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Study protocol of a randomized controlled trial on two new dissemination strategies for a brief, shared-decision-making (SDM) training for oncologists: web-based interactive SDM online-training versus individualized context-based SDM face-to-face training.

ABSTRACT: BACKGROUND:Oncological patients often feel left out of important treatment decisions. However, when physicians engage them in shared decision-making (SDM), patients benefit in many ways and the situation is improved. SDM can effectively be taught to physicians, but participation barriers for SDM physician group trainings are high, making it hard to convince physicians to participate. With this in mind, we aim to develop and evaluate two new dissemination strategies for a brief, SDM training program based upon a proven SDM group-training concept: an individualized context-based SDM face-to-face training (IG I) and a web-based interactive SDM online training (IG II). We aim to analyze which improvements can be achieved by IG I and II compared to a control group (CG) in physician SDM competence and performance as well as the impact on the physician-patient relationship. Furthermore, we analyze differences in satisfaction concerning the two dissemination strategies by means of a training evaluation. METHODS/DESIGN:We examine - based on a three-armed randomized controlled trial (IG I, IG II, CG) - the effectiveness of two new dissemination strategies for a SDM training program compared to a CG receiving no SDM training (voluntary access to SDM training as an incentive for participation after completion of the study). We aim to include 162 physicians randomized to one of the three arms. There will be two assessment points in time (before intervention: T0 and post-training: T1). The main outcome is the SDM competence of physicians as measured by an established observational assessment rating system (OPTION-12) by means of consultations with Standardized Patients. Standardized Patients are individuals trained to act as "real" patients. Secondary outcome measures are the SDM performance (SDM-Q-9) and the Questionnaire on the Quality of Physician-Patient-Interaction (QQPPI) both rated by Standardized Patients as well as the physicians' training evaluation. DISCUSSION:This trial will assess the effectiveness and acceptability of two new dissemination strategies for a brief, SDM training program for physicians. Opportunities and challenges regarding implementation in daily routines will be discussed. TRIAL REGISTRATION:ClinicalTrials.gov, Identifier: NCT02674360 . Prospectively registered on 4 February 2016.

SUBMITTER: Muller N

PROVIDER: S-EPMC6323749 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Study protocol of a randomized controlled trial on two new dissemination strategies for a brief, shared-decision-making (SDM) training for oncologists: web-based interactive SDM online-training versus individualized context-based SDM face-to-face training.

Müller Nicole N Gschwendtner Kathrin M KM Dwinger Sarah S Bergelt Corinna C Eich Wolfgang W Härter Martin M Bieber Christiane C

Trials 20190107 1

<h4>Background</h4>Oncological patients often feel left out of important treatment decisions. However, when physicians engage them in shared decision-making (SDM), patients benefit in many ways and the situation is improved. SDM can effectively be taught to physicians, but participation barriers for SDM physician group trainings are high, making it hard to convince physicians to participate. With this in mind, we aim to develop and evaluate two new dissemination strategies for a brief, SDM train ...[more]

PMID: 30616653

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Project description:BackgroundHealthcare providers need training to implement shared decision making (SDM). In Norway, we developed "Ready for SDM", a comprehensive SDM curriculum tailored to various healthcare providers, settings, and competence levels, including a course targeting interprofessional healthcare teams. The overall aim was to evaluate a train-the-trainer (TTT) program for healthcare providers wanting to offer this course within their hospital trust.MethodsOur observational descriptive design was informed by Kirkpatrick´s Model of Educational Outcomes. The South-Eastern Regional Health Authority invited healthcare providers from all health trusts in its jurisdiction to attend. The TTT consisted of a one-day basic course with lectures on SDM, exercises and group reflections followed by a two-day advanced course including an SDM observer training. Immediately after each of the two courses, reaction and learning (Kirkpatrick levels 1 and 2) were assessed using a self-administered questionnaire. After the advanced course, observer skills were operationalized as accuracy of the participants' assessment of a consultation compared to an expert assessment. Within three months post-training, we measured number of trainings conducted and number of healthcare providers trained (Kirkpatrick level 3) using an online survey. Qualitative and quantitative descriptive analysis were performed.ResultsTwenty-one out of 24 (basic) and 19 out of 22 (advanced) healthcare providers in 9 health trusts consented to participate. The basic course was evaluated as highly acceptable, the advanced course as complex and challenging. Participants identified a need for more training in pedagogical skills and support for planning implementation of SDM-training. Participants achieved high knowledge scores and were positive about being an SDM trainer. Observer skills regarding patient involvement in decision-making were excellent (mean of weighted t = .80). After three months, 67% of TTT participants had conducted more than two trainings each and trained a total of 458 healthcare providers.ConclusionFindings suggest that the TTT is a feasible approach for supporting large-scale training in SDM. Our study informed us about how to improve the advanced course. Further research shall investigate the efficacy of the training in the context of a comprehensive multifaceted strategy for implementing SDM in clinical practice.Trial registrationRetrospectively registered at ISRCTN (99432465) March 25, 2020.

