A cluster randomised controlled trial of the effect of a treatment algorithm for hypertension in patients with type 2 diabetes

BACKGROUND: Good blood pressure (BP) control reduces the risk of complications in people with type 2 diabetes, yet many do not achieve this. Guidelines for managing hypertension recommend increasing antihypertensive medications until control is achieved, but the effect of such recommendations in routine primary care is unknown. AIM: To evaluate the effectiveness of a BP treatment algorithm in primary care patients with type 2 diabetes. DESIGN OF STUDY: A cluster randomised controlled trial of 1534 patients with type 2 diabetes. SETTING: Forty-two practices in Nottingham, UK. METHOD: Practices were randomised to continue usual care or to use a treatment algorithm designed so that practice nurses and GPs would increase antihypertensive treatment in steps until the target of 140/80 mmHg was reached. Participants were assessed by a clinical interview and case note review at recruitment and at 1 year. The primary outcome measure was the proportion of participants achieving target BP at 1 year. RESULTS: At 1 year there was no difference between the proportions of participants with well controlled BP in the intervention and control arms (36.6% versus 34.3%; P = 0.27). Mean systolic and diastolic blood pressures were identical in the two arms (143/78 mmHg). There was some evidence that participants in the intervention arm were more likely to be receiving higher doses of their antihypertensive drugs, although there was no significant difference in the number of different antihypertensive drugs prescribed. Participants in the intervention arm had a higher rate of primary care BP-related consultations over 12 months than those receiving usual care (rate ratio = 1.55, 95% confidence interval [CI] = 1.26 to 1.88, P<0.001). CONCLUSION: Despite increased monitoring and possibly higher doses of medication there was no improvement in blood pressure control. Improvements achieved by specialist nurse-led clinics in secondary care may not translate to people with type 2 diabetes in primary care settings.     

REDIRECT: cluster randomised controlled trial of GP training in first-episode psychosis

Background

Delays in accessing care for young people with a first episode of psychosis are significantly associated with poorer treatment response and higher relapse rates.

Aim

To assess the effect of an educational intervention for GPs on referral rates to early-intervention services and the duration of untreated psychosis for young people with first-episode psychosis.

Design of study

Stratified cluster randomised controlled trial, clustered at practice level.

Setting

Birmingham, England.

Method

Practices with access to the three early-intervention services in three inner-city primary care trusts in Birmingham were eligible for inclusion. Intervention practices received an educational intervention addressing GP knowledge, skills, and attitudes about first-episode psychosis. The primary outcome was the difference in the number of referrals to early-intervention services between practices. Secondary outcomes were duration of untreated psychosis, time to recovery, use of the Mental Health Act, and GP consultation rate during the developing illness.

Results

A total of 110 of 135 eligible practices (81%) were recruited; 179 young people were referred, 97 from intervention and 82 from control practices. The relative risk of referral was not significant: 1.20 (95% confidence interval [CI] = 0.74 to 1.95; P = 0.48). No effect was observed on secondary outcomes except for ‘delay in reaching early-intervention services’, which was statistically significantly shorter in patients registered in intervention practices (95% CI = 83.5 to 360.5; P = 0.002).

Conclusion

GP training on first-episode psychosis is insufficient to alter referral rates to early-intervention services or reduce the duration of untreated psychosis; however, there is a suggestion that training facilitates access to the new specialist teams for early psychosis.     

Case finding for chronic obstructive pulmonary disease in primary care: a pilot randomised controlled trial

Background

Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality. However, much of the disease burden remains undiagnosed.

Aim

To compare the yield and cost effectiveness of two COPD case-finding approaches in primary care.

Design and setting

Pilot randomised controlled trial in two general practices in the West Midlands, UK.

Method

A total of 1634 ever-smokers aged 35–79 years with no history of COPD or asthma were randomised into either a ‘targeted’ or ‘opportunistic’ case-finding arm. Respiratory questionnaires were posted to patients in the ‘targeted’ arm and provided to patients in the ‘opportunistic’ arm at routine GP appointments. Those reporting at least one chronic respiratory symptom were invited for spirometry. COPD was defined as pre-bronchodilator forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC)<0.7 and FEV1<80% of predicted. Primary outcomes were the difference in the proportion of patients diagnosed with COPD and the cost per case detected.

