Dataset Information

Navigating high-risk surgery: protocol for a multisite, stepped wedge, cluster-randomised trial of a question prompt list intervention to empower older adults to ask questions that inform treatment decisions.

ABSTRACT:

Introduction

Older patients frequently undergo operations that carry high risk for postoperative complications and death. Poor preoperative communication between patients and surgeons can lead to uninformed decisions and result in unexpected outcomes, conflict between surgeons and patients, and treatment inconsistent with patient preferences. This article describes the protocol for a multisite, cluster-randomised trial that uses a stepped wedge design to test a patient-driven question prompt list (QPL) intervention aimed to improve preoperative decision making and inform postoperative expectations.

Methods and analysis

This Patient-Centered Outcomes Research Institute-funded trial will be conducted at five academic medical centres in the USA. Study participants include surgeons who routinely perform vascular or oncological surgery, their patients and families. We aim to enrol 40 surgeons and 480 patients over 24 months. Patients age 65 or older who see a study-enrolled surgeon to discuss a vascular or oncological problem that could be treated with high-risk surgery will be enrolled at their clinic visit. Together with stakeholders, we developed a QPL intervention addressing preoperative communication needs of patients considering major surgery. Guided by the theories of self-determination and relational autonomy, this intervention is designed to increase patient activation. Patients will receive the QPL brochure and a letter from their surgeon encouraging its use. Using audio recordings of the outpatient surgical consultation, patient and family member questionnaires administered at three time points and retrospective chart review, we will compare the effectiveness of the QPL intervention to usual care with respect to the following primary outcomes: patient engagement in decision making, psychological well-being and post-treatment regret for patients and families, and interpersonal and intrapersonal conflict relating to treatment decisions and treatments received.

Ethics and dissemination

Approvals have been granted by the Institutional Review Board at the University of Wisconsin and at each participating site, and a Certificate of Confidentiality has been obtained. Results will be reported in peer-reviewed publications and presented at national meetings.

Trial registration number

NCT02623335.

SUBMITTER: Taylor LJ

PROVIDER: S-EPMC5729991 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ImportancePoor preoperative communication can have serious consequences, including unwanted treatment and postoperative conflict.ObjectiveTo compare the effectiveness of a question prompt list (QPL) intervention vs usual care on patient engagement and well-being among older patients considering major surgery.Design, setting, and participantsThis randomized clinical trial used a stepped-wedge design to randomly assign patients to a QPL intervention (n = 223) or usual care (n = 223) based on the timing of their visit with 1 of 40 surgeons at 5 US study sites. Patients were 60 years or older with at least 1 comorbidity and an oncologic or vascular (cardiac, neurosurgical, or peripheral vascular) problem that could be treated with major surgery. Family members were also enrolled (n = 263). The study dates were June 2016 to November 2018. Data analysis was by intent-to-treat.InterventionsA brochure of 11 questions to ask a surgeon developed by patient and family stakeholders plus an endorsement letter from the surgeon were sent to patients before their outpatient visit.Main outcomes and measuresPrimary patient engagement outcomes included the number and type of questions asked during the surgical visit and patient-reported Perceived Efficacy in Patient-Physician Interactions scale assessed after the surgical visit. Primary well-being outcomes included (1) the difference between patient's Measure Yourself Concerns and Well-being (MYCaW) scores reported after surgery and scores reported after the surgical visit and (2) treatment-associated regret at 6 to 8 weeks after surgery.ResultsOf 1319 patients eligible for participation, 223 were randomized to the QPL intervention and 223 to usual care. Among 446 patients, the mean (SD) age was 71.8 (7.1) years, and 249 (55.8%) were male. On intent-to-treat analysis, there was no significant difference between the QPL intervention and usual care for all patient-reported primary outcomes. The difference in MYCaW scores for family members was greater in usual care (effect estimate, 1.51; 95% CI, 0.28-2.74; P = .008). When the QPL intervention group was restricted to patients with clear evidence they reviewed the QPL, a nonsignificant increase in the effect size was observed for questions about options (odds ratio, 1.88; 95% CI, 0.81-4.35; P = .16), expectations (odds ratio, 1.59; 95% CI, 0.67-3.80; P = .29), and risks (odds ratio, 2.41; 95% CI, 1.04-5.59; P = .04) (nominal α = .01).Conclusions and relevanceThe results of this study were null related to primary patient engagement and well-being outcomes. Changing patient-physician communication may be difficult without addressing clinician communication directly.Trial registrationClinicalTrials.gov identifier: NCT02623335.

