PAADRN: Patient Activation After DXA Result Notification

• Sponsor: Fredric D Wolinsky (Other)
• Overall Status: Completed
• CT.gov ID: NCT01507662
• Collaborator: University of Alabama at Birmingham (Other), Kaiser Permanente (Other), University of Toronto (Other), University of Pittsburgh (Other)
• Enrollment: 7,749
• Locations: 4
• Arms: 2
• Duration (Months): 45
• Patients Per Site: 1937.3
• Patients Per Site Per Month: 43.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis; Bone Diseases, Metabolic	Behavioral: Bone Mineral Density Result Letter and Bone Health Brochure	N/A

Detailed Description

Bone mineral density (BMD) peaks in early adulthood and declines progressively with aging. As BMD declines from normal, to low (formerly called osteopenia), to osteoporosis, risk of fractures progressively increases. In an effort to prevent bone loss and reduce fracture risk, most widely accepted guidelines including the U.S. Preventive Services Task Force and Surgeon General's Office now recommend BMD screening of older adults using dual energy x-ray absorptiometry (DXA). The rationale for screening is that patients and their providers will use DXA results as a "cue to action" and take necessary steps to enhance bone health through lifestyle modification (e.g., weight bearing exercise), Calcium/Vitamin D supplementation, and pharmacotherapy when indicated. However, multiple studies have demonstrated that patients and providers often fail take recommended actions following DXA testing, thus defeating much of the purpose of screening. Over the past five years we have systematically developed and pilot tested a low-cost and practical patient activation intervention based upon the Health Belief Model. The intervention consists of the DXA scanning center mailing each patient a customized letter containing the results of their DXA scan plus educational information about osteoporosis, supplemented by a follow-up phone call from a nurse educator. Preliminary studies have demonstrated that the intervention is well received by both patients and providers and enhances bone-related quality of care. The overarching objective of the current proposal is to rigorously examine the impact of our patient activation intervention on bone-related quality of care in adults undergoing screening DXA scans through a randomized-controlled trial conducted at three study sites. In addition, we will examine the real-world costs associated with our intervention and the impact of our intervention on the overall cost-effectiveness of BMD screening. We hypothesize that the activation intervention will increase optimization of Calcium/Vitamin D intake, enhance use of pharmacotherapy when indicated, will improve patient satisfaction with their bone-related healthcare, and improve patients' osteoporosis specific knowledge when compared with usual care

Study Design

• Study Type: Interventional
• Actual Enrollment: 7749 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Health Services Research
• Official Title: Patient Activation After DXA Result Notification
• Study Start Date: Feb 1, 2012
• Actual Primary Completion Date: Nov 1, 2015
• Actual Study Completion Date: Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BMD Result Letter and Brochure Patients who receive the intervention - BMD result letter with brochure.	Behavioral: Bone Mineral Density Result Letter and Bone Health Brochure; 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.
No Intervention: Control Those who received usual care

Outcome Measures

Primary Outcome Measures

1. Guideline Concordant Osteoporosis Therapy [12 weeks after DXA]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. patients presenting for DXA

2. age 50 years of age or older

Exclusion Criteria:

1. non-English speakers

2. prisoners

3. people who have mental disabilities

4. individuals younger than age 50 years

5. individuals who do not have access to a telephone

6. deaf patients

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	Kaiser Permanente Georgia	Atlanta	Georgia	United States	30305
3	University of Iowa	Iowa City	Iowa	United States	52242
4	University of Toronto	Toronto	Ontario	Canada	M5S 1A1

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Fredric Wolinsky, PhD, University of Iowa

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.

• Responsible Party: Fredric D Wolinsky, Professor, University of Iowa
• ClinicalTrials.gov Identifier: NCT01507662
• Other Study ID Numbers: 201107758
• First Posted: Jan 11, 2012
• Last Update Posted: Nov 10, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Fredric D Wolinsky, Professor, University of Iowa: Bone Density; Absorptiometry, Photon; Osteoporosis; Bone, Diseases, Metabolic; Patient Education as Topic; Fractures, Bone/Prevention and Control
• Additional relevant MeSH terms: Osteoporosis; Bone Diseases; Bone Diseases, Metabolic; Metabolic Diseases

Study Results

Participant Flow

Recruitment Details	Patients presenting for DXA centers were recruited through February 2012 to August 2014 at three health centers-the University of Iowa (UI), the University of Alabama at Birmingham (UAB), and Kaiser Permanente of Georgia (KPGA).

Arm/Group Title	BMD Result Letter and Brochure	Control
Arm/Group Description	Patients who receive the intervention - BMD result letter with brochure Bone Mineral Density Result Letter and Bone Health Brochure: 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.	Usual care
Period Title: Overall Study
STARTED	3898	3851
COMPLETED	3082	3020
NOT COMPLETED	816	831

Baseline Characteristics

Arm/Group Title	BMD Result Letter and Brochure	Control	Total
Arm/Group Description	Patients who receive the intervention - BMD result letter with brochure Bone Mineral Density Result Letter and Bone Health Brochure: 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.	Usual care	Total of all reporting groups
Overall Participants	3898	3851	7749
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.5 (8.4)	66.7 (8.2)	66.6 (8.3)
Sex: Female, Male (Count of Participants)
Female	3259 83.6%	3230 83.9%	6489 83.7%
Male	639 16.4%	621 16.1%	1260 16.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	74 1.9%	77 2%	151 1.9%
Not Hispanic or Latino	3824 98.1%	3774 98%	7598 98.1%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	4 0.1%	3 0.1%	7 0.1%
Asian	37 0.9%	43 1.1%	80 1%
Native Hawaiian or Other Pacific Islander	0 0%	1 0%	1 0%
Black or African American	842 21.6%	814 21.1%	1656 21.4%
White	2981 76.5%	2954 76.7%	5935 76.6%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	34 0.9%	36 0.9%	70 0.9%
Region of Enrollment (participants) [Number]
United States	3898 100%	3851 100%	7749 100%

Outcome Measures

1. Primary Outcome

Title	Guideline Concordant Osteoporosis Therapy
Description	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.
Time Frame	12 weeks after DXA

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BMD Result Letter and Brochure	Control
Arm/Group Description	Patients who receive the intervention - BMD result letter with brochure Bone Mineral Density Result Letter and Bone Health Brochure: 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.	Usual care
Measure Participants	3898	3851
Count of Participants [Participants]	2537 65.1%	2477 64.3%

Adverse Events

Time Frame	Due to the minimal risk nature of our study we did not collect adverse event data. We did track people for one year after enrollment.
Adverse Event Reporting Description	Due to the minimal risk nature of our study we did not collect adverse event data.
Arm/Group Title	BMD Result Letter and Brochure		Control
Arm/Group Description	Patients who receive the intervention - BMD result letter with brochure Bone Mineral Density Result Letter and Bone Health Brochure: 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.		Usual care
All Cause Mortality
	BMD Result Letter and Brochure		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	26/3898 (0.7%)		18/3851 (0.5%)
Serious Adverse Events
	BMD Result Letter and Brochure		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	BMD Result Letter and Brochure		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.