Project description:BackgroundThe Shared Decision Making Questionnaire (SDM-Q-9 and SDM-Q-Doc) is a 9-item measure of the decisional process in medical encounters from both patients' and physicians' perspectives. It has good acceptance, feasibility, and reliability. This systematic review aimed to 1) evaluate the use of the SDM-Q-9 and SDM-Q-Doc in intervention studies on shared decision making (SDM) in clinical settings, 2) describe how the SDM-Q-9 and SDM-Q-Doc performed regarding sensitivity to change, and 3) assess the methodological quality of studies and study protocols that use the measure.MethodsWe conducted a systematic review of studies published between 2010 and October 2015 that evaluated interventions to facilitate SDM. The search strategy comprised three databases (EMBASE, PsycINFO, and Medline), reference tracking, citation tracking, and personal knowledge. Two independent reviewers screened titles and abstracts as well as full texts of potentially relevant records. We extracted the data using a pilot tested sheet, and we assessed the methodological quality of included studies using the Quality Assessment Tools from the U.S. National Institute of Health (NIH).ResultsFive completed studies and six study protocols fulfilled the inclusion criteria. The measure was used in a variety of health care settings, mainly in Europe, to evaluate several types of interventions. The reported mean sum scores ranged from 42 to 75 on a scale from 0 to 100. In four studies no significant change was detected in the mean-differences between main groups. In the fifth study the difference was small. Quality assessment revealed a high risk of bias in four of the five completed studies, while the study protocols received moderate quality ratings.ConclusionsWe found a wide range of areas in which the SDM-Q-9 and SDM-Q-Doc were applied. In the future this review may help researchers decide whether the measure fits their purposes. Furthermore, the review revealed risk of bias in previous trials that used the measure, and may help future trials decrease this risk. More research on the measure's sensitivity to change is strongly suggested.

Project description:BackgroundShared decision making is a crucial component of evidence-based practice, but a lack of training in the "how to" of it is a major barrier to its uptake.ObjectiveTo evaluate the effectiveness of a brief intervention for facilitating shared decision making skills in clinicians and student clinicians.DesignMulti-centre randomized controlled trial.ParticipantsOne hundred and seven medical students, physiotherapy or occupational therapy students undertaking a compulsory course in evidence-based practice as part of their undergraduate or postgraduate degree from two Australian universities.InterventionThe 1-h small-group intervention consisted of facilitated critique of five-step framework, strategies, and pre-recorded modelled role-play. Both groups were provided with a chapter about shared decision making skills.Main measuresThe primary outcome was skills in shared decision making and communicating evidence [Observing Patient Involvement (OPTION) scale, items from the Assessing Communication about Evidence and Patient Preferences (ACEPP) Tool], rated by a blinded assessor from videorecorded role-plays.Secondary outcomesconfidence in these skills and attitudes towards patient-centred communication (Patient Practitioner Orientation Scale (PPOS)).Key resultsOf participants, 95 % (102) completed the primary outcome measures. Two weeks post-intervention, intervention group participants scored significantly higher on the OPTION scale (adjusted group difference?=?18.9, 95 % CI 12.4 to 25.4), ACEPP items (difference?=?0.9, 95 % CI 0.5 to 1.3), confidence measure (difference?=?13.1, 95 % CI 8.5 to 17.7), and the PPOS sharing subscale (difference?=?0.2, 95 % CI 0.1 to 0.5). There was no significant difference for the PPOS caring subscale.ConclusionsThis brief intervention was effective in improving student clinicians' ability, attitude towards, and confidence in shared decision making facilitation. Following further testing of the longer-term effects of this intervention, incorporation of this brief intervention into evidence-based practice courses and workshops should be considered, so that student clinicians graduate with these important skills, which are typically neglected in clinician training.

