Dataset Information

Crohn's disease shared decision making intervention leads to more patients choosing combination therapy: a cluster randomised controlled trial.

ABSTRACT:

Background

Crohn's disease requires effective patient-clinician communication for successful illness and medication management. Shared decision making (SDM) has been suggested to improve communication around early intensive therapy. However, effective evidence-based SDM interventions for Crohn's disease are lacking, and the impact of SDM on Crohn's disease decision making and choice of therapy is unclear.

Aim

To test the impact of SDM on choice of therapy, quality of the decision and provider trust compared to standard Crohn's disease care.

Methods

We conducted a multi-site cluster randomised controlled trial in 14 diverse gastroenterology practices in the US.

Results

A total of 158 adult patients with Crohn's disease within 15 years of their diagnosis, with no prior Crohn's disease complications, and who were candidates to receive immunomodulators or biologics, participated in the study. Among these, 99 received the intervention and 59 received standard care. Demographics were similar between groups, although there were more women assigned to standard care, and a slightly shorter disease duration among those in the intervention group. Participants in the intervention group more frequently chose combination therapy (25% versus 5% control, p < 0.001), had a significantly lower decisional conflict (p < 0.05) and had greater trust in their provider (p < 0.05).

Conclusions

With rapidly expanding medication choices for Crohn's disease and slow uptake of early intensive therapy, SDM can personalise treatment strategies and has the potential to move the field of Crohn's disease management forward with an ultimate goal of consistently treating this disease early and intensively in appropriate patients.

Trial registration

Evaluating a Shared Decision Making Program for Crohn's Disease, ClinicalTrials.gov Identifier NCT02084290 https://clinicaltrials.gov/ct2/show/NCT02084290.

SUBMITTER: Zisman-Ilani Y

PROVIDER: S-EPMC9790033 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature

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Publications

Crohn's disease shared decision making intervention leads to more patients choosing combination therapy: a cluster randomised controlled trial.

Zisman-Ilani Yaara Y Thompson Kimberly D KD Siegel Lori S LS Mackenzie Todd T Crate Damara J DJ Korzenik Joshua R JR Melmed Gil Y GY Kozuch Patricia P Sands Bruce E BE Rubin David T DT Regueiro Miguel D MD Cross Raymond R Wolf Douglas C DC Hanson John S JS Schwartz Ronald M RM Vrabie Raluca R Kreines Michael D MD Scherer Timothy T Dubinsky Marla C MC Siegel Corey A CA

Alimentary pharmacology & therapeutics 20221114 2

<h4>Background</h4>Crohn's disease requires effective patient-clinician communication for successful illness and medication management. Shared decision making (SDM) has been suggested to improve communication around early intensive therapy. However, effective evidence-based SDM interventions for Crohn's disease are lacking, and the impact of SDM on Crohn's disease decision making and choice of therapy is unclear.<h4>Aim</h4>To test the impact of SDM on choice of therapy, quality of the decision ...[more]

PMID: 36377259

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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.

Project description:BackgroundLow back pain is a common and disabling condition leading to large health service and societal costs. Although there are several treatment options for back pain little is known about how to improve patient choice in treatment selection. The purpose of this study was to pilot a decision support package to help people choose between low back pain treatments.MethodsThis was a single-centred pilot cluster randomised controlled trial conducted in a community physiotherapy service. We included adults with non-specific low back pain referred for physiotherapy. Intervention participants were sent an information booklet prior to their first consultation. Intervention physiotherapists were trained to enhance their skills in shared informed decision making. Those in the control arm received care as usual. The primary outcome was satisfaction with the treatment received at four months using a five-point Likert Scale dichotomised into "satisfaction" (very satisfied or somewhat satisfied) and "non-satisfaction" (neither satisfied nor dissatisfied, somewhat dissatisfied or very dissatisfied).ResultsWe recruited 148 participants. In the control arm 67% of participants were satisfied with their treatment and in the intervention arm 53%. The adjusted relative risk of being satisfied was 1.28 (95% confidence interval 0.79 to 2.09). For most secondary outcomes the trend was towards worse outcomes in the intervention group. For one measure; the Roland Morris Disability Questionnaire, this difference was clinically important (2.27, 95% confidence interval 0.08 to 4.47). Mean healthcare costs were slightly lower (£38 saving per patient) within the intervention arm but health outcomes were also less favourable (0.02 fewer QALYs); the estimated probability that the intervention would be cost-effective at an incremental threshold of £20,000 per QALY was 16%.ConclusionWe did not find that this decision support package improved satisfaction with treatment; it may have had a substantial negative effect on clinical outcome, and is very unlikely to prove cost-effective. That a decision support package might have a clinically important detrimental effect is of concern. To our knowledge this has not been observed previously. Decision support packages should be formally tested for clinical and cost-effectiveness, and safety before implementation.Trial registrationCurrent Controlled Trials ISRCTN46035546 registered on 11/02/10.

