Assessing the impact of TB/HIV services integration on TB treatment outcomes and their relevance in TB/HIV monitoring in Ghana

Background The impact of the human immunodeficiency virus (HIV) on tuberculosis (TB), and the implications for TB and HIV control, is a public health challenge in Ghana – almost a quarter (23%) of all TB cases were HIV positive in 2010. The integration of TB/HIV services has therefore emerged as an essential component of the national response to TB and HIV. The aim is to reduce fragmentation, improve access, enhance efficiency and improve quality of care. Ghana’s TB/HIV policy comprises three linked sets of activities: effective implementation of the Stop TB Strategy for TB control, improved HIV prevention and care, and the implementation of additional TB/HIV activities. Different models of service delivery with increasing integration of TB/HIV activities are expected to provide greater access to more comprehensive care. The objective of this paper is to assess the impact of TB/HIV integration on TB treatment outcomes and to explore the usefulness of TB treatment outcomes as TB/HIV indicators. Methods A before-and-after study to observe the introduction of TB/HIV activities into TB programmes in three hospitals with different levels of integration was conducted. Anonymised patient data was collated from TB registers from each facility, and analysed to determine if TB treatment outcomes changed significantly after integration. Results TB treatment success was 50% (95% CI 49 – 52) prior to, and 69% (95% CI 65 – 73) after, integration (Χ2 43.96, p < 0.00). Treatment success increased from 43% to 53% at the one-stop shop (OSS), from 69% to 78% at the partially integrated site (PIS) and substantially from 46% to 78% at the referral site (RS) (Χ2 64.54; p<0.01). Defaults and cases transferred out reduced from 14.3% and 15.3% prior to integration, to 1.4% and 9.0% after integration, respectively, accounting for a significant increase in treatment success. Death rates remained high at 18% in all cases studied and 25% in HIV-associated cases after integration. Conclusion TB/HIV integration may improve TB treatment success, but its exact impact is difficult to ascertain due to non-specificity and design limitations. TB mortality may be more useful as an indicator for monitoring TB/HIV activities in Ghana

Process evaluation of integrated diabetes management at primary healthcare facilities in Pakistan: a mixed-methods study

Background: Integrated care for diabetes and associated conditions at primary level health facilities can make care available to a much larger population, especially in rural areas. Aim: This process evaluation was to understand how the authors' integrated care was implemented and experienced by the care providers and patients, and to inform modifications prior to province-wide scale-up. Design & setting: The mixed-method study was conducted as part of a cluster randomised trial on integrated diabetes care at 14 public health facilities. Method: The care practices were assessed by analysing the routine clinical records of 495 registered patients with diabetes. Then semi-structured interviews with service providers and patients were used to understand their respective care experiences. A framework approach was applied to analyse and interpret the qualitative data. Results: The intervention and the study were implemented as intended under routine conditions in rural health centres. Key service processes effectively delivered included: skill-based training; screening and diagnostic tests; treatment card records; and the additional case management as per desk guide, including monitoring progress in glucose and weight at follow-up consultations, and mobile phone calls to help adherence. However, social and cultural factors affected clients' ability to change lifestyles, especially for women. The intervention effect was limited by the short study follow-up of only 9 months. Conclusion: Integrated diabetes care was feasible, both for providers and patients, and potentially scalable at primary care facilities under routine conditions in Pakistan. Additional operational interventions are required for sustained drug supplies, supervision, in-service training, and to address the social challenges to healthy activity and eating, especially for women

Is integrated private-clinic based early child development care effective? A clustered randomised trial in Pakistan

Background In Pakistan, high prevalence of delays in early child development (ECD) is associated with poverty and lack of mothers’ caregiving skills. GP clinics, the main sources of care in poor urban localities, lack quality ECD care delivery. A contextualised intervention was developed and tested to enable GPs to deliver clinic-based, tool-assisted ECD counselling of mothers on a quarterly basis. Aim To assess the effectiveness of delivering a contextualised ECD mother-counselling intervention. Design & setting Clustered randomised controlled trial, in poor urban localities of Pakistan. Locality clusters were allocated to intervention and control arm using simple randomisation. Method A total of 2327 mother–child pairs were recruited at 32 GP clinics, one from each cluster-locality; 16 GP clinics per arm. The clinic-based counselling intervention covering child stimulation, nutrition, and maternal mental health was delivered mainly by clinic assistants to mothers at ≤6 weeks, and 3, 6, and 9 months of child age. At 12 months of child age, each mother–child pair was assessed for the primary outcome, that is, delays in the five development domains (determined by Ages and Stages Questionnaire-3 [ASQ-3] score); and secondary outcomes, namely the prevalence of stunting and maternal depression (determined by Patient Health Questionnaire-9 [PHQ-9] score). The outcome assessors were blinded to the cluster–arm allocation. Outcome analyses were calculated on cluster-level. Results At 12 months, the number of children with delay in two or more development domains was significantly lower in the intervention arm (-0.17 [95% confidence interval {CI} = -0.26 to -0.09]; P<0.001) compared to the control arm. The difference in the prevalence of child stunting and maternal depression were also significant at -0.21% (95% CI = -0.30 to -0.13; P<0.001) and -0.23% (95% CI = -0.29 to -0.18; P = 0.000) respectively. Conclusion Contextualised ECD care, when delivered at GP clinics in poor urban localities, can effectively reduce the developmental delays during the first 12 months of the child's life

