Background
Methods
Trial design
Recruitment, eligiblity criteria and sampling procedure
Intervention
1 Short Name | Educational peer visit |
2 Goal and rationale | Improvement of doctor-patient communication and interaction between GP and patient, raising GP awareness for patients with poorly controlled diabetes type 2, their individual agenda and concepts of disease and taking it into account in the process of shared decision making, putting more focus on the patient perspective without overstraining both, doctor and patient |
3 Materials | Oral input, computer-based decision-aid tool arriba-debate, peer-to-peer-discussion |
4 Procedures | Trained GPs visited participating GPs in their practice. During the visitation, specific problems/factors influencing the doctor-patient-communication and the treatment of patients with poorly controlled type 2 diabetes were discussed with the GP (e.g. different ideas of therapy on GPs and patient's sides resulting in ineffective doctor-patient communication, lack of interest, resignation, frustration, anger). In addition, the peer GP introduced the basics of narrative based communication to the GP and gave individual feedback to patient cases the GP had experienced to be difficult. Additionally, during the visitation, the computer-based decision-aid tool arriba-debate was introduced to the GP. The tool offers patient-targeted visualizations of the effect of possible behaviour changes (e.g. smoking stop, exercise) and therapy (medication) on the individual risk of coronary heart disease under consideration of individual parameters (e.g. sex, age, blood pressure, cholesterol, blood glucose level) |
5 Providers of intervention | Trained general practitioners (peers) |
6 Mode of delivery | On site visit, oral presentation, introduction of the decision-aid tool and discussion |
7 Location | GP practice |
8 Frequency | Once following completion of baseline data collection between the 3rd quarter of 2012 and the 1st quarter of 2013; duration approximately 1–1.5 h, total of 47 intervention practices received a peer visit |
9 Planned tailoring | No |
10 Fidelity enhancement | Memo written by peer |
1 Short Name | Additional training for GPs to promote patient-centred communication |
2 Goal and rationale | Exploration of individual patient expectations, concepts of disease and barriers in the process of shared decision making in patients with poorly controlled diabetes type 2 |
3 Materials | Theoretical input on narrative-based communication, group training on practical use of these skills, computer-based decision-aid arriba-debate |
4 Procedures | Introduction of theoretical background on narrative-based communication (incl. three-step-conversation). Group training sessions (max. 3–4 participants) under considerations of personal experiences and defaulted roles. The issues of the sequences differed, starting with a low-threshold one (e.g. vacation), followed by the experience of an in-acute disease (e.g. cold), ending with a practical oriented issue (e.g. GP as protagonist in the practice). Roles were changed after every session (narrator, asker, observer) to give all participants the opportunity to slip in each role. Subsequently, feedback about the practical implementation was given and discussion about transferability in daily routine was carried out Finally, the computer-based decision-aid tool arriba-debate and its use in daily routine in the GP-practice was discussed |
5 Providers of intervention | The training was performed by qualified scientific researchers of the study sites in Rostock, Düsseldorf and Witten |
6 Mode of delivery | Single intervention 10 out of the 54 GPs in the intervention group of DEBATE |
7 Location | The training was performed in two of the study sites Total of five trainings with altogether 10 GPs were performed |
8 Frequency | Each training lasted about 3 h |
9 Planned tailoring | No |
10 Fidelity enhancement |
Control
Outcomes
Sample size
Stopping rules
Randomization
Allocation concealment mechanism
Blinding
Measures against bias
Statistical methods
Results
Recruitment and participant flow
Baseline data
Intervention | Control | Total | ||||
---|---|---|---|---|---|---|
N | % | N | % | N | % | |
Number of patients | 435 | 52.2 | 398 | 47.8 | 833 | 100.0 |
Sex | ||||||
Male | 241 | 55.4 | 212 | 53.3 | 453 | 54.4 |
Female | 194 | 44.6 | 186 | 46.7 | 380 | 45.6 |