Results

Twenty-six per cent (212/815) in the ‘targeted’ and 13.6% (111/819) in the ‘opportunistic’ arm responded to the questionnaire and 78.3% (166/212) and 73.0% (81/111), respectively, reported symptoms; 1.2% (10/815) and 0.7% (6/819) of patients in the ‘targeted’ and ‘opportunistic’ arms were diagnosed with COPD (difference in proportions = 0.5% [95% confidence interval {CI} = –0.5% to 3.08%]). Over a 12-month period, the ‘opportunistic’ case-finding yield could be improved to 1.95% (95% CI = 1.0% to 2.9%). The cost-per case detected was £424.56 in the ‘targeted’ and £242.20 in the ‘opportunistic’ arm.

Conclusion

Opportunistic case finding may be more effective and cost effective than targeting patients with a postal questionnaire alone. A larger randomised controlled trial with adequate sample size is required to test this.     

Self-management support for moderate-to-severe chronic obstructive pulmonary disease: a pilot randomised controlled trial

Background

Better self management could improve quality of life (QoL) and reduce hospital admissions in chronic obstructive pulmonary disease (COPD), but the best way to promote it remains unclear.

Aim

To explore the feasibility, effectiveness and cost effectiveness of a novel, layperson-led, theoretically driven COPD self-management support programme.

Design and setting

Pilot randomised controlled trial in one UK primary care trust area.

Method

Patients with moderate to severe COPD were identified through primary care and randomised 2:1 to the 7-week-long, group intervention or usual care. Outcomes at baseline, 2, and 6 months included self-reported health, St George’s Respiratory Questionnaire (SGRQ), EuroQol, and exercise.

Results

Forty-four per cent responded to GP invitation, 116 were randomised: mean (standard deviation [SD]) age 69.5 (9.8) years, 46% male, 78% had unscheduled COPD care in the previous year. Forty per cent of intervention patients completed the course; 35% attended no sessions; and 78% participants completed the 6-month follow-up questionnaire. Results suggest that the intervention may increase both QoL (mean EQ-5D change 0.12 (95% confidence interval [CI] = –0.02 to 0.26) higher, intervention versus control) and exercise levels, but not SGRQ score. Economic analyses suggested that with thresholds of £20 000 per quality-adjusted life-year gained, the intervention is likely to be cost-effective.

Conclusion

This intervention has good potential to meet the UK National Institute for Health and Clinical Excellence criteria for cost effectiveness, and further research is warranted. However, to make a substantial impact on COPD self-management, it will also be necessary to explore other ways to enable patients to access self-management education.     

Weight-management interventions in primary care: a pilot randomised controlled trial

Background

There is a paucity of randomised controlled trials of weight management in primary care.

Aim

To ascertain the feasibility of a full trial of a nurse-led weight-management programme in general practice.

Design of study

Factorial randomised control trial.

Setting

Primary care, UK.

Method

A total of 123 adults (80.3% women, mean age 47.2 years) with body mass index ≥27 kg/m², recruited from eight practices, were randomised to receive structured lifestyle support (n = 30), structured lifestyle support plus pedometer (n = 31), usual care (n = 31), or usual care plus pedometer (n = 31) for a 12-week period.

Results

A total of 103 participants were successfully followed up. The adjusted mean difference in weight in structured support compared to usual care groups was −2.63 kg (95% confidence interval [CI] = −4.06 to −1.20 kg), and for pedometer compared to no pedometer groups it was −0.11 kg (95% CI = −1.52 to 1.30 kg). One in three participants in the structured-support groups (17/50, 34.0%) lost 5% or more of their initial weight, compared to less than one in five (10/53, 18.9%) in usual-care groups; provision of a pedometer made little difference (14/48, 29.2% pedometer; 13/55, 23.6% no pedometer). Difference in waist circumference change between structured-support and usual-care groups was −1.80 cm (95% CI = −3.39 to −0.20 cm), and between the pedometer and no pedometer groups it was −0.84 cm (95% CI = −2.42 to 0.73 cm). When asked about their experience of study participation, most participants found structured support helpful.

