Parents' Trigger Tool for Children with Medical Complexity – PAT‐CMC: Development of a recognition tool for clinical deterioration at home

Abstract

Aim

To develop a trigger tool for parents and lay caregivers of children with medical complexity (CMC) at home and to validate its content.

Design

This was a multi‐method study, using qualitative data, a Delphi method and a concept mapping approach.

Methods

A three‐round electronic Delphi was performed from December 2021 to April 2022 with a panel of 23 expert parents and 30 healthcare providers, supplemented by a preliminary qualitative exploration of children's signs of deterioration and three consensus meetings to develop the PArents' Trigger Tool for Children with Medical Complexity (PAT‐CMC). Cognitive interviews with parents were performed to assess the comprehensiveness and comprehensibility of the tool. The COREQ checklist, the COSMIN guidelines and the CREDES guidelines guided the reporting respectively of the qualitative study, the development and content validity of the trigger tool and the Delphi study.

Results

The PAT‐CMC was developed and its content validated to recognize clinical deterioration at home. The tool consists of 7 main clusters of items: Breathing, Heart, Devices, Behaviour, Neuro‐Muscular, Nutrition/Hydration and Other Concerns. A total of 23 triggers of deterioration were included and related to two recommendations for escalation of care, using a traffic light coding system.

Conclusion

Priority indicators of clinical deterioration of CMC were identified and integrated into a validated trigger tool designed for parents or other lay caregivers at home, to recognize signs of acute severe illness and initiate healthcare interventions.

Impact

The PAT‐CMC was developed to guide families in recognizing signs of deterioration in CMC and has potential for initiating an early escalation of care. This tool may also be useful to support education provided by healthcare providers to families before hospital discharge.

Patient or Public Contribution

Parents of CMC were directly involved in the selection of relevant indicators of children's clinical deterioration and the development of the trigger tool. They were not involved in the design, conducting, reporting or dissemination plans of this research.

1. INTRODUCTION

Children with medical complexity (CMC) are patients aged 0–18 years with special healthcare needs, characterized by the presence of known chronic conditions, due to congenital or acquired multi‐systemic diseases, associated with functional deficits, disabilities and neurological impairment, dependent on medical/technological aids for daily activities (Cohen et al., 2011). CMC have been identified by (Cohen et al., 2011) as an important subgroup of Children With Special Health Care Needs (CSHCN) because they are the most medically frail and have the most intensive health care needs related to the high resource use and cost of care. The areas of need encompass all body systems. The medically complex condition of these children often leads to frequent onset of complications and early clinical deterioration with negative health outcomes related to increased morbidity and unplanned admissions, impacting on the quality of life of the child and family and even up to mortality (Barnert et al., 2018). Although CMC account for 0.67%–1.7% of paediatric admissions, their healthcare utilization is disproportionately high, characterized by a high prevalence of medical technological assistance (69%) and healthcare costs of up to 3.5 times higher (Berry et al., 2011; Cohen et al., 2012). Readmission rates are especially high in this population: around 24%–27% at thirty days (Berry et al., 2011; Cohen et al., 2012; Mallory et al., 2017) reaching 78% at 2 years, with an inpatient mortality rate of 5.9% (Cohen et al., 2012).

Family's ability to safely care for their CMC in their home environment can substantially reduce hospital readmissions (Sobotka et al., 2020). Outcomes related to parents' active participation in CMC home disease management include the early identification of clinical deterioration at home, which enables to promptly respond to the onset of complications to permit timely care escalation (Nelson et al., 2016). In a study conducted in the United States of America on hospital readmission drivers, care coordinators who coordinate in‐home care for families of CMC reported that parental experience and expertise influence the frequency of hospital readmissions, which tends to decrease with time, experience and support from quality home health nursing. After the initial transition period, parents gain confidence in their child's care over time and are able to manage high‐level home care when fully trained and supported (Sobotka et al., 2020). Reducing power imbalances and providing accurate and accessible information is essential to support parents' decision‐making process (Jonas et al., 2022).

Establishing a practice that supports the early identification of children at risk by equipping caregivers of CMC with trigger tools could be an effective strategy to reduce deterioration events.

Using trigger tools to identify early indicators of clinical deterioration, parents of CMC could promptly activate the health service to provide timely and effective care interventions, avoiding serious complications (Gill et al., 2016; Gray et al., 2022; Parshuram et al., 2018). This would be fundamental to prevent the progression of clinical deterioration and thus shift care from expensive recurrent admissions to home‐based management of the chronic condition, improving both quality of care and quality of life (Nelson et al., 2016).