Project description:PURPOSE:The SDM-Q-9 and SDM-Q-Doc measure patient and physician perception of the extent of shared decision making (SDM) during a physician-patient consultation. So far, no self-report instrument for SDM was available in Dutch, and validation of the scales in other languages has been limited. The aim of this study was to translate both scales into Dutch and assess their psychometric characteristics. METHODS:Participants were patients and their treating physicians (general practitioners and medical specialists). Patients (N = 182) rated their consultation using the SDM-Q-9, 43 physicians rated their consultations using the SDM-Q-Doc (N = 201). Acceptability, reliability (internal consistency), and the factorial structure of the instruments were determined. For convergent validity the CPSpost was used. RESULTS:Reliabilities of both scales were high (alpha SDM-Q-9 0.88; SDM-Q-Doc 0.87). The SDM-Q-9 and SDM-Q-Doc total scores correlated as expected with the CPSpost (SDM-Q-9: r = 0.29; SDM-Q-Doc: r = 0.48) and were significantly different between the CPSpost categories, with lowest mean scores when the physician made the decision alone. Principal Component Analyses showed a two-component model for each scale. A confirmatory factor analysis yielded a mediocre, but acceptable, one-factor model, if Item 1 was excluded; for both scales the best indices of fit were obtained for a one-factor solution, if both Items 1 and 9 were excluded. CONCLUSION:The Dutch SDM-Q-9 and SDM-Q-Doc demonstrate good acceptance and reliability; they correlated as expected with the CPSpost and are suitable for use in Dutch primary and specialised care. Although the best model fit was found when excluding Items 1 and 9, we believe these items address important aspects of SDM. Therefore, also based on the coherence with theory and comparability with other studies, we suggest keeping all nine items of the scale. Further research on the SDM-concept in patients and physicians, in different clinical settings and different countries, is necessary to gain a better understanding of the SDM-construct and its measurement.

Project description:IntroductionShared decision-making (SDM) is not yet widely used when making decisions in German hospitals. Making SDM a reality is a complex task. It involves training healthcare professionals in SDM communication and enabling patients to actively participate in communication, in addition to providing sound, easy to understand information on treatment alternatives in the form of evidence-based patient decision aids (EbPDAs). This project funded by the German Innovation Fund aims at designing, implementing and evaluating a multicomponent, large-scale and integrative SDM programme-called SHARE TO CARE (S2C)-at all clinical departments of a University Hospital Campus in Northern Germany within a 4-year time period.Methods and analysisS2C tackles the aforementioned components of SDM: (1) training physicians in SDM communication, (2) activating and empowering patients, (3) developing EbPDAs in the most common/relevant diseases and (4) training other healthcare professionals in SDM coaching. S2C is designed together with patients and providers. The physicians' training programme entails an online and an in situ training module. The decision coach training is based on a similar but less comprehensive approach. The development of online EbPDAs follows the International Patient Decision Aid Standards and includes written, graphical and video-based information. Validated outcomes of SDM implementation are measured in a preintervention and postintervention evaluation design. Process evaluation accompanies programme implementation. Health economic impact of the intervention is investigated using a propensity-score-matched approach based on potentially preference-sensitive hospital decisions.Ethics and disseminationEthics committee review approval has been obtained from Medical Ethics Committee of the Medical Faculty of the Christian-Albrechts-University Kiel. Project information and results will be disseminated at conferences, on project-hosted websites at University Hospital Medical Center Schleswig Holstein and by S2C as well as in peer-reviewed and professional journals.

Project description:Quality cancer care requires addressing patients' emotions, which oncologists infrequently do. Multiday courses can teach oncologists skills to handle emotion; however, such workshops are long and costly.To test whether a brief, computerized intervention improves oncologist responses to patient expressions of negative emotion.Randomized, controlled, parallel-group trial stratified by site, sex, and oncologic specialty. Oncologists were randomly assigned to receive a communication lecture or the lecture plus a tailored CD-ROM. (ClinicalTrials.gov registration number: NCT00276627)Oncology clinics at a comprehensive cancer center and Veterans Affairs Medical Center in Durham, North Carolina, and a comprehensive cancer center in Pittsburgh, Pennsylvania.48 medical, gynecologic, and radiation oncologists and 264 patients with advanced cancer.Oncologists were randomly assigned in a 1:1 ratio to receive an interactive CD-ROM about responding to patients' negative emotions. The CD-ROM included tailored feedback on the oncologists' own recorded conversations.Postintervention audio recordings were used to identify the number of empathic statements and responses to patients' expressions of negative emotion. Surveys evaluated patients' trust in their oncologists and perceptions of their oncologists' communication skills.Oncologists in the intervention group used more empathic statements (relative risk, 1.9 [95% CI, 1.1 to 3.3]; P = 0.024) and were more likely to respond to negative emotions empathically (odds ratio, 2.1 [CI, 1.1 to 4.2]; P = 0.028) than control oncologists. Patients of intervention oncologists reported greater trust in their oncologists than did patients of control oncologists (estimated mean difference, 0.1 [CI, 0.0 to 0.2]; P = 0.036). There was no significant difference in perceptions of communication skills.Long-term effects were not examined. The findings may not be generalizable outside of academic medical centers.A brief computerized intervention improves how oncologists respond to patients' expressions of negative emotions.National Cancer Institute.

