Table 1

Objectives, contextual features and data collection for PACK Child process evaluation

ObjectiveContextual level/featureData collection
(1) To determine the organisational and social context of PACK Child training as it is delivered and embedded into routine practiceMacro
National policy and service protocols; broader context of South African healthcare system and role of primary care; funding and regulatory arrangements for primary care clinical practice; discourses of healthcare (eg, widely circulated discourses on management of paediatric chronic illnesses)
Local health area/facility policies or service protocols on management and treatment of patients; geographic and demographic profile of clinics; the main social actors involved in determining intervention delivery (ie, healthcare staff, patients, managers, policy makers) and the different sites and scenes which impact on how PACK is adapted and delivered (eg, local area management meetings, translation of PACK materials).
  1. Interviews with approximately 10 national and provincial managers and policymakers on structural interventions to facilitate PACK Child implementation.

  2. Documentary analysis of how guide/stationery integrate together and structure paediatric care. (i) PACK Child guides, (ii) IMCI guides, (iii) Integrated Clinical Stationery.

  1. Training sessions’ attendance logs, including numbers and staff profiles.

  2. One day of observation of non-clinical areas per facility, such as waiting rooms and receptionists’ areas, to understand clinic organisation and deployment of staff, procedures and protocols which may impact on the implementation of PACK Child.

  3. One semistructured interview with the manager at each facility about organisational processes impacting on PACK Child.

(2) To determine the fidelity of intervention deliveryMicro
Main (ie, training sessions, consultations) activities and subsidiary activities (eg, additional training/meetings, receptionist screening of patients) of intervention delivery and interactional arrangements of each activity.
  1. Staff questionnaire on views and use of PACK Child during and at end of study. On average, 10 clinical staff per facility will be asked about number of training sessions attended and frequency of using PACK Child. One manager questionnaire per facility on numbers of staff, clinical rooms, scheduling and location of training sessions.

  2. Observation of training sessions at each site. Focus on delivery, response and points of difficulty. In Phase 1, observations of all eight training sessions will be conducted. This will inform theoretical sampling of observations of training in Phases 2 and 3. Up to three observations per facility will be conducted in Phases 2 and 3.

  3. Ethnographic observation of child consultations. With consent from both staff and carer/child, a researcher will observe and audio-record consultations to understand dosage and intensity of PACK Child integration into routine practice. In Phase 1, up to two observations will be conducted after each training session (16 in total) to develop the theoretical sampling frame for Phases 2 and 3. In Phases 2 and 3, up to four observations per facility will be conducted. At the end of Phase 3, we will also return to the Phase 1 clinic to observe up to four consultations to obtain insight into sustainability of PACK Child.

(3) To determine staff perspectives of delivery and participation in the training interventionPerspectives on meso challenges and micro challenges of intervention delivery.
  1. Staff questionnaire (average 10 per site—same questionnaire as detailed in Objective 2) on views and use of PACK Child including ease of use, impact on quality of care, management of patients, time management, prescribing and confidence in using PACK Child.

  2. Interviews with consenting facility trainers and two trained staff delivering intervention per facility at the completion of training. Interviews will explore facility context, views of training, barriers and facilitators of delivery, integration of PACK Child with IMCI during consultations, effect on workflow, clinical competency and interoperability of PACK Adult and PACK Child.

(4) To determine carer’s (and children as appropriate) perspectives of how PACK Child consultations meet carer and child needsPerspectives on responses to interventions and experience of condition.
  • 1. Interviews with carers and child (as appropriate).

  • Carer’s/children from each facility will be asked to consent to interviews during implementation to understand their experiences and perceptions of their child’s health, previous contacts with primary and secondary healthcare and to assess their response to PACK Child within individual consultations. We will work with nurses in the facility to identify and approach suitable participants. Carers will also be asked to consent to observation of consultations. For a subsample of carers/children, we will therefore have both interview and ethnographic observational data. In Phase 1, up to two interviews will be conducted after each training session (16 in total) to develop the theoretical sampling frame for Phases 2 and 3. In Phases 2 and 3, up to four interviews will be conducted per facility.

(5) To determine how to optimise delivery of PACK Child within routine practice
(6) To determine which components of the PACK Child intervention affect which change in healthcare processes and outcomes
(7) Barriers to and facilitators of change through implementation of PACK Child guide in primary care
Analysis of the relationship between intervention components and macro-contextual, meso-contextual, micro-contextual features. This will enable the development of theoretical propositions of how to optimise delivery within routine practice to produce different outcomes.
  1. Qualitative data will be triangulated to examine how PACK Child intervention interacts with macro-contextual, meso-contextual and micro-contextual features to affect which change. Development of theoretical propositions of how adjusting contextual features may bring about different outcomes.

  2. Quantitative and qualitative analyses will be integrated to produce an overall interpretation of implementation and theoretical fidelity of PACK Child.

  3. Findings will be shared with clinicians, managers and policymakers within three focus groups at end of Phase 3 to understand perspectives of how best to optimise delivery, barriers and facilitators of change.

  • IMCI, Integrated Management of Childhood Illness; PACK, Practical Approach to Care Kit.