Table 1 Study aims and expected outcomes

Aim 1: Shared decision-making (SDM): Assess the efficacy of the intervention in increasing provider and patient engagement in SDM

Primary clinical outcome: Level of engagement in SDM process regarding PSA-based screening

Rating of audio-recorded medical visits using the Observing Patient Involvement (OPTION) Scale [10] and patients and providers self-assessment of SDM [11, 12]

Does the intervention increase patient-provider engagement in SDM?

Patients in the intervention arm will demonstrate more engagement (higher scores) in the SDM process than patients in the control arm

Aim 2: Quality of Decision: Assess the efficacy of the intervention in improving the quality of the provider-patient SDM process

Secondary outcomes: Patient Quality of Engagement in Decision-Making (PQED) regarding PSA-based screening

Change in pre-posttests using an average difference in pre-posttest scores of four subscales:

• Prostate Cancer and Screening Knowledge [13]

• Decisional Confidence [14]

• Decisional Self-efficacy [15]

• Satisfaction with Decision [16]

Does the intervention increase patients’ knowledge, decision confidence, satisfaction, and self-efficacy regarding PSA-screening decisions?

Patients in the intervention arm will report higher change between pre-posttests scores, than patients in the control arm

Preference-Congruent Decision-making (PCDM)

Comparison score between the intention-to-screen [17] and data on actual PSA-tests extracted from the patient electronic health record

Does the intervention increase preference-congruent decision-making regarding PSA-screening?

Patients in the intervention arm will report higher congruence between intention-to-screen and real action, than patients in the control arm

Evaluation of study:

Evaluate the acceptability of intervention and study procedures

Exploratory outcomes: Acceptability of intervention (decision aid) and study procedures (recruitment, assessments, and medical encounter)

Summed score of the adapted version of three measures [18]:

• Intervention Measure (AIM)

• Intervention Appropriateness Measure (IAM)

• Feasibility of Intervention Measure (FIM)

Were study procedures and intervention accepted by participants?

A high percentage of participants will rate the study procedures and intervention as acceptable, or highly acceptable