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Shared treatment decision making improves adherence and outcomes in poorly controlled asthma.

ABSTRACT: Poor adherence to asthma controller medications results in poor treatment outcomes.To compare controller medication adherence and clinical outcomes in 612 adults with poorly controlled asthma randomized to one of two different treatment decision-making models or to usual care.In shared decision making (SDM), nonphysician clinicians and patients negotiated a treatment regimen that accommodated patient goals and preferences. In clinician decision making, treatment was prescribed without specifically eliciting patient goals/preferences. The otherwise identical intervention protocols both provided asthma education and involved two in-person and three brief phone encounters.Refill adherence was measured using continuous medication acquisition (CMA) indices-the total days' supply acquired per year divided by 365 days. Cumulative controller medication dose was measured in beclomethasone canister equivalents. In follow-up Year 1, compared with usual care, SDM resulted in: significantly better controller adherence (CMA, 0.67 vs. 0.46; P < 0.0001) and long-acting beta-agonist adherence (CMA, 0.51 vs. 0.40; P = 0.0225); higher cumulative controller medication dose (canister equivalent, 10.9 vs. 5.2; P < 0.0001); significantly better clinical outcomes (asthma-related quality of life, health care use, rescue medication use, asthma control, and lung function). In Year 2, compared with usual care, SDM resulted in significantly lower rescue medication use, the sole clinical outcome available for that year. Compared with clinician decision making, SDM resulted in: significantly better controller adherence (CMA, 0.67 vs. 0.59; P = 0.03) and long-acting beta-agonist adherence (CMA, 0.51 vs. 0.41; P = 0.0143); higher cumulative controller dose (CMA, 10.9 vs. 9.1; P = 0.005); and quantitatively, but not significantly, better outcomes on all clinical measures.Negotiating patients' treatment decisions significantly improves adherence to asthma pharmacotherapy and clinical outcomes. Clinical trials registered with www.clinicaltrials.gov (NCT00217945 and NCT00149526).

SUBMITTER: Wilson SR

PROVIDER: S-EPMC2841026 | biostudies-literature | 2010 Mar

REPOSITORIES: biostudies-literature

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Shared treatment decision making improves adherence and outcomes in poorly controlled asthma.

Wilson Sandra R SR Strub Peg P Buist A Sonia AS Knowles Sarah B SB Lavori Philip W PW Lapidus Jodi J Vollmer William M WM

American journal of respiratory and critical care medicine 20091217 6

<h4>Rationale</h4>Poor adherence to asthma controller medications results in poor treatment outcomes.<h4>Objectives</h4>To compare controller medication adherence and clinical outcomes in 612 adults with poorly controlled asthma randomized to one of two different treatment decision-making models or to usual care.<h4>Methods</h4>In shared decision making (SDM), nonphysician clinicians and patients negotiated a treatment regimen that accommodated patient goals and preferences. In clinician decisio ...[more]

PMID: 20019345

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Project description:BACKGROUND:Shared decision-making (SDM) is a model of interaction between doctors and patients in which both actors contribute to the medical decision-making process. SDM has raised great interest in mental healthcare over the last decade, as it is considered a fundamental part of patient-centered care. However, there is no research evaluating the efficacy of SDM compared to usual care (CAU), as it relates to quality of care and more specifically treatment adherence, in bipolar disorder (BD). METHODS/DESIGN:This is a 12-month multi-centre, cluster-randomized controlled trial comparing the efficacy of SDM to CAU. Adult BD patients (n =?300) will be eligible after stabilization for at least 4 weeks following an acute mood episode. The intervention will consist of applying the standardized SDM process as developed by the Ottawa Hospital Research Institute in order to choose the maintenance treatment of BD. A multidisciplinary team developed a decision aid "choose my long-term treatment with my doctor" for BD patients to clarify possible therapeutic options. Primary outcome will assess the patient's level of adherence (based on hetero-evaluation) of ongoing treatment at 12 months. Secondary outcomes will assess the difference between the 2 groups of patients in terms of adherence to maintenance drug therapy based on other measures (self-assessment scale and plasma levels of mood stabilizers). Additionally, other dimensions will be assessed: decisional conflict, satisfaction with care and involvement in decision making, beliefs about treatment, therapeutic relationship, knowledge about information for medical decision and clinical outcomes (depression, mania, functioning and quality of life). The primary endpoint will be analysed without adjustment by comparison of adherence scores between the two groups using Student t-tests or Mann-Whitney tests according to the variable distribution. A set of secondary analyses will be adjusted for covariates of clinical interest using generalized linear mixed regression models. DISCUSSION:This will be the first study evaluating the effect of an SDM intervention on patient adherence in BD. This is also an innovative protocol because it proposes the development of an evidence-based tool that should help patients and clinicians to initiate discussions regarding the use of BD treatment. TRIAL REGISTRATION:The study has been registered with ClinicalTrials.gov as NCT03245593 .

