomes from engaging patients who receive opioids in Internetbased programs using study data. Problem Policy, treatment, education and research gaps = shortfalls in pain care. Relieving pain in America - A blueprint for transforming prevention, care, education, and research, Institute of Medicine, 2011 Persistent pain impacts The annual U.S. cost is $600 billion. On any given day, an estimated 116 million U.S. adults are affected. (IOM, 2011) 2

2011 Prescription painkiller overdose deaths among women About 18 U.S.

3 Opioid Overdose: An Epidemic U.S. Unintentional Opioid Overdose Deaths Number of deaths 16,000 14,000 12,000 10,000 8,000 6,000 4,000 2, ,500 11,500 2, CDC, 2011 Prescription painkiller overdose deaths among women About 18 U.S. women die every day of an opioid overdose National Vital Statistics System, (deaths include suicides) Conundrum of opioids Risks of diversion, abuse, and unintentional overdose co-exist with evidence of excellent pain control when opioids are used appropriately. $72 billion in direct healthcare costs related to opioid pain reliever misuse and abuse. (IOM, 2011) 3

Gaps in persistent pain care Self-management is an an essential part of clinical practice guidelines for for persistent pain. (ICSI, 2011) Yet access to behavioral and cognitive therapies is limited.

4 Gaps in persistent pain care Self-management is an an essential part of clinical practice guidelines for for persistent pain. (ICSI, 2011) Yet access to behavioral and cognitive therapies is limited. Self-management The tasks individuals must undertake to live with chronic health conditions. Programs aim to increase knowledge, skills, and confidence. (Lorig & Holman, 2003; Bender et al, 2011) Goal-setting: Adopt new behaviors Coping: Building confidence, selfefficacy Cognitions: Address thoughts & feelings Group persuasion: Social support QOL Education: Adherence Literature review Systematic review 17 RCTs of Internet-based pain self-management programs (N=2,503) Most had positive effects pain, activity, costs Inconsistent effects on depression/anxiety More rigorous studies needed (Bender et al. 2011) 4

Gaps in literature Few studies test self-management interventions for broader populations Few studies recruit from clinical settings or specifically target those with higher

, 2007) Pilot study 2011 Seek more stable population Expect major depressive disorder symptoms (54%) Find pain-specific self-management program Wilson, M., Roll, J. et al.

5 Gaps in literature Few studies test self-management interventions for broader populations Few studies recruit from clinical settings or specifically target those with higher disability None specifically recruit patients on opioids Little known about how technology can be utilized in addressing access to care (Foster et al., 2007) Pilot study 2011 Seek more stable population Expect major depressive disorder symptoms (54%) Find pain-specific self-management program Wilson, M., Roll, J. et al., Journal of Emergency Nursing, 2013 Research question How does an Internet-based selfmanagement program affect pain experiences among patients with persistent pain who receive opioid medications? 5

Theoretical background Social Cognitive Theory Self-efficacy Confidence in controlling pain experiences can have positive impact on physical & psychological functioning (Gatchel et al., 2007) Dr.

6 Theoretical background Social Cognitive Theory Self-efficacy Confidence in controlling pain experiences can have positive impact on physical & psychological functioning (Gatchel et al., 2007) Dr. Albert Bandura Individual and Family Self-management Theory Ryan & Sawin 2008 Self-Management Science Center Context Process Outcome Risks and Protective Factors The Self Management Process Proximal Distal Condition-Specific Factors Physical & Social Environment Individual & Family Factors Knowledge & Beliefs Knowledge & Beliefs (self-efficacy) Self-Regulation Skills & Self-regulation Abilities skills & ability Social Facilitation Social Facilitation Individual & Family Self Management Behaviors Health Status Quality of Life Cost of Health Intervention Intervention: Individual/family centered interventions Intervention Web-based pain self-management program 8 weeks of online lessons, activities, and support group (Ruehlman, Karoly, & Enders, 2011) Cognitive Thinking Better Emotional Feeling Better Chronic Pain Management Program Behavioral Doing More Social Relating Better 6

