Clinical trial NCT02290223: Patient Activation to Address Chronic Pain and Opioid Management in Primary Care
Official title: Patient Activation to Address Chronic Pain and Opioid Management in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Chronic pain
Analgesics, Opioid
Cognitive Therapy
Behavior Therapy
Mindfulness
Psychophysiology
Biofeedback, Psychology
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2014-11-14
Enrollment: 376
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?

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.

Eligibility 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

Primary outcomes:
measure: Patient Activation
timeFrame: Baseline and 6 and 12 months post randomization
Secondary outcomes:
measure: Quality of Life: Physical Health
timeFrame: Baseline and 6 and 12 months post randomization
measure: Quality of Life: Mental Health
timeFrame: Baseline and 6 and 12 months post randomization
measure: Overall Health
timeFrame: Baseline and 6 and 12 months post randomization
measure: PHQ-9 Depression
timeFrame: Baseline and 6 and 12 months post randomization
measure: Satisfaction With Care
timeFrame: Baseline and 6 and 12 months post randomization
measure: Opioid Misuse SOAPP
timeFrame: Baseline and 6 and 12 months post randomization
measure: Opioid Misuse COMM
timeFrame: Baseline and 6 and 12 months post randomization
measure: Pain Coping
timeFrame: 6 and 12 months post randomization
measure: Self-Efficacy
timeFrame: Baseline and 6 and 12 months post randomization
measure: Pain Intensity
timeFrame: Baseline and 6 and 12 months post randomization
measure: Function: Everyday Physical Activities
timeFrame: Baseline and 6 and 12 months post randomization
measure: Function: Social Activities and Roles
timeFrame: Baseline and 6 and 12 months post randomization
measure: Patient Provider Communication
timeFrame: Baseline and 6 and 12 months post randomization
measure: Patient Provider Interactions
timeFrame: Baseline and 6 and 12 months post randomization
measure: Health Care Utilization Service Visits (EHR)
timeFrame: Baseline and 6 and 12 months post randomization
measure: Health Care Utilization Portal Use (EHR)
timeFrame: Baseline and 6 and 12 months post randomization
measure: Use of Online Health and Wellness Resources (Self-reported)
timeFrame: Baseline and 6 and 12 months post randomization
measure: Attendance at Health Education Classes (Self-reported)
timeFrame: Baseline and 6 and 12 months post randomization
measure: Prescription Opioid Use (EHR)
timeFrame: Baseline and 6 and 12 months post randomization
measure: Pain Management Strategies- Mindfulness, Meditation and Relaxation
timeFrame: Baseline and 6 and 12 months post randomization
measure: Pain Management Strategies- Exercise, Stretching or Physical Therapy
timeFrame: Baseline and 6 and 12 months post randomization
measure: Goals for Opioid Use at Baseline
timeFrame: baseline
measure: Met Baseline Goals for Opioid Use at 6 and 12 Months
timeFrame: 6 and 12 months post-randomization
measure: Substance Use
timeFrame: Baseline and 6 and 12 month post-randomization
measure: Alcohol Use
timeFrame: Baseline and 6 and 12 months post-randomization
measure: Tobacco Use
timeFrame: Baseline and 6 and 12 months post-randomization
Other outcomes:
Locations:
city: San Jose
country: United States
facility: Kaiser Permanente, San Jose Medical Center
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente, Santa Clara Medical Center
state: California
Study officials:
affiliation: Kaiser Permanente
name: Cynthia I Campbell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Institute of Medicine (US) Committee on Advancing Pain Research, Care, and Education. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington (DC): National Academies Press (US); 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK91497/
citation: Gureje O, Simon GE, Von Korff M. A cross-national study of the course of persistent pain in primary care. Pain. 2001 May;92(1-2):195-200. doi: 10.1016/s0304-3959(00)00483-8.
citation: Boudreau D, Von Korff M, Rutter CM, Saunders K, Ray GT, Sullivan MD, Campbell CI, Merrill JO, Silverberg MJ, Banta-Green C, Weisner C. Trends in long-term opioid therapy for chronic non-cancer pain. Pharmacoepidemiol Drug Saf. 2009 Dec;18(12):1166-75. doi: 10.1002/pds.1833.
citation: Caudill-Slosberg MA, Schwartz LM, Woloshin S. Office visits and analgesic prescriptions for musculoskeletal pain in US: 1980 vs. 2000. Pain. 2004 Jun;109(3):514-519. doi: 10.1016/j.pain.2004.03.006.
citation: Ballantyne JC. Pain medicine: repairing a fractured dream. Anesthesiology. 2011 Feb;114(2):243-6. doi: 10.1097/ALN.0b013e3182039f87. No abstract available.
