Skip to main content
Top
Published in: Osteoporosis International 12/2016

01-12-2016 | Original Article

Patient-activation and guideline-concordant pharmacological treatment after bone density testing: the PAADRN randomized controlled trial

Authors: P. Cram, F. D. Wolinsky, Y. Lou, S. W. Edmonds, S. F. Hall, D. W. Roblin, N. C. Wright, M. P. Jones, K. G. Saag, on behalf of the PAADRN Investigators

Published in: Osteoporosis International | Issue 12/2016

Login to get access

Abstract

Summary

Patients often do not know or understand their bone density test results, and pharmacological treatment rates are low. In a clinical trial of 7749 patients, we used a tailored patient-activation result letter accompanied by a bone health brochure to improve appropriate pharmacological treatment. Treatment rates, however, did not improve.

Introduction

Patients often do not know or understand their dual-energy x-ray absorptiometry (DXA) test results, which may lead to suboptimal care. We tested whether usual care augmented by a tailored patient-activation DXA result letter accompanied by an educational brochure would improve guideline-concordant pharmacological treatment compared to usual care only.

Methods

We conducted a randomized, controlled, double-blinded, pragmatic clinical trial at three health care centers in the USA. We randomized 7749 patients ≥50 years old and presenting for DXA between February 2012 and August 2014. The primary clinical endpoint at 12 and 52 weeks post-DXA was receiving guideline-concordant pharmacological treatment. We also examined four of the steps along the pathway from DXA testing to that clinical endpoint, including (1) receiving and (2) understanding their DXA results and (3) having subsequent contact with their provider and (4) discussing their results and options.

Results

Mean age was 66.6 years, 83.8 % were women, and 75.3 % were non-Hispanic whites. Intention-to-treat analyses revealed that guideline-concordant pharmacological treatment was not improved at either 12 weeks (65.1 vs. 64.3 %, p = 0.506) or 52 weeks (65.2 vs. 63.8 %, p = 0.250) post-DXA, even though patients in the intervention group were more likely (all p < 0.001) to recall receiving their DXA results letter at 12 weeks, correctly identify their results at 12 and 52 weeks, have contact with their provider at 52 weeks, and have discussed their results with their provider at 12 and 52 weeks.

