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

NCT02290223 | Completed Results DMC

• 1 other identifier: CN-14-1928-H
• Study Type: interventional
• Target: 376
• Locations: 1 country
• Sites: 2

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?

Conditions

Chronic Pain

Keywords

Chronic pain; Analgesics, Opioid; Cognitive Therapy; Behavior Therapy; Mindfulness; Psychophysiology; Biofeedback, Psychology

Outcome Measures

Primary Outcomes (1)

• Patient Activation

  The 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.Each item is rated 1-4 (strongly disagree =1 to strongly agree=4) and a total raw score is generated (0-52). Raw scores are converted to activation scores using a published conversion table. PAM scores are reported on a 1-100 scale, with higher scores associated with positive health outcomes such as participation in health care and treatment adherence.

  Baseline and 6 and 12 months post randomization

Secondary Outcomes (26)

• Quality of Life: Physical Health

  Baseline and 6 and 12 months post randomization

• Quality of Life: Mental Health

  Baseline and 6 and 12 months post randomization

• Overall Health

  Baseline and 6 and 12 months post randomization

• PHQ-9 Depression

  Baseline and 6 and 12 months post randomization

• Satisfaction With Care

  Baseline and 6 and 12 months post randomization

Study Arms (2)

Patient Activation Group Intervention

EXPERIMENTAL

The experimental procedure is a behavioral based treatment model, plus usual care which is is determined by patients' individual providers, according to practice guidelines related to specific conditions.

Behavioral: Behavioral Based Treatment Model

Usual Care

NO INTERVENTION

Usual care is determined by patients' individual providers, according to practice guidelines related to specific conditions.

Interventions

Behavioral Based Treatment Model BEHAVIORAL

Behavioral based treatment consists of four 90 minute group sessions, one meeting per week. The sessions addressed: empowering patients to take an active role in pain management and overall health; pain management lifestyle practices; use of health information technology resources for active self-care; education on neurobiology of pain and opioids; and improving communication with providers.

Patient Activation Group Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaiser Permanente: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (2)

Kaiser Permanente, San Jose Medical Center

San Jose, California, 95119, United States

Location

Kaiser Permanente, Santa Clara Medical Center

Santa Clara, California, 95051, United States

Location

Related Publications (79)

• 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/

  PMID: 22553896 BACKGROUND

• 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.

  PMID: 11323140 BACKGROUND

• 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.

  PMID: 19718704 BACKGROUND

• 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.

  PMID: 15157714 BACKGROUND

• Ballantyne JC. Pain medicine: repairing a fractured dream. Anesthesiology. 2011 Feb;114(2):243-6. doi: 10.1097/ALN.0b013e3182039f87. No abstract available.

  PMID: 21239973 BACKGROUND

• 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.

  PMID: 19124635 BACKGROUND

• 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.

  PMID: 21862533 BACKGROUND

• 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.

  PMID: 21670333 BACKGROUND

• 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.

  PMID: 20837826 BACKGROUND

• 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.

  PMID: 20083830 BACKGROUND

• 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.

  PMID: 21083382 BACKGROUND

• 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.

  PMID: 21482847 BACKGROUND

• 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.

  PMID: 21893626 BACKGROUND

• 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.

  PMID: 19187890 BACKGROUND

• 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.

  PMID: 19187889 BACKGROUND

• 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.

  PMID: 20533971 BACKGROUND

• 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.

  PMID: 20334974 BACKGROUND

• 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.

  PMID: 22412109 BACKGROUND

• 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.

  PMID: 21467287 BACKGROUND

• 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.

  PMID: 22048730 BACKGROUND

• 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.

  PMID: 19796521 BACKGROUND

• 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.

  PMID: 20409500 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 21821559 BACKGROUND

• 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.

  PMID: 22778117 BACKGROUND

• 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.

  PMID: 19643676 BACKGROUND

• 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.

