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Pre-consultation educational group intervention to improve shared decision-making in postmastectomy breast reconstruction: study protocol for a pilot randomized controlled trial.

ABSTRACT: The Pre-Consultation Educational Group INTERVENTION pilot study seeks to assess the feasibility and inform the optimal design for a definitive randomized controlled trial that aims to improve the quality of decision-making in postmastectomy breast reconstruction patients.This is a mixed-methods pilot feasibility randomized controlled trial that will follow a single-center, 1:1 allocation, two-arm parallel group superiority design.The University Health Network, a tertiary care cancer center in Toronto, Canada.Adult women referred to one of three plastic and reconstructive surgeons for delayed breast reconstruction or prophylactic mastectomy with immediate breast reconstruction.We designed a multi-disciplinary educational group workshop that incorporates the key components of shared decision-making, decision-support, and psychosocial support for cancer survivors prior to the initial surgical consult. The intervention consists of didactic lectures by a plastic surgeon and nurse specialist on breast reconstruction choices, pre- and postoperative care; a value-clarification exercise led by a social worker; and discussions with a breast reconstruction patient.Usual care includes access to an informational booklet, website, and patient volunteer if desired.Expected pilot outcomes include feasibility, recruitment, and retention targets. Acceptability of intervention and full trial outcomes will be established through qualitative interviews. Trial outcomes will include decision-quality measures, patient-reported outcomes, and service outcomes, and the treatment effect estimate and variability will be used to inform the sample size calculation for a full trial.Our pilot study seeks to identify the (1) feasibility, acceptability, and design of a definitive RCT and (2) the optimal content and delivery of our proposed educational group intervention. Thirty patients have been recruited to date (8 April 2013), of whom 15 have been randomized to one of three decision support workshops. The trial will close as planned in May 2013.NCT01857882.

SUBMITTER: Platt J

PROVIDER: S-EPMC3708760 | biostudies-literature | 2013 Jul

REPOSITORIES: biostudies-literature

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Pre-consultation educational group intervention to improve shared decision-making in postmastectomy breast reconstruction: study protocol for a pilot randomized controlled trial.

Platt Jennica J Baxter Nancy N Jones Jennifer J Metcalfe Kelly K Causarano Natalie N Hofer Stefan O P SO O'Neill Anne A Cheng Terry T Starenkyj Elizabeth E Zhong Toni T

Trials 20130706

<h4>Background</h4>The Pre-Consultation Educational Group INTERVENTION pilot study seeks to assess the feasibility and inform the optimal design for a definitive randomized controlled trial that aims to improve the quality of decision-making in postmastectomy breast reconstruction patients.<h4>Methods/design</h4>This is a mixed-methods pilot feasibility randomized controlled trial that will follow a single-center, 1:1 allocation, two-arm parallel group superiority design.<h4>Setting</h4>The Univ ...[more]

PMID: 23829442

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Project description:BackgroundStrabismus is a complex disease that has various treatment approaches each with its own advantages and drawbacks. In this context, shared decisions making (SDM) is a communication process with the provider sharing all the relevant treatment alternatives, all the benefits, and risks of each procedure, while the patient shares all the preferences and values regarding his/her choices. In that way, SDM is a bidirectional process that goes beyond the typical informed consent. Therefore, it is known a little of the extent to which SDM influences the satisfaction with the treatment outcome along with strabismus patients. To study this correlation, an SDM-Q-9 questionnaire was provided within surgical consultations where treatment decisions were made; the SDM-Q-9 aims to assess the relationship between the post-operative patient's satisfaction and their SMD score.MethodsThe study is considered a prospective observational pilot study. Eligible patients were adult patients diagnosed with strabismus, who had multiple treatment options, were given at the right of choice without being driven into a physician's preference. Ninety-three strabismus patients were asked to fill out the SDM-Q-9 questionnaire related to their perception of SDM during the entire period of strabismus treatment. After the treatment, patients were asked to rate their satisfaction level with the surgical outcome as excellent, good, fair, and poor. Descriptive statistics and the linear regression statistical tests (Spearman, Mann Whitney U, and Kriskal-Wallis) were used as analysis tools.ResultsThe average age of the participants was 24, where 50.6% were women. The mean SDM-Q-9 score among patients was 32 (IQR = 3). The postoperative patient satisfaction was rated as being excellent by 16 (17.2%) patients, good by 38 (40.9%), fair by 32 (34.4%), and poor by 7 patients (7.5%). Data analysis by linear regression statistical tests showed a positive correlation between the SDM-Q-9 score and the patient satisfaction related to the surgery outcome (B = 0.005, p < 0.001). Criteria in assessing patients' satisfaction were age, gender, and strabismus type. A positive correlation between SDM and real satisfaction (r = 0.834, p < 0.01) was found with age, and no significant relationship was found while taking into consideration the responder's gender and the strabismus type.ConclusionsAssessing patient satisfaction after choosing a treatment for strabismus method helped us evaluate the gaps in constructive dialogue that would lead to a positive outcome for both patient and clinician. The correlation between the SDM process and the patients' satisfaction with surgery outcome, adjusted by age, has been established. These findings can serve as a springboard to further communicative improvements related to the SDM process and between patients and physicians, thereby consequently leading to patients' satisfaction raise in strabismus care. The study underlines the importance of further analysis and validation of on-ground interactions among the adolescent and adult patients and the clinicians across the strabismus management trajectory. A multicentral study and its validation will follow.