7 Primary aim: Determine whether the Chronic Pain Management Program has a significant effect on pain intensity and pain interference among patients with persistent pain who are prescribed opioid medications. Secondary aims: Determine the effect of the CPMP on depressive symptoms, opioid medication misuse behaviors, pain self-efficacy, health care utilization, and patients impression of clinical change. Evaluate engagement in the program. Categorize and compare self-reported selfmanagement strategies, medication use, health care utilization, goals, and perceptions of using the CPMP. Methods Design Prospective, longitudinal, randomized controlled experimental design with repeated measures of primary outcomes Treatment group trialing Chronic Pain Management Program (CPMP) versus treatment as usual (TAU) wait-list group 7

8 Methods: population & setting Adult patients with persistent pain with a current opioid prescription North Idaho primary care providers Internet recruitment from pain sites and Pacific Northwest clinics added Rural and urban communities Federally qualified health centers Pain clinics Procedure 1. Baseline measurements via secure computer survey system: TX group receives program 2. Both groups tested every 2 weeks: pain intensity, pain interference, depressive symptoms, health care utilization, coping strategies. 3. Posttest at 8 weeks includes: opioid misuse measures, patient impression of change, pain self-efficacy, medication inventory, progress towards stated goals. 4. TAU group offered program - continues with bi-weekly measurements Measurements Selection guided by IMMPACT the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (Dworkin et al., 2005) Brief Pain Inventory (BPI) Patient Health Questionnaire (PHQ-8) Pain Self-efficacy (PSEQ) Current Opioid Misuse Measure (COMM) Patient Global Impression of Change (PGIC) Bi-weekly surveys (health care utilization, coping) Program evaluation Medication inventory and goals 8

9 Descriptive statistics Primary data analysis Chi-square and independent samples t-tests Analysis of Variance (ANOVA) 2 (between: treatment vs. comparison) x 5 (within: time 1-5) mixed design ANOVA 2 x 2 mixed design ANOVA Number Needed to Treat (NNT) Secondary data analysis Descriptive and exploratory Inferential statistics to estimate effects of secondary outcomes measurements Correlations to evaluate relationship between engagement level and outcomes measurements Descriptive and inferential statistics to categorize and compare: self-management strategies, medication use, health care utilization, goals, and perceptions related to use of the CPMP. Findings: Recruitment results Referral source Provider referred Self-referred Location 150 mile radius of Coeur d Alene, ID 29 U.S. states Rural Urban N % Randomized 114: (57 TX, 57 TAU) Lost to follow up: 21% TX, 18% TAU: Final 45 TX, 47 TAU Those who did not complete (n = 12) were significantly more likely to have been referred from a provider than self-referred (x 2 = 4.6, p =.03). 9

10 Findings: Sample description Gender Female Male N (%) Mean (SD) Range 72 (78.3) 20 (21.7) Married/Partner 60 (65.2) Education Some college 4 yr degree or higher Most common diagnoses Back/spine conditions Fibromyalgia Arthritis/osteoarthritis Migraine headache 36 (39.1) 33 (35.9) 41 (45) 27 (29) 24 (26) 20 (22) Age 49.3 (11.6) Daily morphine equivalent in milligrams 95 (109.5) 5 mg 640 mg/day Brief Pain Inventory (BPI) Pain Intensity Mean Score TX TAU Baseline Posttest Group x time interaction F ( 3.43, 272 ) = 0.38; p =.80; η 2 partial = 0.005; observed power 12.7% Brief Pain Inventory (BPI) Pain Interference Mean Score TX TAU Baseline Posttest Group x time interaction F( 3.39, 272 ) = 0.93; p = 0.45; η 2 partial = 0.013; observed power 26.8% 10

Number Needed to Treat Pain Intensity: Clinically meaningful improvement of 2 points 18% of TX group and 6% of TAU group On average, 8 people would need to be treated to achieve clinically meaningful