citation: Deyo RA, Mirza SK, Turner JA, Martin BI. Overtreating chronic back pain: time to back off? J Am Board Fam Med. 2009 Jan-Feb;22(1):62-8. doi: 10.3122/jabfm.2009.01.080102.
citation: Dhalla IA, Persaud N, Juurlink DN. Facing up to the prescription opioid crisis. BMJ. 2011 Aug 23;343:d5142. doi: 10.1136/bmj.d5142. No abstract available.
citation: Grady D, Berkowitz SA, Katz MH. Opioids for chronic pain. Arch Intern Med. 2011 Sep 12;171(16):1426-7. doi: 10.1001/archinternmed.2011.213. Epub 2011 Jun 13. No abstract available.
citation: Katz MH. Long-term opioid treatment of nonmalignant pain: a believer loses his faith. Arch Intern Med. 2010 Sep 13;170(16):1422-4. doi: 10.1001/archinternmed.2010.335. No abstract available.
citation: McLellan AT, Turner BJ. Chronic noncancer pain management and opioid overdose: time to change prescribing practices. Ann Intern Med. 2010 Jan 19;152(2):123-4. doi: 10.7326/0003-4819-152-2-201001190-00012. No abstract available.
citation: Okie S. A flood of opioids, a rising tide of deaths. N Engl J Med. 2010 Nov 18;363(21):1981-5. doi: 10.1056/NEJMp1011512. No abstract available.
citation: Sullivan MD. Limiting the potential harms of high-dose opioid therapy: comment on "Opioid dose and drug-related mortality in patients with nonmalignant pain". Arch Intern Med. 2011 Apr 11;171(7):691-3. doi: 10.1001/archinternmed.2011.101. No abstract available.
citation: Von Korff M, Kolodny A, Deyo RA, Chou R. Long-term opioid therapy reconsidered. Ann Intern Med. 2011 Sep 6;155(5):325-8. doi: 10.7326/0003-4819-155-5-201109060-00011.
citation: Chou R, Fanciullo GJ, Fine PG, Miaskowski C, Passik SD, Portenoy RK. 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. J Pain. 2009 Feb;10(2):131-46. doi: 10.1016/j.jpain.2008.10.009.
citation: Chou R, Fanciullo GJ, Fine PG, Adler JA, Ballantyne JC, Davies P, Donovan MI, Fishbain DA, Foley KM, Fudin J, Gilson AM, Kelter A, Mauskop A, O'Connor PG, Passik SD, Pasternak GW, Portenoy RK, Rich BA, Roberts RG, Todd KH, Miaskowski C; American Pain Society-American Academy of Pain Medicine Opioids Guidelines Panel. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. J Pain. 2009 Feb;10(2):113-30. doi: 10.1016/j.jpain.2008.10.008.
citation: Papaleontiou M, Henderson CR Jr, Turner BJ, Moore AA, Olkhovskaya Y, Amanfo L, Reid MC. Outcomes associated with opioid use in the treatment of chronic noncancer pain in older adults: a systematic review and meta-analysis. J Am Geriatr Soc. 2010 Jul;58(7):1353-69. doi: 10.1111/j.1532-5415.2010.02920.x. Epub 2010 Jun 1.
citation: Sullivan MD, Von Korff M, Banta-Green C, Merrill JO, Saunders K. Problems and concerns of patients receiving chronic opioid therapy for chronic non-cancer pain. Pain. 2010 May;149(2):345-353. doi: 10.1016/j.pain.2010.02.037. Epub 2010 Mar 23.
citation: Sullivan MD, Ballantyne JC. What are we treating with long-term opioid therapy? Arch Intern Med. 2012 Mar 12;172(5):433-4. doi: 10.1001/archinternmed.2011.2156. No abstract available.
citation: Volkow ND, McLellan TA. Curtailing diversion and abuse of opioid analgesics without jeopardizing pain treatment. JAMA. 2011 Apr 6;305(13):1346-7. doi: 10.1001/jama.2011.369. No abstract available.
citation: Centers for Disease Control and Prevention (CDC). Vital signs: overdoses of prescription opioid pain relievers---United States, 1999--2008. MMWR Morb Mortal Wkly Rep. 2011 Nov 4;60(43):1487-92.
citation: Warner M, Chen LH, Makuc DM. Increase in fatal poisonings involving opioid analgesics in the United States, 1999-2006. NCHS Data Brief. 2009 Sep;(22):1-8.