  PMID: 17244101 BACKGROUND

• 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.

  PMID: 21044259 BACKGROUND

• 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.

  PMID: 23916677 BACKGROUND

• 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.

  PMID: 22566443 BACKGROUND

• 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.

  PMID: 21029353 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 21474265 BACKGROUND

• 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.

  PMID: 23381511 BACKGROUND

• 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.

  PMID: 10488010 BACKGROUND

• Driessen E, Hollon S. Motivational interviewing from a cognitive behavioral perspective. Cogn Behav Pract. 2011;18:70-73

  BACKGROUND

• 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.

  PMID: 20423957 BACKGROUND

• Miller WR, Rollnick S, eds. Motivational Interviewing : Preparing People for Change. 2nd ed. New York: Guildord Press; 2002

  BACKGROUND

• 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.

  PMID: 23440672 BACKGROUND

• 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.

  PMID: 24281273 BACKGROUND

• 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.

  PMID: 18028043 BACKGROUND

• 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.

  PMID: 18950440 BACKGROUND

• 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.

  PMID: 15102235 BACKGROUND

• 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.

  PMID: 14659516 BACKGROUND

• 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.

  PMID: 23836747 BACKGROUND

• 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/

  PMID: 25009856 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 22827502 BACKGROUND

• 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.

  PMID: 11594896 BACKGROUND

• Cohen J. Statistical Power Analysis for the Behavioral Sciences. 2nd ed. Hillsdale, NJ: Lawrence Erlbaum Associates; 1988

  BACKGROUND

• 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.

  PMID: 17634969 BACKGROUND

• 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.

  PMID: 9699234 BACKGROUND

• 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.

  PMID: 17060538 BACKGROUND

• 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.

  PMID: 11055449 BACKGROUND

• 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.

  PMID: 19728074 BACKGROUND

• 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.

  PMID: 16336556 BACKGROUND

• 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.

  PMID: 15230939 BACKGROUND

• 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.

  PMID: 17170635 BACKGROUND

• 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.

  PMID: 18030539 BACKGROUND

• 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.

  PMID: 19060254 BACKGROUND

• PROMIS Network Center. PROMIS (Patient Reported Outcome Measurement Information System). USA.gov. http://www.nihpromis.org/?AspxAutoDetectCookieSupport=1#3. Accessed January 18, 2014

  BACKGROUND

• 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.

  PMID: 25848562 BACKGROUND

• 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.

  PMID: 22034123 BACKGROUND

• 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.

  PMID: 22422138 BACKGROUND

• 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.

  PMID: 23497200 BACKGROUND

• 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.

  PMID: 23387911 BACKGROUND

• 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.

  PMID: 10109801 BACKGROUND

• 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.

  PMID: 23815777 BACKGROUND

• 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.

  PMID: 17574367 BACKGROUND

• 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.

  PMID: 18571875 BACKGROUND

• 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.

  PMID: 18574361 BACKGROUND

• 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.

  PMID: 23381517 RESULT

• Does MB, Adams SR, Kline-Simon AH, Marino C, Charvat-Aguilar N, Weisner CM, Rubinstein AL, Ghadiali M, Cowan P, Young-Wolff KC, Campbell CI. A patient activation intervention in primary care for patients with chronic pain on long term opioid therapy: results from a randomized control trial. BMC Health Serv Res. 2024 Jan 22;24(1):112. doi: 10.1186/s12913-024-10558-3.

  PMID: 38254073 DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Monique Does, Project Manager
• Organization: Kaiser NCAL Division of Research

monique.does@kp.org

510-891-3612

Study Officials

• Cynthia I Campbell, PhD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2014
• First Posted: November 14, 2014
• Study Start: June 1, 2015
• Primary Completion: September 6, 2017
• Study Completion: September 6, 2017
• Last Updated: October 18, 2019
• Results First Posted: October 18, 2019

Record last verified: 2019-09

Locations

US (2)