Age (median) | 65.9 | 65.8 | 65.9 | |||
Marital statusa | ||||||
Single | 46 | 10.6 | 41 | 10.3 | 87 | 10.5 |
Married | 273 | 62.8 | 229 | 57.7 | 502 | 60.3 |
Divorced | 30 | 6.9 | 52 | 13.1 | 82 | 9.9 |
Widowed | 86 | 19.8 | 75 | 18.9 | 161 | 19.4 |
Living with a partnerb | ||||||
Yes | 291 | 67.1 | 252 | 63.6 | 543 | 65.4 |
No | 143 | 32.9 | 144 | 36.4 | 287 | 34.6 |
Year of diagnosis (mean) | 12.4 | 10.8 | 11.6 |
Outcomes
Subjective shared decision making (SDM-Q-9)
Intervention group | Control group | Between group differences | ||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Change from baseline | Change from baseline | Intervention group - Control group | ||||||||||||||||
SDM | N | Mean | SD | Adjusted Mean | 95% CI | p-Value | N | Mean | SD | Adjusted Mean | 95% CI | p-Value | Adjusted Mean | 95% CI | p Value | |||
Baseline | 395 | 23.68 | 13.6 | 370 | 22.42 | 14.4 | ||||||||||||
6 months follow up | 372 | 19.59 | 13.4 | -3.57 | -4.98 | -2.17 | <.0001 | 342 | 19.21 | 14.5 | -3.20 | -4.62 | -1.78 | <.0001 | -0.37 | -2.20 | 1.45 | 0.6847 |
12 months follow up | 338 | 19.90 | 14.3 | -3.27 | -4.71 | -1.82 | <.0001 | 312 | 19.83 | 14.7 | -2.89 | -4.35 | -1.44 | 0.0001 | ||||
18 months follow up | 326 | 20.83 | 14.0 | -3.28 | -4.75 | -1.81 | <.0001 | 286 | 19.64 | 14.6 | -2.91 | -4.39 | -1.42 | 0.0002 | ||||
24 months follow up | 318 | 20.91 | 14.4 | -3.17 | -4.66 | -1.69 | <.0001 | 284 | 19.77 | 15.2 | -2.80 | -4.30 | -1.30 | 0.0003 |
Intervention group | Control group | Between group differences | ||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Change from baseline | Change from baseline | Intervention group - Control group | ||||||||||||||||
SDM | N | Mean | SD | Adjusted Mean | 95% CI | p-Value | N | Mean | SD | Adjusted Mean | 95% CI | p-Value | Adjusted Mean | 95% CI | p Value | |||
Baseline | 349 | 23.36 | 13.3 | 370 | 22.42 | 14.4 | ||||||||||||
6 months follow up | 328 | 19.83 | 13.4 | -2.98 | -4.44 | -1.51 | 0.0001 | 342 | 19.21 | 14.5 | -3.11 | -4.50 | -1.71 | <.0001 | 0.13 | -1.71 | 1.97 | 0.8893 |
12 months follow up | 296 | 20.32 | 14.2 | -2.57 | -4.08 | -1.07 | 0.0010 | 312 | 19.83 | 14.7 | -2.70 | -4.14 | -1.27 | 0.0003 | ||||
18 months follow up | 289 | 20.90 | 13.8 | -2.72 | -4.24 | -1.20 | 0.0006 | 286 | 19.64 | 14.6 | -2.85 | -4.31 | -1.38 | 0.0002 | ||||
24 months follow up | 282 | 21.05 | 14.4 | -2.57 | -4.12 | -1.02 | 0.0013 | 284 | 19.77 | 15.2 | -2.70 | -4.19 | -1.21 | 0.0004 |
Patient-centeredness (PACIC-D)
Intervention group | Control group | Between group differences | ||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Change from baseline | Change from baseline | Intervention group - Control group | ||||||||||||||||
PACIC-D | N | Mean | SD | Adjusted Mean | 95% CI | p Value | N | Mean | SD | Adjusted Mean | 95% CI | p Value | Adjusted Mean | 95% CI | p Value | |||
Baseline | 404 | 2.42 | 0.8 | 373 | 2.39 | 0.9 | ||||||||||||
6 months follow up | 370 | 2.48 | 0.9 | 0.03 | -0.05 | 0.12 | 0.4340 | 339 | 2.41 | 0.9 | 0.02 | -0.06 | 0.11 | 0.5782 | 0.01 | -0.10 | 0.12 | 0.8677 |
12 months follow up | 342 | 2.50 | 0.9 | 0.06 | -0.03 | 0.15 | 0.1627 | 314 | 2.47 | 1.0 | 0.05 | -0.04 | 0.14 | 0.2390 | ||||
18 months follow up | 321 | 2.53 | 0.9 | 0.09 | 0.00 | 0.18 | 0.0518 | 282 | 2.52 | 1.0 | 0.08 | -0.01 | 0.17 | 0.0844 | ||||
24 months follow up | 318 | 2.52 | 0.9 | 0.04 | -0.05 | 0.13 | 0.3877 | 282 | 2.45 | 1.0 | 0.03 | -0.06 | 0.12 | 0.5173 |
Intervention group | Control group | Between group differences | ||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Change from baseline | Change from baseline | Intervention group - Control group | ||||||||||||||||
PACIC-D | N | Mean | SD | Adjusted Mean | 95% CI | p Value | N | Mean | SD | Adjusted Mean | 95% CI | p Value | Adjusted Mean | 95% CI | p Value | |||
Baseline | 355 | 2.41 | 0.8 | 373 | 2.39 | 0.9 | ||||||||||||
6 months follow up | 326 | 2.50 | 0.9 | 0.05 | -0.04 | 0.14 | 0.2484 | 339 | 2.41 | 0.9 | 0.03 | -0.06 | 0.11 | 0.5369 | 0.03 | -0.09 | 0.14 | 0.6582 |
12 months follow up | 302 | 2.53 | 0.9 | 0.09 | 0.00 | 0.18 | 0.0630 | 314 | 2.47 | 1.0 | 0.06 | -0.03 | 0.15 | 0.1649 | ||||
18 months follow up | 284 | 2.56 | 0.9 | 0.12 | 0.02 | 0.22 | 0.0166 | 282 | 2.52 | 1.0 | 0.09 | -0.00 | 0.19 | 0.0500 | ||||
24 months follow up | 283 | 2.52 | 0.9 | 0.06 | -0.04 | 0.15 | 0.2349 | 282 | 2.45 | 1.0 | 0.03 | -0.06 | 0.12 | 0.4982 |