Feasibility and efficacy of shared decision making for first-admission schizophrenia: a randomized clinical trial.
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SUBMITTER: Ishii M
PROVIDER: S-EPMC5294770 | biostudies-literature | 2017 Feb
REPOSITORIES: biostudies-literature
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Feasibility and efficacy of shared decision making for first-admission schizophrenia: a randomized clinical trial.
Ishii Mio M Okumura Yasuyuki Y Sugiyama Naoya N Hasegawa Hana H Noda Toshie T Hirayasu Yoshio Y Ito Hiroto H
BMC psychiatry 20170206 1
<h4>Background</h4>The feasibility of shared decision making (SDM) for patients with schizophrenia remains controversial due to the assumed inability of patients to cooperate in treatment decision making. This study evaluated the feasibility and efficacy of SDM in patients upon first admission for schizophrenia.<h4>Methods</h4>This was a randomized, parallel-group, two-arm, open-label, single-center study conducted in an acute psychiatric ward of Numazu Chuo Hospital, Japan. Patients with the di ...[more]
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Project description:Shared decision making is a promising model for patient-centred medicine, resulting in better clinical outcomes overall. In the mental health field, interventions that consider the patient-centred perspective--such as patient quality of life, involvement in the treatment, treatment satisfaction, and working alliance--have increased and better clinical outcomes discovered for patients with schizophrenia. However, few studies have examined the efficacy of shared decision making for schizophrenia treatment. The objective of this study is to evaluate the effect of a shared decision making intervention compared to treatment as usual on patient satisfaction at discharge for first-admission patients with schizophrenia.This is a randomised, parallel-group, two-arm, open-label, single-centre study currently being conducted in an acute psychiatric ward of Numazu Chuo Hospital, Japan. We are recruiting patients between 16 and 65 years old who are admitted to the ward with a diagnosis of schizophrenia without prior experience of psychiatric admission. Fifty-eight participants are being randomised into a shared decision making intervention group or a treatment as usual control group in a 1:1 ratio. The intervention program was developed based on a shared decision making model and is presented as a weekly course lasting the duration of the patients' acute psychiatric ward stay. The primary outcome measure is patient satisfaction at discharge as assessed by the Client Satisfaction Questionnaire. Due to the study's nature, neither the patient nor staff can be blinded.This is the first randomised controlled trial to evaluate the efficacy of shared decision making for patients with early-treatment-stage schizophrenia. The intervention program in this study is innovative in that it includes both of the patient and staff who are involved in the treatment.The study has been registered with ClinicalTrials.gov as NCT01869660.
| S-EPMC4021257 | biostudies-literature
Project description:ObjectivesSignificant practice variation is seen in the management of syncope in the emergency department (ED). We sought to evaluate the feasibility of performing a randomized controlled trial of a shared decision making (SDM) tool for low-to-intermediate-risk syncope patients presenting to the ED.MethodsWe performed a randomized controlled trial of adults (≥30 years) with unexplained syncope who presented to an academic ED in the United States. Patients with a serious diagnosis identified in the ED were excluded. Patients were randomized, 1:1, to receive either usual care or a personalized syncope decision aid (SynDA) meant to facilitate SDM. Our primary outcome was feasibility, i.e., ability to enroll 50 patients in 24 months. Secondary outcomes included patient knowledge, involvement (measured with OPTION-5), rating of care, and clinical outcomes at 30 days post-ED visit.ResultsAfter screening 351 patients, we enrolled 50 participants with unexplained syncope from January 2017 to January 2019. The most common reason for exclusion was lack of clinical equipoise to justify SDM (n = 124). Patients in the SynDA arm tended to have greater patient involvement, as shown by higher OPTION-5 scores: 52/100 versus 27/100 (between-group difference = -25.4, 95% confidence interval = -13.5 to -37.3). Both groups had similar levels of clinical knowledge, ratings of care, and serious clinical outcomes at 30 days.ConclusionsAmong ED patients with unexplained syncope, a randomized controlled trial of a shared decision-making tool is feasible. Although this study was not powered to detect differences in clinical outcomes, it demonstrates feasibility, while providing key lessons and effect sizes that could inform the design of future SDM trials.
