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Table 2 Measures table

From: Improving diabetic patients’ adherence to treatment and prevention of cardiovascular disease (Office Guidelines Applied to Practice—IMPACT Study)—a cluster randomized controlled effectiveness trial

Variables

Instruments

Methods

Analysis

Time

Knowledge and attitude about patient-centered care, SDM, use of DSTs

Pre and post survey of providers

Semi-structured interviews

90 min. CME interactive orientation sections with providers and exit interviews

Descriptive pre-post analysis

Thematic analysis of transcribed interviews using Dedoose

Pre and post physician education

End of study

Medication adherence

Medication Events Monitoring Systems ( eCap).

Cronbach’s alpha=.0.85

ARMS Survey

eCap upload to BRIC

RA will administer form to patient pre/post intervention to evaluate treatment medication adherence

Linear or generalized linear mixed effects model and Beta regression to evaluate changes over time for groups 1 and 2

Baseline, 6 and 12 months

Patient Activation Measure Scores/Level

Patient Activation Measure (PAM) Cronbach’s alpha=.91

RA administers form to patient pre and post intervention

Linear or generalized linear mixed effects model for change overtime for groups 1 and 2

Baseline, 6 and 12 months

Self-Efficacy Scores

Stanford 6-Item Self Efficacy Scale

Summary DM Self-Activities Measure (SDSCA)

RA administers form to patient pre and post intervention to evaluate change in self-efficacy

Linear or generalized linear mixed effects models for change over time for groups 1 and 2

Baseline, 6 and 12 months

Rate of use of aspirin/antiplatelets, beta-blockers, ACEI/ARBs, cholesterol assessment and treatment, DM medications

PAI agreement in chart

Patient medication list

Patient medical record

Texting log

Chart audits to compare the rate of use of aspirin/antiplatelets, beta-blockers, ACEI, cholesterol assessment and treatment of DM

Linear or generalized linear mixed effects model for change overtime for groups 1 and 2

Baseline, 6 and 12 months

Rate of BP control

Diabetic Control (HbA1c)

Digital sphygmomanometer , HbA1c assessment in the community lab using standard instrument

Three BP measurements, 1 minute intervals, using appropriate cuff Reliable point-of-care HbA1c test

Linear or generalized linear mixed effects model for change overtime for groups 1 and 2

Average BP and HbA1c at baseline, 6 and 12 months

Combined Outcome Measure for Risk Communication & Treatment Decision Making Effectiveness (COMRADE)

COMRADE questionnaire

Cronbach’s alpha=.92

CollaboRate SDM Measure

RA administers form pre/post intervention to evaluate satisfaction with shared decision-making

Linear or generalized linear mixed effects model for change overtime for groups 1 and 2

COMRADE use at baseline, 6 and 12 months

PAI + Texting use rate & acceptability rating by clinical staff

PAI agreement forms; Texting log; pre/post physician/staff surveys; physician/staff interviews

RA records and chart abstraction to determine PAI + Texting use

Staff meeting and survey to explore adoption + practice diary entries

Determine rate of use of PAI +Texting

Frequencies of responses to evaluation surveys

Chart Abstraction at 6 months. RA tracks rates throughout study