2. BACKGROUND

The use of Paediatric Early Warning System Scores (PEWS) in paediatric clinical practice is a rather recent concept, still mostly limited to the hospital setting. Such systems consist of scales that assign scores to vital signs or other clinical indicators according to their deviation from normal age‐related values (Duncan et al., 2006; Parshuram et al., 2009). Trigger systems are based instead on individual predefined thresholds for vital signs above which a response system is activated if reached or surpassed. They are simpler and more intuitive, as they use objective clear indicators of deterioration for which immediate action must be taken (Chapman et al., 2016).

Current tools for home monitoring of children are limited and focus mainly on acute conditions (Gilleland et al., 2019; Neill et al., 2015; Price et al., 2013; Verzantvoort et al., 2018) or on single chronic conditions such as asthma, cystic fibrosis, diabetes, heart disease and symptoms due to chemotherapy in children with cancer (Gaskin et al., 2018; MacGillivray & Flavin, 2014; Rudd et al., 2020; Van Horck et al., 2017). Recently, an expert group of parents and multidisciplinary providers created and assessed the initial validity of the “Severe Illness Getting Noticed Sooner” (SIGNS‐for‐Kids), a paediatric illness recognition tool to help lay caregivers to identify and initiate medical attention in an undifferentiated population of infants and children (Gray et al., 2022). The variable and multisystem conditions of CMC make the implementation of home trigger tools a challenge. However, CMC have been shown to share common health consequences, often experiencing hospital admissions for complications that can be similar for all (Simon et al., 2012). Such similarities present an opportunity for new home monitoring strategies that are appropriate and generalizable to CMC, focusing on the most common drivers of clinical deterioration leading to emergency department or hospital admissions rather than individual diagnoses (Nkoy et al., 2021).

To our knowledge, there are few reports of priority indicators of clinical deterioration identifiable by parents of CMC and no trigger tools have been developed for parents at home despite the extreme need for monitoring of those children to prevent critical consequences.

3. THE STUDY

3.1. Aims

The aim of this study was to develop a trigger tool for parents and lay caregivers of children with medical complexity at home and to validate its content.

Secondary objectives were to (1) describe and rate the importance of the signs and symptoms of clinical deterioration as evaluated by parents of CMC and healthcare providers (HCPs) caring for those children; (2) design a trigger tool using a concept mapping participative approach; (3) evaluate the comprehensiveness and comprehensibility of the newly developed trigger tool.

4. METHODS

4.1. Design

This was a quantitative‐driven mixed‐method validation study, using qualitative data, a Delphi method and a concept mapping approach to develop and design a trigger tool for parents of children with medical complexity.

First, we performed a secondary analysis of a qualitative study on parents' process of identifying and responding to the clinical deterioration of their CMC to explore relevant signs and symptoms of clinical deterioration for parents at home (Genna et al., 2022). Second, a three‐round Delphi study was undertaken to identify and prioritize signs of clinical deterioration in CMC at home to ensure the relevance of the items to be included in the final list of indicators of illness. Third, Concept Mapping sessions were performed with a group of expert HCPs to develop and validate the comprehensiveness of a trigger tool for parents of CMC at home. Finally, parents of CMC were interviewed on the comprehensiveness and the comprehensibility of the trigger tool to let target users test the final version.

The steps of our study process, conducted from December 2020 to December 2022, are outlined in Figure 1.

FIGURE 1.

Flowchart of the study process. The larger rectangles represent the different phases: the qualitative study (phase I), the Delphi study, consisting of three rounds (phase II), the concept mapping sessions (phase III) and cognitive interviews with parents of CMC (phase IV). The detailed sequence of data collection, data analyses performed and results obtained in each phase are shown in each of the larger rectangles through light blue rectangles in horizontal sequence. CMC, children with medical complexity; HCPs, healthcare providers.

4.2. Phase 1: The qualitative study

4.2.1. Data collection

A secondary analysis of data drawn from a previous grounded theory study aimed at exploring the parents' process of identifying and responding to the clinical deterioration of CMC at home was conducted to obtain a qualitative description of the signs and symptoms of deterioration of CMC observed by parents at home. The primary study methods and results are reported elsewhere (Genna et al., 2022). Parents of CMC were enrolled by the research team during planned outpatient visits on‐site in a tertiary paediatric hospital in Italy. HCPs caring for CMC were enrolled at the same site through the nursing and medical clinical leaders. Data were collected through seven focus groups (FG) conducted by a doctorally prepared nurse supported by two team members trained in qualitative research methods.

CMC's signs and symptoms of clinical deterioration were investigated through open‐ended questions until achieving data saturation. An interview guide was used to explore their personal experience and process in managing the health of their CMC and the child's episodes of clinical deterioration that had previously occurred at home (Supplementary File S1).