Project description:Background Guidelines promote shared decision-making (SDM) for anticoagulation in patients with atrial fibrillation. We recently showed that adding a within-encounter SDM tool to usual care (UC) increases patient involvement in decision-making and clinician satisfaction, without affecting encounter length. We aimed to estimate the extent to which use of an SDM tool changed adherence to the decided care plan and clinical safety end points. Methods and Results We conducted a multicenter, encounter-level, randomized trial assessing the efficacy of UC with versus without an SDM conversation tool for use during the clinical encounter (Anticoagulation Choice) in patients with nonvalvular atrial fibrillation considering starting or reviewing anticoagulation treatment. We conducted a chart and pharmacy review, blinded to randomization status, at 10 months after enrollment to assess primary adherence (proportion of patients who were prescribed an anticoagulant who filled their first prescription) and secondary adherence (estimated using the proportion of days for which treatment was supplied and filled for direct oral anticoagulant, and as time in therapeutic range for warfarin). We also noted any strokes, transient ischemic attacks, major bleeding, or deaths as safety end points. We enrolled 922 evaluable patient encounters (Anticoagulation Choice=463, and UC=459), of which 814 (88%) had pharmacy and clinical follow-up. We found no differences between arms in either primary adherence (78% of patients in the SDM arm filled their first prescription versus 81% in UC arm) or secondary adherence to anticoagulation (percentage days covered of the direct oral anticoagulant was 74.1% in SDM versus 71.6% in UC; time in therapeutic range for warfarin was 66.6% in SDM versus 64.4% in UC). Safety outcomes, mostly bleeds, occurred in 13% of participants in the SDM arm and 14% in the UC arm. Conclusions In this large, randomized trial comparing UC with a tool to promote SDM against UC alone, we found no significant differences between arms in primary or secondary adherence to anticoagulation or in clinical safety outcomes. Registration URL: https://www.clinicaltrials.gov; Unique identifier: clinicaltrials.gov. Identifier: NCT02905032.

Project description:Background:Practice facilitation is a method of introducing and sustaining organizational change. It involves the use of skilled healthcare professionals called practice facilitators (PFs) to help address the challenges associated with implementing evidence-based guidelines and complex interventions into practice. PFs provide a framework for translating research into practice by building relationships, improving communication, fostering change, and sharing resources. Nurses are well positioned to serve as PFs for the implementation of complex interventions, however, there is little evidence currently available to describe nurses in this role. Additionally, the best strategies to implement complex interventions into practices are still not fully understood. Combining practice facilitation with the train-the-trainer model has the potential to spread knowledge and skills. Shared decision making (SDM), which involves patients and providers jointly engaging in decisions around treatment options, has been shown to improve outcomes for patients with asthma. The goal of this manuscript is to describe and evaluate the practice facilitation process from the ADAPT-NC Study which successfully utilized research nurses to implement a complex asthma SDM toolkit intervention into primary care practices. Methods:As part of a larger study, 10 primary care practices were recruited for a facilitator-led dissemination intervention involving a 12-week rollout of an asthma SDM toolkit (trial registration: 1.28.2014, #NCT02047929). An experienced lead PF trained research nurses as PFs from each of the 4 participating practice-based research networks (PBRNs) in a train-the-trainer model utilizing a one-day training event and subsequent remote meetings. Evaluation of PF engagement was measured through process improvement surveys. Results:Overall, the asthma SDM intervention was successfully implemented within the 4 PBRNs. All 10 facilitator-led practices remained engaged with their PFs, with 8 out of the 10 practices able to incorporate and sustain SDM visits or clinics. Responses from the surveys for process improvement yielded improved PF communication and team dynamics over time. Conclusions:This study demonstrated effective use of research nurses as practice facilitators during the dissemination of an asthma SDM intervention into primary care practices, adding to the knowledge of best practices by describing a model of large-scale implementation of a complex intervention through practice facilitation with nurses. Trial registration:"Comparing Traditional and Participatory Dissemination of a Shared Decision Making Intervention" was retrospectively registered at https://clinicaltrials.gov/ on January 28th, 2014 (NCT02047929).