Conclusion

A tailored DXA result letter and educational brochure failed to improve guideline-concordant care in patients who received DXA.
Literature
1.
go back to reference World Health Organization (1994) Assessment of fracture risk and its application to screening for postmenopausal osteoporosis. Tech Rep Ser 843:1–129 World Health Organization (1994) Assessment of fracture risk and its application to screening for postmenopausal osteoporosis. Tech Rep Ser 843:1–129
2.
go back to reference Anonymous (1993) Consensus development conference: diagnosis, prophylaxis, and treatment of osteoporosis. Am J Med 94:646–650 Anonymous (1993) Consensus development conference: diagnosis, prophylaxis, and treatment of osteoporosis. Am J Med 94:646–650
3.
go back to reference Kanis JA, McCloskey EV, Johansson H, Cooper C, Rizzoli R, Reginster JY (2013) European guidance for the diagnosis and management of osteoporosis in postmenopausal women. Osteoporos Int 24:23–57CrossRefPubMed Kanis JA, McCloskey EV, Johansson H, Cooper C, Rizzoli R, Reginster JY (2013) European guidance for the diagnosis and management of osteoporosis in postmenopausal women. Osteoporos Int 24:23–57CrossRefPubMed
4.
go back to reference US Department of Health and Human Services (2004) Bone health and osteoporosis: a report of the Surgeon General. US Department of Health and Human Services, Rockville US Department of Health and Human Services (2004) Bone health and osteoporosis: a report of the Surgeon General. US Department of Health and Human Services, Rockville
5.
go back to reference National Osteoporosis Foundation (2014) Clinician’s guide to prevention and treatment of osteoporosis. National Osteoporosis Foundation, Washington, DC National Osteoporosis Foundation (2014) Clinician’s guide to prevention and treatment of osteoporosis. National Osteoporosis Foundation, Washington, DC
6.
7.
go back to reference Kanis JA, McCloskey EV, Johansson H, Strom O, Borgstrom F, Oden A (2008) Case finding for the management of osteoporosis with FRAX—assessment and intervention thresholds for the UK. Osteoporos Int 19:1395–1408CrossRefPubMed Kanis JA, McCloskey EV, Johansson H, Strom O, Borgstrom F, Oden A (2008) Case finding for the management of osteoporosis with FRAX—assessment and intervention thresholds for the UK. Osteoporos Int 19:1395–1408CrossRefPubMed
8.
go back to reference National Osteoporosis Foundation (2010) Clinician’s guide to prevention and treatment of osteoporosis. National Osteoporosis Foundation, Washington, DC National Osteoporosis Foundation (2010) Clinician’s guide to prevention and treatment of osteoporosis. National Osteoporosis Foundation, Washington, DC
9.
go back to reference Johnell O, Kanis JA (2006) An estimate of the worldwide prevalence and disability associated with osteoporotic fractures. Osteoporos Int 17:1726–1733CrossRefPubMed Johnell O, Kanis JA (2006) An estimate of the worldwide prevalence and disability associated with osteoporotic fractures. Osteoporos Int 17:1726–1733CrossRefPubMed
10.
go back to reference Wright NC, Looker AC, Saag KG, Curtis JR, Delzell ES, Randall S, Dawson-Hughes B (2014) The recent prevalence of osteoporosis and low bone mass in the United States based on bone mineral density at the femoral neck or lumbar spine. J Bone Miner Res 29:2520–2526CrossRefPubMedPubMedCentral Wright NC, Looker AC, Saag KG, Curtis JR, Delzell ES, Randall S, Dawson-Hughes B (2014) The recent prevalence of osteoporosis and low bone mass in the United States based on bone mineral density at the femoral neck or lumbar spine. J Bone Miner Res 29:2520–2526CrossRefPubMedPubMedCentral
11.
go back to reference Nelson HD, Haney EM, Chou R, Dana T, Fu R, Bougatsos C (2010) Screening for osteoporosis: systematic review to update the 2002 US Preventive Services Task Force Recommendation. Agency for Healthcare Research and Quality, Rockville Nelson HD, Haney EM, Chou R, Dana T, Fu R, Bougatsos C (2010) Screening for osteoporosis: systematic review to update the 2002 US Preventive Services Task Force Recommendation. Agency for Healthcare Research and Quality, Rockville
13.
go back to reference Amarnath AL, Franks P, Robbins JA, Xing G, Fenton JJ (2015) Underuse and overuse of osteoporosis screening in a regional health system: a retrospective cohort study. J Gen Intern Med 30:1733–1740CrossRefPubMed Amarnath AL, Franks P, Robbins JA, Xing G, Fenton JJ (2015) Underuse and overuse of osteoporosis screening in a regional health system: a retrospective cohort study. J Gen Intern Med 30:1733–1740CrossRefPubMed
14.
