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Table 3 Outcomes and data sources

From: Implementing integrated hypertension and diabetes management using the World Health Organization’s HEARTS model: protocol for a pilot study in the Guatemalan national primary care system

Outcome

Description and data sources

Primary outcomes

 Feasibility

FIM questionnaires and MOH data from DHIS2 (quantitative); semi-structured interviews with MOH participants (qualitative)

 Acceptability

AIM questionnaires and MOH data from DHIS2 (quantitative); semi-structured interviews with patient and MOH participants (qualitative)

Secondary outcomes

 Clinical outcomes

  Number of patients receiving hypertension medication treatment per month (“hypertension treatment rate”)

MOH data from SIGSA (quantitative)

  Number of patients receiving diabetes medication treatment per month (“diabetes treatment rate”)

MOH data from SIGSA (quantitative)

  Proportion achieving glycemic control (FBG < 115 mg/dl or RBG < 160 mg/dl) among patients with diabetes

MOH data from DHIS2 (quantitative)

  Proportion achieving control of blood pressure (< 130/80 mmHg) among patients with hypertension

MOH data from DHIS2 (quantitative)

  Number of patients receiving hypertension medication treatment per month (“hypertension treatment rate”)

MOH data from SIGSA (quantitative)

 Implementation outcomes

  Adoption

Number of participating health facilities, defined as having enrolled at least one patient with hypertension or diabetes (quantitative); reasons for variation (qualitative)

  Fidelity (health worker training on hypertension and diabetes treatment protocols)

Proportion of health workers in each district attending all training sessions, chart audit of prescriptions to assess guideline concordance (quantitative); reasons for variation (qualitative)

  Fidelity (team-based care and task sharing)

Proportion of primary health districts conducting at least one care coordination meeting; reasons for variation (qualitative)

  Fidelity (access to medicines and diagnostics)

Monthly availability of MOH medications and diagnostics (quantitative) and reasons for variation (qualitative)

  Fidelity (facility-based electronic monitoring tool)

Proportion of patient visits captured in DHIS2 each month compared to comprehensive records in SIGSA (quantitative) and reasons for variation (qualitative)

  Fidelity (systems monitoring and feedback)

Proportion of quarterly reports viewed by health district administrators (quantitative) and reasons for variation (qualitative)

  Usability (facility-based electronic monitoring tool)

System Usability Scale [48, 49] (quantitative) and reasons for variation (qualitative)

  Sustainability

Program Sustainability Assessment Tool [50, 51] and Clinical Sustainability Assessment Tool [52, 53] (select questions)

 Patient-related outcomes measures

  Diabetes distress

Diabetes Distress Scale [54, 55], 2-item screening and physician distress subscale

  Disability

WHO Disability Assessment Schedule [56]

  Multimorbidity treatment burden

Multimorbidity Illness Perceptions Scale [57, 58], treatment burden subscale

  1. Abbreviations: CSAT Clinical Sustainability Assessment Tool, DBP Diastolic blood pressure, DHIS2 District Health Information System, FBG Fasting blood glucose, MOH Ministry of Health, PSAT Program Sustainability Assessment Tool, RBG Random blood glucose, SBP Systolic blood pressure, SIGSA Health Management Information System, WHO World Health Organization