Project description:BackgroundChoosing an antipsychotic medication is an important medical decision in the treatment of schizophrenia. This decision requires risk-benefit assessments of antipsychotics, and thus, shared-decision making between physician and patients is strongly encouraged. Although the efficacy and side-effect profiles of antipsychotics are well-established, there is no clear framework for the communication of the evidence between physicians and patients. For this reason, we developed an evidence-based shared-decision making assistant (SDM-assistant) that presents high-quality evidence from network meta-analysis on the efficacy and side-effect profile of antipsychotics and can be used as a basis for shared-decision making between physicians and patients when selecting antipsychotic medications.MethodsThe planned matched-pair cluster-randomised trial will be conducted in acute psychiatric wards (n = 14 wards planned) and will include adult inpatients with schizophrenia or schizophrenia-like disorders (N = 252 participants planned). On the intervention wards, patients and their treating physicians will use the SDM-assistant, whenever a decision on choosing an antipsychotic is warranted. On the control wards, antipsychotics will be chosen according to treatment-as-usual. The primary outcome will be patients' perceived involvement in the decision-making during the inpatient stay as measured with the SDM-Q-9. We will also assess therapeutic alliance, symptom severity, side-effects, treatment satisfaction, adherence, quality of life, functioning and rehospitalizations as secondary outcomes. Outcomes could be analysed at discharge and at follow-up after three months from discharge. The analysis will be conducted per-protocol using mixed-effects linear regression models for continuous outcomes and logistic regression models using generalised estimating equations for dichotomous outcomes. Barriers and facilitators in the implementation of the intervention will also be examined using a qualitative content analysis.DiscussionThis is the first trial to examine a decision assistant specifically designed to facilitate shared-decision making for choosing antipsychotic medications, i.e., SDM-assistant, in acutely ill inpatients with schizophrenia. If the intervention can be successfully implemented, SDM-assistant could advance evidence-based medicine in schizophrenia by putting medical evidence on antipsychotics into the context of patient preferences and values. This could subsequently lead to a higher involvement of the patients in decision-making and better therapy decisions.Trial registrationGerman Clinical Trials Register (ID: DRKS00027316 , registration date 26.01.2022).

Project description:IntroductionSocioeconomic disparities for breast cancer surgical care exist. Although the aetiology of the observed socioeconomic disparities is likely multifactorial, patient engagement during the surgical consult is critical. Shared decision-making may reduce health disparities by addressing barriers to patient engagement in decision-making that disproportionately impact socioeconomically disadvantaged patients. In this trial, we test the impact of a decision aid on increasing socioeconomically disadvantaged patients' engagement in breast cancer surgery decision-making.Methods and analysisThis multisite randomised trial is conducted through 10 surgical clinics within the National Cancer Institute Community Oncology Research Program (NCORP). We plan a stepped-wedge design with clinics randomised to the time of transition from usual care to the decision aid arm. Study participants are female patients, aged ≥18 years, with newly diagnosed stage 0-III breast cancer who are planning breast surgery. Data collection includes a baseline surgeon survey, baseline patient survey, audio-recording of the surgeon-patient consultation, a follow-up patient survey and medical record data review. Interviews and focus groups are conducted with a subset of patients, surgeons and clinic stakeholders. The effectiveness of the decision aid at increasing patient engagement (primary outcome) is evaluated using generalised linear mixed-effects models. The extent to which the effect of the decision aid intervention on patient engagement is mediated through the mitigation of barriers is tested in joint linear structural equation models. Qualitative interviews explore how barriers impact engagement, especially for socioeconomically disadvantaged women.Ethics and disseminationThis protocol has been approved by the National Cancer Institute Central Institutional Review Board, and Certificate of Confidentiality has been obtained. We plan to disseminate the findings through journal publications and national meetings, including the NCORP network. Our findings will advance the science of medical decision-making with the potential to reduce socioeconomic health disparities.Trial registration numberClinicalTrials.gov Registry (NCT03766009).