go back to reference U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services (2015) Your guide to Medicare’s preventive services. Centers for Medicare & Medicaid Services, Baltimore U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services (2015) Your guide to Medicare’s preventive services. Centers for Medicare & Medicaid Services, Baltimore
16.
go back to reference Liu Z, Weaver J, de Papp A, Li Z, Martin J, Allen K, Hui S, Imel EA (2016) Disparities in osteoporosis treatments. Osteoporos Int 27:509–519CrossRefPubMed Liu Z, Weaver J, de Papp A, Li Z, Martin J, Allen K, Hui S, Imel EA (2016) Disparities in osteoporosis treatments. Osteoporos Int 27:509–519CrossRefPubMed
17.
go back to reference Cram P, Rosenthal GE, Ohsfeldt R, Wallace RB, Schlechte J, Schiff GD (2005) Failure to recognize and act on abnormal test results: the case of screening bone densitometry. Jt Comm J Qual Patient Saf 31:90–97PubMed Cram P, Rosenthal GE, Ohsfeldt R, Wallace RB, Schlechte J, Schiff GD (2005) Failure to recognize and act on abnormal test results: the case of screening bone densitometry. Jt Comm J Qual Patient Saf 31:90–97PubMed
18.
go back to reference Pickney CS, Arnason JA (2005) Correlation between patient recall of bone densitometry results and subsequent treatment adherence. Osteoporos Int 16:1156–1160CrossRefPubMed Pickney CS, Arnason JA (2005) Correlation between patient recall of bone densitometry results and subsequent treatment adherence. Osteoporos Int 16:1156–1160CrossRefPubMed
19.
go back to reference Cadarette SM, Beaton DE, Gignac MA, Jaglal SB, Dickson L, Hawker GA (2007) Minimal error in self-report of having had DXA, but self-report of its results was poor. J Clin Epidemiol 60:1306–1311CrossRefPubMed Cadarette SM, Beaton DE, Gignac MA, Jaglal SB, Dickson L, Hawker GA (2007) Minimal error in self-report of having had DXA, but self-report of its results was poor. J Clin Epidemiol 60:1306–1311CrossRefPubMed
20.
go back to reference Majumdar SR, McAlister FA, Johnson JA et al (2012) Interventions to increase osteoporosis treatment in patients with ‘incidentally’ detected vertebral fractures. Am J Med 125:929–936CrossRefPubMed Majumdar SR, McAlister FA, Johnson JA et al (2012) Interventions to increase osteoporosis treatment in patients with ‘incidentally’ detected vertebral fractures. Am J Med 125:929–936CrossRefPubMed
21.
go back to reference Ciaschini PM, Straus SE, Dolovich LR et al (2010) Community based intervention to optimize osteoporosis management: randomized controlled trial. BMC Geriatr 10:60CrossRefPubMedPubMedCentral Ciaschini PM, Straus SE, Dolovich LR et al (2010) Community based intervention to optimize osteoporosis management: randomized controlled trial. BMC Geriatr 10:60CrossRefPubMedPubMedCentral
22.
go back to reference Majumdar SR, Johnson JA, McAlister FA, Bellerose D, Russell AS, Hanley DA, Morrish DW, Maksymowych WP, Rowe BH (2008) Multifaceted intervention to improve diagnosis and treatment of osteoporosis in patients with recent wrist fracture: a randomized controlled trial. CMAJ 178:569–575CrossRefPubMedPubMedCentral Majumdar SR, Johnson JA, McAlister FA, Bellerose D, Russell AS, Hanley DA, Morrish DW, Maksymowych WP, Rowe BH (2008) Multifaceted intervention to improve diagnosis and treatment of osteoporosis in patients with recent wrist fracture: a randomized controlled trial. CMAJ 178:569–575CrossRefPubMedPubMedCentral
23.
go back to reference Majumdar SR, Johnson JA, Lier DA et al (2007) Persistence, reproducibility, and cost-effectiveness of an intervention to improve the quality of osteoporosis care after a fracture of the wrist: results of a controlled trial. Osteoporos Int 18:261–270CrossRefPubMed Majumdar SR, Johnson JA, Lier DA et al (2007) Persistence, reproducibility, and cost-effectiveness of an intervention to improve the quality of osteoporosis care after a fracture of the wrist: results of a controlled trial. Osteoporos Int 18:261–270CrossRefPubMed
24.
go back to reference Majumdar SR, Rowe BH, Folk D et al (2004) A controlled trial to increase detection and treatment of osteoporosis in older patients with a wrist fracture. Ann Intern Med 141:366–373CrossRefPubMed Majumdar SR, Rowe BH, Folk D et al (2004) A controlled trial to increase detection and treatment of osteoporosis in older patients with a wrist fracture. Ann Intern Med 141:366–373CrossRefPubMed
25.
