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

ABSTRACT: 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.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.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.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?

SUBMITTER: Cram P

PROVIDER: S-EPMC5572571 | biostudies-literature | 2016 Dec

REPOSITORIES: biostudies-literature

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

Cram P P Wolinsky F D FD Lou Y Y Edmonds S W SW Hall S F SF Roblin D W DW Wright N C NC Jones M P MP Saag K G KG

Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA 20160630 12

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.<h4>Introduction</h4>Patients often do not know or understand their dual-energy x-ray absorptiometry (DXA) test results, which may lead to suboptimal care. We te ...[more]

PMID: 27363400

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Project description:Calcium and vitamin D intake and exercise are suboptimal among older adults. Following bone densitometry, a letter communicating individualized fracture risk accompanied by an educational brochure improved participants' lifestyle-but no more than existing communication strategies-over 52 weeks. Simple communication strategies are insufficient for achieving optimal levels of bone health behaviors. PURPOSE:The Patient Activation After DXA Result Notification (PAADRN) study was designed to evaluate whether a letter with individualized fracture risk and an educational brochure mailed to patients soon after their DXA might improve bone health behaviors (daily calcium intake, vitamin D supplementation, and weekly exercise sessions) compared to slower, less individualized communication characterizing usual care. METHODS:Participants ??50 years were recruited, at three sites, following their DXA and randomized with 1:1 allocation to intervention and control (usual care only) groups. Data were collected at enrollment interview and by phone survey at 12 and 52 weeks thereafter. Intention-to-treat analyses were conducted on 7749 of the 20,397 eligible participants who enrolled. Changes in bone health behaviors were compared within and between study groups. Average treatment effects and heterogeneity of treatment effects were estimated with multivariable linear and logistic regression models. RESULTS:In unadjusted analyses, calcium intake, vitamin D supplementation, and weekly exercise sessions increased significantly over 52 weeks within both the intervention and control groups (all p?<?0.001). In unadjusted analyses and multivariable models, increases in each behavior did not significantly differ between the intervention and control groups. Intervention group participants with a >?20% 10-year fracture risk at enrollment did, however, have a significantly greater increase in calcium intake compared to other study participants (p?=?0.031). CONCLUSIONS:Bone health behaviors improved, on average, over 52 weeks among all participants following a DXA. Receipt of the PAADRN letter and educational brochure did not directly improve bone health behaviors compared to usual care. TRIAL REGISTRATION:The Patient Activation after DXA Result Notification (PAADRN) Study is registered at ClinicalTrials.Gov: NCT01507662, https://clinicaltrials.gov/ct2/show/NCT01507662.

Project description:In a large, pragmatic clinical trial, we calculated the costs of achieving four successful patient-centered outcomes using a tailored patient activation DXA result letter accompanied by a bone health brochure. The cost to achieve one successful outcome (e.g., a 0.5 standard deviation improvement in care satisfaction) ranged from $127.41 to $222.75. INTRODUCTION:Pragmatic randomized controlled trials (RCTs) should focus on patient-centered outcomes and report the costs for achieving those outcomes. We calculated per person incremental intervention costs, the number-needed-to-treat (NNT), and incremental per patient costs (cost per NNT) for four patient-centered outcomes in a direct-to-patient bone healthcare intervention. METHODS:The Patient Activation after DXA Result Notification (PAADRN) pragmatic RCT enrolled 7749 patients presenting for DXA at three health centers between February 2012 and August 2014. Interviews occurred at baseline and 52 weeks post-DXA. Intervention subjects received an individually tailored DXA result letter accompanied by an educational bone health brochure 4 weeks post-DXA, while the usual care subjects did not. Outcomes focused on patients (a) correctly identifying their results, (b) contacting their providers, (c) discussing their results with their providers, and (d) satisfaction with their bone healthcare. NNTs were determined using intention-to-treat linear probability models, per person incremental intervention costs were calculated, and costs per NNT were computed. RESULTS:Mean age was 66.6 years old, 83.8% were women, and 75.3% were non-Hispanic whites. The incremental per patient cost (costs per NNT) to increase the ability of a patient to (a) correctly identify their DXA result was $171.07; (b) contact their provider about their DXA result was $222.75; (c) discuss their DXA result with their provider was $193.55; and (d) achieve a 0.5 SD improvement in satisfaction with their bone healthcare was $127.41. CONCLUSION:An individually tailored DXA result letter accompanied by an educational brochure can improve four patient-centered outcomes at a modest cost. TRIAL REGISTRATION:clinicaltrials.gov identifier NCT01507662.

