Table 1 Study outcome assessment

 Primary feasibility outcomes

Participant recruitment rates

Continuous (%)

≥ 30% of those eligible will be considered success

Percentage recruited and rate of recruitment (of those screened, of those eligible, and of those approached).

Percentage of those recruited (signed informed consent) who complete the end of study assessment at 3 months.

Count of percentages and rates over time

Participant retention rate

Continuous (%)

≥ 90% is considered success

Study resource utilization

Continuous ($CND)

< $1500 per patient recruited and completing the study

Study costs per patient recruited

Cost of personnel, supplies, travel, etc., to run the study/# patients recruited

 Secondary feasibility outcomes

Process assessments

Management assessments

Scientific assessments

Mix of continuous, categorical, and qualitative data

Implementation is successful and feasible, questionnaires are acceptable, and data gathered are reliable and valid

Detailed questions in feasibility assessment

Descriptive

B. Clinical outcomes

 Primary clinical outcome

Adverse anticoagulant safety event composite (AASE)

Continuous (%)

Intervention group will have fewer AASE compared to the control group

Count of AASE at the end of the study (3 months). Rates will be expressed as mean rate per patient-year by research assistant.

Chi-square test

 Secondary clinical outcomes

Coordination and continuity of care

Continuous

Intervention will have higher ratings than control

Coordination and continuity of care questionnaire partially administered post-discharge and finalized at study end (3 months) by telephone.

T tests

Patient quality of life

Continuous

Intervention will improve more than control

EQ5D-5L—difference in mean change scores at the end of the study.

T tests

OAC management knowledge - patient

Continuous

Intervention will have higher scores than control

OAC knowledge questionnaire

T tests

Satisfaction with care (providers & patients)

Continuous

Intervention will have higher scores than control

Satisfaction questionnaires

Descriptive analysis

Medication Problems

Continuous

Intervention will have fewer medication problems than control

Composite of OAC-APEQ, COMPETE adherence, and medication error scores

T tests

Cost-effectiveness

Continuous

Intervention will be cost-effective compared to control using a threshold of $50,000 per QALY.

Cost per AASE avoided and cost per quality-adjusted life-years (QALYs)

Economic analysis

Individual Clinical Events: a) Bleeding events (clinically relevant), b) Thromboembolic events (all); c) Deaths; d) Hospitalizations or ED visits

Continuous

Intervention will have lower event rates than control

Event rate counts from end-study interviews

T tests