A Pilot Randomised Controlled Trial to Assess the Impact on Blood Pressure Control of Empowering Patients to Become Involved in Their Own Blood Pressure Management.

Prevention and treatment of hypertension and target organ disease remain important public health challenges which must be addressed (SIGN 2001). There is sound evidence that control of hypertension can significantly reduce the incidence of stroke and cardiac events (Mulrow and Pignone 2001). National guidelines for the identification and treatment of hypertension have been issued (Ramsey et al 1999, SIGN 2001) and a local version of the national guidelines has been issued to all GPs in Lothian. However, although there is evidence that most patients with hypertension are identified, many do not have their hypertension adequately controlled (Colhoun et al 1998), and GPs are reluctant to treat mild hypertension or hypertension in the elderly (Dickerson et al 1995a,b, Frijlen et al 2001).

Without additional interventions to encourage change in medical practice, the effects of clinical guidelines are generally limited (Effective Health Care 1994, Oxman et al 1995). A large number of additional interventions have been used to encourage the adoption of clinical guidelines including continuing medical education, dissemination of educational materials, educational outreach, local opinion leaders, audit and feedback, manual or computerised reminders, mass media campaigns, continuous quality improvement programmes (Effective Health Care 1999). All have some effect, but none are overwhelmingly successful or effective in all circumstances (Effective Health Care 1999, Davies et al 1995, Grimshaw et al 1995) It is suggested that multiple interventions may be more effective than single ones (Wensing and Grol 1994, Greco and Eisenberg 1993).

There is increasing evidence that in Primary Care patients' expectations have a significant effect on the treatment they get from their GP (Tomlin et al 1999, Howitt and Armstrong 1999). Mass media campaigns targeting patients have been found to influence professional practice (Grilli et al 2000). However, evaluation of the effect of locally provided patient information has been limited to the effect that it has on patient behaviour (e.g. compliance with dietary advice or medication) and not on the effect in may have on medical practice.

One initiative, which has not been fully evaluated, is distribution of the guidelines to patients. The large AHCPR guideline programme in the United States included the full guideline, a summary for professionals and a summary for patients (Colling 1994). Evaluation appeared to be limited to the distribution of these guidelines and the impact on practice was not measured (Colling 1994). When the Scottish (SIGN) clinical guideline programme was initiated much of the AHCPR methodology was adopted and acknowledged, but the patient guideline was not included. The purpose of this study is to evaluate the effect of providing patients with a clinical guideline (edited to be understandable to a lay person) on the overall management and control of their hypertension coupled with an explicit exhortation from the medical team to become involved in their own care.

3. Trial objectives and purpose: The trial aims to determine if the provision of a patient guideline on the management of hypertension.