Table 1 Method and sources of data collection
Outcome | Outcome measure | Data source | Method and timing of data collection |
|---|---|---|---|
Objective 1 | |||
Feasibility of trial conduct | Recruitment period length | Trial conduct logs [10] | Maintained prospectively by study personnel |
| Â | Recruitment response rate | Â | Â |
| Â | Participant retention rate | Â | Â |
| Â | Questionnaire completion rate | Â | Â |
|  | Resource use (personnel and funds) | Financial account summaries | Produced at study completion by the financial analyst affiliated with the principal investigator’s institutional research office Corroborated by expense and personnel logs maintained prospectively by study personnel |
Objective 2 | |||
Intervention fidelity | Total and mean number of appointments over study period | Trial conduct logs | Maintained prospectively by study personnel |
| Â | Number of times MyDiabetesPlan was used | Website usage logs | Â |
| Â | Number of plans completed | Â | Â |
| Â | Time needed to complete MyDiabetesPlan | Audiotapes of clinical encounters | Consent obtained from participants at time of clinical encounter during study period Entire clinical encounter audiotaped then transcribed verbatim |
| Â | Time needed to complete each section | Â | Â |
| Â | Integration of MyDiabetesPlan into clinical encounter | Â | Â |
Additional patient-centred and HCP-centred outcomes | |||
Socio-demographic information | Providers: gender, duration in practice, practice load, academic/community | Online or mailed survey | At study start |
| Â | Patients: age, gender, ethnicity, age at diagnosis, comorbidities, smoking status, educational attainment, annual income | Â | Â |
Patient-centred outcomes | Decisional conflict [25] | Online or mailed survey | Completed by patient at baseline, at six months, and at study completion for a total of three data points over a 12-month period Reminded twice by email or telephone at two-week intervals to complete the questionnaires |
| Â | Diabetes distress [26] | Â | Â |
| Â | Health-related quality of life [27] | Â | Â |
| Â | Chronic illness care [28] | Â | Â |
HCP-centred outcomes | Intention to engage in IP-SDM [29] | Online or mailed survey | Completed by HCP at baseline, at six months, and at study completion for a total of 3 data points over a 12-month period Reminded twice by email or telephone at two-week intervals to complete the questionnaires |