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

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.

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

10.2196/preprints.35543 ◽

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)).

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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

BMC Family Practice ◽

10.1186/s12875-021-01436-6 ◽

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.

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

Epidemiology and Psychiatric Sciences ◽

10.1017/s2045796020000505 ◽

2020 ◽

Vol 29 ◽

Cited By ~ 2

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).

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

Journal of Clinical Medicine ◽

10.3390/jcm8060904 ◽

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.

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

Innovation in Aging ◽

10.1093/geroni/igab046.703 ◽

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.

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

Medical Decision Making ◽

10.1177/0272989x20943520 ◽

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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Does a simple web-based intervention facilitate the articulation of patients’ unvoiced agenda for a consultation with their diabetologists? A qualitative study

BMJ Open ◽

10.1136/bmjopen-2018-026588 ◽

2019 ◽

Vol 9 (6) ◽

pp. e026588 ◽

Cited By ~ 1

Author(s):

Julia Frost ◽

Andy Gibson ◽

Obioha Ukoumunne ◽

Bijay Vaidya ◽

Nicky Britten

Keyword(s):

Decision Making ◽

Qualitative Study ◽

Shared Decision Making ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Shared Decision ◽

Structured Interviews ◽

Web Based ◽

Patients With Diabetes

ObjectiveTo explore whether a preconsultation web-based intervention enables patients with diabetes to articulate their agenda in a consultation in the hospital outpatient clinic with their diabetologist.Methods and designA qualitative study embedded in a pragmatic pilot randomised controlled trial.SettingTwo city outpatient departments in England.Participants25 patients attending a follow-up consultation and 6 diabetologists.InterventionThe PACE-D, a web-based tool adapted for patients with diabetes to use before their consultation to generate an agenda of topics to discuss with their diabetologist.Data collection25 participants had their consultation with their diabetologist audio-recorded: 12 in the control arm and 13 in the intervention arm; 12 of the latter also had their PACE-D intervention session and a consultation recorded. Semi-structured interviews with 6 diabetologists, and 12 patients (6 in the intervention group and 6 in the control group).AnalysisThematic discourse analysis undertaken with patient representatives trained in qualitative data analysis techniques.ResultsWe identified four consultation types: diabetologist facilitated; patient identified; consultant facilitated and patient initiated and patient ignored. We also identified three critical aspects that explained the production and utilisation of the agenda form: existing consultative style; orientation to the use of the intervention and impact on the consultation. Where patients and diabetologists have a shared preference for a consultant-led or patient-led consultation, the intervention augments effective communication and shared decision making. However, where preferences diverge (eg, there is a mismatch in patients' and diabetologists' preferences and orientations), the intervention does not improve the potential for shared decision making.ConclusionA simple web-based intervention facilitates the articulation of patients’ unvoiced agenda for a consultation with their diabetologist, but only when pre-existing consultation styles and orientations already favour shared decision making. More needs to be done to translate patient empowerment in the consultation setting into genuine self-efficacy.Trial registration numberISRCTN75070242.

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Effect of Shared Decision-making on Anxiety of Women Recommended for Prenatal Screening Tests in Southeast of Iran

Journal of Family & Reproductive Health ◽

10.18502/jfrh.v14i3.4673 ◽

2020 ◽

Author(s):

Zahra Moudi ◽

Raheleh Jam ◽

Hossein Ansari ◽

Mostafa Montazer Zohour

Keyword(s):

