Is Early Childhood Development Care at Public Health Facilities in Pakistan Effective? A Cluster Randomized Controlled Trial.

BACKGROUND: Significant brain development in children occurs from birth to 2 years, with environment playing an important role. Stimulation interventions are widely known to be effective in enhancing early childhood development (ECD). This study aims to assess the feasibility and effectiveness of integrating ECD care delivered by lady health visitors (LHVs) at public health facilities in rural Pakistan. METHOD: A cluster randomized controlled trial was conducted through public health facilities in 2 districts of Punjab, Pakistan. A total of 22 clusters (rural health centers and subdistrict hospitals) were randomly allocated to receive routine care (control: n=11 clusters, 406 mother-child pairs) or counseling (intervention: n=11 clusters, 398 mother-child pairs). All children aged 11-12 months without any congenital abnormality were eligible for enrollment. The intervention was delivered by the LHVs to mothers with children aged 12-24 months in 3 quarterly sessions. RESULTS: The primary outcome was the prevention of ECD delays in children aged 24 months (assessed with the Ages and Stages Questionnaire-3). Analysis was done on an intention-to-treat basis. A total of 804 mother-child pairs were registered in the study, of which 26 (3.3%) pairs were lost to follow-up at the endpoint. The proportion of children with 2 or more developmental delays was significantly less in the intervention arm (13%) as compared to the control arm (41%) at an endpoint (odds ratio=0.21; 95% confidence interval=0.11, 0.42). Children in the intervention arm also had significantly better anthropometric measurements when aged 24 months than the children in the control arm. CONCLUSION: The integrated ECD care intervention for children aged 12-24 months at public health facilities was found to be effective in enhancing ECD and reducing the proportion of children with global development delays.

Process evaluation of chest camps for increased tuberculosis case finding in Punjab, Pakistan.

BACKGROUND: To contribute to the World Health Organization's End TBStrategy, the active tuberculosis (TB) case-finding approach has been proven effective. METHODS: A total of 66 chest camps were organised for patients in 15 selected districts in Punjab, Pakistan, in 2017. A mixed-method process evaluation was conducted in four randomly selected districts to evaluate the use of chest camps for active TB case finding to reach the maximum number of people with TB and to assess the implementation outcomes, such as effectiveness, feasibility, fidelity, and costs. RESULTS: Results indicated that 1458 attendees visited 24 chest camps in four selected districts. Among attendees, 297 presumptive cases were found and smear-tested; and 34 of the smear-tested were diagnosed as smear-positive TB patients. The prevalence of smear-positive TB patients among the chest camp participants was found to be 2.3%. The findings from interviews showed that preparation of chest camp activities, especially the involvement of community leaders, was found to be effective in achieving the desired level of attendance. The respondents found attending the chest camps for TB symptoms feasible and acceptable. The chest camp costs approximately US$280, including the pre-camp mobilisation events, whereas the cost per TB-positive patient was found to be US$197.64. CONCLUSIONS: The higher number of attendees without TB symptoms, the low proportion of smear-negative case registrations; and relatively high unit cost (per patient detected) were the areas identified for further attention. The study supports the continuation of chest camp activity, with further attention required for quality and efficiency concerns.

Effectiveness of an Integrated Care Package for Refugee Mothers and Children: Protocol for a Cluster Randomized Controlled Trial.

BACKGROUND: Thousands of Rohingya refugee mothers at the world's largest refugee camp located in Bangladesh are at risk of poor mental health. Accordingly, their children are also vulnerable to delayed cognitive and physical development. OBJECTIVE: The aim of this study is to evaluate the effectiveness of an integrated care package in reducing the prevalence of developmental delays among children aged 1 year and improving their mothers' mental health status. METHODS: This is a parallel, two-arm, single-blind, cluster randomized controlled trial (cRCT). A total of 704 mother-child dyads residing at the Kutupalong refugee camp in Cox's Bazar, Bangladesh, will be recruited from 22 clusters with 32 mother-child dyads per cluster. In the intervention arm, an integrated early childhood development and maternal mental health package will be delivered every quarter to mothers of newborns by trained community health workers until the child is 1 year old. Our primary outcome is a reduction in the prevalence of two or more childhood developmental delays of infants aged 1 year compared to the usual treatment. The secondary outcomes include reduced stunting among children and the prevalence of maternal depression. We will also assess the cost-effectiveness of the integrated intervention, and will further explore the intervention's acceptability and feasibility. RESULTS: At the time of submission, the study was at the stage of endpoint assessment. The data analysis started in December 2020, and the results are expected to be published after the first quarter of 2021. CONCLUSIONS: This study will address the burden of childhood developmental delays and poor maternal mental health in a low-resource setting. If proven effective, the delivery of the intervention through community health workers will ensure the proposed intervention's sustainability. TRIAL REGISTRATION: ISRCTN Registry ISRCTN10892553; https://www.isrctn.com/ISRCTN10892553. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/25047.

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.

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.

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.

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.

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.

Process evaluation of integrated early child development care at private clinics in poor urban Pakistan: a mixed methods study.

BACKGROUND: In poor urban Pakistan, private GP clinics lack adequate services to promote early child development (ECD) care. A clinic-based contextualised ECD intervention was developed for quarterly tool-assisted counselling of mothers. AIM: To explore the experience and implementation of ECD intervention by the private care providers and clients, for further adaptation for scaling of quality ECD care, at primary level private healthcare facilities in Pakistan. DESIGN & SETTING: A mixed methods approach using quantitative records review and qualitative interviews at poor urban clinics in Rawalpindi and Lahore, Pakistan. METHOD: Quantitative data from study-specific records were reviewed for 1242 mother-child pairs registered in the intervention. A total of 18 semi-structured interviews with clinic staff, mothers, and research staff were conducted at four clinics. The interviews were audiorecorded and transcribed verbatim. RESULTS: District Health Office (DHO) support allowed transparent and effective selection and training of clinic providers. Public endorsement of ECD care at private clinics and the addition of community advocates promoted ECD care uptake. Clinic settings were found feasible for clinic assistants, and acceptable to mothers, for counselling sessions. Mothers found ECD counselling methods more engaging compared to the usual care provided. CONCLUSION: In poor urban settings where public health care is scarce, minimal programme investment on staff training and provision of minor equipment can engage private clinics effectively in delivering ECD care.