Project description:BackgroundGastroesophageal reflux is common among patients with asthma but often causes mild or no symptoms. It is not known whether treatment of gastroesophageal reflux with proton-pump inhibitors in patients who have poorly controlled asthma without symptoms of gastroesophageal reflux can substantially improve asthma control.MethodsIn a parallel-group, double-blind trial, we randomly assigned 412 participants with inadequately controlled asthma, despite treatment with inhaled corticosteroids, and with minimal or no symptoms of gastroesophageal reflux to receive either 40 mg of esomeprazole twice a day or matching placebo. Participants were followed for 24 weeks with the use of daily asthma diaries, spirometry performed once every 4 weeks, and questionnaires that asked about asthma symptoms. We used ambulatory pH monitoring to ascertain the presence or absence of gastroesophageal reflux in the participants. The primary outcome was the rate of episodes of poor asthma control, as assessed on the basis of entries in asthma diaries.ResultsEpisodes of poor asthma control occurred with similar frequency in the placebo and esomeprazole groups (2.3 and 2.5 events per person-year, respectively; P=0.66). There was no treatment effect with respect to individual components of the episodes of poor asthma control or with respect to secondary outcomes, including pulmonary function, airway reactivity, asthma control, symptom scores, nocturnal awakening, or quality of life. The presence of gastroesophageal reflux, which was documented by pH monitoring in 40% of participants with minimal or no symptoms, did not identify a subgroup of patients that benefited from treatment with proton-pump inhibitors. There were fewer serious adverse events among patients receiving esomeprazole than among those receiving placebo (11 vs. 17).ConclusionsDespite a high prevalence of asymptomatic gastroesophageal reflux among patients with poorly controlled asthma, treatment with proton-pump inhibitors does not improve asthma control. Asymptomatic gastroesophageal reflux is not a likely cause of poorly controlled asthma. (ClinicalTrials.gov number, NCT00069823.)

Project description:BackgroundDespite widespread use, there are few studies evaluating the consumer Choosing Wisely questions.MethodsWe evaluated the impact of the Choosing Wisely questions on consumers' decision-making outcomes. Adults living in Australia were presented with a hypothetical low-value care scenario. Using a 2×2×2 between-subjects factorial design, they were randomized to either the Choosing Wisely questions ("Questions"), a shared decision-making (SDM) preparation video ("Video"), both interventions, or control (no intervention). Primary outcomes were 1) self-efficacy to ask questions and be involved in decision-making and 2) intention to engage in SDM.ResultsA total of 1,439 participants (45.6% with "inadequate" health literacy) were eligible and included in the analysis. Intention to engage in SDM was higher in people randomized to the Video (mean difference [MD] = 0.24 [scale 0-6], 95% confidence interval [CI]: 0.14, 0.35), Questions (MD = 0.12, 95% CI: 0.01, 0.22), and both interventions (MD = 0.33, 95% CI: 0.23-0.44, P < 0.001, d = 0.28) compared with control. Combining interventions had a greater impact than presenting the Questions alone (MD = 0.22, 95% CI: 0.11, 0.32; P < 0.001). Those who received the Video or both interventions reported lower intention to follow the low-value treatment plan without further questioning (all P < 0.05) and more positive attitudes toward SDM (all P < 0.05) compared with control. Intervention acceptability was high in all study arms (>80%), but proactive access was low (1.7%-20.8%). Compared with control, participants who received one or both interventions asked more questions that mapped to the Choosing Wisely questions (all P < .001). There were no main effects of either intervention on self-efficacy or knowledge.ConclusionsThe Choosing Wisely questions and a video to promote SDM may improve intention to engage in SDM and support patients in identifying questions that align with the Choosing Wisely campaign (with some additional benefits of the video intervention).Trial registrationANZCTR376477.HighlightsWe conducted a randomized controlled trial online with adults living in Australia to test the effectiveness of the consumer Choosing Wisely questions and a shared decision-making (SDM) preparation video.Both interventions improved intention to engage in SDM and supported participants to identify questions that align with the Choosing Wisely campaign.There were some additional benefits of the Video intervention in reducing willingness to accept low-value treatment for low-back pain without asking questions; however, neither intervention changed participants' self-efficacy to ask questions and be involved in decision-making nor affected perceptions of preparedness to engage in SDM or knowledge of rights to be involved in health care decision-making.The simple, low-cost nature of the interventions may make them appropriate for implementation within a suite of approaches to address low-value care at a population level.

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Shared treatment decision making improves adherence and outcomes in poorly controlled asthma.

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Shared treatment decision making improves adherence and outcomes in poorly controlled asthma.

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