IngentaConnect A factorial randomised controlled trial of decision analysis and ...

Abstract:

Background: There is a lack of evidence regarding the value of to ls designed to aid decision making in patients with newly diagnosed hypertension.

Aim: To evaluate two interventions for as isting newly diagnosed hypertensive patients in the decision whether to start drug therapy for reducing blood pressure.

Design of study: Factorial randomised controlled trial.

Setting: Twenty-one general practices in south-west England, UK.

Method: Adults aged 32 to 80 years with newly diagnosed hypertension were randomised to receive either: (a) computerised utility assessment interview with individualised risk assessment and decision analysis; or (b) information video and leaflet about high blood pres ure; or (c) both interventions; or (d) neither intervention. Outcome measures were decisional conflict, knowledge, state anxiety, intentions regarding starting treatment, and actual treatment decision.

Results: Of 217 patients randomised, 212 (98%) were analysed at the primary fol ow-up (mean age = 59 years, 49% female). Decision analysis patients had lower decisional conflict than those who did not receive this intervention (27.6 versus 38.9, 95% confidence interval [CI] for adjusted difference = -13.0 to -5.8, P <0.001), greater knowledge about hypertension (73% versus 67%, adjusted 95% CI = 2% to 9%, P = 0.0 3) and no evidence of increased state anxiety (34.8 versus 36.8, adjusted 95% CI = -5.6 to 0.1, P = 0.055). Video/leaflet patients had lower decisional conflict than corresponding controls (30.3 versus 36.8, adjusted 95% CI = -7.4 to -0.6, P = 0.021), greater knowledge (75% versus 65%, adjusted 95% CI = 6% to 13%, P <0.0 1) and no evidence of increased state anxiety (35.7 versus 36.1, adjusted 95% CI = -3.9 to 1.7, P = 0.46). There were no differences between either of the interventions and their respective controls in the proportion of patients prescribed antihypertensive medication (67%).

Conclusions: This trial demonstrates that, among patients facing a real treatment decision, interventions to inform patients about hypertension and to clarify patients' values concerning outcomes of treatment are f ective in reducing decisional conflict and increasing patient knowledge, while not resulting in any increases in state anxiety.

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A factorial randomised controlled trial of decision analysis and an information video plus leaflet for newly diagnosed hypertensive patients