Project description:BackgroundPalliative systematic treatment offers uncertain and often limited benefits, and the burden can be high. Hence, treatment decisions require shared decision making (SDM). This trial examined the independent and combined effect of an oncologist training and a patient communication aid on SDM.MethodsIn this multicenter randomized controlled trial with four parallel arms (2016-2018), oncologists (n = 31) were randomized to receive SDM communication skills training or not. The training consisted of a reader, two group sessions, a booster session, and a consultation room tool (10 hours). Patients (n = 194) with advanced cancer were randomized to receive a patient communication aid or not. The aid consisted of education on SDM, a question prompt list, and a value clarification exercise. The primary outcome was observed SDM as rated by blinded observers from audio-recorded consultations. Secondary outcomes included patient-reported SDM, patient and oncologist satisfaction, patients' decisional conflict, patient quality of life 3 months after consultation, consultation duration, and the decision made.ResultsThe oncologist training had a large positive effect on observed SDM (Cohen's d = 1.12) and on patient-reported SDM (d = 0.73). The patient communication aid did not improve SDM. The combination of interventions did not add to the effect of training oncologists only. The interventions affected neither patient nor oncologist satisfaction with the consultation nor patients' decisional conflict, quality of life, consultation duration, or the decision made.ConclusionTraining medical oncologists in SDM about palliative systemic treatment improves both observed and patient-reported SDM. A patient communication aid does not. The incorporation of skills training in (continuing) educational programs for medical oncologists is likely to stimulate the widely advocated uptake of shared decision making in clinical practice.Trial registrationNetherlands Trial Registry NTR 5489.Implications for practiceTreatment for advanced cancer offers uncertain and often small benefits, and the burden can be high. Hence, treatment decisions require shared decision making (SDM). SDM is increasingly advocated for ethical reasons and for its beneficial effect on patient outcomes. Few initiatives to stimulate SDM are evaluated in robust designs. This randomized controlled trial shows that training medical oncologists improves both observed and patient-reported SDM in clinical encounters (n = 194). A preconsultation communication aid for patients did not add to the effect of training oncologists. SDM training effectively changes oncologists' practice and should be implemented in (continuing) educational programs.

Project description:Design and objectivesWe performed a systematic review of studies evaluating healthcare provider (HCP) trainings in shared decision-making (SDM) to analyse their evaluation strategies.Setting and participantsHCP trainings in SDM from all healthcare settings.MethodsWe searched scientific databases (Medline, PsycInfo, CINAHL), performed reference and citation tracking, contacted experts in the field and scanned the Canadian inventory of SDM training programmes for healthcare professionals. We included articles reporting data of summative evaluations of HCP trainings in SDM. Two reviewers screened records, assessed full-text articles, performed data extraction and assessed study quality with the integrated quality criteria for review of multiple study designs (ICROMS) tool. Analysis of evaluation strategies included data source use, use of unpublished or published measures and coverage of Kirkpatrick's evaluation levels. An evaluation framework based on Kirkpatrick's evaluation levels and the Quadruple Aim framework was used to categorise identified evaluation outcomes.ResultsOut of 7234 records, we included 41 articles reporting on 30 studies: cluster-randomised (n=8) and randomised (n=9) controlled trials, controlled (n=1) and non-controlled (n=7) before-after studies, mixed-methods (n=1), qualitative (n=1) and post-test (n=3) studies. Most studies were conducted in the USA (n=9), Germany (n=8) or Canada (n=7) and evaluated physician trainings (n=25). Eleven articles met ICROMS quality criteria. Almost all studies (n=27) employed HCP-reported outcomes for training evaluation and most (n=19) additionally used patient-reported (n=12), observer-rated (n=10), standardised patient-reported (n=2) outcomes or training process and healthcare data (n=10). Most studies employed a mix of unpublished and published measures (n=17) and covered two (n=12) or three (n=10) Kirkpatrick's levels. Identified evaluation outcomes covered all categories of the proposed framework.ConclusionsStrategies to evaluate HCP trainings in SDM varied largely. The proposed evaluation framework maybe useful to structure future evaluation studies, but international agreement on a core set of outcomes is needed to improve evidence.Prospero registration numberCRD42016041623.

Dataset Information

Study protocol of a randomized controlled trial on two new dissemination strategies for a brief, shared-decision-making (SDM) training for oncologists: web-based interactive SDM online-training versus individualized context-based SDM face-to-face training.

Publications

Study protocol of a randomized controlled trial on two new dissemination strategies for a brief, shared-decision-making (SDM) training for oncologists: web-based interactive SDM online-training versus individualized context-based SDM face-to-face training.

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