Conclusion

The structured lifestyle support package could make substantial contributions to improving weight-management services. A trial of the intervention in general practice is feasible and practicable.     

Successful GP intervention with frequent attenders in primary care: randomised controlled trial.

BACKGROUND: Frequent attenders to GP clinics can place an unnecessary burden on primary care. Interventions to reduce frequent attendance have had mixed results. AIM: To assess the effectiveness of a GP intervention to reduce frequent-attender consultations. DESIGN OF STUDY: Randomised controlled trial with frequent attenders divided into an intervention group and two control groups (one control group was seen by GPs also providing care to patients undergoing the intervention). SETTING: A health centre in southern Spain. METHOD: Six GPs and 209 randomly-selected frequent attenders participated. Three GPs were randomly allocated to perform the new intervention: of the 137 frequent attenders registered with these three GPs, 66 were randomly allocated to receive the intervention (IG) and 71 to a usual care control group (CG2). The other three GPs offered usual care to the other 72 frequent attenders (CG1). The main outcome measure was the total number of consultations 1 year post-intervention. Baseline measurements were recorded of sociodemographic characteristics, provider-user interface, chronic illnesses, and psychosocial variables. GPs allocated to the new intervention received 15 hours' training which incorporated biopsychosocial, organisational, and relational approaches. After 1 year of follow-up frequent attenders were contacted. An intention-to-treat analysis was used. RESULTS: A multilevel model was built with three factors: time, patient, and doctor. After adjusting for covariates, the mean number of visits at 1 year in IG was 13.10 (95% confidence interval [CI]=11.39 to 14.94); in the CG1 group was 19.37 (95% CI=17.31 to 21.55); and in the CG2 group this was 16.72 (95% CI=4.84 to 18.72). CONCLUSION: The new intervention with GPs resulted in a significant and relevant reduction in frequent-attender consultations. Although further trials are needed, this intervention is recommended to GPs interested in reducing consultations by their frequent attenders.     

Treatment needs and diagnosis awareness in primary care patients with chronic kidney disease

Background

GPs in England are required to keep a register of patients with chronic kidney disease (CKD). National Institute for Health and Clinical Excellence (NICE) guidelines recommend regular follow-up, but patients are perceived to be low risk and not requiring active management.

Aim

To assess treatment needs of CKD stage 3 patients in primary care, as well as their awareness of CKD.

Design and setting

A cross-sectional analysis from a longitudinal prospective study in 32 general practices.

Method

A total of 1741 participants underwent clinical assessment including urine and blood tests. Participants were asked about awareness of their CKD. Results were reviewed and a letter recommending treatment in line with NICE guidelines was sent to their GP.

Results

The mean age of participants was 73 ± 9 years; 60% (n = 1052) were female and diabetes was present in 17%; 67% of participants required further intervention. Most required improved control of hypertension (n = 1576; 33.1% of cohort). Other recommendations included advice to investigate anaemia (n = 1142; 8.2%) or stop nephrotoxic drugs (n = 1120; 7.5%). Less than 6% of participants met NICE criteria for referral to nephrology services and 41% were unaware of their CKD diagnosis. Multivariable analysis identified subjects with formal educational qualifications, age <75 years, estimated glomerular filtration rate (eGFR) 30–44 ml/min/1.73 m², and significant albuminuria as more likely to be aware of their diagnosis.

Conclusion

The study data show that the majority of patients required at least one intervention to improve the management of their CKD. Most interventions could be delivered in primary care and only a minority required nephrology referral. Many patients were unaware of their CKD diagnosis, and efforts should be made to improve this to facilitate involvement in their care.     

