This is a case study.

Theoretical framework of the case study.

The CAIPaDi model is divided into interventions focused on medical care, diabetes education, lifestyle interventions, and mental health evaluations. These interventions aim to comprehensively evaluate and treat diabetes and comorbidities, train the patient for self-care, and prevent disabling complications.

It comprises two phases. The first phase consists of four visits, each one month apart. The second phase encompasses annual evaluations. In every visit, blood and cabinet tests and urine samples are performed. Nine specialists evaluate the patients every time, including endocrinologists, optometrists/ophthalmologists, diabetes educators, nutritionists, dentists, psychologists and psychiatrists, foot care specialists, and exercise specialists [12, 13]. All specialists registered indicators specific to each area, according to the ICHOM set.

Since the nine specialists in each visit attend all patients, the CAIPaDi program gave 91,062 consultations over the five years, of which 10,118 were about Diabetes education.

Selection criteria

We conducted a descriptive analysis of patients enrolled between October 31, 2013, and June 30, 2023. The sampling method was a non-probability, convenience sampling. Inclusion criteria consisted of adult patients with T2D with less than five years of diagnosis, non-smokers, and without disabling chronic complications such as chronic kidney disease, ischaemic heart disease, cerebrovascular disease, limb amputations, or severe visual impairment. The CAIPaDi program was originally designed to attend patients with type 2 diabetes due to the high prevalence that exists in our country. Likewise, it was initially considered to attend patients with less than 5 years of diagnosis since the program has a preventive approach to the chronic complications of diabetes. Exclusion criteria were a mental or psychiatric illness that prevents them from learning and following instructions, chronic complications of the disease, patients undergoing treatment for any cancer, pregnant women, alcohol consumption that interferes with their work or social activities, an illness that requires surgery or prevents carrying out physical activity, and patients with BMI > 45 kg/m2.

Outcomes measurement

Relevant indicators of each intervention have been recorded using SMID (Comprehensive Diabetes Monitoring System) software, which is designed to have a checklist to comply with in each consultation. According to the standard outcomes proposed by ICHOM, several items were evaluated in our study regarding diabetes control, acute events, chronic complications, health services, survival, and patient-reported outcome measures, as seen in Table 2.

Table 2 Summary by sex and age group for International Consortium for Health Outcomes Measurement (ICHOM) diabetes control variables. Percentages shown in parenthesis (%)Overview of the ICHOM parameters and their relevance to evaluating healthcare interventions

All sets of patient-centered outcome measures created by ICHOM are developed using the following parameters: clinical outcomes, patient-reported outcomes, outcome measures, case-mix variables, and time points. In the Diabetes Set, clinical outcomes cover diabetes control, survival, chronic complications, and acute events. Patient-reported outcomes address quality of life, symptom burden, and functional status; these are “directly reported by the patient without interpretation of the patient’s response by the clinician or anyone else” [14]. Outcome measures are the tools selected to measure each outcome in the categories defined within each parameter. Patient-reported outcome measures (PROMs) will measure patient-reported outcomes. Case-mix variables represent any factor related to the patient and/or the clinical condition, including its treatment, which may impact any outcome. Finally, through a standardized timeline, outcomes and case-mix variables can be measured based on the different time points indicated for each group of outcomes or variables specifically.

The importance of including and meeting all the aforementioned parameters lies, first and foremost, in measuring outcomes through a patient-centered perspective, therefore focusing on outcomes that matter to patients and improving their overall experience previous to, during, and post-treatment. Further, they allow healthcare providers to standardize outcomes measurement for all patients living with a given disease. When healthcare providers base their decision-making, define processes, and evaluate quality and performance based on uniform measures, comparability across providers across institutions, regions, and even countries becomes possible and more meaningful. As a result, there is more space for benchmarking and healthcare improvement, as providers can evaluate their performance compared to others and identify areas of opportunity for improvement.