Project description:BackgroundShared decision-making (SDM) is widely recommended and required by the Centers for Medicare and Medicaid for patients considering lung cancer screening (LCS).ObjectiveWe examined clinicians' communication practices and perceived barriers of SDM for LCS at three medical centers with established screening programs.DesignMulticenter qualitative study of clinicians participating in LCS.ApproachWe performed semi-structured interviews, which were transcribed and analyzed using directed content analysis, guided by a theoretical model of patient-clinician communication.ParticipantsWe interviewed 24 clinicians including LCS coordinators (2), pulmonologists (3), and primary care providers (17), 4 of whom worked for the LCS program, a thoracic surgeon, and a radiologist.ResultsAll clinicians agreed with the goal of SDM, to ensure the screening decision was congruent with the patient's values. The depth and type of information presented by each clinician role varied considerably. LCS coordinators presented detailed information including numeric estimates of benefit and harm. Most PCPs explained the process more generally, focusing on logistics and the high rate of nodule detection. No clinician explicitly elicited values or communication preferences. Many PCPs tailored the conversation based on their implicit understanding of patients' values and preferences, gained from past experiences. PCPs reported that time, lack of detailed personal knowledge of LCS, and patient preferences were barriers to SDM. Many clinicians perceived that a significant proportion of patients were not interested in specific percentages and preferred to receive a clinician recommendation.ConclusionsOur results suggest that clinicians support the goal of SDM for LCS decisions but PCPs may not perform some of its elements. The lack of completion of some elements, such as PCPs' lack of in-depth information exchange, may reflect perceived patient preferences for communication. As LCS is implemented, further research is needed to support a personalized, patient-centered approach to produce better outcomes.

Project description:BackgroundWhether to undergo postmastectomy breast reconstruction (PMBR) is a challenging, preference-sensitive decision. It is therefore paramount to optimize decision quality through ensuring patients' knowledge and aligning treatments with their personal preferences. This study assessed the effects of a preconsultation educational group intervention (PEGI) on patient knowledge, state-trait anxiety, and decisional conflict (patient uncertainty in decision making) during the decision-making process.MethodsThis phase 3 randomized controlled trial assessed effects of a PEGI in women without active breast cancer undergoing delayed PMBR, or prophylactic mastectomy with immediate PMBR. Both groups underwent routine education before consultation. In addition, the intervention group underwent a PEGI composed of presentations from a plastic surgeon and nurse, a value clarification exercise, and shared experiences from PMBR patients before the consultation with the plastic surgeon. Before and 1-week after consultation, outcome measures were assessed using the Decisional Conflict Scale, State-Trait Anxiety Inventory, and the BREAST-Q.ResultsOf the 219 women deemed eligible, a total of 156 women were recruited and randomized. Treatment fidelity was 96% and retention was 88%. At baseline, there were no significant differences in terms of demographic or clinical status, knowledge, state-trait anxiety, and decisional conflict. Patient knowledge about PMBR improved in both groups; however, the degree of knowledge attainment was significantly greater in the PEGI group (24.5% improvement in the intervention group compared with 13.5% in the routine education group, P < 0.001). The reduction in decisional conflict from baseline to follow-up was greater in the intervention group compared with the routine education; however, the difference only approached significance (P = 0.09).ConclusionsThe provision of a preconsultation educational group intervention has been shown to significantly close the knowledge gap on PMBR in patients seeking delayed breast reconstruction or prophylactic mastectomy with immediate breast reconstruction compared with routine education alone.

Project description:Background. Accurate diagnosis of patients' preferences is central to shared decision making. Missing from clinical practice is an approach that links pretreatment preferences and patient-reported outcomes. Objective. We propose a Bayesian collaborative filtering (CF) algorithm that combines pretreatment preferences and patient-reported outcomes to provide treatment recommendations. Design. We present the methodological details of a Bayesian CF algorithm designed to accomplish 3 tasks: 1) eliciting patient preferences using conjoint analysis surveys, 2) clustering patients into preference phenotypes, and 3) making treatment recommendations based on the posttreatment satisfaction of like-minded patients. We conduct a series of simulation studies to test the algorithm and to compare it to a 2-stage approach. Results. The Bayesian CF algorithm and 2-stage approaches performed similarly when there was extensive overlap between preference phenotypes. When the treatment was moderately associated with satisfaction, both methods made accurate recommendations. The kappa estimates measuring agreement between the true and predicted recommendations were 0.70 (95% confidence interval = 0.052-0.88) and 0.73 (0.56-0.90) under the Bayesian CF and 2-stage approaches, respectively. The 2-stage approach failed to converge in settings in which clusters were well separated, whereas the Bayesian CF algorithm produced acceptable results, with kappas of 0.73 (0.56-0.90) and 0.83 (0.69-0.97) for scenarios with moderate and large treatment effects, respectively. Limitations. Our approach assumes that the patient population is composed of distinct preference phenotypes, there is association between treatment and outcomes, and treatment effects vary across phenotypes. Findings are also limited to simulated data. Conclusion. The Bayesian CF algorithm is feasible, provides accurate cluster treatment recommendations, and outperforms 2-stage estimation when clusters are well separated. As such, the approach serves as a roadmap for incorporating predictive analytics into shared decision making.

Dataset Information

Pre-consultation educational group intervention to improve shared decision-making in postmastectomy breast reconstruction: study protocol for a pilot randomized controlled trial.

Publications

Pre-consultation educational group intervention to improve shared decision-making in postmastectomy breast reconstruction: study protocol for a pilot randomized controlled trial.

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