Quality-improvement strategies for the management of hypertension in chronic kidney disease in primary care: a systematic review

Background

Chronic kidney disease (CKD) is a relatively recently recognised condition. People with CKD are much more likely to suffer from cardiovascular events than progress to established renal failure. Controlling systolic blood pressure should slow the progression of disease and reduce mortality and morbidity. However, no systematic review has been conducted to explore the effectiveness of quality-improvement interventions to lower blood pressure in people with CKD.

Aim

To assess the effectiveness of quality-improvement interventions to reduce systolic blood pressure in people with CKD in primary care, in order to reduce cardiovascular risk and slow the progression of renal disease.

Method

Papers were identified from the trial data bases of the Cochrane Effective Practice and Organisation of Care Group (EPOC) and Cochrane renal groups. In a three-round process, at least two investigators read the papers independently. Studies were initially excluded based on their abstracts, if these were not relevant to primary care. Next, full papers were read, and again excluded on relevance. Quantitative and, where this was not possible, qualitative analyses of the findings were performed.

Results

The selected studies were usually carried out on high-risk populations including ethnic minorities. The interventions were most often led by nurses or pharmacists. Three randomised trials showed a combined effect of a reduction in systolic blood pressure of 10.50 mmHg (95% confidence interval [CI] = 5.34 to 18.41 mmHg). One non-randomised study showed a reduction in systolic blood pressure of 9.30 mmHg (95% CI = 3.01 to 15.58 mmHg).

Conclusion

Quality-improvement interventions can be effective in lowing blood pressure, and potentially in reducing cardiovascular risk and slowing progression in CKD. Trials are needed in low-risk populations to see if the same improvements can be achieved.     

Aged garlic extract lowers blood pressure in patients with treated but uncontrolled hypertension: A randomised controlled trial

Objective

To assess the effect, tolerability and acceptability of aged garlic extract as an adjunct treatment to existing antihypertensive medication in patients with treated, but uncontrolled, hypertension.

Design

A double-blind parallel randomised placebo-controlled trial involving 50 patients whose routine clinical records in general practice documented treated but uncontrolled hypertension. The active treatment group received four capsules of aged garlic extract (960 mg containing 2.4 mg S-allylcysteine) daily for 12 weeks, and the control group received matching placebos. The primary outcome measures were systolic and diastolic blood pressure at baseline, 4, 8 and 12 weeks, and change over time. We also assessed tolerability during the trial and acceptability at 12 weeks.

Results

In patients with uncontrolled hypertension (SBP ≥ 140 mm Hg at baseline), systolic blood pressure was on average 10.2 ± 4.3 mm Hg (p = 0.03) lower in the garlic group compared with controls over the 12-week treatment period. Changes in blood pressure between the groups were not significant in patients with SBP < 140 mm Hg at baseline. Aged garlic extract was generally well tolerated and acceptability of trial treatment was high (92%).

Conclusion

Our trial suggests that aged garlic extract is superior to placebo in lowering systolic blood pressure similarly to current first line medications in patients with treated but uncontrolled hypertension.     

Cluster randomised controlled trial of the effectiveness of primary care mental health workers

BACKGROUND: Mental health issues are a core part of the work of primary care and are the second most common reason for consultations. There is some evidence that the quality of primary care mental health provision is variable. AIM: To evaluate the effectiveness of primary care mental health workers with regards to satisfaction with care, mental health symptoms, use of the voluntary sector, and cost effectiveness of care. DESIGN OF STUDY: Cluster randomised controlled trial. SETTING: Practices in the Heart of Birmingham Primary Care Trust, Birmingham, England. METHOD: Nineteen practices and 368 patients (18 to 65 years of age) with a diagnosis of a new or ongoing common mental health problem were recruited. Sixteen practices and 284 patients completed the trial. RESULTS: Patients in intervention practices had a higher mean level of general satisfaction than those in control practices (difference between group scores of 8.3, 95% confidence interval = 1.3 to 15.3, P = 0.023). The two groups did not differ in mental health symptom scores or use of the voluntary sector. CONCLUSION: For patients with common mental health problems, primary care mental health workers may be effective at increasing satisfaction with an episode of care.     