Effectiveness of an integrated diabetes care package at primary healthcare facilities: a cluster randomised trial in Pakistan

Background: There were an estimated 7 million people living with diabetes in Pakistan in 2014, and this is predicted to reach 11.4 million by 2030. Aim: To assess if an integrated care package can achieve better control of diabetes. Design & setting: The pragmatic cluster randomised controlled trial (cRCT) was conducted from December 2014–June 2016 at 14 primary healthcare facilities in Sargodha district. Opportunistic screening, diagnostic testing, and patient recording processes were introduced in both the control 'testing, treating, and recording' (TTR) arm, and the intervention 'additional case management' (ACM) arm, which also included a clinical care guide and pictorial flipbook for lifestyle education, associated clinician training, and mobile phone follow-up. Method: Clinics were randomised on a 1:1 basis (sealed envelope lottery method) and 250 patients recruited in the ACM arm and 245 in the TTR-only arm (age ≥25 years and HbA1c >7%). The primary outcome was mean change in HbA1c (%) from baseline to 9-month follow-up. Patients and staff were not blinded. Results: The primary outcome was available for n = 238/250 (95.2%) participants in the ACM arm and n = 219/245 (89.4%) participants in the TTR-only arm (all clusters). Cluster level mean outcome was -2.26 pp (95% confidence intervals [CI] = -2.99 to -1.53) for the ACM arm, and -1.44 pp (95% CI = -2.34 to -0.54) for the TTR-only arm. Cluster level mean ACM–TTR difference (covariate-unadjusted) was -0.82 pp (95% CI = -1.86 to 0.21; P = 0.11). Conclusion: The ACM intervention in public healthcare facilities did not show a statistically significant effect on HbA1c reduction compared to the control (TTR-only) arm. Future evaluation should assess changes after a longer follow-up period, and minimal care enhancement in the comparator (control) arm

Effectiveness of delivering integrated COPD care at public healthcare facilities: a cluster randomised trial in Pakistan

Background In Pakistan chronic obstructive pulmonary disease (COPD) prevalence is 2.1% in adults aged >40 years. Despite being a health policy focus, integrated COPD care has remained neglected, with wide variation in practice. Aim To assess whether enhanced care at public health facilities resulted in better control of COPD, treatment adherence, and smoking cessation. Design & setting A two-arm cluster randomised controlled trial was undertaken in 30 public health facilities (23 primary and 7 secondary), across three districts of Punjab, between October 2014–December 2016. Both arms had enhanced diagnosis and patient recording processes. Intervention facilities also had clinical care guides; drugs for COPD; patient education flipcharts; associated staff training; and mobile phone follow-up. Method Facilities were randomised in a 1:1 ratio (sealed envelope independent lottery method), and 159 intervention and 154 control patients were recruited. The eligibility criteria were as follows: diagnosed with COPD, aged ≥18 years, and living in the catchment area. The primary outcome was change in BODE (Body mass index, airway Obstruction, Dyspnoea, Exercise capacity) index score from baseline to final follow-up visit. Staff and patients were not blinded. Results Six-month primary outcomes were available for 147/159 (92.5%) intervention and 141/154 (91.6%) control participants (all clusters). The primary outcome results cluster-level analysis were as follows: mean intervention outcome = -1.67 (95% confidence intervals [CI] = -2.18 to -1.16); mean control outcome = -0.66 (95% CI = -1.09 to -0.22); and covariate-adjusted mean intervention–control difference = -0.96 (95% CI = -1.49 to -0.44; P = 0.001). Conclusion The findings of this trial and a separate process evaluation study support the scaling of this integrated COPD care package at primary and secondary level public health facilities in Pakistan and similar settings