go back to reference Leslie WD, LaBine L, Klassen P, Dreilich D, Caetano PA (2012) Closing the gap in postfracture care at the population level: a randomized controlled trial. CMAJ 184:290–296CrossRefPubMedPubMedCentral Leslie WD, LaBine L, Klassen P, Dreilich D, Caetano PA (2012) Closing the gap in postfracture care at the population level: a randomized controlled trial. CMAJ 184:290–296CrossRefPubMedPubMedCentral
26.
go back to reference Outman RC, Curtis JR, Locher JL, Allison JJ, Saag KG, Kilgore ML (2012) Improving osteoporosis care in high-risk home health patients through a high-intensity intervention. Contemp Clin Trials 33:206–212CrossRefPubMed Outman RC, Curtis JR, Locher JL, Allison JJ, Saag KG, Kilgore ML (2012) Improving osteoporosis care in high-risk home health patients through a high-intensity intervention. Contemp Clin Trials 33:206–212CrossRefPubMed
27.
go back to reference Cranney A, Lam M, Ruhland L, Brison R, Godwin M, Harrison MM, Harrison MB, Anastassiades T, Grimshaw JM, Graham ID (2008) A multifaceted intervention to improve treatment of osteoporosis in postmenopausal women with wrist fractures: a cluster randomized trial. Osteoporos Int 19:1733–1740CrossRefPubMed Cranney A, Lam M, Ruhland L, Brison R, Godwin M, Harrison MM, Harrison MB, Anastassiades T, Grimshaw JM, Graham ID (2008) A multifaceted intervention to improve treatment of osteoporosis in postmenopausal women with wrist fractures: a cluster randomized trial. Osteoporos Int 19:1733–1740CrossRefPubMed
28.
go back to reference Warriner AH, Outman RC, Feldstein AC et al (2014) Effect of self-referral on bone mineral density testing and osteoporosis treatment. Med Care 52:743–750CrossRefPubMedPubMedCentral Warriner AH, Outman RC, Feldstein AC et al (2014) Effect of self-referral on bone mineral density testing and osteoporosis treatment. Med Care 52:743–750CrossRefPubMedPubMedCentral
29.
go back to reference Morisky DE, Bowler MH, Finlay JS (1982) An educational and behavioral approach toward increasing patient activation in hypertension management. J Commun Health 7:171–182CrossRef Morisky DE, Bowler MH, Finlay JS (1982) An educational and behavioral approach toward increasing patient activation in hypertension management. J Commun Health 7:171–182CrossRef
30.
go back to reference Hibbard JH, Greene J (2013) What the evidence shows about patient activation: better health outcomes and care experiences; fewer data on costs. Health Aff 32:207–214CrossRef Hibbard JH, Greene J (2013) What the evidence shows about patient activation: better health outcomes and care experiences; fewer data on costs. Health Aff 32:207–214CrossRef
31.
go back to reference Hibbard JH, Stockard J, Mahoney ER, Tusler M (2004) Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res 39:1005–1026CrossRefPubMedPubMedCentral Hibbard JH, Stockard J, Mahoney ER, Tusler M (2004) Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res 39:1005–1026CrossRefPubMedPubMedCentral
32.
go back to reference Hibbard J, Gilburt H (2014) Supporting people to manage their health: an introduction to patient activation. The King’s Fund, London Hibbard J, Gilburt H (2014) Supporting people to manage their health: an introduction to patient activation. The King’s Fund, London
33.
go back to reference Greene J, Hibbard JH (2012) Why does patient activation matter? An examination of the relationships between patient activation and health-related outcomes. J Gen Intern Med 27:520–526CrossRefPubMed Greene J, Hibbard JH (2012) Why does patient activation matter? An examination of the relationships between patient activation and health-related outcomes. J Gen Intern Med 27:520–526CrossRefPubMed
34.
go back to reference Marshall R, Beach MC, Saha S, Mori T, Loveless MO, Hibbard JH, Cohn JA, Sharp VL, Korthuis PT (2013) Patient activation and improved outcomes in HIV-infected patients. J Gen Intern Med 28:668–674CrossRefPubMedPubMedCentral Marshall R, Beach MC, Saha S, Mori T, Loveless MO, Hibbard JH, Cohn JA, Sharp VL, Korthuis PT (2013) Patient activation and improved outcomes in HIV-infected patients. J Gen Intern Med 28:668–674CrossRefPubMedPubMedCentral
35.
go back to reference Mitchell SE, Gardiner PM, Sadikova E, Martin JM, Jack BW, Hibbard JH, Paasche-Orlow MK (2014) Patient activation and 30-day post-discharge hospital utilization. J Gen Intern Med 29:349–355CrossRefPubMed Mitchell SE, Gardiner PM, Sadikova E, Martin JM, Jack BW, Hibbard JH, Paasche-Orlow MK (2014) Patient activation and 30-day post-discharge hospital utilization. J Gen Intern Med 29:349–355CrossRefPubMed
36.
