Improving completion of advance directives in the primary care setting: a randomized controlled trial. Effectiveness of computer-generated reminders for increasing discussions about advance directives and completion of advance directive forms. A randomized, controlled trial. Strategies to promote the use of advance directives in a residency outpatient practice. Advance directives for patients compulsorily admitted to hospital with serious mental illness. Randomised controlled trial. Effect of joint crisis plans on use of compulsory treatment in psychiatry: single blind randomised controlled trial. Patient-based outcome results from a cluster randomized trial of shared decision making skill development and use of risk communication aids in general practice. Do local opinion leaders augment hospital quality improvement efforts? A randomized trial to promote adherence to unstable angina guidelines. Intensive support to improve clinical decision making in cardiovascular care: a randomised controlled trial in general practice. A randomized, controlled trial to improve advance care planning among patients undergoing cardiac surgery.
Since 1991, hospitals have asked patients whether they have advance directives, but few patients complete these documents. We assessed two simple interventions to improve completion of advance directives among elderly or chronically ill outpatients.
                We conducted a cluster randomized controlled trial involving 1079 patients from five general medicine clinics that were affiliated with an academic medical center. Patients were either > or =70 years of age or > or =50 years old with a chronic illness. The study comprised three arms: physician reminders recommending documentation of advance directives, physician reminders plus mailing advance directives to patients together with educational literature, or neither intervention (control). The main outcome measure was completion of an advance directive.
                After 28 weeks, 1.5% (5/332) of patients in the physician reminder group, 14% (38/277) in the physician reminder plus patient mailing group, and 1.8% (5/286) in the control group had completed advance directives. In multivariate analyses, patients in the physician reminder plus patient mailing group were much more likely than controls to have completed advance directives (odds ratio [OR] = 5.9; 95% confidence interval [CI]: 1.5 to 22), whereas patients in the physician reminder-only group were no more likely than controls to have completed advance directives (OR = 0.88; 95% CI: 0.21 to 3.7).
                Mailing health care proxy and living will forms and literature to patients before an appointment at which their physicians received a reminder about advance directives yielded a small but significant improvement in completion of these documents. A physician reminder alone did not have an effect. Physicians can increase the rate of completion of advance directive forms by discussing directives with their patients, but the means by which physicians can be induced to initiate these discussions are unclear. Computer-generated reminders have been shown to increase physician compliance with practice guidelines.
                To determine the effects of computer-generated reminders to physicians on the frequency of advance directive discussions between patients and their primary caregivers and the frequency of consequent establishment of advance directives.
                Randomized, controlled trial with a 2 x 2 factorial design.
                An outpatient general medicine practice associated with an urban public hospital.
                Participants were 1) 1009 patients who were at least 75 years of age or were at least 50 years of age with serious underlying disease and 2) 147 primary care physicians (108 housestaff and 39 faculty).
                Computer-generated reminders that recommended discussion of one or both of two types of advance directives compared with no reminders.
                Discussions about advance directives, determined by patient interviews after all scheduled patient-physician outpatient encounters, and completed advance directive forms. The study period was approximately 1 year.
                Physicians who did not receive reminders (controls) discussed advance directives with 4% of the study patients compared with 24% for physicians who received both types of reminders (adjusted odds ratio, 7.7 [95% CI, 3.4 to 18]; P < 0.001). Physicians who did not receive reminders completed advance directive forms with only 4% of their study patients compared with 15% for physicians who received both types of reminders (adjusted odds ratio, 7.0 [CI, 2.9 to 17]; P < 0.001). Overall, 45% of patients with whom advance directives were discussed completed at least one type of advance directive.
                Simple computer-generated reminders aimed at primary caregivers can increase the rates of discussion of advance directives and completion of advance directive forms among elderly outpatients with serious illnesses. To evaluate patient education and resident education strategies to promote advance directives in the outpatient setting, and to assess barriers to implementation.
                Controlled clinical trial.
                The internal medicine residents' practice of an urban, university medical center.
                Medical residents and 250 patients seen at least twice in the 3 months prior to the study.
                We randomized practice days: one to patient education, one to resident education, and three controls. Resident education consisted of a lecture, a videotape of a model advance directives discussion, and videotaping of an actual discussion by each resident, followed by individual review. Patient education consisted of distributing pamphlets in the waiting room and offering all patients an opportunity to discuss advance directives.
                We interviewed 187 of these patients (response rate 75%) and surveyed 62 residents (response rate 70%). After 18 months, there were no significant differences in the number of advance directives in charts among the three groups. Documented advance directives discussions with patients in the resident education group increased from 3% to 17% (p < .001), more than those in the patient education (5%) or control group (10%, p = .04). Residents in the resident education group were more likely to report discussing advance directives than those in the patient education or control groups (p = .05). Lack of time (95%) and lack of continuity (76%) were the most frequently cited barriers. In multivariate logistic regression, nonwhite race and non-U.S. birth were negatively associated with patient interest in advance directives. Patient race and birthplace were not associated with actual discussions of advance directives.
