Dataset Information

Effectiveness of a Question Prompt List Intervention for Older Patients Considering Major Surgery: A Multisite Randomized Clinical Trial.

ABSTRACT:

Importance

Poor preoperative communication can have serious consequences, including unwanted treatment and postoperative conflict.

Objective

To 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 participants

This 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.

Interventions

A 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 measures

Primary 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.

Results

Of 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 relevance

The 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 registration

ClinicalTrials.gov identifier: NCT02623335.

SUBMITTER: Schwarze ML

PROVIDER: S-EPMC6822097 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:IntroductionOlder 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 analysisThis 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 disseminationApprovals 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 numberNCT02623335.

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.

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Project description:IntroductionQuestion prompt lists (QPLs) have been found to support patients to ask questions and improve the information they receive from doctors. However, some QPL tools, which have been available online for almost 15 years, have little published data on their impact in real-world settings. This study's aim was to understand patients' attitudes and experiences accessing health information and to assess the impact of introducing two generic QPLs over 3 months.MethodsA longitudinal qualitative study consisting of three semi-structured interviews over a three-month period was conducted with 31 purposively selected participants, adults ≥18 years, recruited online and through social media. Participants were introduced to two different QPLs currently available online ('Question Builder'; 'AskShareKnow'). Inductive thematic analysis of a total of 92 semi-structured telephone interviews was conducted during May-November 2020.ResultsThree main themes are described. (1) Participants described barriers and facilitators to accessing health information: navigating a complex health system; difficulty asking questions of their healthcare professionals and that they value doctors with good communication skills. (2) QPLs helped some participants recognize the role of question-asking in consultations, made them feel more empowered and helped them prepare and prioritize. (3) Participants wanted QPLs to be easier to use, be accessible when needed and that question-asking and QPLs should be normalized in medical consultations.ConclusionsWell-designed and easily accessible QPLs can empower people to ask questions and be more involved in decisions about their health care. Endorsement of question-asking in consultations by healthcare professionals and providing QPL tools at the point of contact with health services will be key to realizing the potential of QPLs.Patient or public contributionThis study was completed in conjunction with a reference group consisting of a consumer representative, representatives from the Australian Commission on Safety and Quality in Health Care, Healthdirect Australia Ltd., and the research team.