4.2.2. Data analysis

Qualitative data for this secondary analysis were analysed using content analysis. Qualitative content analysis is a widely used approach in health studies and involves the extraction of the main themes describing that phenomenon to a synthesis of the most descriptive categories (Elo et al., 2014). It is a flexible and inductive approach: starting from the data you gradually extract more general categories describing the phenomenon while maintaining a link with the data (Sandelowski, 2010). Two researchers with experience in qualitative data analysis, independently, analysed the recordings and the verbatim transcribed interviews to identify recurrent signs and symptoms of deterioration, discussed in each focus group. Data were synthesized into subcategories and then grouped into categories. The items were compared between parents and HCPs to highlight and present similarities and differences. Any divergent opinions concerning the categories were resolved through discussion with a third member to reach consensus.

4.3. Phase 2: The Delphi study

The purpose of the Delphi method is to build opinions by a group of experts in an iterative manner (Dalkey & Helmer‐Hirschberg, 1962; Twin, 2021). This methodology enables a selected group of experts, called “panel,” to work together: at each round, expert opinions are aggregated to reach the highest level of final consensus on a research topic (Hyndman & Athanasopoulos, 2021). The Delphi methodology uses iterative cycles of anonymous questionnaires and related feedback of group responses (Barrett & Heale, 2020).

4.3.1. Study setting and sample

This study involved a convenience and purposive sample of parents of children with medical complexity and of healthcare providers that cared for them at the outpatient or inpatient services of a tertiary care children's hospital and the nurses working in home‐care teams. Healthcare providers were involved because of their professional expertise in the recognition and care of deteriorating CMC. Their contribution to identifying the priority signs and symptoms of clinical deterioration was sought to compare their opinions with those reported by the parents of CMC.

4.3.2. Sampling and recruitment

Parents of participating CMC were enrolled by the research team, either by phone or in‐person, during outpatient visits in the hospital. Participating HCPs experienced in caring for CMC were selected through the nursing coordinators and physicians in charge of CMC in the departments involved.

The current study included two selected parallel panels of expert parents of CMC and the respective HCPs caring for those children, who were invited to participate in each planned round of the Delphi study, to explore consensus within and across groups. A panel of 10–15 members is usually recommended (Jorm, 2015). We aimed to have at least 20 respondents for each round for both expert parents of CMC and HCP panels. The inclusion criteria were (1) parents having a child with medical complexity and experience in their care >2 years; (2) HCPs with >2 years of experience in caring for CMC in the outpatient, ward, intensive care or home care settings. Contact details were obtained through professional contacts (Nurse coordinators and Physicians in charge of CMC at the hospital). If less than 10 HCPs were identified per profession (physicians and nurses) and less than two per setting (i.e., inpatient or outpatient), we asked nurses and physicians to provide the contact details of other colleagues to reach the required number.

We recruited a total of 67 potential respondents (35 parents, 32 HCPs) for all the rounds of the Delphi study. During enrolment, participants were informed of the voluntary nature of this study and the expected to participate in the planned rounds of the Delphi study.

4.3.3. Data collection

Round 1 of Delphi used an open‐ended qualitative question to elicit a list of signs and symptoms of clinical deterioration of CMC at home (at least 3) (Supplementary File S2). The survey was sent via email in December 2021. A reminder was sent via phone messages at 2 weeks and at 3 weeks. Participants were given 4 weeks to respond to the survey. Two weeks were allocated to allow the research team to review all the responses and develop the next survey.

Opinions from different panels can be analysed either all together or separately (Sinha et al., 2011); in our case, they were analysed separately to ensure that the opinions of parents of CMC remained central and were of equal importance to those of HCPs and to compare differences between them.

The list of signs and symptoms identified from the first Delphi round was analysed using a qualitative content analysis method. These responses were analysed by two independent skilled researchers, grouped in clusters that included similar responses, but duplicates were eliminated. In case of disagreement, consensus was reached with the involvement of a third researcher. This list of signs and symptoms of CMC deterioration was compared with the qualitative results of Phase 1 to evaluate similarities and differences between the clusters and items to identify any relevant additional items to be included in Delphi round 2.

In Round 2, a list of all the clusters and warning signs and symptoms resulting from the first round was sent to the groups of experts asking them to rank each item on a Likert scale, from 1 to 6 (from 1 “not at all important” to 6 “extremely important”) (Supplementary File S2). The purpose of this phase was to have a priority list of signs and symptoms of deterioration in CMC.

The signs and symptoms considered relevant only for one of the two panels were included in the list of items to be evaluated in the third round for both panels. Feedback, presented as the mean score obtained for each item by each panel, was provided simultaneously with the third survey.

