Evaluating a Strategy to Improve Pre-Anesthesia Care Discussions (My Anesthesia Choice-Hip Fracture)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorUniversity of Pennsylvania

About this trial

The objective of this study is to assess the implementation process for and the effectiveness of a quality improvement (QI) strategy to increase shared decision-making around anesthesia options for hip fracture surgery at 6 US hospitals. The QI strategy is to be facilitated by a clinician-administered 1-page bedside conversation aid designed to improve the quality of physician-patient communication, paired with brief clinician training. The evaluation will occur via a stepped wedge, cluster randomized trial to be carried out over a period of 34 months.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Sequential

Treatments tested in this trial

  • My Anesthesia Choice-HF Model

    Behavioral

    Brief clinician training on shared decision making, paired with provision of a 1-page tabular format conversation aid listing answers to frequently asked questions regarding common anesthesia options for hip fracture surgery (spinal anesthesia; general anesthesia)

Treatment groups

1,881 Participants
are divided into 2 treatment groups
Group A: Usual CareNo intervention 0 interventions
Group B: My Anesthesia Choice- HFActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Intervention reach (primary implementation outcome)

Reach of the intervention will be assessed as the rate of use of the conversation aid during the active implementation phase at each site among eligible patients during the pre-anesthesia evaluation. Data will be collected during the implementation phase at each site.

Time frame
Day of surgery
2

Shared Decision-Making Process scale score (SDMP; primary effectiveness outcome)

SDMP is a 4-item measure of shared decision making; this will be assessed on eligible patients during the pre-implementation and implementation phases of the study to allow for comparison of scores among eligible patients treated in the two periods

Time frame
Postoperative day 0-3

Secondary outcomes

1

CollaboRATE shared decision making scale score (secondary effectiveness outcome).

A 3-item measure of shared decision making; this will be assessed on eligible patients during the pre-implementation and implementation phases of the study to allow for comparison of scores among eligible patients treated in the two periods

Time frame
Postoperative day 0-3

Other outcomes

1

Decisional conflict

The fraction of patients reporting decisional conflict about anesthesia pre-implementation versus active implementation periods will be assessed via the 4-item SURE measure.

Time frame
Postoperative day 0-3
2

Knowledge regarding anesthesia options

Patient-reported knowledge about anesthesia options during the pre-implementation versus active implementation periods will be assessed by a 6-item brief knowledge evaluation

Time frame
Postoperative day 0-3
3

Willingness to recommend anesthesia type

Patient satisfaction with anesthesia care during the pre-implementation versus active implementation periods will be assessed by a single-item "willingness to recommend to friends and family" satisfaction measure.

Time frame
Postoperative day 0-3
4

Anesthesia type received

The fraction of patients receiving general versus spinal anesthesia will be compared during the pre-implementation versus active implementation periods.

Time frame
Day of surgery

Sponsors and contacts

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University of Pennsylvania

Lead sponsor

Wake Forest University Health Sciences

Collaborator

University of Florida

Collaborator

Dartmouth-Hitchcock Medical Center

Collaborator

Henry Ford Health System

Collaborator

The Cleveland Clinic

Collaborator

Dartmouth College

Collaborator

Washington University School of Medicine

Collaborator