citation: Coben JH, Davis SM, Furbee PM, Sikora RD, Tillotson RD, Bossarte RM. Hospitalizations for poisoning by prescription opioids, sedatives, and tranquilizers. Am J Prev Med. 2010 May;38(5):517-24. doi: 10.1016/j.amepre.2010.01.022.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Trescott CE, Beck RM, Seelig MD, Von Korff MR. Group Health's initiative to avert opioid misuse and overdose among patients with chronic noncancer pain. Health Aff (Millwood). 2011 Aug;30(8):1420-4. doi: 10.1377/hlthaff.2011.0759.
citation: Von Korff MR. Opioids for chronic noncancer pain: as the pendulum swings, who should set prescribing standards for primary care? Ann Fam Med. 2012 Jul-Aug;10(4):302-3. doi: 10.1370/afm.1422. No abstract available.
citation: Ballantyne JC. Patient-centered health care: are opioids a special case? Spine J. 2009 Sep;9(9):770-2. doi: 10.1016/j.spinee.2009.06.006. Epub 2009 Jul 29. No abstract available.
citation: Frantsve LM, Kerns RD. Patient-provider interactions in the management of chronic pain: current findings within the context of shared medical decision making. Pain Med. 2007 Jan-Feb;8(1):25-35. doi: 10.1111/j.1526-4637.2007.00250.x.
citation: Matthias MS, Parpart AL, Nyland KA, Huffman MA, Stubbs DL, Sargent C, Bair MJ. The patient-provider relationship in chronic pain care: providers' perspectives. Pain Med. 2010 Nov;11(11):1688-97. doi: 10.1111/j.1526-4637.2010.00980.x.
citation: Matthias MS, Krebs EE, Collins LA, Bergman AA, Coffing J, Bair MJ. "I'm not abusing or anything": patient-physician communication about opioid treatment in chronic pain. Patient Educ Couns. 2013 Nov;93(2):197-202. doi: 10.1016/j.pec.2013.06.021. Epub 2013 Aug 2.
citation: Frosch DL, May SG, Rendle KA, Tietbohl C, Elwyn G. Authoritarian physicians and patients' fear of being labeled 'difficult' among key obstacles to shared decision making. Health Aff (Millwood). 2012 May;31(5):1030-8. doi: 10.1377/hlthaff.2011.0576.
citation: Upshur CC, Bacigalupe G, Luckmann R. "They don't want anything to do with you": patient views of primary care management of chronic pain. Pain Med. 2010 Dec;11(12):1791-8. doi: 10.1111/j.1526-4637.2010.00960.x. Epub 2010 Oct 1.
citation: 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
citation: 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
citation: 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
citation: 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
citation: Chewning B, Bylund CL, Shah B, Arora NK, Gueguen JA, Makoul G. Patient preferences for shared decisions: a systematic review. Patient Educ Couns. 2012 Jan;86(1):9-18. doi: 10.1016/j.pec.2011.02.004. Epub 2011 Apr 6.
citation: Hibbard JH, Greene J. What the evidence shows about patient activation: better health outcomes and care experiences; fewer data on costs. Health Aff (Millwood). 2013 Feb;32(2):207-14. doi: 10.1377/hlthaff.2012.1061.
citation: Towle A, Godolphin W. Framework for teaching and learning informed shared decision making. BMJ. 1999 Sep 18;319(7212):766-71. doi: 10.1136/bmj.319.7212.766. No abstract available.
citation: Driessen E, Hollon S. Motivational interviewing from a cognitive behavioral perspective. Cogn Behav Pract. 2011;18:70-73
citation: Rollnick S, Butler CC, Kinnersley P, Gregory J, Mash B. Motivational interviewing. BMJ. 2010 Apr 27;340:c1900. doi: 10.1136/bmj.c1900. No abstract available.
citation: Miller WR, Rollnick S, eds. Motivational Interviewing : Preparing People for Change. 2nd ed. New York: Guildord Press; 2002
citation: Debar LL, Kindler L, Keefe FJ, Green CA, Smith DH, Deyo RA, Ames K, Feldstein A. A primary care-based interdisciplinary team approach to the treatment of chronic pain utilizing a pragmatic clinical trials framework. Transl Behav Med. 2012 Dec 1;2(4):523-530. doi: 10.1007/s13142-012-0163-2. Epub 2012 Aug 30.
citation: Edlund MJ, Martin BC, Russo JE, DeVries A, Braden JB, Sullivan MD. The role of opioid prescription in incident opioid abuse and dependence among individuals with chronic noncancer pain: the role of opioid prescription. Clin J Pain. 2014 Jul;30(7):557-64. doi: 10.1097/AJP.0000000000000021.