                Even with intensive efforts to educate outpatients and residents about advance directives, important barriers remain, raising questions about how best to promote advance directives among outpatients. An advance directive is a statement of a person's preferences for treatment, should he or she lose capacity to make treatment decisions in the future.
                To evaluate whether use of advance directives by patients with mental illness leads to lower rates of compulsory readmission to hospital.
                In a randomised controlled trial in two psychiatric services in inner London, 156 in-patients about to be discharged from compulsory treatment under the Mental Health Act were recruited. The trial compared usual psychiatric care with usual care plus the completion of an advance directive. The primary outcome was the rate of compulsory readmission.
                Fifteen patients (19%) in the intervention group and 16 (21%) in the control group were readmitted compulsorily within 1 year of discharge. There was no difference in the numbers of compulsory readmissions, numbers of patients readmitted voluntarily, days spent in hospital or satisfaction with psychiatric services.
                Users' advance instruction directives had little observable impact on the outcome of care at 12 months. To investigate whether a form of advance agreement for people with severe mental illness can reduce the use of inpatient services and compulsory admission or treatment.
                Single blind randomised controlled trial, with randomisation of individual patients. The investigator was blind to allocation.
                Eight community mental health teams in southern England.
                160 people with an operational diagnosis of psychotic illness or non-psychotic bipolar disorder who had experienced a hospital admission within the previous two years.
                The joint crisis plan was formulated by the patient, care coordinator, psychiatrist, and project worker and contained contact information, details of mental and physical illnesses, treatments, indicators for relapse, and advance statements of preferences for care in the event of future relapse.
                Admission to hospital, bed days, and use of the Mental Health Act over 15 month follow up.
                Use of the Mental Health Act was significantly reduced for the intervention group, 13% (10/80) of whom experienced compulsory admission or treatment compared with 27% (21/80) of the control group (risk ratio 0.48, 95% confidence interval 0.24 to 0.95, P = 0.028). As a consequence, the mean number of days of detention (days spent as an inpatient while under a section of the Mental Health Act) for the whole intervention group was 14 compared with 31 for the control group (difference 16, 0 to 36, P = 0.04). For those admitted under a section of the Mental Health Act, the number of days of detention was similar in the two groups (means 114 and 117, difference 3, -61 to 67, P = 0.98). The intervention group had fewer admissions (risk ratio 0.69, 0.45 to 1.04, P = 0.07). There was no evidence for differences in bed days (total number of days spent as an inpatient) (means 32 and 36, difference 4, -18 to 26, P = 0.15 for the whole sample; means 107 and 83, difference -24, -72 to 24, P = 0.39 for those admitted).
                Use of joint crisis plans reduced compulsory admissions and treatment in patients with severe mental illness. The reduction in overall admission was less. This is the first structured clinical intervention that seems to reduce compulsory admission and treatment in mental health services. Shared decision-making (SDM) between professionals and patients is increasingly advocated from ethical principles. Some data are accruing about the effects of such approaches on health or other patient-based outcomes. These effects often vary substantially between studies.
                Our aim was to evaluate the effects of training GPs in SDM, and the use of simple risk communication aids in general practice, on patient-based outcomes.
                A cluster randomized trial with crossover was carried out with the participation of 20 recently qualified GPs in urban and rural general practices in Gwent, South Wales. A total of 747 patients with known atrial fibrillation, prostatism, menorrhagia or menopausal symptoms were invited to a consultation to review their condition or treatments. After baseline, participating doctors were randomized to receive training in (i) SDM skills; or (ii) the use of simple risk communication aids, using simulated patients. The alternative training was then provided for the final study phase. Patients were randomly allocated to a consultation during baseline or intervention 1 (SDM or risk communication aids) or intervention 2 phases. A randomly selected half of the consultations took place in 'research clinics' to evaluate the effects of more time for consultations, compared with usual surgery time. Patient-based outcomes were assessed at exit from consultation and 1 month follow-up. These were: COMRADE instrument (principal measures; subscales of risk communication and confidence in decision), and a range of secondary measures (anxiety, patient enablement, intention to adhere to chosen treatment, satisfaction with decision, support in decision making and SF-12 health status measure). Multilevel modelling was carried out with outcome score as the dependent variable, and follow-up point (i.e. exit or 1 month later for each patient), patient and doctor levels of explanatory variables.
                No statistically significant changes in patient-based outcomes due to the training interventions were found: COMRADE risk communication score increased 0.7 [95% confidence interval (CI) -0.92 to 2.32] after risk communication training and 0.9 (95% CI -0.89 to 2.35) after SDM training; and COMRADE satisfaction with communication score increased by 1.0 (95% CI -1.1 to 3.1) after risk communication, and decreased by 0.6 (95% CI 2.7 to -1.5) after SDM training. Patients' confidence in the decision (2.1 increase, 95% CI 0.7-3.5, P < 0.01) and expectation to adhere to chosen treatments (0.7 increase, 95% CI 0.04-1.36, P < 0.05) were significantly greater among patients seen in the research clinics (when more time was available) compared with usual surgery time. Most outcomes deteriorated between exit and 1 month later. There was no interaction between intervention effects.
