Effectiveness of individual feedback and coaching on shared decision-making consultations in oncology care: Study protocol for a randomized clinical trial (Preprint)

2021 ◽  
Author(s):  
Haske Van Veenendaal ◽  
Loes J Peters ◽  
Dirk T Ubbink ◽  
Fabienne E Stubenrouch ◽  
Anne M Stiggelbout ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Randomized Clinical Trial ◽  
Shared Decision Making ◽  
Intervention Group ◽  
Control Group ◽  
Decision Making Process ◽  
Shared Decision ◽  
Oncology Patients ◽  
Oncology Care

BACKGROUND Shared decision-making (SDM) is particularly important in oncology since many treatments involve serious side effects, and treatment decisions involve a trade-off of benefits and risks. However, implementation of SDM in oncology care is challenging and clinicians state that it is difficult to apply SDM in their actual workplace. Training clinicians is known to be an effective means of improving SDM, but is considered time-consuming. OBJECTIVE This study addresses the effectiveness of an individual SDM training program, using the concept of deliberate practice. METHODS This multicentre single-blinded randomized clinical trial will be performed in 12 Dutch hospitals. Clinicians involved in decisions with oncology patients are invited to participate in the study and are allocated to the control group or intervention group. All clinicians will record 3 decision-making processes, with 3 different oncology patients. Clinicians in the intervention group receive the SDM-intervention: completing E-learnings, reflecting on feedback reports, doing a self-assessment and defining 1-3 personal learning questions, and participating in face-to-face coaching. Clinicians in the control group do not receive the SDM-intervention until the end of the study. The primary outcome will be the extent in which clinicians involve their patients in the decision-making process, as scored using the OPTION-5 instrument. As secondary outcome patients will rate their perceived involvement in the decision-making and the duration of the consultations will be registered. RESULTS We hypothesize that clinicians exposed to this intervention are more likely to adopt SDM behaviours than clinicians who do not. A secondary aim is to evaluate whether patients perceive more involvement in the decision-making process. CONCLUSIONS This theory-based and blended approach will increase our knowledge about effective and feasible training methods for clinicians in the field of SDM. The intervention will be tailored to the context of individual clinicians and will target knowledge, attitude and skills of clinicians. Patients are involved in the design and implementation of the study. CLINICALTRIAL This trial is retrospectively registered (Netherlands Trial Registry number NL9647; August 03, 2021, https://www.trialregister.nl/trial/9647). All participating clinicians and their patients will receive information about the study and complete an informed consent form beforehand. Approval for the study was obtained from the Ethical Review Board (medical research ethics committee Delft and Leiden, the Netherlands (N20.170)).

A randomized clinical trial of TrialTALK, a communication tool to facilitate treatment-related shared decision making.

2018 ◽  
Vol 36 (34_suppl) ◽  
pp. 45-45
Author(s):  
Toby Christopher Campbell ◽  
Mallory Jasicki ◽  
Kristine L Kwekkeboom ◽  
Margaret L Schwarze ◽  
Amy Zelenski ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Shared Decision Making ◽  
Intervention Group ◽  
Average Score ◽  
Control Group ◽  
Trial Participation ◽  
Training Methods ◽  
Shared Decision ◽  
Communication Tool

45 Background: Cancer treatment decision making involves timely, high-risk, life altering shared decision-making conversations between patients, their families, and their oncologists. As such, these conversations are a prime target for a carefully designed, easy to interpret approach to facilitate preference-sensitive decision making. Patients need several important pieces of information delivered in a way that is easy to interpret. The TrialTALK approach has two core elements: a verbal approach and a pen and paper (P&P) diagram. The P&P diagram includes the diagnosis with prognostic implications, all available treatment options including best supportive care alone, estimates for efficacy, and anticipated impact on daily life. The verbal conversation corresponds to the diagram and includes a phrase to encourage deliberation, and empathic responses. Our trial is evaluating the effectiveness of TrialTALK to influence decision making, in particular clinical trial participation. Here, we report the results of the initial oncologist training. Methods: 28 oncologists volunteered to participate and were randomly assigned to control (Group A, n=13) or intervention (Group B, n=15). Oncologists in the intervention group each received two hours of training, including simulated conversations with feedback and optional 1:1 follow up for troubleshooting. At the conclusion of training, oncologists completed a video-recorded simulated encounter with an actor. Trainers reviewed P&P diagrams in real time and provided feedback. Results: We used a fidelity checklist to assess effectiveness of the training. We considered ≥ 14 points out of a possible 20 as an acceptable use of TrialTALK. The average score was 14.8 ± 2. Scores ranged 10-18. 12 of 15 intervention oncologists demonstrated adoption of the tool after 2 hours of training. Conclusions: Oncologist can effectively learn to use TrialTALK. The ongoing study will estimate preliminary efficacy of the TrialTALK intervention in regards to patient decision making and participation in clinical trials.