| S-EPMC7483321 | biostudies-literature
Project description:BackgroundMyDiabetesPlan is a web-based, interactive patient decision aid that facilitates patient-centred, diabetes-specific, goal-setting and shared decision-making (SDM) with interprofessional health care teams.ObjectiveAssess the feasibility of (1) conducting a cluster randomized controlled trial (RCT) and (2) integrating MyDiabetesPlan into interprofessional primary care clinics.MethodsWe conducted a cluster RCT in 10 interprofessional primary care clinics with patients living with diabetes and at least two other comorbidities; half of the clinics were assigned to MyDiabetesPlan and half were assigned to usual care. To assess recruitment, retention, and resource use, we used RCT conduct logs and financial account summaries. To assess intervention fidelity, we used RCT conduct logs and website usage logs. To identify barriers and facilitators to integration of MyDiabetesPlan into clinical care across the IP team, we used audiotapes of clinical encounters in the intervention groups.ResultsOne thousand five hundred and ninety-seven potentially eligible patients were identified through searches of electronic medical records, of which 1113 patients met the eligibility criteria upon detailed chart review. A total of 425 patients were randomly selected; of these, 213 were able to participate and were allocated (intervention: n = 102; control: n = 111), for a recruitment rate of 50.1%. One hundred and fifty-one patients completed the study, for a retention rate of 70.9%. A total of 5745 personnel-hours and $6104 CAD were attributed to recruitment and retention activities. A total of 179 appointments occurred (out of 204 expected appointments-two per participant over the 12-month study period; 87.7%). Forty (36%), 25 (23%), and 32 (29%) patients completed MyDiabetesPlan at least twice, once, and zero times, respectively. Mean time for completion of MyDiabetesPlan by the clinician and the patient during initial appointments was 37 min. From the clinical encounter transcripts, we identified diverse strategies used by clinicians and patients to integrate MyDiabetesPlan into the appointment, characterized by rapport building and individualization. Barriers to use included clinician-related, patient-related, and technical factors.ConclusionAn interprofessional approach to SDM using a decision aid was feasible. Lower than expected numbers of diabetes-specific appointments and use of MyDiabetesPlan were observed. Addressing facilitators and barriers identified in this study will promote more seamless integration into clinical care. Trial registration Clinicaltrials.gov Identifier: NCT02379078. Date of Registration: February 11, 2015. Protocol version: Version 1; February 26, 2015.
| S-EPMC8609876 | biostudies-literature
Project description:BackgroundShared 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/designThis 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.DiscussionThis 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 registrationThe study has been registered with ClinicalTrials.gov as NCT03245593 .
| S-EPMC5899333 | biostudies-literature
Project description:AimsAlthough shared decision-making (SDM) has the potential to improve health outcomes, psychiatrists often exclude patients with more severe mental illnesses or more acute conditions from participation in treatment decisions. This study examines whether SDM is facilitated by an approach which is specifically adapted to the needs of acutely ill patients (SDM-PLUS).MethodsThe study is a multi-centre, cluster-randomised, non-blinded, controlled trial of SDM-PLUS in 12 acute psychiatric wards of five psychiatric hospitals addressing inpatients with schizophrenia or schizoaffective disorder. All patients fulfilling the inclusion criteria were consecutively recruited for the trial at the time of their admission to the ward. Treatment teams of intervention wards were trained in the SDM-PLUS approach through participation in two half-day workshops. Patients on intervention wards received group training in SDM. Staff (and patients) of the control wards acted under 'treatment as usual' conditions. The primary outcome parameter was the patients' perceived involvement in decision-making at 3 weeks after study enrolment, analysed using a random-effects linear regression model.ResultsIn total, 161 participants each were recruited in the intervention and control group. SDM-PLUS led to higher perceived involvement in decision-making (primary outcome, analysed patients n = 257, mean group difference 16.5, 95% CI 9.0-24.0, p = 0.002, adjusted for baseline differences: β 17.3, 95% CI 10.8-23.6, p = 0.0004). In addition, intervention group patients exhibited better therapeutic alliance, treatment satisfaction and self-rated medication compliance during inpatient stay. There were, however, no significant improvements in adherence and rehospitalisation rates in the 6- and 12-month follow-up.ConclusionsDespite limitations in patient recruitment, the SDM-PLUS trial has shown that the adoption of behavioural approaches (e.g. motivational interviewing) for SDM may yield a successful application to mental health. The authors recommend strategies to ensure effects are not lost at the interface between in- and outpatient treatment.Trial registration: The trial was registered at Deutsches Register Klinischer Studien (DRKS00010880).