In Round 3 of the Delphi study, a third online survey was sent to the participants reporting the mean priority scores assigned to the signs and symptoms during round 2. Respondents were asked to rate again their level of agreement using a Likert scale of 1–6, considering the feedback given on the scores (Supplementary File S2).

4.3.4. Data analysis

Descriptive statistics were used to analyse the socio‐demographic variables.

Analysis of data from subsequent Delphi rounds requires a quantitative definition of consensus to include each item. In the current study, consensus on “relevant” signs and symptoms was defined a priori by the research team as items that scored ≥4, by ≥75% of panel members. The use of the proportion of participants agreeing in a specific rating range is a common way to define consensus (Jorm, 2015).

The answers from round 2 and 3 were analysed according to the consensus definition. The t‐test for unpaired observations was used to calculate significant differences on the importance attributed to the signs and symptoms of deterioration between both rounds to justify the agreement between the second and third Delphi rounds. Cohen's d standardized mean difference was used to calculate the effect size using the means and standard deviations of rounds 2 and 3. The interpretation of effect size is defined as small (0.2), medium (0.5) and large (>0.8) (Cohen, 1988).

4.4. Phase 3: Concept mapping

We chose concept mapping to organize priority indicators of clinical deterioration, relate them to one another, cluster them and create the trigger tool for parents of CMC. Concept mapping is a participative method of organizing and representing concepts, focused on a topic, involving input from more relatively homogeneous participants to generate an interpretable conceptual map (Green et al., 2012). We used the relational approach (Novak & Gowin, 1984) according to the method, where concept maps are generated by participants, through interviews, to identify the connections between concepts and thus construct a visual representation of findings (Conceição et al., 2017).

4.4.1. Data collection and data analysis

Three sessions were conducted via the Zoom video conferencing application for remote communication by the study investigators.

First, the multiprofessional team of ten experts in the care of CMC received the list of signs and symptoms of clinical deterioration of CMC with a score ≥4 that emerged from the Delphi study. They were asked to independently group the signs and symptoms by cluster according to their similarity. Afterwards, during the meetings, the team discussed the clusters produced by each member and a final solution by clusters of priority indicators was agreed. Each item/trigger was discussed for potential inclusion based on consensus, in terms of relevance and comprehensiveness to the main question. A rating cut off ≥5 was decided for inclusion, while items rated between 4 and 5 were discussed for potential inclusion. Finally, recommendations matched to the indicators of deterioration according to the level of severity were discussed and agreed for the trigger tool.

4.5. Phase 4: Cognitive interviews

Cognitive interviews regarding the trigger tool were conducted to assess its comprehensibility and comprehensiveness for parents and further confirm the content validity (Terwee et al., 2018).

Parents of CMC with at least 2 years of experience were enrolled by the research team during planned outpatient visits on‐site, with the support of the attending physician that cared for them.

The parents of CMC were asked about each cluster and item and the instructions of the trigger tool in its final form (final wording and layout) by a research team member trained in qualitative research methods using an interview guide (Supplementary File S3). All interviews were audio‐recorded. During the interviews, the investigator took notes on the participant's opinions and comments regarding the comprehensibility and comprehensiveness of the trigger tool. Three investigators performed qualitative content analysis of the interview data and revised the trigger tool accordingly.

4.6. Ethical considerations

The institutional ethics committee approved the study. Participants at each phase of study were informed of the purpose and nature of the study, were informed about the steps taken to ensure anonymity and confidentiality and about the option to withdraw from the study at any time. Participation was voluntary and anonymous. They were asked to sign an informed consent. Any personal names and identifying information were removed and data were stored on a password‐protected in‐hospital database.

4.7. Rigour

The COnsolidated criteria for REporting Qualitative research (COREQ) checklist for qualitative research was used to verify that all the items had been addressed (Tong et al., 2007). The COSMIN (Consensus‐based Standards for the selection of health Measurement Instruments) guidelines were used to guide the development phase and content validity of the trigger tool (Terwee et al., 2018). Methods and results are reported in line with the “Recommendations for the Conducting and Reporting of Delphi Studies” (CREDES) (Jünger et al., 2017), which promotes consistency and quality in conducting Delphi studies (Supplementary File S4_EQUATOR CHECKLIST).