scholarly journals Shared decision making and patient-centeredness for patients with poorly controlled type 2 diabetes mellitus in primary care—results of the cluster-randomised controlled DEBATE trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Anja Wollny ◽  
Christin Löffler ◽  
Eva Drewelow ◽  
Attila Altiner ◽  
Christian Helbig ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Decision Making ◽  
Type 2 Diabetes Mellitus ◽  
Shared Decision Making ◽  
Intervention Group ◽  
Control Group ◽  
Shared Decision ◽  
Patient Centeredness

Abstract Background We investigate whether an educational intervention of GPs increases patient-centeredness and perceived shared decision making in the treatment of patients with poorly controlled type 2 diabetes mellitus? Methods We performed a cluster-randomized controlled trial in German primary care. Patients with type 2 diabetes mellitus defined as HbA1c levels ≥ 8.0% (64 mmol/mol) at the time of recruitment (n = 833) from general practitioners (n = 108) were included. Outcome measures included subjective shared decision making (SDM-Q-9; scale from 0 to 45 (high)) and patient-centeredness (PACIC-D; scale from 1 to 5 (high)) as secondary outcomes. Data collection was performed before intervention (baseline, T0), at 6 months (T1), at 12 months (T2), at 18 months (T3), and at 24 months (T4) after baseline. Results Subjective shared decision making decreased in both groups during the course of the study (intervention group: -3.17 between T0 and T4 (95% CI: -4.66, -1.69; p < 0.0001) control group: -2.80 (95% CI: -4.30, -1.30; p = 0.0003)). There were no significant differences between the two groups (-0.37; 95% CI: -2.20, 1.45; p = 0.6847). The intervention's impact on patient-centeredness was minor. Values increased in both groups, but the increase was not statistically significant, nor was the difference between the groups. Conclusions The intervention did not increase patient perceived subjective shared decision making and patient-centeredness in the intervention group as compared to the control group. Effects in both groups might be partially attributed to the Hawthorne-effect. Future trials should focus on patient-based intervention elements to investigate effects on shared decision making and patient-centeredness. Trial registration The trial was registered on March 10th, 2011 at ISRCTN registry under the reference ISRCTN70713571.

scholarly journals Implementing shared decision-making on acute psychiatric wards: a cluster-randomized trial with inpatients suffering from schizophrenia (SDM-PLUS)

2020 ◽  
Vol 29 ◽  
Author(s):  
J. Hamann ◽  
F. Holzhüter ◽  
S. Blakaj ◽  
S. Becher ◽  
B. Haller ◽  
...  
Keyword(s):  
Decision Making ◽  
Shared Decision Making ◽  
Primary Outcome ◽  
Intervention Group ◽  
Psychiatric Hospitals ◽  
Mental Illnesses ◽  
Control Group ◽  
Shared Decision ◽  
Acute Psychiatric Wards ◽  
Perceived Involvement

Abstract Aims Although 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). Methods The 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. Results In 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. Conclusions Despite 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).

scholarly journals Shared Decision-Making in Chronic Patients with Polypharmacy: An Interventional Study for Assessing Medication Appropriateness

