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.

Conflict of interest statement

Conflict of Interest Disclosures: All authors reported receiving Patient-Centered Outcomes Research Institute (PCORI) grants. Dr Schwarze reported receiving funding from the National Institutes of Health (NIH) (grant R21AG055876-01), the National Palliative Care Research Center, and The Cambia Health Foundation’s Sojourns Scholar Leadership Program. Dr Hanlon reported receiving grants from the NIH. Dr Rathouz reported receiving compensation from Sunovion Pharmaceuticals for participation on a data and safety monitoring board. Dr Taylor reported being supported by a training award (T32CA090217) from the NIH. Dr Zimmermann reported being supported by a training award (2T32HL110853-06) from the NIH. Dr Kata reported receiving grants from the National Institute on Aging.

Figures

Figure 1.. CONSORT Diagram for Patients Enrolled in the Study

CONSORT indicates Consolidated Standards of Reporting Trials; QPL, question prompt list; T0, time of enrollment and surgical visit; T1, survey administration 24 to 48 hours after meeting with the surgeon; T2, 1 to 2 weeks after surgery or 6 weeks after enrollment; and T3, 6 to 8 weeks after surgery or 12 to 14 weeks after enrollment. aData available for the difference in Measure Yourself Concerns and Well-being (MYCaW) scores, T2 minus T1 and T3 minus T1, are less than the number available for analysis because 72 patients and 39 family members in the QPL intervention group and 48 patients and 28 family members in the usual care group noted they had no concerns to rate at T1.

Figure 2.. Numbers of Options, Expectations, and Risks Questions Asked by Patients and Family Members During Conversations With Study-Enrolled Surgeons

The question prompt list (QPL) intervention cohort is restricted to 93 patients who had a discussion about major oncologic or vascular (cardiac, neurosurgical, or peripheral vascular) surgery and who had clear evidence they had reviewed the QPL. OR indicates odds ratio.

Figure 3.. Observing Patient Involvement in Decision Making (OPTION5) Scores for Conversations About Major Surgery Between Surgeons and Patients With an Oncologic or Vascular Problem

QPL indicates question prompt list.