Chronic kidney disease in patients with diabetes mellitus type 2 or hypertension in general practice

Background

The prevalence and severity of chronic kidney disease (CKD) in primary care patients with diabetes or hypertension is unknown.

Aim

To assess the prevalence and severity of CKD in patients with diabetes and hypertension; and identify whether age, sex, diabetes, and hypertension are associated with CKD.

Design of study

Cross-sectional survey.

Setting

Two Dutch primary health care centres (15 954 enlisted patients).

Method

Patients, aged ≥25 years, with known diabetes type 2 (n = 471) or hypertension (n = 960), were selected on 1 October 2006. Initial screening uptake rates were assessed from the electronic patient records, and patients were invited when blood or urine measurements were missing. The presence of albuminuria was determined, glomerular filtration rate estimated, and clinical characteristics extracted.

Results

Initial screening uptake rates were 93% and 69% for diabetes and hypertension, respectively, and increased to 97% (n = 455) and 87% (n = 836) after active invitation. The prevalence of CKD was 28% in diabetes and 21% in hypertension only. The presence of diabetes was independently associated with albuminuria (odds ratio [OR] 4.23; 95% confidence interval [CI] = 2.67 to 6.71), but not with decreased estimated GFR (eGFR) (OR 0.75; 95% CI = 0.54 to 1.04). Age showed the strongest association with decreased eGFR (OR 2.73; 95% CI = 2.02 to 3.70).

Conclusion

In primary care, more than one-quarter of patients with diabetes and about one-fifth of patients with hypertension have CKD. The high prevalence justifies longitudinal follow-up in order to evaluate whether intensified cardiovascular risk management is beneficial in this primary care population.     

Effectiveness of a smartphone application to promote physical activity in primary care: the SMART MOVE randomised controlled trial

Background

Physical inactivity is a major, potentially modifiable, risk factor for cardiovascular disease, cancer, and other chronic diseases. Effective, simple, and generalisable interventions that will increase physical activity in populations are needed.

Aim

To evaluate the effectiveness of a smartphone application (app) to increase physical activity in primary care.

Design and setting

An 8-week, open-label, randomised controlled trial in rural, primary care in the west of Ireland.

Method

Android smartphone users >16 years of age were recruited. All participants were provided with similar physical activity goals and information on the benefits of exercise. The intervention group was provided with a smartphone app and detailed instructions on how to use it to achieve these goals. The primary outcome was change in physical activity, as measured by a daily step count between baseline and follow-up.

Results

A total of 139 patients were referred by their primary care health professional or self-referred. In total, 37 (27%) were screened out and 12 (9%) declined to participate, leaving 90 (65%) patients who were randomised. Of these, 78 provided baseline data (intervention = 37; control = 41) and 77 provided outcome data (intervention = 37; control = 40). The mean daily step count at baseline for intervention and control groups was 4365 and 5138 steps per day respectively. After adjusting, there was evidence of a significant treatment effect (P = 0.009); the difference in mean improvement in daily step count from week 1 to week 8 inclusive was 1029 (95% confidence interval 214 to 1843) steps per day, favouring the intervention. Improvements in physical activity in the intervention group were sustained until the end of the trial.

Conclusion

A simple smartphone app significantly increased physical activity over 8 weeks in a primary care population.     

Open Access Tubal aSsessment for the initial management of infertility in general practice (the OATS trial): a pragmatic cluster randomised controlled trial

Background

GPs investigate approximately half of all infertile couples with semen analysis and endocrine blood tests. For assessment of tubal status, hysterosalpingography (HSG) is recommended as a first-line investigation for women not known to have comorbidities.

Aim

To test whether providing GPs with open access to HSG results in infertile couples progressing to a diagnosis and management plan sooner than with usual management.

Design of study

A pragmatic cluster randomised controlled trial.

Setting

Seventy-one of 173 general practices in north-east England agreed to participate.