5. FINDINGS

5.1. Phase 1: The qualitative study

A total of seven focus groups were conducted, four with the parents of CMC, one with clinical nurses caring for CMC in a tertiary care paediatric hospital, one with home care nurses and one with hospital physicians caring for CMC. Nineteen parents of CMC and sixteen HCPs with experience in CMC (specifically six clinical nurses, four home care nurses and six physicians) participated in the study. Parents that participated in the FG were predominantly mothers (18/19, 95%), the age of their CMC was of 9.9 (SD = 7.9) years, the child's diagnosis was predominantly neuromuscular (10/18, 56%). HCPs were predominantly nurses (10/16, 63%) and had a mean of 9.3 (SD = 4.8) years of clinical experience with CMC.

Qualitative content analysis revealed three main categories “Signs and Symptoms of deterioration,” “Device functioning” and “Other factors.” Each of these is articulated in subcategories which describe the main signs and symptoms that parents observe to recognize the clinical deterioration of their CMC at home. Table 1 reports the frequency of the specific signs and symptoms of deterioration, the main categories, sub‐categories and items. The most important quotes from which the items were identified are shown in Supplementary File S5.

TABLE 1.

Categories, Subcategories and Sign and Symptoms identified through the qualitative study.

Categories	Subcategories	Sign and symptoms	HCPs a	Parents a
Signs and symptoms of deterioration	Vital signs	Heart Rate	+++	++++
		Saturation	+++	++++
		Respiratory Rate	+	++
		Fever	+++	++++
	Respiratory clinical indicators	Respiratory effort/Dyspnoea	++	++++
		Skin complexion /Cyanosis/Pallor	+++	+++
		Retractions/Respiratory anomalies	+	++++
		Secretions/Sialorrhea	+++	++++
	Eating/Hydration	Difficulty urinating /Anuria	++	++
		Eating/Hydration	++	+++
		Difficulty evacuating/Diarrhoea	++	++
	Behavioural/Neurological signs	Crying		++
		Pain/Discomfort	+	++
		Facial expression		++
		Agitation	+	+++
		Apathy	+	++
		Sleep‐wake alterations	++
		Response to stimuli	++	+
		Tremors/Convulsive seizures/Dystonia	+++	+++
	Trends	Change in Behaviour	++	+++
		Change from baseline vital signs	++	++++
		New‐/unusual movements of eyes/mouth /limbs	+	++++
		New respiratory sounds		++
		Perception that something is wrong	+++	++++
Device functioning	Mechanical ventilator	Alteration of ventilator parameters	+	++
		Asynchrony between chest movements and ventilator functioning	+	+
	Percutaneous endoscopic gastrostomy (PEG)	Digestion problems/Gastric stagnation		++
		PEG dislocation	+	+
	Tracheostomy	Decannulation/Dislocation	+	++
		Cannula obstruction		+
Other factors	Responses at home	No response to usual treatment	+++	+++
		Increase in non‐routine interventions (requiring/more frequent O2/ aerosol/aspirations)	++	++
		Inability to intervene/manage on one's own	+++	++

^a Sign and symptoms discussed during each (+) focus group (FG), over a total of four FG with parents and three with healthcare providers (HCPs).

5.2. Phase 2: The Delphi study

A total of 35 parents and 32 HCPs were invited to participate in this study. In round one, 23 parents (66%) and 30 HCPs (94%) responded to the survey, in round two they were 20 (57%) and 27 (84%), respectively, and in round three 20 (57%) and 19 (59%). The demographic characteristics of the parents, their children and the HCPs in the three rounds are presented in Tables 2 and 3.

TABLE 2.

Parents' and children's characteristics.

	Round 1 n = 23	Round 2 n = 20	Round 3 n = 20
Parents' characteristics
Mothers (n, %)	20 (87)	19 (95)	19 (95)
Age, years (mean, SD)	42 ± 10	42 ± 11	44 ± 10
Children's characteristics
Females (n, %)	12 (52)	8 (40)	10 (50)
Age, years (mean, SD)	9 ± 7	11 ± 9	11 ± 7
Diagnosis (n, %)
Congenital or genetic	9 (39)	7 (35)	9 (45)
Neuromuscular	10 (43)	10 (50)	8 (40)
Metabolic	2 (9)	2 (10)	2 (10)
No diagnosis	2 (9)	1 (5)	1 (5)
Years since first diagnosis (mean, SD)	9 ± 6	10 ± 7	10 ± 7

Abbreviations: SD, Standard deviation.

TABLE 3.

Healthcare providers' characteristics.

	Round 1 n = 30	Round 2 n = 27	Round 3 n = 19
Professional profile
Physician (n, %)	11 (37)	10 (37)	9 (47)
Nurse (n, %)	19 (63)	17 (63)	10 (53)
Ward or primary care service (n, %)
Paediatric intensive care	16 (53)	15 (55)	6 (32)
Paediatric semi‐intensive care	3 (10)	3 (11)	2 (10)
General paediatric	4 (13)	4 (15)	6 (32)
Surgical paediatric	2 (7)	1 (4)	2 (10)
Primary care service	5 (17)	4 (15)	3 (16)
Clinical experience with CMC years (mean, SD)	11 ± 8	11 ± 7	12 ± 8

Abbreviations: CMC, children with medical complexity; SD, Standard Deviation.