Decision Making ◽

Pregnant Women ◽

Shared Decision Making ◽

Prenatal Screening ◽

Intervention Group ◽

Screening Tests ◽

Control Group ◽

Shared Decision ◽

Level Of Education ◽

University Level

Objective: To study the effect of shared decision-making (SDM) on the anxiety of women who were recommended for prenatal screening tests. Materials and methods: This quasi-experimental study was conducted on a total of 200 pregnant women who referred to the health centers of Zahedan, Iran, for prenatal care within April 7 to September 7, 2019. The control group received routine care, and the intervention group attended a session based on SDM. The demographic characteristics form and Spielberger Six-item State-Trait Anxiety Inventory were filled out before and immediately after the counseling, as well as before receiving the results of maternal serum biochemical markers. Results: No statistically significant effect of SDM on anxiety was reported between the control and intervention groups immediately after the counseling session (P=0.46). However, the obtained data showed that the mean value of anxiety scores (16.52±3.06) was higher among the women in the intervention group than that reported for the control group (13.80±3.55) on the day before receiving the results of the blood tests (P<0.001). Nevertheless, logistic regression analysis showed only women with a university level of education were likely to have higher anxiety scores than women with lower educational levels (AOR=10.60; 95% CI: 2.07-54.24; P=0.005). Conclusion: Offering prenatal screening can cause a slight increase in the level of anxiety among women with a university level of education. Therefore, it is required to implement supportive strategies to help high-risk pregnant women in coping with anxiety.

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Nocebo effects by providing informed consent in shared decision making? Not necessarily: a randomized pilot-trial using an open-label placebo approach

BMC Medical Ethics ◽

10.1186/s12910-020-00541-y ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Fabian Holzhüter ◽

Johannes Hamann

Keyword(s):

Decision Making ◽

Informed Consent ◽

Shared Decision Making ◽

Pilot Trial ◽

Intervention Group ◽

Trial Registration ◽

Control Group ◽

Shared Decision ◽

Open Label ◽

Nocebo Effects

Abstract Background Thorough information of the patient is an integral part of the process of shared decision making. We aimed to investigate if detailed information about medication may induce nocebo (or placebo) effects. Methods We conducted a randomized, single-blind, pilot-study including n = 51 psychiatric in-patients aged between 18 and 80 years with a depressive disorder and accompanying sleeping disorders. In the intervention group we provided thorough information about adverse effects, while the control group received only a simple consent procedure. In both groups, patients received an open-label placebo pill instead of their sleeping medication. Results No statistically significant differences between the intervention group and the control group were found regarding the main outcome parameter (a visual analogue scale indicating impairment by the new pill). Conclusion In this study, we were not able detect an effect of informed consent vs. simple consent on the emergence of placebo or nocebo effects. This finding is contrary to most assumptions and publications about this topic. Trial registration Trial registration number: DRKS00017653, registered August 30th 2018. Retrosprectively registered.

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Can electronic assessment tools improve the process of shared decision-making? A systematic review

Health Information Management Journal ◽

10.1177/1833358320954385 ◽

2020 ◽

pp. 183335832095438

Author(s):

Nyantara Wickramasekera ◽

Sarah K Taylor ◽

Elizabeth Lumley ◽

Thomas Gray ◽

Emma Wilson ◽

...

Keyword(s):

Systematic Review ◽

Decision Making ◽

Shared Decision Making ◽

Healthcare Professionals ◽

Treatment Plan ◽

Intervention Group ◽

Assessment Tools ◽

Control Group ◽

Shared Decision ◽

Electronic Assessment

Background: Patient involvement in decision-making plays a prominent role in improving the quality of healthcare. Despite this, shared decision-making is not routinely implemented. However, electronic assessment tools that capture patients’ history, symptoms, opinions and values prior to their medical appointment are used by healthcare professionals during patient consultations to facilitate shared decision-making. Objective: To assess the effectiveness of electronic assessment tools to improve the shared decision-making process. Method: A systematic review was conducted following PRISMA guidelines. Published literature was searched on MEDLINE, EMBASE and PsycINFO to identify potentially relevant studies. Data were extracted and analysed narratively. Results: Seventeen articles, representing 4004 participants, were included in this review. The main findings were significant improvement in patient–provider communication and provider management of patient condition in the intervention group compared to the control group. In contrast, patient–provider satisfaction and time efficiency were assessed by relatively few included studies, and the effects of these outcomes were inconclusive. Conclusion: This review found that communication and healthcare professional’s management of a patient’s condition improves because of the use of electronic questionnaires. This is encouraging because the process of shared decision-making is reliant on high-quality communication between healthcare professionals and patients. Implications: We found that this intervention is especially important for people with chronic diseases, as they need to establish a long-term relationship with their healthcare provider and agree to a treatment plan that aligns with their values. More rigorous research with validated instruments is required.

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