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Table 3 Summary of outcomes, measures, and analysis plan using the RE-AIM framework

From: Health TAPESTRY Ontario: protocol for a randomized controlled trial to test reproducibility and implementation

RE-AIM element

Outcome

Outcome measure; source

Data collection time point

Analysis

Reach

The reach of the intervention into the target population

Participants

Proportion of eligible patients who consent; self-report

T0

Simple proportions and range across sites

Sample characteristics

Demographics including chronic conditions; self-report, EMR

T0

Simple proportions and range across sites

Volunteer visits

Number of volunteer visits; program records

T6

Frequency count across sites

Effectiveness

Positive and adverse effects of the intervention

Hospitalizations*

Number of hospitalizations; EMR

T0, T6

Poisson regression or negative binomial regression

Physical activity*

Total minutes spent doing moderate, vigorous, activity and walking (IPAQ); self-report;

T0, T6

Multiple linear regression

Sitting

Hours sitting (IPAQ); self-report

T0, T6

Patient enablement

PEI; self-report

T0, T6

Quality of life

EQ 5D-5L; self-report

T0, T6

Treatment burden

MTBQ; self-report

T0, T6

Disease burden

DBMA; self-report

T0, T6

Emergency room or urgent care

Number of emergency room or urgent care visits; EMR

T0, T6

Poisson regression or negative binomial regression

Poisson regression or negative binomial regression

Falls

Number of falls; EMR

T0, T6

Medications

Number of medications; EMR

T0, T6

Primary care visits

Number of primary care visits; EMR

T0, T6

Negative effects

Unmet expectations; self-report

T6

Descriptive analysis across sites

Labeling effect of screening tools; self-report

T6

Number and nature of serious adverse events; EMR

T6

Adoption

Representation of settings and intervention agents who are willing to initiate and actively participate in program

 

Number of health care providers who consent to participate; program records

T6

Simple proportions across sites

Proportion of health care team members participating by health care profession; program records

T6

Simple proportions across sites, across professions

NoMAD tool£ (NPT traffic light process); program records

T1, T2, T3, T6, T9, T12

Descriptive analysis across sites

Number of volunteers recruited, trained, active, dropouts: program records

T6

Simple proportions across sites

Implementation

Fidelity to the intervention and adaptations

Consistency of delivery as intended

Number of home visits, reports sent to clinic, number and nature of actions from TAP-Huddle; EMR

Fidelity checklist; program records

T6

Frequencies and/or proportions across sites where appropriate

Cost effectiveness

Program costs; program records

QALYs; self-report

T6

Economic evaluation

Barriers and facilitators or adaptations of implementation

Focus groups/interviews, program records

T6 – T12

Descriptive thematic analysis

Maintenance

Extent to which program becomes sustained over time

Extent that program becomes institutionalized, part of practice or policies created

Proportion of patients and team members who recommend program; self-report

T6

Simple proportions across sites

Indication of sites continuing program; program records

T12

Frequency count across sites

NoMAD survey£; self-report

T12

Descriptive analysis across sites

  1. EMR electronic medical record, NPT Normalization Process Theory, QALY quality-adjusted life year, T0 baseline, T6 6-month data collection time point, T12 12-month data collection time point
  2. *Primary outcomes for the study
  3. £Based on Normalization Process Theory