2019 ◽  
Vol 8 (6) ◽  
pp. 904
Author(s):  
Valle Coronado-Vázquez ◽  
Juan Gómez-Salgado ◽  
Javier Cerezo-Espinosa de los Monteros ◽  
Diego Ayuso-Murillo ◽  
Carlos Ruiz-Frutos
Keyword(s):  
Decision Making ◽  
Shared Decision Making ◽  
Intervention Group ◽  
Decision Support Tool ◽  
Control Group ◽  
Potentially Inappropriate Medications ◽  
Shared Decision ◽  
Support Tool ◽  
Inappropriate Medications ◽  
Medication Appropriateness

Potentially inappropriate medications are associated with polypharmacy and polypathology. Some interventions such as pharmacotherapy reviews have been designed to reduce the prescribing of inappropriate medications. The objective of this study is to evaluate how effective a decision-making support tool is for determining medication appropriateness in patients with one or more chronic diseases (hypertension, dyslipidaemia, and/or diabetes) and polypharmacy in the primary care setting. For this, a quasi-experimental study (randomised, controlled and multicentre) has been developed. The study compares an intervention group, which assesses medication appropriateness by applying a decision support tool, with a control group that follows the usual clinical practice. The intervention included a decision support tool in paper format, where participants were informed about polypharmacy, inappropriate medications, associated problems and available alternatives, as well as shared decision-making. This is an informative guide aimed at helping patients with decision-making by providing them with information about the secondary risks associated with inappropriate medications in their treatment, according to the Beers and START/STOPP criteria. The outcome measure was the proportion of medication appropriateness. The proportion of patients who confirmed medication appropriateness after six months of follow-up is greater in the intervention group (32.5%) than in the control group (27.9%) p = 0.008. The probability of medication appropriateness, which was calculated by the proportion of drugs withdrawn or replaced according to the STOPP/Beers criteria and those initiated according to the START criteria, was 2.8 times higher in the intervention group than in the control group (OR = 2.8; 95% CI 1.3–6.1) p = 0.008. In patients with good adherence to the treatment, the percentage of appropriateness was 62.1% in the shared decision-making group versus 37.9% in the control group (p = 0.005). The use of a decision-making support tool in patients with potentially inappropriate medications increases the percentage of medication appropriateness when compared to the usual clinical practice.

scholarly journals Implementation of a Shared Decision-Making Tool for Osteoarthritis Treatment to Reduce Decisional Conflict

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. 186-186
Author(s):  
Yashika Watkins ◽  
Rose Gonzalez ◽  
Charla Johnson ◽  
Ravneet Kaur
Keyword(s):  
Physical Activity ◽  
Decision Making ◽  
Shared Decision Making ◽  
Intervention Group ◽  
The United States ◽  
Control Group ◽  
Shared Decision ◽  
Patient Centered ◽  
Chronic Knee Pain ◽  
Co Morbidity

Abstract Shared decision making is a key component of patient centered care where clinical evidence and the patient’s preference and values are considered. Physical activity and weight loss are often recommendations in the treatment plan, especially in mild to moderate stage of osteoarthritis (OA). Movement is Life (MIL) created an innovative SDM tool to provide a framework for patient-centered discussions. The tool leverages an underlying Markov Model and represents the likely pain, activity levels, and lost productivity at three future time points. By comparing the patient’s likely progression depending on treatment choices compared to doing nothing, the patient has an illustration of future state. A pilot of N=108 women, ages 45-64, with chronic knee pain for at least three months and at least one co-morbidity (obesity, hypertension, diabetes) were randomized to a control (n=54) or intervention (n=54) arm of the study at eight centers across the United States. Results showed the demographic profiles were similar between the groups. At one-month, n=47 control and n=50 intervention patients returned for evaluation. Self-reported level of physical activity increased in the intervention group (56% vs 34%, p = 0.0229). Qualitative feedback from the intervention group indicated high satisfaction with use of the tool. Both groups reported a high likeliness to recommend the provider to a friend or family member. Inclusion of the SDM tool added an average of one minute to the patient counseling time over the control group. The quasi script provides a consistent communication pathway and may reduce disparities by addressing unconscious bias.