11 Number Needed to Treat Pain Intensity: Clinically meaningful improvement of 2 points 18% of TX group and 6% of TAU group On average, 8 people would need to be treated to achieve clinically meaningful improvement in pain intensity within 8 weeks. Pain Interference: Clinically meaningful improvement of 1 point 28.9% of TX group and 29.8% of TAU group Depressive Symptoms (PHQ-8) PHQ-8 Mean Score TX TAU Baseline Posttest Main effect for time: F( 1, 68 ) = 5.952; p =.00; η 2 partial = 0.08; observed power 98.4% Group x time interaction: F( 1, 68 ) = 1.13; p =.34; η 2 partial =0.016; observed power 35.4% Pain Self-efficacy PSEQ Mean Score TX TAU 5 0 Baseline Posttest Main effect for time: F( 1, 82 ) = 10.7; p =.002; η 2 partial = 0.116; observed power 89.9% Group x time interaction: F( 1, 82 ) = 13.6; p =.00; η 2 partial = 0.142; observed power 95.4% 11

Current Opioid Misuse Measure 14 12 10 12.4 10.9 9.1 9.

219; observed power 99.7% Group x time interaction: F( 1, 81 ) = 4.097; p =.046; η 2 partial = 0.048; observed power 51.

5 1 Baseline Posttest Group x time interaction: F( 1, 88 ) =.005; p =.94; η 2 partial = 0.00; observed power 5.

12 Current Opioid Misuse Measure COMM Mean Score 8 6 TX TAU Baseline Posttest Main effect for time: F( 1, 81 ) = 22.65; p =.00; η 2 partial = 0.219; observed power 99.7% Group x time interaction: F( 1, 81 ) = 4.097; p =.046; η 2 partial = 0.048; observed power 51.6% Patient Global Impression of Change Mean Score TX TAU Baseline Posttest Group x time interaction: F( 1, 88 ) =.005; p =.94; η 2 partial = 0.00; observed power 5.1% Program Engagement Level Number of participants (n = 45) Treatment dose positively associated with improvements: pain intensity (r =.30, p =.048) pain interference (r =.33, p =.028) pain self-efficacy (r =.34, p =.029). 12

Bi-weekly surveys Behaviors or activity changes to control pain? 21 yes responses attributed to CPMP TX group reported adding more new behaviors (M = 1.6, SD = 1.6) than those in the TAU group (M = 0.

13 Bi-weekly surveys Behaviors or activity changes to control pain? 21 yes responses attributed to CPMP TX group reported adding more new behaviors (M = 1.6, SD = 1.6) than those in the TAU group (M = 0.9, SD 1.1; t (90) = , p =.02). Bi-weekly surveys TX group 7 of 43 (16.3%) report increasing opioid medicines over the study period compared to TAU 9 of 47 (19.1%). No significant difference between groups (x 2 = 4.11, p =.13). TX group 8 of 26 (30.8%) report adding or increasing antidepressant over the 8-week study period compared to TAU 7 of 39 (17.9%). No significant difference between groups (x 2 = 1.44, p =.23). Bi-weekly surveys TX group, 9 of 43 (20.9%) reported decreasing or stopping opioid medicines over the study period compared to 3 of 44 (6.8%) in the TAU group (x 2 = 4.11, p =.04). No difference in reported healthcare utilization: most visits to primary care. 13

Most Frequently Reported New Behaviors to Control Pain Behavior TX n (%) TAU n (%) Physical activity/stretching 21 (47%) 20 (42%) Relaxation/breathing exercises/meditation 19 (42%) 2 (4%) Positive

14 Most Frequently Reported New Behaviors to Control Pain Behavior TX n (%) TAU n (%) Physical activity/stretching 21 (47%) 20 (42%) Relaxation/breathing exercises/meditation 19 (42%) 2 (4%) Positive thinking 13 (29%) 1 (2%) Pacing activities/rest 12 (27%) 13 (28%) Hobby/diversional activity 2 (4%) 2 (4%) Progress Towards Goals Top goals related to medicines: reduce or eliminate pain medicines (n = 24) reduce or eliminate non-specified medicines (n = 15). TX group, 17 of 21 (81.0%) at least some progress towards stated medication goal compared to 17 of 35 (48.6%) in the TAU group (x 2 = 5.77, p =.02). Progress Towards Goals Top goals related to overall health and well-being: 1) increase activity, strength or fitness (n = 27) 2) reduce weight (n = 9). 14