| S-EPMC7303792 | biostudies-literature
Project description:IMPORTANCE:For 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. OBJECTIVE:Estimate the effect of DMC on quality of the decision-making process and depression outcomes. DESIGN, SETTING, AND PARTICIPANTS:We 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. INTERVENTION:Depression 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 MEASURES:Decision-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). RESULTS:We 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 RELEVANCE:The 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 REGISTRATION:clinicaltrials.gov Identifier: NCT01502891.
| S-EPMC4754973 | biostudies-literature
Project description:BackgroundLung cancer screening (LCS) is recommended for individuals at high risk due to age and smoking history after a shared decision-making conversation. However, little is known about best strategies for incorporating shared decision-making, especially in a busy primary care setting.ObjectiveTo develop a novel tool, Lung Cancer Assessment of Risk and Education (LungCARE) to guide LCS decisions among eligible primary care patients.DesignPilot cluster randomized controlled trial of LungCARE versus usual care.ParticipantsPatients of providers in a university primary care clinic, who met criteria for LCS.InterventionProviders were randomized to LungCARE intervention or control. LungCARE participants completed a computer tablet-based video assessment of lung cancer educational needs in the waiting room prior to a primary care visit. Patient and provider both received a summary handout of patient concerns and responses.Main measuresAll eligible patients completed baseline interviews by telephone. One week after the index visit, participants completed a follow-up telephone survey that assessed patient-physician discussion of LCS, referral to and scheduling of LCS, as well as LCS knowledge and acceptability of LungCARE. Two months after index visit, we reviewed patients' electronic health records (EHRs) for evidence of a shared decision-making conversation and referral to and receipt of LCS.Key resultsA total of 66 participants completed baseline and follow-up visits (34: LungCARE; 32: usual care). Mean age was 65.9 (± 6.0). Based on EHR review, compared to usual care, LungCARE participants were more likely to have discussed LCS with their physicians (56% vs 25%; p = 0.04) and to be referred to LCS (44% vs 13%; p < 0.02). Intervention participants were also more likely to complete LCS (32% vs 13%; p < 0.01) and had higher knowledge scores (mean score 6.5 (± 1.7) vs 5.5 (± 1.4; p < 0.01).ConclusionsLungCARE increased discussion, referral, and completion of LCS and improved LCS knowledge.Clinical trial registrationNCT03862001.
| S-EPMC10651593 | biostudies-literature
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.
| S-EPMC10422858 | biostudies-literature
Project description:BackgroundClinicians face challenges in promoting colorectal cancer screening due to multiple competing demands. A decision aid that clarifies patient preferences and improves decision quality can aid shared decision making and be effective at increasing colorectal cancer screening rates. However, exactly how such an intervention improves shared decision making is unclear. This study, funded by the National Cancer Institute, seeks to provide detailed understanding of how an interactive decision aid that elicits patient's risks and preferences impacts patient-clinician communication and shared decision making, and ultimately colorectal cancer screening adherence.Methods/designThis is a two-armed single-blinded randomized controlled trial with the target of 300 patients per arm. The setting is eleven community and three academic primary care practices in Metro Detroit. Patients are men and women aged between 50 and 75 years who are not up to date on colorectal cancer screening. ColoDATES Web (intervention arm), a decision aid that incorporates interactive personal risk assessment and preference clarification tools, is compared to a non-interactive website that matches ColoDATES Web in content but does not contain interactive tools (control arm). Primary outcomes are patient uptake of colorectal cancer screening; patient decision quality (knowledge, preference clarification, intent); clinician's degree of shared decision making; and patient-clinician concordance in the screening test chosen. Secondary outcome incorporates a Structural Equation Modeling approach to understand the mechanism of the causal pathway and test the validity of the proposed conceptual model based on Theory of Planned Behavior. Clinicians and those performing the analysis are blinded to arms.DiscussionThe central hypothesis is that ColoDATES Web will improve colorectal cancer screening adherence through improvement in patient behavioral factors, shared decision making between the patient and the clinician, and concordance between the patient's and clinician's preferred colorectal cancer screening test. The results of this study will be among the first to examine the effect of a real-time preference assessment exercise on colorectal cancer screening and mediators, and, in doing so, will shed light on the patient-clinician communication and shared decision making 'black box' that currently exists between the delivery of decision aids to patients and subsequent patient behavior.Trial registrationClinicalTrials.gov ID NCT01514786.
| S-EPMC3842677 | biostudies-literature
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).
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