Delivering integrated hypertension care at private health facilities in urban Pakistan: a process evaluation

Background: In Pakistan about 18% of all adults are affected by hypertension, and only one in eight of the prevalent cases have their hypertension controlled. As in many other low-middle income countries, a public–private partnership approach is being considered for delivering non-communicable disease care in urban areas. Aim: This process evaluation was undertaken to understand how an integrated care intervention was experienced by the care providers and patients, and to inform modifications before possible scaling. Design & setting: The mixed-methods study was conducted as part of a cluster randomised trial on integrated hypertension care at 26 private clinics. Method: The care practices were assessed by analysing the clinical records of 1138 registered patients with hypertension. Then semi-structured interviews with service providers and patients were used to understand their respective care experiences. A framework approach was applied to analyse and interpret the qualitative data. Results: District-led objective selection and context-sensitive staff training helped to get the clinics engaged in partnership working. About one-third of patients with hypertension had associated diabetes or renal compromise. The prescription of drugs is influenced by multiple non-clinical considerations of providers and patients. Many doctors allowed the use of home-based remedies as supplements to the prescribed allopathic drugs. Female patients faced more challenges in managing lifestyle changes. The intervention improved adherence to follow-up visits, but patient attrition remained a challenge. Conclusion: The integrated hypertension care intervention at private clinics is feasible, and leads to improved diagnosis and treatment in low-income country urban setting. The authors recommend continued implementation research and informed scaling of hypertension care at private clinics

Enhanced hypertension care through private clinics in Pakistan: a cluster randomised trial

Background Hypertension in Pakistan affects 33% of people aged ≥45 years, and in urban areas around 70% of basic health care occurs in private facilities. Aim To assess whether enhanced care at urban private clinics resulted in better control of hypertension, cardiovascular disease (CVD) risk factors, and treatment adherence. Design & setting A two-arm cluster randomised controlled trial was conducted at 26 private clinics (in three districts of Punjab) between January 2015–September 2016. Both arms had enhanced screening and diagnosis of hypertension and related conditions, and patient recording processes. Intervention facilities also had a clinical care guide, additional drugs for hypertension, a patient lifestyle education flipchart, associated training, and mobile phone follow-up. Method Clinics were randomised in a 1:1 ratio (sealed envelope lottery method). A total of 574 intervention and 564 control patients in 13 clusters in each arm were recruited (male and female, aged ≥25 years, systolic blood pressure [SBP] >140 mmHg, and/or diastolic blood pressure [DBP] >90 mmHg). The primary outcome was change in SBP from baseline to 9-month follow-up. Staff and patients were not blinded, but outcome assessors were blinded. Results Nine-month primary outcomes were available for 522/574 (90.9%) intervention and 484/564 (85.8%) control participants (all clusters). The unadjusted cluster-level analysis results were as follows: mean intervention outcome was -25.2 mmHg (95% confidence intervals [CI] = -29.9 to -20.6); mean control outcome was -9.4 mmHg (95% CI = 21.2 to 2.2); and mean control–intervention difference was 15.8 (95% CI = 3.6 to 28.0; P = 0.01). Conclusion The findings and separate process evaluation support the scaling of an integrated CVD–hypertension care intervention in urban private clinics in areas lacking public primary care in Pakistan

Feasibility of delivering integrated COPD-asthma care at primary and secondary level public healthcare facilities in Pakistan: a process evaluation

Background: In Pakistan,the estimated prevalence of chronic obstructive pulmonary disease (COPD) and asthma are 2.1% and 4.3% respectively, and existing care is grossly lacking both in coverage and quality. An integrated approach is recommended for delivering COPD and asthma care at public health facilities. Aim: To understand how an integrated care package was experienced by care providers and patients, and to inform modifications prior to scaling up. Design & setting: The mixed-methods study was conducted as part of cluster randomised trials on integrated COPD and asthma care at 30 public health facilities. Method: The care practices were assessed by analysing the clinical records of n = 451 asthma and n = 313 COPD patients. Semi-structured interviews with service providers and patients were used to understand their care experiences. A framework approach was applied to analyse and interpret qualitative data. Results: Utilisation of public health facilities for chronic lung conditions was low, mainly because of the non-availability of inhalers. When diagnosed, around two-thirds (69%) of male and more than half (55%) of female patients had severe airway obstruction. The practice of prescribing inhalers differed between intervention and control arms. Patient non-adherence to follow-up visits remained a major treatment challenge (though attrition was lower and slower in the intervention arm). Around half of the male responders who smoked at baseline reported having quit smoking. Conclusion: The integrated care of chronic lung conditions at public health facilities is feasible and leads to improved diagnosis and treatment in a low-income country setting. The authors recommend scaling of the intervention with continued implementation research, especially on improving patient adherence to treatment