Method

A total of 670 infertile couples presented to 33 intervention practices and 25 control practices over a 2-year period. Practices allocated to the intervention group had access to HSG for those infertile women who fulfilled predefined eligibility criteria. The primary outcome measure was the interval between presentation to the GP and the couple receiving a diagnosis and management plan.

Results

An annual incidence of 0.8 couples per 1000 total population equated to each GP seeing an average of one or two infertile couples each year. Open access HSG was used for 9% of all infertile women who presented to the intervention practices during the study period. The time to reach a diagnosis and management plan for all infertile couples presenting was not affected by the availability of open access HSG (Cox regression hazard ratio = 0.9, 95% confidence interval [CI] = 0.7 to 1.1). For couples who reached a diagnosis and management plan, there was a non-significant difference in time to primary outcome for intervention versus control practices (32.5 weeks versus 30.5 weeks, mean difference 2.2 weeks, 95% CI = 1.6 to 6.1 weeks, P = 0.1). The intracluster correlation coefficient was 0.03 across all practices.

Conclusion

Providing GPs with open access to HSG had no effect on the time taken to reach a diagnosis and management plan for couples with infertility.     

Brief report: intellectual and academic functioning in pediatric chronic kidney disease

OBJECTIVE: Examine the intellectual and academic functioning in children with chronic kidney disease (CKD). METHODS: Using a cross-sectional design, children with CKD (n = 30) were compared to matched controls (n = 41) on measures of intelligence, achievement, and rates of learning disabilities (LD) variously defined. RESULTS: Children with CKD were at higher risk for grade retention (p < .001) and absenteeism (p < .01), and evidenced mild impairments on measures of intelligence (p < .001), math (p < .01), reading (p < .05), and satisfied criteria for a low achievement definition of LD (p < .01) more frequently than control group participants. Renal function was a significant predictor (p < .02) of intellectual and academic scores in the CKD group. CONCLUSIONS: Educational and psychosocial supports are critical for children with CKD, and it may be important to monitor their cognitive functioning and academic progress over time.     

Efficacy of two interventions on the discontinuation of benzodiazepines in long-term users: 36-month follow-up of a cluster randomised trial in primary care

Background

Primary care interventions that promote cessation of benzodiazepine (BZD) use in long-term users are effective at 1 year, but their efficacy at 3 years is uncertain.

Aim

To assess the 3-year efficacy of two primary care interventions delivered by GPs on cessation of BZD use in long-term users.

Design and setting

Multicentre, three-arm, cluster randomised, controlled trial, with random allocation at the GP level.

Method

Seventy-five GPs and 532 patients were randomly allocated to three groups: usual care (control), structured intervention with stepped-dose reduction and follow-up visits (SIF), or structured intervention with written stepped-dose reduction (SIW). The primary outcome was BZD use at 36 months.

Results

At 36 months, 66/168 patients (39.2%) in the SIW group, 79/191 patients (41.3%) in the SIF group, and 45/173 patients (26.0%) in the control group had discontinued BZD use. The relative risks (RR) adjusted by cluster were 1.51 (95% CI = 1.10 to 2.05; P = 0.009) in the SIW group and 1.59 (95% CI = 1.15 to 2.19; P = 0.005) in the SIF group. A total of 131/188 patients (69.7%) who successfully discontinued BZD use at 12 months remained abstinent at 36 months. The groups showed no significant differences in anxiety, depression, or sleep dissatisfaction at 36 months.

Conclusion

The interventions were effective on cessation of BZD use; most patients who discontinued at 12 months remained abstinent at 3 years. Discontinuation of BZD use did not have a significant effect on anxiety, depression, or sleep quality.     

Removal of kidney stones by extracorporeal shock wave lithotripsy is associated with delayed progression of chronic kidney disease

Purpose

This study aimed to elucidate whether stone removal by extracorporeal shock wave lithotripsy (ESWL) is associated with delayed chronic kidney disease (CKD) progression.