citation: Edlund MJ, Sullivan M, Steffick D, Harris KM, Wells KB. Do users of regularly prescribed opioids have higher rates of substance use problems than nonusers? Pain Med. 2007 Nov-Dec;8(8):647-56. doi: 10.1111/j.1526-4637.2006.00200.x.
citation: Brown JL, Edwards PS, Atchison JW, Lafayette-Lucey A, Wittmer VT, Robinson ME. Defining patient-centered, multidimensional success criteria for treatment of chronic spine pain. Pain Med. 2008 Oct;9(7):851-62. doi: 10.1111/j.1526-4637.2007.00357.x.
citation: Casarett D, Karlawish J, Sankar P, Hirschman K, Asch DA. Designing pain research from the patient's perspective: what trial end points are important to patients with chronic pain? Pain Med. 2001 Dec;2(4):309-16. doi: 10.1046/j.1526-4637.2001.01041.x.
citation: Turk DC, Dworkin RH, Allen RR, Bellamy N, Brandenburg N, Carr DB, Cleeland C, Dionne R, Farrar JT, Galer BS, Hewitt DJ, Jadad AR, Katz NP, Kramer LD, Manning DC, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robinson JP, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Witter J. Core outcome domains for chronic pain clinical trials: IMMPACT recommendations. Pain. 2003 Dec;106(3):337-345. doi: 10.1016/j.pain.2003.08.001.
citation: Greene J, Hibbard JH, Sacks R, Overton V. When seeing the same physician, highly activated patients have better care experiences than less activated patients. Health Aff (Millwood). 2013 Jul;32(7):1299-305. doi: 10.1377/hlthaff.2012.1409.
citation: Institute of Medicine (US) Committee on Health Literacy; Nielsen-Bohlman L, Panzer AM, Kindig DA, editors. Health Literacy: A Prescription to End Confusion. Washington (DC): National Academies Press (US); 2004. Available from http://www.ncbi.nlm.nih.gov/books/NBK216032/
citation: 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.
citation: Kline-Simon AH, Falk DE, Litten RZ, Mertens JR, Fertig J, Ryan M, Weisner CM. Posttreatment low-risk drinking as a predictor of future drinking and problem outcomes among individuals with alcohol use disorders. Alcohol Clin Exp Res. 2013 Jan;37 Suppl 1(0 1):E373-80. doi: 10.1111/j.1530-0277.2012.01908.x. Epub 2012 Jul 24.
citation: Weisner C, Mertens J, Parthasarathy S, Moore C, Lu Y. Integrating primary medical care with addiction treatment: a randomized controlled trial. JAMA. 2001 Oct 10;286(14):1715-23. doi: 10.1001/jama.286.14.1715.
citation: Cohen J. Statistical Power Analysis for the Behavioral Sciences. 2nd ed. Hillsdale, NJ: Lawrence Erlbaum Associates; 1988
citation: Demidenko E. Sample size and optimal design for logistic regression with binary interaction. Stat Med. 2008 Jan 15;27(1):36-46. doi: 10.1002/sim.2980.
citation: Hsieh FY, Bloch DA, Larsen MD. A simple method of sample size calculation for linear and logistic regression. Stat Med. 1998 Jul 30;17(14):1623-34. doi: 10.1002/(sici)1097-0258(19980730)17:143.0.co;2-s.
citation: Sullivan MD, Edlund MJ, Zhang L, Unutzer J, Wells KB. Association between mental health disorders, problem drug use, and regular prescription opioid use. Arch Intern Med. 2006 Oct 23;166(19):2087-93. doi: 10.1001/archinte.166.19.2087.
citation: Weisner C, Mertens J, Parthasarathy S, Moore C, Hunkeler EM, Hu T, Selby JV. The outcome and cost of alcohol and drug treatment in an HMO: day hospital versus traditional outpatient regimens. Health Serv Res. 2000 Oct;35(4):791-812.
citation: Green CA, Perrin NA, Polen MR, Leo MC, Hibbard JH, Tusler M. Development of the Patient Activation Measure for mental health. Adm Policy Ment Health. 2010 Jul;37(4):327-33. doi: 10.1007/s10488-009-0239-6. Epub 2009 Aug 29.
citation: Hibbard JH, Mahoney ER, Stockard J, Tusler M. Development and testing of a short form of the patient activation measure. Health Serv Res. 2005 Dec;40(6 Pt 1):1918-30. doi: 10.1111/j.1475-6773.2005.00438.x.
citation: Hibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res. 2004 Aug;39(4 Pt 1):1005-26. doi: 10.1111/j.1475-6773.2004.00269.x.