Application of ICHOM Parameters

The ICHOM Set defines health-related quality of life, including psychological wellbeing, depression, and diabetes distress as the PROs most relevant to patients. The CAIPaDi program includes the use of the Diabetes Quality of Life (DQoL), the Hospital Anxiety and Depression (HADS), and the Problem Areas in Diabetes Questionnaire (PAID-20) PROMs to measure said outcomes, respectively. Clinical outcomes in the set include survival, disease control, chronic complications, health service utilization, and acute events. The CAIPaDi program measured the aforementioned outcomes as follows: survival is measured through vital status; disease control is measured through glycemic control, both through fasting glucose and HbA1c levels, blood pressure control, and lipid profile control; chronic complications are measured through treatment complications, nervous system complications, and micro and macrovascular complications which translate in cases of amputation, nephropathy, dialysis, and cardiovascular events, respectively; healthcare services utilization is measured through days of hospitalization related and number of emergency room visits, related to the disease; and finally, acute events are measured through episodes of diabetic ketoacidosis, hyperglycemic hyperosmolar syndrome, and severe hypoglycemic episodes.

The ICHOM Set requires at least two follow-up visits in each patient's first year of treatment, during which PROs will be measured in each visit, CROs will be measured at least annually, and case-mix variables will be measured. The CAIPaDi program includes at least four follow-up visits during the first year and at least one annual follow-up visit subsequently. This meets and exceeds the timeline indicated in the ICHOM Set.

Presentation of quantitative data, such as changes in patient-reported outcomes, healthcare utilization metrics, and cost-effectiveness measures.

Based on the data collected through PROMs included in the CAIPaDi program previously mentioned, after 9 follow-up visits, the patients whose results indicated depression nearly halved, as well as those whose results indicated anxiety. Similarly, the number of patients who presented scores indicating "emotional burnout" lowered by almost 75% by the first year of treatment through this program. The overall quality of life decreased initially during the first months of treatment but later stabilized and remained at an average of 72 points through the DQoL tool between three months and five years of follow-up. Further, an estimated US $7264 per patient was saved throughout nine visits in five years, on average, complication-related emergency hospital visits, hospitalization, and treatment [15].

Statistical analysis

This is a descriptive study. Data are presented as mean (± SD) or median and interquartile ranges (25–75) if they followed or did not have a normal distribution, respectively; according to the Kolmogorov–Smirnov test, percentages were used for discrete values.

For the analysis, we included 3241 patients at the initial visit, 2295 patients after three months of entering the program, 1492 patients at the first annual consultation, 1005 patients at the second annual visit, 663 patients at the third annual visit, 388 patients at the fourth annual visit and 204 patients after a 5-year follow-up. The decrease in sample size is due to abandonment, or some patients still need to arrive at their next evaluation visit. Likewise, given that some patients started treatment in later years, they have yet to reach five years of follow-up.

To examine the effect of adherence to the program on health improvement, we evaluated the positive chance of diabetes control variables using McNemar's test during the two follow-up periods. First, from the initial visit to the 5-year follow-up, and second, from the visit after three months to the 5-year follow-up. For the McNemar test, we constructed a "paired" contingency table for two visits involving the improvement/non-improvement of glycated hemoglobin, blood pressure, low-density lipoprotein-cholesterol, and BMI. Positive change or improvement was defined as hemoglobin ≤ 7%, blood pressure ≤ 130/80 mmHg, LDL-c ≤ 100 mg/dl, and no obesity. For BMI categories, we evaluated the improvement in 5-year follow-up in two forms: 1) obese vs. non-obese patients and 2) normal weight vs. non-normal weight patients. Finally, we defined overall improvement (presence/absence) as a successful glycated hemoglobin ≤ 7% and improvement in any of the other three performance variables (blood pressure ≤ 130/80 mmHg, LDL-c ≤ 100 mg/dl, and non-obesity). We performed a logistic regression analysis to examine the effects of demographic and psychological variables on overall improvement.