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Randomized Controlled Trial
. 2013 Sep 11:14:135.
doi: 10.1186/1471-2296-14-135.

Shared decision-making in antihypertensive therapy: a cluster randomised controlled trial

Iris Tinsel  1 , Anika Buchholz, Werner Vach, Achim Siegel, Thorsten Dürk, Angela Buchholz, Wilhelm Niebling, Karl-Georg Fischer
Affiliations
Randomized Controlled Trial

Shared decision-making in antihypertensive therapy: a cluster randomised controlled trial

Iris Tinsel et al. BMC Fam Pract. .

Abstract

Background: Hypertension is one of the key factors causing cardiovascular diseases. A substantial proportion of treated hypertensive patients do not reach recommended target blood pressure values. Shared decision making (SDM) is to enhance the active role of patients. As until now there exists little information on the effects of SDM training in antihypertensive therapy, we tested the effect of an SDM training programme for general practitioners (GPs). Our hypotheses are that this SDM training (1) enhances the participation of patients and (2) leads to an enhanced decrease in blood pressure (BP) values, compared to patients receiving usual care without prior SDM training for GPs.

Methods: The study was conducted as a cluster randomised controlled trial (cRCT) with GP practices in Southwest Germany. Each GP practice included patients with treated but uncontrolled hypertension and/or with relevant comorbidity. After baseline assessment (T0) GP practices were randomly allocated into an intervention and a control arm. GPs of the intervention group took part in the SDM training. GPs of the control group treated their patients as usual. The intervention was blinded to the patients. Primary endpoints on patient level were (1) change of patients' perceived participation (SDM-Q-9) and (2) change of systolic BP (24h-mean). Secondary endpoints were changes of (1) diastolic BP (24h-mean), (2) patients' knowledge about hypertension, (3) adherence (MARS-D), and (4) cardiovascular risk score (CVR).

Results: In total 1357 patients from 36 general practices were screened for blood pressure control by ambulatory blood pressure monitoring (ABPM). Thereof 1120 patients remained in the study because of uncontrolled (but treated) hypertension and/or a relevant comorbidity. At T0 the intervention group involved 17 GP practices with 552 patients and the control group 19 GP practices with 568 patients. The effectiveness analysis could not demonstrate a significant or relevant effect of the SDM training on any of the endpoints.

Conclusion: The study hypothesis that the SDM training enhanced patients' perceived participation and lowered their BP could not be confirmed. Further research is needed to examine the impact of patient participation on the treatment of hypertension in primary care.

Trial registration: German Clinical Trials Register (DRKS): DRKS00000125.

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Figures

Figure 1
Figure 1
Recruitment and study procedure including loss to follow-up. GP practices = general practitioner practices. * Details of discontinued GP practices: high work load and lack of staff. ** Details of invalid data: Enrolment in contrary to the inclusion criteria (patients were not member of a statutory health insurance or had not received repeated antihypertensive medication) or questionnaires were missing. *** Details of discontinued patients in both study arms: 1) Intervention group: 171 patients missed at least one follow-up (31.0%). Thereof data of 88 patients are completely lost (15.9%) (loss of T1, T2, and T3) and data of 83 patients (15.0%) are partially available (loss of T1, T2 or T3). 2) Control group: 211 patients missed at least one follow-up (37.1%; including 1 GP practice* with 3 active patients). Thereof data of 86 patients are completely lost (15.1%) (loss of T1, T2, and T3) and data of 125 patients (22.0%) are partially available (loss of T1, T2, or T3). Number of patients available for each analysis is listed in Table 1. Reasons for discontinuation of the patients: patients’ desire (N = 241), change of GP practice (N =18), cardiovascular death (N = 2), other death (N =10), loss of GP practice (3 patients), other cause (N = 65), missing Documentation (N = 41).
Figure 2
Figure 2
Perceived participation measured by SDM-Q-9 in intervention and control group from T0 (baseline) to T3.
Figure 3
Figure 3
Average change of SDM-Q-9 from T1, T2, and T3 relative to T0 (baseline) in intervention and control group.
Figure 4
Figure 4
Systolic blood pressure from T0 (screening value), and T1 (baseline) to T3 in intervention and control group.
Figure 5
Figure 5
Average change of systolic blood pressure from T2 and T3 relative to baseline (T1) in intervention and control group.
See this image and copyright information in PMC

References

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