5.2.1. Round Delphi 1

The first survey generated a list of signs and symptoms of deterioration in CMC (69 responses for parents and 133 for HCPs). The items were aggregated using content analysis. The result was a total of 34 signs and symptoms of deterioration in CMC grouped into 7 clusters: Neurological Status, Breathing, Vital Signs, Feeding, Diuresis/Alvus, Temperature‐Skin, Other Signs and Symptoms. Two additional items (“Lack of response to usual treatment” and “Onset of a new problem compared with baseline conditions”) deemed relevant were added, as resulting from the qualitative study component.

5.2.2. Round Delphi 2 and 3

In round 2 of the Delphi, a total of 30 signs and symptoms of deterioration in CMC were rated with an importance score ≥4 by more than 75% of the members of both expert panels.

In round 3, parents with CMC reached agreement on the importance of all 30 signs and symptoms of deteriorating CMC presented, compared to round 2. HCPs, on the other hand, reached agreement with an importance score ≥4 for 21 signs and symptoms of deterioration of CMC. Nine items did not reach agreement by more than 75% of the members on a level of importance ≥4.

The items selected by the participants for inclusion in the list of warning signs and symptoms of clinical deterioration of CMC in order of mean score of importance by rounds 2 and 3, the t test values with their respective significances and Cohen's D are shown in Tables 4 (for parents) and 5 (for HCPs). Figure 2 shows the rating differences between parents and healthcare providers in round 3.

TABLE 4.

Parents' rating of the most important signs and symptoms of deterioration in CMC, based on the highest mean of round 3.

Item	Mean ± SD		T‐test	Cohen's D	p value
	Round 2	Round 3
Respiratory effort	5.65 ± 1.18	5.90 ± 0.45	−0.88	0.3	.38
Peripheral oxygen saturation	5.65 ± 0.99	5.70 ± 0.57	−0.20	0.1	.85
Respiratory Rate	5.40 ± 1.39	5.50 ± 0.69	−0.29	0.1	.77
Changes in respiratory movements	5.30 ± 1.34	5.45 ± 1.00	−0.40	0.1	.69
Cyanosis	5.10 ± 1.45	5.45 ± 0.94	−0.91	0.3	.37
Heart Rate	5.25 ± 1.21	5.35 ± 0.67	−0.32	0.1	.75
Malfunctioning of life‐support devices	5.00 ± 1.78	5.25 ± 1.52	−0.48	0.2	.64
Agitation or Low Reactivity	5.25 ± 1.16	5.10 ± 1.29	0.39	0.1	.70
Lack of response to usual treatment	5.20 ± 1.47	5.1 ± 1.37	0.22	0.1	.83
Altered respiratory secretions	5.30 ± 1.42	5.05 ± 1.28	0.59	0.2	.56
Onset of a new problem. compared to baseline conditions	5.40 ± 1.27	5.00 ± 0.92	1.14	0.4	.26
Changes in behaviour compared to baseline	5.25 ± 1.12	4.90 ± 1.21	0.95	0.3	.35
PEG/PEJ dislocation or malfunction	4.75 ± 1.80	4.9 ± 1.55	−0.28	0.1	.78
Convulsive/epileptic seizures and tremors	4.65 ± 1.81	4.9 ± 1.55	−0.47	0.1	.64
Fever	4.90 ± 1.65	4.85 ± 1.60	0.10	0.0	.92
Decreased urine output	4.05 ± 2.14	4.80 ± 1.67	−1.24	0.4	.22
Changes in social interaction	4.95 ± 1.36	4.75 ± 1.07	0.52	0.2	.61
Changes in facial expressions	4.95 ± 1.50	4.75 ± 1.33	0.45	0.1	.66
Tracheostomy dislocation or malfunction	4.55 ± 2.04	4.75 ± 1.86	−0.32	0.1	.75
Pallor	4.50 ± 1.64	4.75 ± 1.29	−0.54	0.2	.60
Blood pressure	4.35 ± 1.60	4.70 ± 1.30	−0.76	0.2	.45
Alterations in home ventilator pressure parameters/volumes	4.70 ± 1.89	4.65 ± 1.63	0.09	0.0	.93
Hypertonia or Hypotonia	4.70 ± 1.59	4.60 ± 1.31	0.22	0.1	.83
Crying‐sensation of discomfort‐pain	5.05 ± 1.57	4.55 ± 1.50	1.03	0.3	.31
Dysphagia/Difficulty swallowing	5.00 ± 1.62	4.55 ± 1.79	0.83	0.3	.41
Sleep/wake alterations	4.70 ± 1.53	4.55 ± 1.32	0.33	0.1	.74
Weight loss	4.35 ± 2.01	4.55 ± 1.47	−0.36	0.1	.72
Coughing	4.25 ± 1.65	4.45 ± 1.70	−0.38	0.1	.71
Vomiting	4.00 ± 2.03	4.45 ± 1.67	−0.77	0.2	.45
Diarrhoea	3.80 ± 1.91	4.20 ± 1.44	−0.75	0.2	.46