Project description:BackgroundMost conditions in orthopaedic surgery are preference-sensitive, where treatment choices are based on the patient's values and preferences. One set of tools increasingly used to help align treatment choices with patient preferences are question prompt lists (QPLs), which are comprehensive lists of potential questions that patients can ask their physicians during their encounters. Whether or not a comprehensive orthopaedic-specific question prompt list would increase patient-perceived involvement in care more effectively than might three generic questions (the AskShareKnow questions) remains unknown; learning the answer would be useful, since a three-question list is easier to use compared with the much lengthier QPLs.Question/purposeDoes an orthopaedic-specific question prompt list increase patient-perceived involvement in care compared with the three generic AskShareKnow questions?MethodsWe performed a pragmatic randomized controlled trial of all new patients visiting a multispecialty orthopaedic clinic. A pragmatic design was used to mimic normal clinical care that compared two clinically acceptable interventions. New patients with common orthopaedic conditions were enrolled between August 2019 and November 2019 and were randomized to receive either the intervention QPL handout (orthopaedic-specific QPL with 45 total questions, developed with similar content and length to prior QPLs used in hand surgery, oncology, and palliative care) or a control handout (the AskShareKnow model questions, which are: "What are my options? What are the benefits and harms of those options? How likely are each of those benefits and harms to happen to me?") before their visits. A total of 156 patients were enrolled, with 78 in each group. There were no demographic differences between the study and control groups in terms of key variables. After the visit, patients completed the Perceived Involvement in Care Scale (PICS), a validated instrument designed to evaluate patient-perceived involvement in their care, which served as the primary outcome measure. This instrument is scored from 0 to 13, with higher scores indicating higher perceived involvement.ResultsThere was no difference in mean PICS scores between the intervention and control groups (QPL 8.3 ± 2.3, control 8.5 ± 2.3, mean difference 0.2 [95% CI -0.53 to 0.93 ]; p = 0.71.ConclusionIn patients undergoing orthopaedic surgery, a QPL does not increase patient-perceived involvement in care compared with providing patients the three AskShareKnow questions. Implementation of the three AskShareKnow questions can be a more efficient way to improve patient-perceived involvement in their care compared with a lengthy QPL.Level of evidenceLevel II, therapeutic study.

Project description:ObjectivesThis study involved the development of a question prompt list (QPL) booklet designed to facilitate communication and shared decision-making between parents/carers of children diagnosed with attention-deficit/hyperactivity disorder (ADHD) and their clinicians; and user-testing of the QPL to assess its usability.DesignBest practice in information writing and design was used to format the QPL content into a 16-page booklet. We then applied user-testing, which uses mixed methods to assess document performance with small cohorts of participants and then improves it in an iterative process. Individual interviews assessed the ability of QPL users to locate and understand key points of information, followed by a semistructured questionnaire, to ascertain their general views about the booklet.Setting and participantsTesting was undertaken with two cohorts of 10 parents/carers of children with ADHD (n=20); matched on age, gender and educational attainment.Tested documentsIn round 1, we tested 15 key points of information related to the QPL. Participant responses and feedback from round 1 informed a revised version of the booklet, tested in a subsequent round.Primary outcome measureThe target was for 8/10 of the participants to be able to find and demonstrate an understanding of all key information points, in accordance with European guidelines for medicine leaflet testing.ResultsAfter round 1, problems related to 4/15 information points were identified (booklet purpose; preparing for appointments; asking about a second medical opinion; selecting which questions to ask). Participants also made suggestions regarding the booklet's layout and design. After round 2, all information points were located and understood by at least 8/10 participants.ConclusionsThis is the first study to have developed a usable ADHD-specific QPL for use by parents/carers of children with ADHD during clinical consultations, and the first demonstration of the utility of user-testing methods in ensuring QPL usability.