Implementation of a comprehensive intervention for patients at high risk of cardiovascular disease in rural China: A pragmatic cluster randomized controlled trial

Objective: This study aims to assess whether a standard intervention package of cardiovascular disease (CVD) care was being delivered effectively, and if it was associated with improved lifestyle and biomedical indicators. Methods: In rural China, we implemented a pragmatic cluster randomized controlled trial for 12 months, randomized at the township hospital level, and compared with usual care. Intervention case management guideline, training and performance monitoring meeting and patient support activities were designed to fit within the job description of family doctors in the township hospitals and comprised: 1) prescription of a standardised package of medicines targeted at those with hypertension or diabetes; 2) advice about specific lifestyle interventions; and 3) advice about medication adherence. Participants were 50-74 years old, had hypertension and CVD risk scores >20% or diabetes, but were excluded if a history of severe CVD events. We also randomly selected 100 participants from six selected clusters per arm as a panel to collect intermediate biomedical indicators over time. Results: A total of 28,130 participants, in 33 intervention and 34 control township hospitals, were recruited. Compared with the control arm, participants in the intervention arm had substantially improved prescribing rates of anti-hypertensives, statins and aspirin (P0.05). Conclusion: Implementation of the package by family doctors was feasible and improved prescribing and some lifestyle changes. Additional measures such as reducing medication costs and patient education are required. Trial registration: Current Controlled Trials ISRCTN58988083

Effect of a training and educational intervention for physicians and caregivers on antibiotic prescribing for upper respiratory tract infections in children at primary care facilities in rural China: a cluster-randomised controlled trial

Background: Inappropriate antibiotic prescribing contributes to the generation of drug resistance worldwide, and is particularly common in China. We assessed the effectiveness of an antimicrobial stewardship programme aiming to reduce inappropriate antibiotic prescribing in paediatric outpatients by targeting providers and caregivers in primary care hospitals in rural China. Methods: We did a pragmatic, cluster-randomised controlled trial with a 6-month intervention period. Clusters were primary care township hospitals in two counties of Guangxi province in China, which were randomly allocated to the intervention group or the control group (in a 1:1 ratio in Rong county and in a 5:6 ratio in Liujiang county). Randomisation was stratified by county. Eligible participants were children aged 2–14 years who attended a township hospital as an outpatient and were given a prescription following a primary diagnosis of an upper respiratory tract infection. The intervention included clinician guidelines and training on appropriate prescribing, monthly prescribing peer-review meetings, and brief caregiver education. In hospitals allocated to the control group, usual care was provided, with antibiotics prescribed at the individual clinician's discretion. Patients were masked to their allocated treatment group but doctors were not. The primary outcome was the antibiotic prescription rate in children attending the hospitals, defined as the cluster-level proportion of prescriptions for upper respiratory tract infections in 2–14-year-old outpatients, issued during the final 3 months of the 6-month intervention period (endline), that included one or more antibiotics. The outcome was based on prescription records and analysed by modified intention-to-treat. This study is registered with the ISRCTN registry, number ISRCTN14340536. Findings: We recruited all 25 eligible township hospitals in the two counties (14 hospitals in Rong county and 11 in Liujiang county), and randomly allocated 12 to the intervention group and 13 to the control group. We implemented the intervention in three internal pilot clusters between July 1, 2015, and Dec 31, 2015, and in the remaining nine intervention clusters between Oct 1, 2015 and March 31, 2016. Between baseline (the 3 months before implementation of the intervention) and endline (the final 3 months of the 6-month intervention period) the antibiotic prescription rate at the individual level decreased from 82% (1936/2349) to 40% (943/2351) in the intervention group, and from 75% (1922/2548) to 70% (1782/2552) in the control group. After adjusting for the baseline antibiotic prescription rate, stratum (county), and potentially confounding patient and prescribing doctor covariates, this endline difference between the groups represented an intervention effect (absolute risk reduction in antibiotic prescribing) of −29% (95% CI −42 to −16; p=0·0002). Interpretation: In China's primary care setting, pragmatic interventions on antimicrobial stewardship targeting providers and caregivers substantially reduced prescribing of antibiotics for childhood upper respiratory tract infections. Funding: Department of International Development (UKAID) through Communicable Diseases Health Service Delivery