Project description:ObjectivesThis study aimed to examine how patients perceive shared decision-making regarding CT scan referral and use of the five Choosing Wisely questions with their general practitioner (GP).DesignThis is a qualitative exploratory study using semistructured interviews.SettingThis study was conducted in a large metropolitan public healthcare organisation in urban Australia.ParticipantsFollowing purposive sampling, 20 patients and 2 carers participated. Patient participants aged 18 years or older were eligible if they were attending the healthcare organisation for a CT scan and referred by their GP. Carers/family were eligible to participate when they were in the role of an unpaid carer and were aged 18 years or older. Participants were required to speak English sufficiently to provide informed consent. Participants with cognitive impairment were excluded.FindingsEighteen interviews were conducted with the patient only. Two interviews were conducted with the patient and the patient's carer. Fourteen participants were female. Five themes resulted from the thematic analysis: (1) needing to know, (2) questioning doctors is not necessary, (3) discussing scans is not required, (4) uncertainty about questioning and (5) valuing the Choosing Wisely questions. Participants reported that they presented to their GP with a health problem that they needed to understand and address. Participants accepted their GPs decision to prescribe a CT scan to identify the nature of their problem. They reported ambivalence about engaging in shared decision-making with their doctor, although many participants reported valuing the Choosing Wisely questions.ConclusionsShared decision-making is an important principle underpinning Choosing Wisely. Practice implementation requires understanding patients' motivations to engage in shared decision-making with a focus on attitudes, beliefs, knowledge and emotions. Systems-level support and education for healthcare practitioners in effective communication is important. However, this needs to emphasise communication with patients who have varying degrees of motivation to engage in shared decision-making and Choosing Wisely.

Project description:OBJECTIVE:To translate an informed shared decision-making programme (ISDM-P) for patients with type 2 diabetes from a specialised diabetes centre to the primary care setting. DESIGN:Patient-blinded, two-arm multicentre, cluster randomised controlled trial of 6 months follow-up; concealed randomisation of practices after patient recruitment and acquisition of baseline data. SETTING:22 general practices providing care according to the German Disease Management Programme (DMP) for type 2 diabetes. PARTICIPANTS:279 of 363 eligible patients without myocardial infarction or stroke. INTERVENTIONS:The ISDM-P comprises a patient decision aid, a corresponding group teaching session provided by medical assistants and a structured patient-physician encounter.Control group received standard DMP care. PRIMARY AND SECONDARY OUTCOME MEASURES:Primary endpoint was patient adherence to antihypertensive or statin drug therapy by comparing prescriptions and patient-reported uptake after 6 months. Secondary endpoints included informed choice, risk knowledge (score 0-11 from 11 questions) and prioritised treatment goals of patients and doctors. RESULTS:ISDM-P: 11 practices with 151 patients; standard care: 11 practices with 128 patients; attrition rate: 3.9%. There was no difference between groups regarding the primary endpoint. Mean drug adherence rates were high for both groups (80% for antihypertensive and 91% for statin treatment). More ISDM-P patients made informed choices regarding statin intake, 34% vs 3%, OR 16.6 (95% CI 4.4 to 63.0), blood pressure control, 39% vs 3%, OR 22.2 (95% CI 5.3 to 93.3) and glycated haemoglobin, 43% vs 3%, OR 26.0 (95% CI 6.5 to 104.8). ISDM-P patients achieved higher levels of risk knowledge, with a mean score of 6.96 vs 2.86, difference 4.06 (95% CI 2.96 to 5.17). In the ISDM-P group, agreement on prioritised treatment goals between patients and doctors was higher, with 88.5% vs 57%. CONCLUSIONS:The ISDM-P was successfully implemented in general practices. Adherence to medication was very high making improvements hardly detectable. TRIAL REGISTRATION NUMBER:ISRCTN77300204; Results.