15 Program evaluation Assessed usability, quality of information, usefulness 7-item Likert scale 1 7 (N = 65; Mean 5.2) Most frequent positive responses: stopping negative thoughts and/or focusing on the positive (n = 15). engaging in healthy activities, including paced physical exercise, relaxation or socialization (n = 12 ). Program evaluation Most frequent negative responses: difficulty navigating program features (n = 16) desire for more direction or reminders (n = 12). Wait-list results Variable BPI Pain Intensity BPI Pain Interference Baseline Mean (SD) Posttest Week 8 Mean (SD) Posttest Week 16 Mean (SD) df F p Partial eta squared 5.3 (1.8) 5.3 (1.9) 5.2 (2.1) 2, (1.9) 5.8 (2.3) 5.5 (2.6) 2, PHQ (5.6) 11.3 (6.1) 4.7 (5.0) 2, *.619 PSEQ 24.2 (13.2) 21.9 (15.0) 25.4 (14.6) 2, COMM 11.2 (4.9) 9.3 (5.1) 10.0 (6.7) 2, PGIC 3.3 (1.9) 3.5 (2.0) 3.3 (2.2) 2, * Significant at the level 15

Participant comments This program really helped me to realize that chronic pain and a diagnosis of a condition that has no cure doesn't mean it s hopeless.

16 Participant comments This program really helped me to realize that chronic pain and a diagnosis of a condition that has no cure doesn't mean it s hopeless. I've come to realize that a lot of how I need to deal with the pain is my attitude. Before, I felt so alone, that no one understood me. I also had given up on finding work I could do. Because of this program, it encouraged me to find resources that would help me find work I found a program that does vocational rehabilitation they will help me find a line of work that I can do with my limitations. It was extremely helpful for me to shift my mind and spirit to focus on the good and wellness instead of sickness! My actual pain is about the same, but it seems to cause me less stress. I feel I have better coping mechanisms in place now. We don't have many tools to bring to the fight against our pain..this is a tool everyone NEEDS. Limitations Sample underpowered to detect small, significant differences Placebo/attention effects -> equivalent change in depressive symptoms/pain interference Variations in participant referral source Variations in pain conditions and how pain scores can be impacted Lack of diversity in gender, race 16

Future research How can we increase engagement? Prompting, reminders, encouragement Provider led, insurance reimbursement Computer access and assistance How can we identify and address depression?

17 Future research How can we increase engagement? Prompting, reminders, encouragement Provider led, insurance reimbursement Computer access and assistance How can we identify and address depression? Which self-management techniques are most helpful? Can they be matched to participant characteristics to optimize response? Diagnosis, opioid dose, goals of treatment Conclusions Internet-based selfmanagement interventions can improve pain selfefficacy and reported opioid misuse behaviors among patients with persistent pain. Participation levels are positively associated with improvements in pain intensity, pain interference and pain self-efficacy. Questions? Marian Wilson, PhD, MPH, RN-BC Nurse Scientist Texas Health Resources Dallas, TX 17

