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Table 1 Outcome measures according to data collection periods

From: What matters most: protocol for a randomized controlled trial of breast cancer surgery encounter decision aids across socioeconomic strata

 

TIMEPOINT

 

-T0

T0

Baseline

T1

In-Visit

T2

Post-Visit

T3

1 wk. PSa

T4

12 wks PSb

T5

1 yr. PS

CONSENT AND ENROLLMENT

 Eligibility Screen

X

      

 Informed Consent

X

      

 Allocation (via surgeon confirmation)

X

      

INTERVENTIONS

 Arm 1: Option Grid

  

X

    

 Arm 2: Picture Option Grid

  

X

    

 Arm 3: Usual Care

  

X

    

OUTCOME MEASURES

 Rates of recruitment – documented and tracked in REDCap

 

X

     

 Discontinuation rates – documented and tracked in REDCap

 

X

 

X

X

X

X

 Demographic data – 6 items, self-reported

 

X

     

 Health literacy – 1-item Chew’s health literacy screening

 

X

     

 Decision quality (primary outcome measure) – validated 16-item DQI, subscale adapted for low SES

   

X

X

  

 Knowledge – validated 5-item DQI knowledge subscale

 

X

 

(X)

(X)

  

 Treatment intention – self-reported via DQI

   

(X)

   

 Treatment choice – obtained from medical records

    

X

  

 Quality of life – validated 6-item EQ-5D-5 L

 

X

   

X

 

 Anxiety – validated 8-item PROMIS anxiety short form

 

X

 

X

X

X

 

 Shared decision-making (observed) – validated OPTION5

  

X

    

 Shared decision-making (self-reported) – validated 3-item CollaboRATE

   

X

   

 Decision regret – validated 5-item decision regret scale

    

X

X

X

 Integration of health care delivery – validated 4-item IntegRATE

 

X

   

X

 

 Financial toxicity – four items from validated COST measure and self-report of out-of-pocket medical expenses in the past month

    

X

X

X

 Intervention’s patterns of use – questions and photos of intervention

   

X

X

  

System level factors + feasibility and acceptability in routine care

 Ethnographic methods

 

X

X

X

X

X

 

 Semi-structured interviews

     

X

 
  1. PS post-surgery
  2. (X) included in full DQI
  3. aor first post-operative visit
  4. bor second post-operative visit