Study Measures, Variables and Data Sources
| Variable/Definition | Data Source | Data Collection/Analysis |
|---|---|---|
| Assess the Feasibility, Appropriateness and Acceptability of INTEGRATE-D | ||
| Acceptability – extent to which intervention is agreeable, palatable, satisfactory | Assessed via survey15 and semi-structured interview. Survey had four questions per variable. See Online Appendix for items. | Collected from clinic members exposed to the intervention ICs at the end of the intervention. Descriptive analysis for ICs only. Survey scores, which ranged from 1 (strongly disagree) to 5 (strongly agree) for each clinic member response were averaged at the clinic-level. |
| Appropriateness – extent to which intervention fits and is compatible for addressing issue or problem | ||
| Feasibility – extent to which an intervention can be successfully used or carried out | ||
| Compare changes in use of quality-improving strategies | ||
| Clinics’ ability to implement quality improving strategies related integrated type 2 diabetes care | Assessed via survey using 14 items from the Change Process Capability Questionnaire (CPCQ).30 See Appendix 2 for items. | One person at IC and CCs completed the survey at the same time, pre- and post-intervention. Survey scores, which ranged from −2 (strongly disagree) to +2 (strongly agree), were summed for each clinic with possible sums ranging from −28 to +28. Average aggregate scores were compared between IC versus CCs |
| Compare changes in process of care screening rates | ||
| A1C screening – binary variable indicating whether the patient was screened at least once during the period | Electronic Health Record (EHR) data abstracted through manual and automated methods | Operationalized at the patient level for pre- and post-intervention periods, means aggregated at the clinic-level for IC and CC. Pre-intervention defined as the time during the 12 months before the intervention; post-intervention defined as any time during the 12 months following the start of the intervention. |
| Cholesterol screening - binary variable indicating whether the patient was screened at least once during the period | ||
| Nephropathy screening - binary variable indicating whether the patient was screened at least once during the period | ||
| Psychosocial screenings – binary variables indicating whether the patient was screened at least once during the period for depression (PHQ-2 and/or PHQ-9) and/or for diabetes distress (DD)1 | ||
| Compare changes in clinical outcomes (PHQ-9 scores and A1C levels) | ||
| Behavioral health – change in symptoms (PHQ-9) for patients with depression symptoms (PHQ-9 > 9); data abstracted through manual and automated methods | Operationalized at the patient level for pre- and post-intervention periods, means aggregated for intervention and control clinics; pre-intervention defined as score closest to the intervention start date; post-intervention defined as score closest to the intervention end date. | |
| Diabetes Management – change in A1C for patients diagnosed with type 2 diabetes | ||
| Confounding Variables - Patient socio-demographics, comorbidity, insurance, and utilization | ||
| Age, gender, language preference, race/ethnicity, income/federal poverty level, insurance type, physical, mental/behavioral health comorbidity, healthcare utilization | EHR data abstracted through manual and automated methods | Operationalized at the patient level |
↵1 Diabetes distress (DD) screening was implemented by IC; clinics did not screen for this pre-intervention.
Abbreviations: IC, intervention clinics; CC, control clinics.