The Tools for Integrated Management of Childhood Illness (TIMCI) study protocol: a multi-country mixed-method evaluation of pulse oximetry and clinical decision support algorithms

Figures & data

Figure 1. Overview of the multi-country, multi-method TIMCI evaluation – study design and main outcomes. Abbreviations: CDSA: clinical decision support algorithm; RCT: randomised controlled trial; KII: key informant interviews; HMIS: health management information system; DALY: disease-adjusted life years.

Table 1. Overview of the study setting and intervention according by country.

	India (Uttar Pradesh)	Kenya	Senegal	Tanzania
U5 mortality	44–60/1000 live births [36]	37/1000 live births [37]	39/1000 live births [37]	43/1000 live births [38]
Geographical areas & altitude [37]	Unnao: 101–139 m Sitapur: 108-158 m Deoria: 55–100 m	Kakamega: 1458–1592 m Kitui: 621–1605 m Uasin Gishu 1007–2886 m	Thiès: −3–137 m	Sengerema: 1229–1328 m Tanga CC: −2–238 m Kaliua: 1052–1655 m
Facilities included	Small facilities; 1–2 providers consulting sick children. Basic preventive & curative outpatient services
	PHCs	Level 2 (dispensaries)	Health posts	Dispensaries
	Larger primary care facilities (or higher level facilities providing outpatient primary care services). Multiple providers consulting sick children; 24/7 emergency services, (limited) admission capacity
	CHCs	Level 3 (HCs/SCHs)	N/A	HCs
Staff using intervention	Non-specialist (MBBS) doctors; + paediatricians in some CHCs	Clinical officers, nurses, (+doctors in L3)	Nurses and nurse-assistants	Nurses, clinical officers; + doctors in large HCs
Referral	Refer to DH or CHC with paediatrician. Access to free ambulances with O2, but subject to availability	L2 refer to L3 or directly to hospital depending on services. Ambulances for emergencies (hospital-based); most patients organize own transport	Most HPs refer to ‘referral’ HCs; some refer directly to hospital (based on services & proximity); ambulances available	Refer to HCs or DHs. Mostly private transport e.g. boda bodas (motorbikes), bajaji (tricycles) and taxis
Oxygen availability	O2 cylinders/concentrators at PHCs & CHCs; piped O2 at hospitals	Some HCs have O2 cylinders/concentrators; hospitals have O2 (type varies)	Very few HPs have O2 cylinders; O2 at referral HCs and hospitals (type varies)	All HCs have O2 cylinders; hospitals have O2 (type varies)
Pulse oximetry use criteria	All sick infants & children		● All young infants under 2 months of age ● All 2–59 months with cough/difficulty breathing ● Children 2–59 months with IMCI/CDSA moderate (yellow)/severe (red) classifications
When to refer (and give O2 if available)	SpO2 < 90% Reinforced if SpO2 < 94% + severe illness	SpO2 < 90%	SpO2 < 92% Reinforced if SpO2 92 to < 95% + severe illness	SpO2 < 90%
CDSA	(Pilot only)	IMNCI + additional diagnoses and granularity, including: skin, abdominal/gastrointestinal, urinary, ENT, eye, MSK/injuries/anomalies (variation according to Ministries of Health + national guidelines)
Training	In-person: 1-day pulse oximetry (intervention arm only) Online: 1-day IMNCI refresher (intervention + control) ‘On-the-job’ training for additional staff at CHCs	In-person group training for 1 providers/facility: 1-week integrated IMNCI + pulse oximetry 2-day CDSA + record keeping ‘On-the-job’ training for additional staff (~3–4/facility)	In-person group training for 2 providers/facility: 1-week integrated IMNCI, pulse oximetry, CDSA training ‘On-the-job’ training for 8 facilities	3-month blended distance/in-person IMCI refresher (all arms) In person: 1-day pulse oximetry (intervention arms) 1-day CDSA (CDSA arm only) ‘On-the-job’ training as needed for new staff
Mentorship & supportive supervision	Joint, by district officials & PATH every 2 months; debrief with Chief Medical Officer	Joint, by MOH & county DoH, SC child health focal person, PATH, quarterly; monthly by SC child health focal person; debrief with CHMT and facilities (online). Whatsapp support.	1 supportive supervision visit to all facilities with debrief after training; subsequent quarterly visitsDHIS2 data monitoring & additional paper forms (on pulse oximetry, referral)	In-person & phone supportive supervision; monthly PATH/CHMT joint facility visits. Two one-day joint provider meetings per district
M&E	Weekly summary data on pulse oximetry use	Weekly summary data on pulse oximetry + CDSA use
Community engagement	Engagement with ASHAs to co-develop and deliver communication materials on danger signs and health seeking behaviour; district community engagement workshops	CSOs, using national materials adapted with CHMTs, engaged with CHVs. Health facility education, advocacy, media broadcasts, community dialogues.	MoH materials & messages adapted by CSOs, used through talks, home visits, advocacy, social mobilisation, facility education sessions	CSOs and CHWs engagement with village leaders, community members, community theatre, household visits