Project description:Patients may exhibit risky bone health behaviors. In a large pragmatic clinical trial, we tested whether a tailored patient activation DXA result letter accompanied by a bone health brochure led to smoking and excessive drinking cessations. The intervention did not, however, alter these risky bone health behaviors. INTRODUCTION:Besides dual-energy x-ray absorptiometry (DXA) screening and pharmacotherapy when indicated, beneficial bone health behaviors including proper calcium and vitamin D intake and weight-bearing and muscle-strengthening exercise should be encouraged. Similarly, risky bone health behaviors like smoking and excessive drinking should be discouraged. We examined whether a direct-to-patient activation intervention led to smoking and excessive drinking cessations. METHODS:The Patient Activation after DXA Result Notification (PAADRN) pragmatic clinical trial enrolled 7749 patients between February 2012 and August 2014. Interviews occurred at baseline and 12 and 52 weeks later. Intervention subjects were mailed an individually tailored DXA results letter accompanied by a bone health educational brochure 4 weeks post-DXA. Usual care subjects were not sent these materials. Smoking and excessive drinking were assessed by self-report at each interview. Intention-to-treat linear probability models were used. RESULTS:Mean age was 66.6 years, 83.8% were women, and 75.3% were Non-Hispanic-Whites. Smoking was reported at baseline by 7.6% of the intervention group vs. 7.7% of the usual care group (p = 0.873). Excessive drinking was reported at baseline by 6.5% of the intervention group vs. 6.5% of the usual care group (p = 0.968). Intention-to-treat analyses indicated no significant differences between the intervention vs. usual care groups at either 12 or 52 weeks post-DXA (all p values ? 0.346). CONCLUSION:An individually tailored DXA result letter accompanied by an educational brochure did not lead to smoking or excessive drinking cessations in patients who received DXA. TRIAL REGISTRATION:clinicaltrials.gov identifier NCT01507662.

Project description:Determining whether observed differences in health care can be called disparities requires persistence of differences after adjustment for relevant patient, provider, and health system factors. We examined whether providing dual-energy x-ray absorptiometry (DXA) test results directly to patients might reduce or eliminate racial differences in osteoporosis-related health care.We analyzed data from 3484 white and 1041 black women who underwent DXA testing at 2 health systems participating in the Patient Activation after DXA Result Notification (PAADRN) pragmatic clinical trial (ClinicalTrials.gov NCT-01507662) between February 2012 and August 2014. We examined 7 outcomes related to bone health at 12 weeks and 52 weeks post-DXA: (1) whether the patient correctly identified their DXA baseline results; (2) whether the patient was on guideline-concordant osteoporosis pharmacotherapy; (3) osteoporosis-related satisfaction; (4) osteoporosis knowledge; (5 and 6) osteoporosis self-efficacy for exercise and for diet; and (7) patient activation. We examined whether unadjusted differences in outcomes between whites and blacks persisted after adjusting for patient, provider, and health system factors.Mean age was 66.5 years and 29% were black. At baseline black women had less education, poorer health status, and were less likely to report a history of osteoporosis (P<0.001 for all). In unadjusted analyses black women were less likely to correctly identify their actual DXA results, more likely to be on guideline-concordant therapy, and had similar patient activation. After adjustment for patient demographics, baseline health status and other factors, black women were still less likely to know their actual DXA result and less likely to be on guideline-concordant therapy, but black women had greater patient activation.Adjustment for patient and provider level factors can change how racial differences are viewed, unmasking new disparities, and providing explanations for others.

Project description:IMPORTANCE:"Nudges" that influence decision making through subtle cognitive mechanisms have been shown to be highly effective in a wide range of applications, but there have been few experiments to improve clinical practice. OBJECTIVE:To investigate the use of a behavioral "nudge" based on the principle of public commitment in encouraging the judicious use of antibiotics for acute respiratory infections (ARIs). DESIGN, SETTING, AND PARTICIPANTS:Randomized clinical trial in 5 outpatient primary care clinics. A total of 954 adults had ARI visits during the study timeframe: 449 patients were treated by clinicians randomized to the posted commitment letter (335 in the baseline period, 114 in the intervention period); 505 patients were treated by clinicians randomized to standard practice control (384 baseline, 121 intervention). INTERVENTIONS:The intervention consisted of displaying poster-sized commitment letters in examination rooms for 12 weeks. These letters, featuring clinician photographs and signatures, stated their commitment to avoid inappropriate antibiotic prescribing for ARIs. MAIN OUTCOMES AND MEASURES:Antibiotic prescribing rates for antibiotic-inappropriate ARI diagnoses in baseline and intervention periods, adjusted for patient age, sex, and insurance status. RESULTS:Baseline rates were 43.5% and 42.8% for control and poster, respectively. During the intervention period, inappropriate prescribing rates increased to 52.7% for controls but decreased to 33.7% in the posted commitment letter condition. Controlling for baseline prescribing rates, we found that the posted commitment letter resulted in a 19.7 absolute percentage reduction in inappropriate antibiotic prescribing rate relative to control (P?=?.02). There was no evidence of diagnostic coding shift, and rates of appropriate antibiotic prescriptions did not diminish over time. CONCLUSIONS AND RELEVANCE:Displaying poster-sized commitment letters in examination rooms decreased inappropriate antibiotic prescribing for ARIs. The effect of this simple, low-cost intervention is comparable in magnitude to costlier, more intensive quality-improvement efforts. TRIAL REGISTRATION:clinicaltrials.gov identifier: NCT01767064.

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

Publications

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

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