Materials and Methods

We conducted a retrospective analysis of 131 nephrolithiasis patients with stage 3 and 4 CKD. We collected baseline clinical and laboratory data, kidney stone characteristics, and history of receiving ESWL. We classified study patients into two groups according to whether they underwent ESWL or not (Non-ESWL group vs. ESWL group). We initially compared annual estimated glomerular filtration rate (eGFR) changes of Non-ESWL group with those of ESWL group before undergoing ESWL. In the next step, we sought to compare annual eGFR changes in the same patients before and after ESWL. Finally, we compared annual eGFR changes between success and failure groups among patients undergoing ESWL.

Results

The mean age of the patients was 62 years and 72.5% were male. The mean observation period was 3.2 years. Non-ESWL group and ESWL group before undergoing ESWL showed similar annual eGFR changes (-1.75±6.5 vs. -1.63±7.2 mL/min/1.73 m²/year, p=0.425). However, eGFR declined slower after undergoing ESWL than before ESWL (annual eGFR changes, -0.29±6.1 vs. -1.63±7.2 mL/min/1.73 m²/year, p<0.05). In addition, among patients in ESWL group, eGFR declined faster in the failure group than in the success group (annual eGFR change, -1.01±4.7 vs. -0.05±5.2 mL/min/1.73 m²/year, p<0.05).

Conclusion

Our results suggest that stone removal by ESWL is associated with delayed deterioration of renal function in CKD patients with nephrolithiasis.     

Understanding the management of early-stage chronic kidney disease in primary care: a qualitative study

Background

Primary care is recognised to have an important role in the delivery of care for people with chronic kidney disease (CKD). However, there is evidence that CKD management is currently suboptimal, with a range of practitioner concerns about its management.

Aim

To explore processes underpinning the implementation of CKD management in primary care.

Design and setting

Qualitative study in general practices participating in a chronic kidney disease collaborative undertaken as part of the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care (CLAHRC) for Greater Manchester.

Method

Semi-structured interviews were conducted with GPs and practice nurses (n = 21). Normalisation Process Theory provided a framework for generation and analysis of the data.

Results

A predominant theme was anxiety about the disclosure of early-stage CKD with patients. The tensions experienced related to identifying and discussing CKD in older people and patients with stage 3A, embedding early-stage CKD within vascular care, and the distribution of work within the practice team. Participants provided accounts of work undertaken to resolve the difficulties encountered, with efforts having tended to focus on reassuring patients. Analysis also highlighted how anxiety surrounding disclosure influenced, and was shaped by, the organisation of care for people with CKD and associated long-term conditions.

Conclusion

Offering reassurance alone may be of limited benefit, and current management of early-stage CKD in primary care may miss opportunities to address susceptibility to kidney injury, improve self-management of vascular conditions, and improve the management of multimorbidity.     

Effects of patient safety culture interventions on incident reporting in general practice: a cluster randomised trial

Background

A constructive safety culture is essential for the successful implementation of patient safety improvements.

Aim

To assess the effect of two patient safety culture interventions on incident reporting as a proxy of safety culture.

Design and setting

A three-arm cluster randomised trial was conducted in a mixed method study, studying the effect of administering a patient safety culture questionnaire (intervention I), the questionnaire complemented with a practice-based workshop (intervention II) and no intervention (control) in 30 general practices in the Netherlands.

Method

The primary outcome, the number of reported incidents, was measured with a questionnaire at baseline and a year after. Analysis was performed using a negative binomial model. Secondary outcomes were quality and safety indicators and safety culture. Mixed effects linear regression was used to analyse the culture questionnaires.

Results

The number of incidents increased in both intervention groups, to 82 and 224 in intervention I and II respectively. Adjusted for baseline number of incidents, practice size and accreditation status, the study showed that practices that additionally participated in the workshop reported 42 (95% confidence interval [CI] = 9.81 to 177.50) times more incidents compared to the control group. Practices that only completed the questionnaire reported 5 (95% CI = 1.17 to 25.49) times more incidents. There were no statistically significant differences in staff perception of patient safety culture at follow-up between the three study groups.

Conclusion

Educating staff and facilitating discussion about patient safety culture in their own practice leads to increased reporting of incidents. It is beneficial to invest in a team-wise effort to improve patient safety.