Patient Activation After DXA Result Notification

NCT01507662 | Completed Results DMC

• 1 other identifier: 201107758
• Study Type: interventional
• Target: 7,749
• Locations: 2 countries
• Sites: 4

Brief Summary

There is growing evidence that patients undergoing bone mineral density testing (BMD) often do not take important steps to improve their bone health. The investigators will conduct a randomized-controlled trial to evaluate the impact of a novel and practical patient activation intervention (mailing patients their bone density test results) on the quality of bone-related healthcare and the cost-effectiveness of BMD testing. Equally important, the investigators intervention could easily be modified to include other patient populations and chronic diseases.

Conditions

Osteoporosis; Bone Diseases, Metabolic

Keywords

Bone Density; Absorptiometry, Photon; Osteoporosis; Bone, Diseases, Metabolic; Patient Education as Topic; Fractures, Bone/Prevention and Control

Outcome Measures

Primary Outcomes (1)

• Guideline Concordant Osteoporosis Therapy

  Guideline concordant was defined as those who prescribed a National Osteoporosis Foundation approved osteoporosis therapy for patients with osteoporosis (T-score of femoral neck, hip, or spine ≤-2.5 or FRAX ≥20 %), or patients with a self-reported history of low impact fracture, or patients with osteopenia (T-score between -1.0 and -2.5 at the femoral neck, hips, or lumbar spine) and a 10-year probability of a major osteoporosis-related fracture ≥20 % OR those who were not prescribed a therapy for patients with no self-reported history of prior DXA and study DXA shows normal BMD and no self-reported history of low impact fracture, or study DXA shows osteopenia (T-score of femoral neck, hip, or spine between -1 and -2.5) and FRAX \<20 %) and no self-reported history of low impact fracture, or self-reported prior DXA but no self-reported history of low impact fracture and no self-reported history of osteoporosis.

  12 weeks after DXA

Study Arms (2)

BMD Result Letter and Brochure

EXPERIMENTAL

Patients who receive the intervention - BMD result letter with brochure.

Behavioral: Bone Mineral Density Result Letter and Bone Health Brochure

Control

NO INTERVENTION

Those who received usual care

Interventions

Bone Mineral Density Result Letter and Bone Health Brochure BEHAVIORAL

Letter mailed to patient to include - Date of DXA, T-score, impression, 10 year major fracture risk with visual depiction of risk, basic bone health guidelines, instructions to follow-up with their healthcare provider. The brochure will include information on osteoporosis, calcium, vitamin D, medicines, exercise, tobacco and alcohol cessation and where to find more information.

BMD Result Letter and Brochure

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients presenting for DXA
• age 50 years of age or older

You may not qualify if:

• non-English speakers
• prisoners
• people who have mental disabilities
• individuals younger than age 50 years
• individuals who do not have access to a telephone
• deaf patients

Sponsors & Collaborators

• Fredric D Wolinsky: lead
• University of Alabama at Birmingham: collaborator
• Kaiser Permanente: collaborator
• University of Toronto: collaborator
• University of Pittsburgh: collaborator

Study Sites (4)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Kaiser Permanente Georgia

Atlanta, Georgia, 30305, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

University of Toronto

Toronto, Ontario, M5S 1A1, Canada

Location

Related Publications (14)

• Edmonds SW, Wolinsky FD, Christensen AJ, Lu X, Jones MP, Roblin DW, Saag KG, Cram P; PAADRN Investigators. The PAADRN study: a design for a randomized controlled practical clinical trial to improve bone health. Contemp Clin Trials. 2013 Jan;34(1):90-100. doi: 10.1016/j.cct.2012.10.002. Epub 2012 Oct 17.

  PMID: 23085132 BACKGROUND

• Edmonds SW, Solimeo SL, Lu X, Roblin DW, Saag KG, Cram P. Developing a bone mineral density test result letter to send to patients: a mixed-methods study. Patient Prefer Adherence. 2014 Jun 5;8:827-41. doi: 10.2147/PPA.S60106. eCollection 2014.

  PMID: 24940049 BACKGROUND

• Edmonds SW, Cram P, Lu X, Roblin DW, Wright NC, Saag KG, Solimeo SL; PAADRN Investigators. Improving bone mineral density reporting to patients with an illustration of personal fracture risk. BMC Med Inform Decis Mak. 2014 Nov 25;14:101. doi: 10.1186/s12911-014-0101-y.

  PMID: 25743200 BACKGROUND

• Edmonds SW, Solimeo SL, Nguyen VT, Wright NC, Roblin DW, Saag KG, Cram P. Understanding Preferences for Osteoporosis Information to Develop an Osteoporosis Patient Education Brochure. Perm J. 2017;21:16-024. doi: 10.7812/TPP/16-024. Epub 2016 Nov 18.

