Diabetes Mellitus, Type 2
Conditions
Keywords
Shared Decision Making, Decision Aids
Brief summary
A cluster randomized trial to assess the efficacy of the Diabetes Medication Choice decision aid among Greek patients with type 2 diabetes mellitus compared with usual care. The tool will serve as a facilitator for the Shared Decision Making process.
Interventions
The Diabetes Medication Choice decision aid cards provide information about medications commonly used to treat type 2 diabetes mellitus. The tool was originally developed and successfully evaluated by Mayo Clinic researchers.
Sponsors
European Foundation for the Study of Diabetes
Mayo Clinic
Aristotle University Of Thessaloniki
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes mellitus for more than one year * Agree to be followed for at least 6 months * Willing to respond to survey questions immediately following the visit * HbA1c value between 7.5% and 10% * Need treatment intensification and there are more than one available treatment options
Exclusion criteria
* Decide not to intensify treatment or to intensify treatment through lifestyle modification, which is a sine qua non for diabetes treatment * Is to transfer to another practice within the next 6 months * Significant cognitive (e.g. dementia) or sensory limitations (e.g. blind) or other reasons (e.g. fatigue, limited attention, sleep deprivation) for which, in the judgment of the study personnel, they could not reasonably provide written informed consent or be able to use the decision aid * Planning to enter a long-term care facility (e.g. nursing home) where medications will be administered by clinical personnel after hospital discharge * Enrolled in other studies that require prolonged participation and follow-up * Unable to speak Greek at a level necessary to complete the patient surveys and ensure involvement in decision making * Women known to be pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Decisional Comfort (0-100, 100=no Conflict) | Day 1 | Quality of the decision making process assessed by means of the Decisional Conflict Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Degree of Patient Knowledge About Available Treatment Alternatives | Day 1 | Patients will complete a 6-item questionnaire addressing general knowledge about type 2 diabetes. |
| Patient and Clinician Satisfaction With the Decision Making Process | Day 1 | Patient satisfaction will be assessed using items from the Decisional Conflict Scale as well as two specific questions that require patients to assess the extent to which they would want for themselves and recommend to others similar decision support. Clinician satisfaction will be assessed using a 6-point likert-type question asking about their satisfaction regarding the discussion they had with their patient. |
| Adherence With Antihyperglycemic Regimens as Reported by the Patient Himself/Herself or Assessed Utilizing the Pharmacy Records | 3 and 6 months after patient initial encounter | — |
| Glycemic Control (HbA1c) | 3 and 6 months after patient initial encounter | — |
Countries
Greece
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Diabetes Medication Choice Decision Aid | 101 |
| Usual Care | 103 |
| Total | 204 |
Baseline characteristics
| Characteristic | Diabetes Medication Choice Decision Aid | Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 65.8 years STANDARD_DEVIATION 11 | 64.4 years STANDARD_DEVIATION 11.3 | 65.1 years STANDARD_DEVIATION 11.1 |
| HbA1c | 8.4 % STANDARD_DEVIATION 0.8 | 8.5 % STANDARD_DEVIATION 0.8 | 8.5 % STANDARD_DEVIATION 0.8 |
| Region of Enrollment Greece | 101 participants | 103 participants | 204 participants |
| Sex: Female, Male Female | 55 Participants | 61 Participants | 116 Participants |
| Sex: Female, Male Male | 46 Participants | 42 Participants | 88 Participants |
| Type 2 diabetes duration >10 years | 53 Participants | 53 Participants | 106 Participants |
| Type 2 diabetes duration 5 - 10 years | 20 Participants | 27 Participants | 47 Participants |
| Type 2 diabetes duration <5 years | 27 Participants | 22 Participants | 49 Participants |
| Type 2 diabetes duration missing data | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 101 | 0 / 103 |
| serious Total, serious adverse events | 0 / 101 | 0 / 103 |
Outcome results
Primary
Overall Decisional Comfort (0-100, 100=no Conflict)
Quality of the decision making process assessed by means of the Decisional Conflict Scale
Time frame: Day 1
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Diabetes Medication Choice Decision Aid | Overall Decisional Comfort (0-100, 100=no Conflict) | 82 units on a scale |
| Usual Care | Overall Decisional Comfort (0-100, 100=no Conflict) | 75.1 units on a scale |
Secondary
Adherence With Antihyperglycemic Regimens as Reported by the Patient Himself/Herself or Assessed Utilizing the Pharmacy Records
Time frame: 3 and 6 months after patient initial encounter
Secondary
Degree of Patient Knowledge About Available Treatment Alternatives
Patients will complete a 6-item questionnaire addressing general knowledge about type 2 diabetes.
Time frame: Day 1
Secondary
Glycemic Control (HbA1c)
Time frame: 3 and 6 months after patient initial encounter
Secondary
Patient and Clinician Satisfaction With the Decision Making Process
Patient satisfaction will be assessed using items from the Decisional Conflict Scale as well as two specific questions that require patients to assess the extent to which they would want for themselves and recommend to others similar decision support. Clinician satisfaction will be assessed using a 6-point likert-type question asking about their satisfaction regarding the discussion they had with their patient.
Time frame: Day 1