TABLE 5.

HCPs' rating of the most important signs and symptoms of deterioration in CMC, based on the highest mean of round 3.

Item	Mean ± SD		T‐test	Cohen's D	p value
	Round 2	Round 3
Respiratory Effort	5.67 ± 0.92	5.84 ± 0.37	−0.78	0.2	.44
Cyanosis	5.56 ± 1.15	5.79 ± 0.42	−0.84	0.3	.40
Malfunctioning of life‐support devices	5.37 ± 1.04	5.58 ± 0.61	−0.78	0.2	.44
Tracheostomy dislocation or malfunction	5.44 ± 1.25	5.53 ± 0.70	−0.26	0.1	.80
Peripheral oxygen saturation	5.30 ± 0.99	5.37 ± 0.76	−0.27	0.1	.79
Changes in respiratory movements	5.19 ± 1.11	5.26 ± 0.81	−0.26	0.1	.80
Convulsive/epileptic seizures and tremors	5.41 ± 0.97	5.05 ± 0.91	1.25	0.4	.22
Agitation or Low Reactivity	5.41 ± 0.89	4.89 ± 0.81	2.00	0.6	.05
Heart Rate	5.19 ± 1.11	4.84 ± 1.01	1.07	0.3	.29
Respiratory Rate	5.11 ± 1.15	4.79 ± 1.03	0.97	0.3	.34
Lack of response to usual treatment	4.78 ± 1.31	4.79 ± 0.98	−0.03	0.0	.97
Crying‐sensation of discomfort‐pain	4.93 ± 1.24	4.74 ± 1.05	0.54	0.2	.59
Changes in social interaction	5.04 ± 1.02	4.68 ± 1.06	1.14	0.3	.26
Alterations in home ventilator pressure parameters/volumes	4.96 ± 1.06	4.68 ± 1.16	0.85	0.3	.40
PEG/PEJ dislocation or malfunction a	4.93 ± 1.30	4.58 ± 0.90	1.01	0.3	.32
Onset of a new problem. compared with baseline conditions	4.70 ± 1.32	4.53 ± 0.96	0.50	0.2	.62
Hypertonia or Hypotonia	5.04 ± 1.19	4.47 ± 1.02	1.67	0.5	.10
Changes in behaviour compared to baseline	5.00 ± 1.07	4.47 ± 1.02	1.67	0.5	.10
Pallor	5.26 ± 1.06	4.42 ± 0.84	2.87	0.9	.01
Decreased urine output a	4.78 ± 1.28	4.42 ± 1.12	0.98	0.3	.33
Fever	5.00 ± 1.14	4.37 ± 0.96	1.97	0.6	.06
Vomiting	4.70 ± 1.23	4.32 ± 1.00	1.13	0.3	.26
Altered respiratory secretions	4.59 ± 1.34	4.32 ± 1.11	0.74	0.2	.46
Dysphagia/Difficulty swallowing a	4.52 ± 1.34	4.32 ± 1.00	0.56	0.2	.58
Coughing a	4.11 ± 1.37	4.21 ± 1.23	−0.25	0.1	.80
Changes in facial expressions a	4.48 ± 1.25	4.16 ± 1.12	0.90	0.3	.37
Blood pressure a	4.44 ± 1.58	4.11 ± 1.10	0.81	0.2	.42
Weight loss a	4.59 ± 1.34	4.00 ± 0.94	1.66	0.5	.10
Diarrhoea a	4.30 ± 1.20	4.00 ± 1.15	0.84	0.3	.41
Sleep/wake alterations a	4.44 ± 1.28	3.89 ± 1.20	1.47	0.4	.15

^a Items reaching an evaluation of importance >4 by <75% of the participants in the third round.

FIGURE 2.

Rating differences between parents and HCPs of the most important indicators (3rd Round Delphi items ≥4) of clinical deterioration in children with medical complexity. HCPs, healthcare providers; HR, heart rate; PE, percutaneous endoscopic; Resp, respiratory; RR, respiratory rate; SpO2, peripheral oxygen saturation.