  PMID: 28080957 BACKGROUND

• Edmonds SW, Cram P, Lou Y, Jones MP, Roblin DW, Saag KG, Wright NC, Wolinsky FD; PAADRN Investigators. Effects of a DXA result letter on satisfaction, quality of life, and osteoporosis knowledge: a randomized controlled trial. BMC Musculoskelet Disord. 2016 Aug 26;17(1):369. doi: 10.1186/s12891-016-1227-0.

  PMID: 27562713 RESULT

• Wolinsky FD, Lou Y, Edmonds SW, Hall SF, Jones MP, Wright NC, Saag KG, Cram P, Roblin DW; PAADRN Investigators. Activating Patients With a Tailored Bone Density Test Results Letter and Educational Brochure: the PAADRN Randomized Controlled Trial. J Clin Densitom. 2017 Oct-Dec;20(4):464-471. doi: 10.1016/j.jocd.2016.08.012. Epub 2016 Sep 16.

  PMID: 27647261 RESULT

• Cram P, Wolinsky FD, Lou Y, Edmonds SW, Hall SF, Roblin DW, Wright NC, Jones MP, Saag KG; PAADRN Investigators. Patient-activation and guideline-concordant pharmacological treatment after bone density testing: the PAADRN randomized controlled trial. Osteoporos Int. 2016 Dec;27(12):3513-3524. doi: 10.1007/s00198-016-3681-9. Epub 2016 Jun 30.

  PMID: 27363400 RESULT

• Roblin DW, Cram P, Lou Y, Edmonds SW, Hall SF, Jones MP, Saag KG, Wright NC, Cromwell LF, Robinson BE, Wolinsky FD; PAADRN Investigators. The Contribution of Patient, Primary Care Physician, and Primary Care Clinic Factors to Good Bone Health Care. Perm J. 2021 Jan;25:1-3. doi: 10.7812/TPP/20.095.

  PMID: 33635767 DERIVED

• Solimeo SL, Nguyen VT, Edmonds SW, Lou Y, Roblin DW, Saag KG, Cram P, Wolinsky FD. Sex differences in osteoporosis self-efficacy among community-residing older adults presenting for DXA. Osteoporos Int. 2019 May;30(5):1033-1041. doi: 10.1007/s00198-019-04854-6. Epub 2019 Jan 30.

  PMID: 30701343 DERIVED

• Hall SF, Wright NC, Wolinsky FD, Lou Y, Edmonds S, Roblin D, Jones M, Saag K, Cram P. The prevalence of overtreatment of osteoporosis: results from the PAADRN trial. Arch Osteoporos. 2018 Sep 28;13(1):103. doi: 10.1007/s11657-018-0517-6.

  PMID: 30267162 DERIVED

• Roblin DW, Cram P, Lou Y, Edmonds SW, Hall SF, Jones MP, Saag KG, Wright NC, Wolinsky FD; PAADRN Investigators. Diet and exercise changes following bone densitometry in the Patient Activation After DXA Result Notification (PAADRN) study. Arch Osteoporos. 2018 Jan 6;13(1):4. doi: 10.1007/s11657-017-0402-8.

  PMID: 29307094 DERIVED

• Wolinsky FD, Hall SF, Lou Y, Edmonds SW, Saag KG, Roblin DW, Wright NC, Jones MP, Cram P; PAADRN Investigators; Curtis JR, Morgan SL, Schlechte JA, Williams JH, Zelman DJ. The cost of a patient activation intervention for achieving successful outcomes: results from the PAADRN randomized controlled trial. Osteoporos Int. 2017 Oct;28(10):3061-3066. doi: 10.1007/s00198-017-4113-1. Epub 2017 Jun 15.

  PMID: 28620779 DERIVED

• Wolinsky FD, Lou Y, Edmonds SW, Saag KG, Roblin DW, Wright NC, Jones MP, Cram P; PAADRN Investigators. The effects of a patient activation intervention on smoking and excessive drinking cessations: results from the PAADRN randomized controlled trial. Osteoporos Int. 2017 Oct;28(10):3055-3060. doi: 10.1007/s00198-017-4101-5. Epub 2017 Jun 1.

  PMID: 28573377 DERIVED

• Cram P, Saag KG, Lou Y, Edmonds SW, Hall SF, Roblin DW, Wright NC, Jones MP, Wolinsky FD; PAADRN Investigators*. Racial Differences and Disparities in Osteoporosis-related Bone Health: Results From the PAADRN Randomized Controlled Trial. Med Care. 2017 Jun;55(6):561-568. doi: 10.1097/MLR.0000000000000718.

  PMID: 28288074 DERIVED

MeSH Terms

Conditions

Osteoporosis; Bone Diseases, Metabolic; Fractures, Bone

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Wounds and Injuries

Results Point of Contact

• Title: Dr. Fredric Wolinsky
• Organization: University of Iowa

fredric-wolinsky@uiowa.edu

(319) 384-3821

Study Officials

• Fredric Wolinsky, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 8, 2011
• First Posted: January 11, 2012
• Study Start: February 1, 2012
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: November 10, 2020
• Results First Posted: April 11, 2017

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (3)