Project description:BackgroundShared decision-making improves the quality of patient care. Unfortunately, shared decision-making is not yet common practice among vascular surgeons. Thus, decision support tools were developed to assist vascular surgeons and their patients in using shared decision-making. This trial aims to evaluate the effectiveness and implementation of decision support tools to improve shared decision-making during vascular surgical consultations in which a treatment decision is to be made.MethodsThe study design is a multicentre stepped-wedge cluster-randomised trial. Eligible patients are adult patients, visiting the outpatient clinic of a participating medical centre for whom several treatment options are feasible and who face a primary treatment decision for their abdominal aortic aneurysm, carotid artery disease, intermittent claudication, or varicose veins. Patients and vascular surgeons in the intervention group receive decision support tools that may help them adopt shared decision-making when making the final treatment decision. These decision support tools are decision aids, consultation cards, decision cards, and a practical training. Decision aids are informative websites that help patients become more aware of the pros and cons of the treatment options and their preferences regarding the treatment choice. Consultation cards with text or decision cards with images are used by vascular surgeons during consultation to determine which aspect of a treatment is most important to their patient. In the training vascular surgeons can practice shared decision-making with a patient actor, guided by a medical psychologist. This trial aims to include 502 vascular surgical patients to achieve a clinically relevant improvement in shared decision-making of 10 out of 100 points, using the 5-item OPTION instrument to score the audio-recordings of consultations.DiscussionIn the OVIDIUS trial the available decision support tools for vascular surgical patients are implemented in clinical practice. We will evaluate whether these tools actually improve shared decision-making in the consultation room. The stepped-wedge cluster-randomised study design will ensure that at the end of the study all participating centres have implemented at least some of the decision support tools and thereby a certain level of shared decision-making.Trial registrationNetherlands Trial Registry, NTR6487 . Registered 7 June 2017. URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6487.

Project description:ImportanceFor antidepressants, the translation of evidence of comparative effectiveness into practice is suboptimal. This deficit directly affects outcomes and quality of care for patients with depression. To overcome this problem, we developed the Depression Medication Choice (DMC) encounter decision aid, designed to help patients and clinicians consider the available antidepressants and the extent to which they improved depression and other issues important to patients.ObjectiveEstimate the effect of DMC on quality of the decision-making process and depression outcomes.Design, setting, and participantsWe conducted a cluster randomized trial of adults with moderate to severe depression considering treatment with an antidepressant. Primary care practices in 10 rural, suburban, and urban primary care practices across Minnesota and Wisconsin were randomly allocated to treatment of depression with or without use of the DMC decision aid.InterventionDepression Medication Choice, a series of cards, each highlighting the effect of the available options on an issue of importance to patients for use during face-to-face consultations.Main outcomes and measuresDecision-making quality as judged by patient knowledge and involvement in decision making, patient and clinician decisional comfort (Decisional Conflict Scale) and satisfaction, encounter duration, medication adherence, depression symptoms, and the Patient Health Questionnaire for depression (PHQ-9).ResultsWe enrolled 117 clinicians and 301 patients (67% women; mean [SD] age, 44 [15] years; mean [SD] PHQ-9 score, 15 [4]) into the trial. Compared with usual care (UC), use of DMC significantly improved patients' decisional comfort (DMC, 80% vs UC, 75%; P = .02), knowledge (DMC, 65% vs UC, 56%; P = .03), satisfaction (risk ratio [RR], from 1.25 [P = .81] to RR, 2.4 [P = .002] depending on satisfaction domain), and involvement (DMC, 47% vs UC, 33%; P<.001). It also improved clinicians' decisional comfort (DMC, 80% vs UC, 68%; P < .001) and satisfaction (RR, 1.64; P = .02). There were no differences in encounter duration, medication adherence, or improvement of depression control between arms.Conclusions and relevanceThe DMC decision aid helped primary care clinicians and patients with moderate to severe depression select antidepressants together, improving the decision-making process without extending the visit. On the other hand, DMC had no discernible effect on medication adherence or depression outcomes. By translating comparative effectiveness into patient-centered care, use of DMC improved the quality of primary care for patients with depression.Trial registrationclinicaltrials.gov Identifier: NCT01502891.

Dataset Information

Crohn's disease shared decision making intervention leads to more patients choosing combination therapy: a cluster randomised controlled trial.

Background

Aim

Methods

Results

Conclusions

Trial registration

Publications

Crohn's disease shared decision making intervention leads to more patients choosing combination therapy: a cluster randomised controlled trial.

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