citation: Mosen DM, Schmittdiel J, Hibbard J, Sobel D, Remmers C, Bellows J. Is patient activation associated with outcomes of care for adults with chronic conditions? J Ambul Care Manage. 2007 Jan-Mar;30(1):21-9. doi: 10.1097/00004479-200701000-00005.
citation: Schmittdiel J, Mosen DM, Glasgow RE, Hibbard J, Remmers C, Bellows J. Patient Assessment of Chronic Illness Care (PACIC) and improved patient-centered outcomes for chronic conditions. J Gen Intern Med. 2008 Jan;23(1):77-80. doi: 10.1007/s11606-007-0452-5. Epub 2007 Nov 21.
citation: Camacho FT, Feldman SR, Balkrishnan R, Kong MC, Anderson RT. Validation and reliability of 2 specialty care satisfaction scales. Am J Med Qual. 2009 Jan-Feb;24(1):12-8. doi: 10.1177/1062860608326416. Epub 2008 Dec 5.
citation: PROMIS Network Center. PROMIS (Patient Reported Outcome Measurement Information System). USA.gov. http://www.nihpromis.org/?AspxAutoDetectCookieSupport=1#3. Accessed January 18, 2014
citation: Broderick JE, DeWitt EM, Rothrock N, Crane PK, Forrest CB. Advances in Patient-Reported Outcomes: The NIH PROMIS((R)) Measures. EGEMS (Wash DC). 2013 Aug 2;1(1):1015. doi: 10.13063/2327-9214.1015. eCollection 2013.
citation: Hinchcliff M, Beaumont JL, Thavarajah K, Varga J, Chung A, Podlusky S, Carns M, Chang RW, Cella D. Validity of two new patient-reported outcome measures in systemic sclerosis: Patient-Reported Outcomes Measurement Information System 29-item Health Profile and Functional Assessment of Chronic Illness Therapy-Dyspnea short form. Arthritis Care Res (Hoboken). 2011 Nov;63(11):1620-8. doi: 10.1002/acr.20591.
citation: Beaumont JL, Cella D, Phan AT, Choi S, Liu Z, Yao JC. Comparison of health-related quality of life in patients with neuroendocrine tumors with quality of life in the general US population. Pancreas. 2012 Apr;41(3):461-6. doi: 10.1097/MPA.0b013e3182328045.
citation: Flynn KE, Reeve BB, Lin L, Cyranowski JM, Bruner DW, Weinfurt KP. Construct validity of the PROMIS(R) sexual function and satisfaction measures in patients with cancer. Health Qual Life Outcomes. 2013 Mar 11;11:40. doi: 10.1186/1477-7525-11-40.
citation: Flynn KE, Lin L, Cyranowski JM, Reeve BB, Reese JB, Jeffery DD, Smith AW, Porter LS, Dombeck CB, Bruner DW, Keefe FJ, Weinfurt KP. Development of the NIH PROMIS (R) Sexual Function and Satisfaction measures in patients with cancer. J Sex Med. 2013 Feb;10 Suppl 1(0 1):43-52. doi: 10.1111/j.1743-6109.2012.02995.x.
citation: EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.
citation: Obradovic M, Lal A, Liedgens H. Validity and responsiveness of EuroQol-5 dimension (EQ-5D) versus Short Form-6 dimension (SF-6D) questionnaire in chronic pain. Health Qual Life Outcomes. 2013 Jul 1;11:110. doi: 10.1186/1477-7525-11-110.
citation: Makoul G, Krupat E, Chang CH. Measuring patient views of physician communication skills: development and testing of the Communication Assessment Tool. Patient Educ Couns. 2007 Aug;67(3):333-42. doi: 10.1016/j.pec.2007.05.005. Epub 2007 Jun 18.
citation: Mertens JR, Flisher AJ, Satre DD, Weisner CM. The role of medical conditions and primary care services in 5-year substance use outcomes among chemical dependency treatment patients. Drug Alcohol Depend. 2008 Nov 1;98(1-2):45-53. doi: 10.1016/j.drugalcdep.2008.04.007. Epub 2008 Jun 20.
citation: Von Korff M, Saunders K, Thomas Ray G, Boudreau D, Campbell C, Merrill J, Sullivan MD, Rutter CM, Silverberg MJ, Banta-Green C, Weisner C. De facto long-term opioid therapy for noncancer pain. Clin J Pain. 2008 Jul-Aug;24(6):521-7. doi: 10.1097/AJP.0b013e318169d03b.
citation: Bernabeo E, Holmboe ES. Patients, providers, and systems need to acquire a specific set of competencies to achieve truly patient-centered care. Health Aff (Millwood). 2013 Feb;32(2):250-8. doi: 10.1377/hlthaff.2012.1120.