Abbreviations: PHC: primary health centre; CHC: community health centre; HP: health posts (poste de santé); HCs: health centres; DH: district hospital; O2: oxygen; SpO2: oxygen saturation; IM(N)CI: integrated management of (neonatal and) childhood illness; ENT: ear, nose, throat; MSK: musculoskeletal; MoH: ministry of health; DoH: department of health; SC: sub-country; CHMT: community health management team; ASHA: government community health worker; CSO: civil society organisation; CHV: community health volunteer; CHW: community health worker.

Figure 2. Pulse oximetry criteria for Senegal and Tanzania. In India and Kenya, Ministries opted to recommend pulse oximetry for all sick young infants and children.

Figure 3. Study flowcharts of the pragmatic cluster RCT and quasi-experimental pre-post study, with interconnections with the embedded mixed-methods studies involving caregivers and children. (1) Location refers to urban/rural for Tanzania and to districts in India. (2) Data collected after consultations include caregiver responses at consultation exit and clinical records. (3) In all countries other than Kenya, data are collected from hospital (or primary care admission area) records for all children reported to have attended a hospital/admission facility (4) If children return to their enrolment facility (or attend any other study facility) during the follow-up period, data about the visit is collected, which includes the same information as gathered on Day 0.

Table 2. Estimated sample sizes for each of the TIMCI sub-studies.

Study	RCT & embedded studies		Pre-post study & embedded studies
	India	Tanzania	Kenya	Senegal
RCT/pre-post study	80 clusters (40/arm) 510 children/cluster Target = 40800 children	66 clusters (22/arm) 1680 children/cluster Target = 110,880 children	19 clusters 391 children/cluster/period Target = min. 14858*	20 clusters 339 children/cluster/period Target = min. 13558*
Service Provision Assessments	12 clusters (6/arm) 5 rounds (pre, quarterly in RCT)	18 clusters (6/arm) 5 rounds (pre, quarterly in RCT	9 clusters 3 rounds (pre, early, late)	8 clusters 3 rounds (pre, early, late)
	2–3 HCP interviews & 10–30 observations & exit interviews/facility/assessment round
Process mapping + time-flow study	6 clusters (pulse ox arm) 3 rounds (pre, early, late)	18 clusters (6/arm) 2 rounds (early, late)	9 clusters 3 rounds (pre, early, late)	8 clusters 2 rounds (pre, late)
	10–30 observations for each process map and time-flow/facility/assessment round
Healthcare Provider IDIs	12–15 IDIs in intervention arm per period (early, late)	12–15 IDIs per intervention arm per period (early, late)	12–15 IDIs per period (early, late)	12–15 IDIs per period (pre, late)
Caregiver IDIs	12–15 IDIs in pulse oximetry arm/period (early, late)	12–15 IDIs per intervention arm/period (early, late)	12–15 IDIs per period (early, late)	12–15 IDIs per period (pre, late)
Stakeholder survey	Approx. 15–20 per period (pre, early, late)/country + global
Stakeholder KIIs	N/A	N/A	12–15 KIIs for each round (early, late)	N/A
Costing study	8 clusters per arm	8 clusters per arm	8 clusters Pre- and post-intervention	8 clusters Pre- and post-intervention

Abbreviations: PHC: primary health centre; CHC: community health centre; HP: health posts (poste de santé); HCs: health centres; DH: district hospital; O2: oxygen; SpO2: oxygen saturation; IM(N)CI: integrated management of (neonatal and) childhood illness; ENT: ear, nose, throat; MSK: musculoskeletal; MoH: ministry of health; DoH: department of health; SC: sub-country; CHMT: community health management team; ASHA: government community health worker; CSO: civil society organisation; CHV: community health volunteer; CHW: community health worker.

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