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

Study design, setting, and participants

A parallel arm, cRCT was conducted between December 2014–June 2016 in the Sargodha district in Punjab, Pakistan. In addition to a district-level secondary hospital, 14 rural health centres and 6 sub-district hospitals provide public funded care to 3.1 million population in the district (2:1 rural–urban split). After checking the in-place basic services (such as laboratory) at each eligible site with the district health office, nine rural health centres, and five sub-district hospitals (total n = 14) were recruited and randomised into the trial. In each of the 14 selected clusters, communal consent for the catchment population's participation in the trial was taken from the community leaders who were identified and invited with the help of staff at respective health facility. These community leaders represented a) religious leaders, b) political leaders (local woman councillor), c) health representative of union council, d) school teachers, e) local press reporters, and f) local businessmen. The study involves only the outpatient department of facilities, which have general practice doctors seeing un-referred primary care patients. A cluster design was used because it would not have been feasible to expect providers to effectively apply or withhold many of the intervention components based on a patient’s treatment allocation (for example, standardised diagnosis), and because of the risk of contamination between patients.

Patients were eligible if they were understood by the facility doctor to be newly diagnosed with diabetes (fasting blood glucose ≥126; random blood glucose ≥200), aged ≥25 years, not pregnant, and not likely to move away from their initial catchment area during follow-up. The authors attempted to recruit all eligible patients attending the selected public facilities between December 2014–September 2015. Informed consent was obtained from patients using a standard consent form administered by an allied professional (paramedic) at the respective public healthcare facility.

Randomisation and blinding

The 14 facilities were randomised to the TTR-only or the ACM arm on a 1:1 basis using a lottery method with sealed envelopes. In the presence of a five member committee, a staff member from the provincial directorate randomly selected seven envelopes for each arm from among 14 sealed envelopes, each containing a recruited facility name. The committee consisted of the Director Non-Communicable diseases in Punjab, two representatives from the Directorate General of Health Services Punjab, and two Association for Social Development representatives. It was not possible to blind healthcare providers or patients to the treatment allocation due to the nature of the trial procedures, such as provider training and patient education. However, the laboratory staff who carried out the testing for outcomes were blinded to the cluster allocation.

Procedures

In the TTR-only arm facilities, the existing situation meant that there was training on screening, diagnosis, testing, and recording, but no operational guidelines available for doctors or allied professionals on the additional case management of diabetes and related high cholesterol. Clinicians therefore managed such conditions according to their existing knowledge and practices, and without reference to any specific guidelines and/or tools. The district health office was requested to make the same drugs available at all facilities, through the routine district drug system, though with some top up in the ACM facilities. For this study, the interventions/ resources provided in both arms were over and above usual care, and included: a) equipment and supplies for patient screening at the first visit, including weight and height scales, glucometers and glucose strips, and electronic sphygmomanometers; b) staff training on patient screening and diagnosis at the first visit; and c) a patient card for recording core biomedical measures at baseline and follow-ups. Patients were also given vouchers so that they could get glycated haemoglobin (HbA1c) and serum cholesterol measured at no cost at specified laboratories. All these TTR inputs were the same for both arms.

In the ACM arm, in addition to the TTR inputs above, all facilities received additional case management ACM enhancements including: a) a context-adapted desk guide for step-by-step management of diabetes and associated high cholesterol, and information about referral of severe or complex cases; b) patient education on diabetes care and lifestyle change, using contextualised communication materials; and c) monthly appointment review and reminders (through SMS text messaging). A more detailed description of the TTR and ACM procedures is provided in Figure 1 .

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Figure 1. Diabetes intervention (ACM) and control (TTR-only) care package details. ACM = additional case management. BP = blood pressure. FBG = fasting blood glucose. RBG = random blood glucose. TTR = testing, treating, and recording.

Two key diabetes drugs, metformin and sulphonylurea, were available both in the TTR-only and ACM arm facilities, mainly through the respective district health office. However, the ACM arm desk-guide included a step-by-step approach to adding drugs and amending dosage of diabetes drugs, as well as recommending a statin if patient had raised cholesterol. Further details are included in the process evaluation study published alongside the results of this trial,¹ and the guides and tools are available elsewhere.¹³

Data collection and outcomes

The inclusion of patients happened at an expected pace (as informed by piloting experience), although this pace varied slightly across facilities. All data were recorded on patients’ chronic disease cards. At both sub-district hospitals and rural health centres, the facility doctor recorded the clinical data (for example, diagnosis, prescription, and blood pressure) and the allied professional recorded the nonclinical data (such as age and weight) at diagnosis and at eight subsequent monthly follow-up visits. The doctor, using electronic sphygmomanometer during clinical consultation, checked and recorded the blood pressure. A designated allied staff member at the facility checked and recorded the fasting and/or random blood glucose levels using a glucometer and strips. A designated non-public laboratory collected samples and tested for HbA1cand serum cholesterol levels, and an allied staff member at the facility noted the results on the patient's card. Data were then transferred from patient record cards and entered into an SPSS database. The research team tried to contact patients who did not return for their 9-month follow-up appointment for 3 months before they were classed as lost to follow-up.

All outcomes were recorded at the patient level. The primary outcome was the percentage point change in HbA1c, the internationally recognised standard test (of glucose control over the previous 3 months), between baseline and 9 months. Secondary outcomes were the change between baseline and 9 month in systolic blood pressure (mmHg), diastolic blood pressure (mmHg), and total serum cholesterol (mg/dL), and 9-month glycaemic control (HbA1c <7%) and hypertension control (systolic blood pressure <140 mmHg).

Statistical analysis

Data were single entered into SPSS (version 17). To minimise data errors, data quality assurance procedures were used, including training of data entry operators and checking data entry quality at regular intervals.¹⁴

All data were analysed according to the original allocation of clusters, but patients with missing outcome and/or covariate data were excluded as necessary (that is, depending on whether the data were required for the analysis). Cluster-level methods of analysis were used that were suitable for cRCTs with relatively few clusters per arm,¹⁵ producing crude and covariate-adjusted results. All adjusted analyses controlled for patient sex, age, number of schooling years, baseline BMI, and smoking status, as well as relevant baseline outcomes. All analyses exclude patients’ missing outcome and/or covariate data, as required by the relevant analysis. In addition, change in HbA1c and glycaemic control analyses were also adjusted for baseline hypertension status, cholesterol level, and HbA1c level. Change in systolic blood pressure and hypertension control analyses were also adjusted for baseline cholesterol level and systolic blood pressure. Change in diastolic blood pressure analysis was also adjusted for baseline cholesterol level and diastolic blood pressure. Change in cholesterol analysis was also adjusted for baseline cholesterol and hypertension status

Statistical significance was set at the 5% level, and two-sided P values were calculated. More details on statistical analyses are available from the author on request.

Sample size calculation

For the primary outcome, the authors aimed to be able to detect a ≥0.5 percentage point decrease in HbA1c from baseline to 9 months in the ACM arm compared to the TTR-only arm. A standard deviation of 2% was assumed,¹⁶ as well as an intracluster correlation coefficient of 0.018,¹⁷ and a 10% loss to follow-up rate. A significance level of 5% was set. To detect the minimum clinically important difference of 0.5 percentage points between the mean change (baseline to follow-up) in HbA1c for the ACM arm compared to the TTR-only arm with 80% power required a total sample size of 448 patients across 14 facilities. The research team therefore aimed to recruit an average of 32 patients per cluster over 6 months.