18 References Alm, A. K., & Norbergh, K.-G. (2010). Nurses' opinions of pain and the assessed need for pain medication for the elderly. Pain Management Nursing. Advance online publication. doi: /j.pmn Centers for Disease Control and Prevention (CDC). (2011). Vital signs: overdoses of prescription opioid pain relievers - United States, Morbidity and Mortality Weekly Report, 60(43), Chou, R., Fanciullo, G. J., Fine, P. G., Miaskowski, C., Passik, S. D., Portenoy, R. K. (2009). Opioids for chronic noncancer pain: prediction and identification of aberrant drug-related behaviors: a review of the evidence for an American Pain Society and American Academy of Pain Medicine clinical practice guideline. Pain, 10(2), DeLeo, J. (2006). Basic science of pain. The Journal of Bone and Joint Surgery, 88- A(S2), Dworkin, R. H., Turk, D. C., Farrar, J. T., Haythornthwaite, J. A., Jensen, M. P., Katz, N. P., Witter, J. (2005). Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain, 113, References Fishbain, D., Cole, B., Lewis, J., Rossomoff, H., & Rosomoff, R. (2008). What percentage of chronic nonmalignant pain patients exposed to chronic opioid analgesic therapy develop abuse/addiction and/or aberrant drug-related behaviors? A structured evidence-based review. Pain Medicine, 9(4), doi:10.111/j x Foster, G., Taylor, S. J. C., Eldridge, S. E., Ramsay, J., Griffiths, C. J. (2007). Selfmanagement education programmes by lay leaders for people with chronic conditions. Cochrane Database of Systematic Reviews, 4. Art. No.: CD DOI: / CD pub2 Gatchel, R., Peng, Y. B., Peters, M. L., Fuchs, P., & Turk, D. (2007). The biopsychosocial approach to chronic pain: Scientific advances and future directions. Psychological Bulletin, 133(4), Glombiewski, J. A., Hartwich-Tersek, J., & Rief, W. (2010). Depression in chronic back pain patients: prediction of pain intensity and pain disability in cognitive-behavioral treatment. Psychosomatics, 51, doi: /appi.psy Institute for Clinical Systems Improvement (ICSI). (2011). Pain, chronic; Assessment and management of (guideline). Retrieved from References Institute of Medicine. (2011). Relieving pain in America: A blueprint for transforming prevention, care, education, and research. National Academies of Sciences. Retrieved from Lorig, K., & Holman, H. (2003). Self-management education: history, definitions, outcomes and mechanisms. Annals of Behavioral Medicine, 26, 1 7. Lorig, K., Ritter, P., Laurent, D., & Plant, K. (2008). The Internet-based arthritis selfmanagement program: A one-year randomized trial for patients with arthritis or fibromyalgia. Arthritis & Rheumatism, 59(7), Macea, D. D., Gajos, K., Calil, Y. A., & Fregni, F. (2010). The efficacy of web-based cognitive behavioral interventions for chronic pain: A systematic and meta-analysis. The Journal of Pain, 11(10), Manchikanti, L., Ailinani, H., Koyyalagunta, D., Datta, S. Singh, V., Eriator, I., Christo, P. (2011). A systematic review of randomized trials of long-term opioid management for chronic non-cancer pain. Pain Physician, 14, McGillion, M.H., Watt-Watson, J. Stevens, B., LeFort, S.M., Coyte, P., Graham, A. (2008). Randomized controlled trial of a psychoeducation program for the self-management of chronic cardiac pain. Journal of Pain and Symptom Management, 36(2). 18

19 References Ruehlman, L., Karoly, P., & Enders, C. (2011). A randomized controlled evaluation of an online chronic pain self management program. Pain, doi: /j.pain Ryan, P., & Sawin, K. (2009).The individual and family self-management theory: Background and perspectives on context, process, and outcomes. Nursing Outlook, 57, Sanders, S., Harden, R. N., Vicente, P. J. (2005). Evidence-based clinical practice guidelines for interdisciplinary rehabilitation of chronic nonmalignant pain syndrome patients. Pain Practice, 5(4), doi: /j x Stein, C., Reinecke, H., & Sorgatz, H. (2010). Opioid use in chronic noncancer pain: guidelines revisited. Current Opinion in Anesthesiology, 23, Wilson, M., Roll, J., Pritchard, P., Masterson, B., Howell, D., & Barbosa-Leiker, C. Depression and pain interference among emergency department chronic pain patients. Poster presentation, Western Institute of Nursing s Annual Communicating Nursing Research Conference, April,

9/19/2018. Conflict of Interest Author Disclosure. Educational Objectives

9/19/2018. Conflict of Interest Author Disclosure. Educational Objectives Health Coaching to Increase Participation in Online Chronic Pain Management Programs: Lessons Learned Teresa Bigand, PhD-C, MSN, RN Marian Wilson, PhD, MPH, RN Mary Roberts, PhD, BSN, RN Jamie Lewis, MD