Article Text
Abstract
Introduction Despite positive health outcomes associated with advance care planning (ACP), little research has investigated the impact of ACP in surgical populations. Our goal is to evaluate how an ACP intervention video impacts the patient centredness and ACP of the patient-surgeon conversation during the presurgical consent visit. We hypothesise that patients who view the intervention will engage in a more patient-centred communication with their surgeons compared with patients who view a control video.
Methods and analysis Randomised controlled superiority trial of an ACP video with two study arms (intervention ACP video and control video) and four visits (baseline, presurgical consent, postoperative 1 week and postoperative 1 month). Surgeons, patients, principal investigator and analysts are blinded to the randomisation assignment.
Setting Single, academic, inner city and tertiary care hospital. Data collection began July 16, 2015 and continues to March 2017.
Participants Patients recruited from nine surgical oncology clinics who are undergoing major cancer surgery.
Interventions In the intervention arm, patients view a patient preparedness video developed through extensive engagement with patients, surgeons and other stakeholders. Patients randomised to the control arm viewed an informational video about the hospital surgical programme.
Main outcomes and measures Primary Outcome: Patient centredness and ACP of patient-surgeon conversations during the presurgical consent visit as measured through the Roter Interaction Analysis System. Secondary outcomes: patient Hospital Anxiety and Depression Scale score; patient goals of care; patient, companion and surgeon satisfaction; video helpfulness; medical decision maker designation; and the frequency patients watch the video. Intent-to-treat analysis will be used to assess the impact of video assignment on outcomes. Sensitivity analyses will assess whether there are differential effects contingent on patient or surgeon characteristics.
Ethics and dissemination This study has been approved by the Johns Hopkins School of Medicine institutional review board and is registered on clinicaltrials.gov (NCT02489799, First received: July 1, 2015).
Trial registration number clinicaltrials.gov, NCT02489799.
- advance care planning
- patient-centered outcomes research
- video tools
- Adult palliative care
This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
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Footnotes
Contributors RAA is the study principal investigator and she directed all study activities and coordinated between team members. Study design: RAA, SRI, TY, MW, AEV, JFPB and DLR; analysis design: RAA, SRI, TY, NLC and DLR; and protocol generation: RAA, SRI, NLC, AMCC and TY.
Funding This work was supported by the Patient Centered Outcomes Research Institute (CDR-12-11-4362).
Competing interests None declared.
Patient consent Obtained.
Ethics approval The Johns Hopkins School of Medicine Institutional Review Board.
Provenance and peer review Not commissioned; externally peer reviewed.