                Patients can be more involved in treatment decisions, and risks and benefits of treatment options can be explained in more detail, without adversely affecting patient-based outcomes. SDM and risk communication may be advocated from values and ethical principles even without evidence of health gain or improvement in patient-based outcomes, but the resources required to enhance these professional skills must also be taken into consideration. These data also indicate the benefits of extra consultation time. The influence of an opinion leader intervention on adherence to Unstable Angina (UA) guidelines compared with a traditional quality improvement model was investigated.
                A group-randomized controlled trial with 2210 patients from 21 hospitals was designed. There were three intervention arms: (1) no intervention (NI); (2) a traditional Health Care Quality Improvement Program (HCQIP); and (3) a physician opinion leader in addition to the HCQIP model (OL). Quality indicators included: electrocardiogram within 20 minutes, antiplatelet therapy within 24 hours and at discharge, and heparin and beta-blockers during hospitalization. Hospitals could determine the specific indicators they wished to target. Potential cases of UA were identified from Medicare claims data. UA confirmation was determined by a clinical algorithm based on data abstracted from medical records. Data analyses included both hospital level analysis (analysis of variance) and patient level analysis (generalized linear models).
                The only statistically significant postintervention difference in percentage compliant was greater improvement for the OL group in the use of antiplatelet therapy at 24 hours in both hospital level (P = 0.01) and patient level analyses (P <0.05) compared with the HCQIP and NI groups. When analyses were confined to hospitals that targeted specific indicators, compared with the HCQIP hospitals, the OL hospitals showed significantly greater change in percentage compliant postintervention in both antiplatelet therapy during the first 24 hours (20.2% vs. -3.9%, P = 0.02) and heparin (31.0% vs.9.1%, P = 0.05).
                The influence of physician opinion leaders was unequivocally positive for only one of five quality indicators. To maximize adherence to best practices through physician opinion leaders, more research on how these physicians influence health care delivery in their organizations will be required. To evaluate the effects of feedback reports combined with outreach visits from trained non-physicians on the clinical decision making of general practitioners (GPs) in cardiovascular care.
                Pragmatic cluster controlled trial with randomisation of practices to support (intervention group) or no special attention (control group); analysis after 2 years.
                124 general practices in The Netherlands.
                185 GPs.
                Compliance rates for 12 evidence-based indicators for the management of patients with hypertension, hypercholesterolaemia, angina pectoris, or heart failure. The evaluation relied on the prospective recording of patient encounters by the participating GPs.
                The GPs reported 30 101 clinical decisions at baseline and 22 454 decisions after the intervention. A significant improvement was seen for five of the 12 indicators: assessment of risk factors in patients with hypercholesterolaemia (odds ratio 2.04; 95% CI 1.44 to 2.88) or angina pectoris (3.07; 1.08 to 8.79), provision of information and advice to patients with hypercholesterolaemia (1.58, 1.17 to 2.13) or hypertension (1.55, 1.35 to 1.77), and checking for clinical signs of deterioration in patients with heart failure (4.11, 2.17 to 7.77). Single handed practices, non-training practices, and practices with older GPs gained particular benefit from the intervention.
                Intensive support from trained non-physicians can alter certain aspects of the clinical decision making of GPs in cardiovascular care. The effect is small and the strategy needs further development. Although many healthcare providers and researchers consider it necessary to assist patients with end-stage chronic illnesses to plan for the end of life, they tend to avoid discussing end-of-life issues with patients before major surgery. Consequently, surgical patients and their families generally have insufficient knowledge to make plans in case of life-threatening complications.
                The objective of this study was to evaluate short-term effects of Patient-Centered Advance Care Planning (PC-ACP).
                Thirty-two dyads of patients undergoing cardiac surgery and their surrogates were randomly assigned to receive either the PC-ACP intervention (PC-ACP) or usual care.
                Measures studied were patient-surrogate congruence regarding goals for future medical care, patient and surrogate knowledge of advance care planning and anxiety, and patient decisional conflict. Congruence and anxiety were measured before and after the intervention. Decisional conflict and knowledge of advance care planning were measured after the intervention.
                Compared with the control group, PC-ACP significantly improved patient-surrogate congruence (Delta=1.27, P<0.01) and reduced patients' decisional conflict (Delta=-0.77, P<0.05). Anxiety change (pre/post) did not differ between treatment and control groups. No difference in knowledge of advance care planning was found between the 2 groups.
                The PC-ACP can be an effective approach to advance care planning. Its specificity and relevance to patients' actual medical conditions (as exemplified by its plans for potential complications related to cardiac surgery) can lead to greater patient-surrogate congruence without increasing decisional conflict and anxiety.
There are too few data available to make definitive recommendations. More intensive forms of advance directive appear to show promise, but currently practice must be guided by evidence other than that derived from randomised trials. More trials are indicated to determine whether higher intensity interventions, such as joint crisis planning, have an effect on outcomes of clinical relevance.