Decision aids to prepare patients for shared decision making: Two randomized controlled experiments on the impact of awareness of preference-sensitivity and personal motives

2020 ◽  
Author(s):  
Marie Eggeling ◽  
Simone Korger ◽  
Ulrike Cress ◽  
Joachim Kimmerle ◽  
Martina Bientzle
Keyword(s):  
Decision Making ◽  
Shared Decision Making ◽  
Cruciate Ligament ◽  
Decision Aids ◽  
Future Research ◽  
Control Group ◽  
Decision Making Process ◽  
Shared Decision ◽  
Decision Strategies ◽  
The Impact

Objective: To participate in shared decision-making (SDM), patients need to understand their options and develop trust in their own decision-making abilities. Two experiments investigated the potential of decision aids (DAs) in preparing patients for SDM by raising awareness of preference-sensitivity (Study 1) and showing possible personal motives for decision-making (Study 2) in addition to providing information about the treatment options.Methods: Participants (Study 1: N=117; Study 2: N=217) were put into two scenarios (Study 1: cruciate ligament rupture; Study 2: contraception), watched a consultation video, and were randomized into one of three groups where they received additional information in the form of 1) narrative patient testimonials; 2) non-narrative decision strategies; 3) an unrelated text (control group). Results: Participants who viewed the patient testimonials or decision strategies felt better prepared for a decision (Study 1: P&lt;.001, η²p=0.43; Study 2: P&lt;.001, η²p=0.57) and evaluated the decision-making process more positively (Study 2: P&lt;.001, η²p=0.13) than participants in the control condition. Decision certainty (Study 1: P&lt;.001, η2p=0.05) and satisfaction (Study 1: P&lt;.001, η2p=0.11; Study 2: P=.003, d=0.29) were higher across all conditions after watching the consultation video, and certainty and satisfaction were lower in the control condition (Study 2: P&lt;.001, η²p=0.05).Discussion: DAs that explain preference-sensitivity and personal motives can be beneficial for improving people’s feelings of being prepared and their perception of the decision-making process. To reach decision certainty and satisfaction, being well informed of one’s options is particularly relevant. We discuss the implications of our findings for future research and the design of DAs.

scholarly journals A Simple Goal Elicitation Tool Improves Shared Decision Making in Outpatient Orthopedic Surgery: A Randomized Controlled Trial

2020 ◽  
Vol 40 (6) ◽  
pp. 766-773
Author(s):  
Kevin Mertz ◽  
Romil F. Shah ◽  
Sara L. Eppler ◽  
Jeffrey Yao ◽  
Marc Safran ◽  
...  
Keyword(s):  
Decision Making ◽  
Randomized Controlled Trial ◽  
Shared Decision Making ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Shared Decision ◽  
Randomized Controlled ◽  
Patient Goals ◽  
Perceived Involvement

Introduction. Shared decision making involves educating the patient, eliciting their goals, and collaborating on a decision for treatment. Goal elicitation is challenging for physicians as previous research has shown that patients do not bring up their goals on their own. Failure to properly elicit patient goals leads to increased patient misconceptions and decisional conflict. We performed a randomized controlled trial to test the efficacy of a simple goal elicitation tool in improving patient involvement in decision making. Methods. We conducted a randomized, single-blind study of new patients presenting to a single, outpatient surgical center. Prior to their consultation, the intervention group received a demographics questionnaire and a goal elicitation worksheet. The control group received a demographics questionnaire only. After the consultation, both groups were asked to complete the Perceived Involvement in Care Scale (PICS) survey. We compared the mean PICS scores for the intervention and control groups using a nonparametric Mann-Whitney Wilcoxon test. Secondary analysis included a qualitative content analysis of the patient goals. Results. Our final cohort consisted of 96 patients (46 intervention, 50 control). Both groups were similar in terms of demographic composition. The intervention group had a significantly higher mean (SD) PICS score compared to the control group (9.04 [2.15] v. 7.54 [2.27], P < 0.01). Thirty-nine percent of patient goals were focused on receiving a diagnosis or treatment, while 21% of patients wanted to receive education regarding their illness or their treatment options. Discussion. A single-step goal elicitation tool was effective in improving patient-perceived involvement in their care. This tool can be efficiently implemented in both academic and nonacademic settings.

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