go back to reference Pilling SA, Williams MB, Brackett RH, Gourley R, Weg MW, Christensen AJ, Kaboli PJ, Reisinger HS (2010) Part I, patient perspective: activating patients to engage their providers in the use of evidence-based medicine: a qualitative evaluation of the VA Project to Implement Diuretics (VAPID). Implement Sci 5:23CrossRefPubMedPubMedCentral Pilling SA, Williams MB, Brackett RH, Gourley R, Weg MW, Christensen AJ, Kaboli PJ, Reisinger HS (2010) Part I, patient perspective: activating patients to engage their providers in the use of evidence-based medicine: a qualitative evaluation of the VA Project to Implement Diuretics (VAPID). Implement Sci 5:23CrossRefPubMedPubMedCentral
38.
go back to reference McLeod KM, McCann SE, Horvath PJ, Wactawski-Wende J (2007) Predictors of change in calcium intake in postmenopausal women after osteoporosis screening. J Nutr 137:1968–1973PubMed McLeod KM, McCann SE, Horvath PJ, Wactawski-Wende J (2007) Predictors of change in calcium intake in postmenopausal women after osteoporosis screening. J Nutr 137:1968–1973PubMed
39.
go back to reference Winzenberg T, Oldenburg B, Frendin S, De Wit L, Riley M, Jones G (2006) The effect on behavior and bone mineral density of individualized bone mineral density feedback and educational interventions in premenopausal women: a randomized controlled trial. BMC Public Health 6:12CrossRefPubMedPubMedCentral Winzenberg T, Oldenburg B, Frendin S, De Wit L, Riley M, Jones G (2006) The effect on behavior and bone mineral density of individualized bone mineral density feedback and educational interventions in premenopausal women: a randomized controlled trial. BMC Public Health 6:12CrossRefPubMedPubMedCentral
40.
go back to reference Edmonds SW, Wolinsky FD, Christensen AJ, Lu X, Jones MP, Roblin DW, Saag KG, Cram P (2013) The PAADRN Study: a design for a randomized controlled practical clinical trial to improve bone health. Contemp Clin Trials 34:90–100CrossRefPubMed Edmonds SW, Wolinsky FD, Christensen AJ, Lu X, Jones MP, Roblin DW, Saag KG, Cram P (2013) The PAADRN Study: a design for a randomized controlled practical clinical trial to improve bone health. Contemp Clin Trials 34:90–100CrossRefPubMed
41.
go back to reference R Development Core Team (2015) A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna R Development Core Team (2015) A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna
42.
go back to reference Edmonds SW, Solimeo SL, Lu X, Roblin DW, Saag KG, Cram P (2014) Developing a bone mineral density test result letter to send to patients: a mixed-methods study. Patient Prefer Adherence 8:827–841CrossRefPubMedPubMedCentral Edmonds SW, Solimeo SL, Lu X, Roblin DW, Saag KG, Cram P (2014) Developing a bone mineral density test result letter to send to patients: a mixed-methods study. Patient Prefer Adherence 8:827–841CrossRefPubMedPubMedCentral
43.
go back to reference Edmonds SW, Cram P, Lu X, Roblin DW, Wright NC, Saag KG, Solimeo SL (2014) Improving bone mineral density reporting to patients with an illustration of personal fracture risk. BMC Med Inform Decis Mak 14:101CrossRefPubMedPubMedCentral Edmonds SW, Cram P, Lu X, Roblin DW, Wright NC, Saag KG, Solimeo SL (2014) Improving bone mineral density reporting to patients with an illustration of personal fracture risk. BMC Med Inform Decis Mak 14:101CrossRefPubMedPubMedCentral
44.
go back to reference Edmonds SW, Solimeo SL, Nguyen VT, Wright NC, Roblin DW, Saag KG, Cram P. (2016). Understanding preferences for osteoporosis information to develop an osteoporosis-patient education brochure. Perm J Edmonds SW, Solimeo SL, Nguyen VT, Wright NC, Roblin DW, Saag KG, Cram P. (2016). Understanding preferences for osteoporosis information to develop an osteoporosis-patient education brochure. Perm J
45.
go back to reference Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG (2009) Research electronic data capture (REDCap)—a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Info 42:377–381CrossRef Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG (2009) Research electronic data capture (REDCap)—a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Info 42:377–381CrossRef
Metadata
Title
Patient-activation and guideline-concordant pharmacological treatment after bone density testing: the PAADRN randomized controlled trial
Authors
P. Cram
F. D. Wolinsky
Y. Lou
S. W. Edmonds
S. F. Hall
D. W. Roblin
N. C. Wright
M. P. Jones
K. G. Saag
on behalf of the PAADRN Investigators
Publication date
01-12-2016
Publisher
Springer London
Published in
Osteoporosis International / Issue 12/2016
Print ISSN: 0937-941X
Electronic ISSN: 1433-2965
DOI
https://doi.org/10.1007/s00198-016-3681-9

Other articles of this Issue 12/2016

Osteoporosis International 12/2016 Go to the issue