5.3. Phase 3: Concept mapping

Ten experts in the care of CMC (six nurses and four physicians) participated in three virtual meetings to produce the final version of the trigger tool. The meetings were facilitated by the principal investigators. The clusters of signs and symptoms that emerged during the qualitative Phase 1 guided item clustering in this phase. The Delphi items with a score ≥4 given by parents were discussed and organized into seven clusters: Breathing, Heart, Devices, Behaviour, Neuro‐Muscular, Nutrition or Hydration and Other Concerns. Among those items, we included 9 items with a score ≥5 and 14 items with a score between 4 and 5, which were considered relevant indicators of deterioration (Increasingly severe pallor and cold extremities, Changes in behaviour and in interaction, Worsening or new onset of hypotonia, hypertonia or dystonia, Decreased urine output, Nutrition not tolerated, Weight variation and onset of oedemas, Persistent vomiting and diarrhoea with difficulty in retaining liquids/therapy, Persistent constipation, Difficulties in managing/understanding the home ventilator alarm, Dislocation or obstruction of tracheostomy with impossibility of reintroduction, Dislocation or obstruction of PEG/PEJ with impossibility of reintroduction, Parental concerns, Lack of response to treatment/therapy and Fever). Vital signs thresholds (Heart Rate, Respiratory Rate, Peripheral Oxygen saturation) were included as an open field in order to be personalized according to the child's age and condition. A total of 23 items were considered for inclusion as important triggers of deterioration for CMC. Items suggestive of severe clinical deterioration were marked in red. Other items suggestive of moderate deterioration were identified through a yellow sign.

5.4. Phase 4: Cognitive interviews

A total of seven parents of CMC were asked about the clustering of the items and the comprehensibility and comprehensiveness of the final output trigger tool through cognitive interviews. Parents confirmed the grouping of items in each cluster. Parents' responses on comprehensibility and comprehensiveness and comments on the trigger tool are presented in Supplementary File S6. Based on comments from the parents in this final set of focused interviews, minor revisions were made to facilitate parents' comprehensibility of the items and the instructions to adapt the trigger tool for the parents of CMC. Changes refer to the addition of items and clarification of some items, such as the occurrence of major apnoeas, the consideration also of the quantity of respiratory secretions, the severity of pallor, the compromised function of devices, the worsening of hypotonia, hypertonia, or dystonia, the duration of constipation and the persistence of vomiting and diarrhoea.

We referred to the parents of CMC who use an appropriate health terminology and technical terms because education on medical terminology regarding their children's complex conditions has already been provided to these parents during hospitalization. Figure 3 shows the final version of the PArents' Trigger Tool for Children with Medical Complexity (PAT‐CMC). The PAT‐CMC tool consists of 7 clusters (Breathing, Heart, Devices, Behaviour, Neuro‐Muscular, Nutrition/Hydration and Other) with a total of 23 items. Finally, it provides two main recommendations in response to the triggers, based on the red or yellow colour and an additional open field where to provide other indications of emergency or observation of clinical deterioration, customized to the child with medical complexity.

FIGURE 3.

PArents' Trigger Tool for Children with Medical Complexity (PAT‐CMC). PEG, percutaneous endoscopic gastrostomy; PEJ, percutaneous endoscopic jejunostomy.

6. DISCUSSION

This study reports on the development and content validation of the PAT‐CMC trigger tool for parents of CMC at home. This tool has been devised to help parents recognize signs of critical deterioration in CMC, to support communication between families and healthcare professionals and provide a structure for parents' education. The signs, cues and indicators included in the PAT‐CMC reported by expert parents of CMC and HCPs correspond to the neurological signs reported for CMC (Chua et al., 2021), the individual baseline vital signs thresholds that characterize these children (Nkoy et al., 2021), the experiences of parents of CMC (Brady et al., 2020) but also the criteria of the Paediatric Advanced Life Support Patient Triangle assessment for children at risk of clinical deterioration (American Heart Association, 2020).

In our study, parents' and HCPs' rating of the importance of the indicators of deterioration of CMC was similar in value and trend. This finding shows that what expert parents identified as relevant signs of deterioration in CMC was in agreement with HCPs. Parents of CMC are reliable partners in detecting subtle signs of impending deterioration in their children (Brady et al., 2020). Engaging families from the beginning of their caring journey is essential for parents' ability to escalate care in their CMC. Parents should be acknowledged as experts of their child's care and should be included in shared decision‐making in a culturally appropriate manner (Jonas et al., 2022).

Parent's self‐care process for caring their CMC is shaped through a dynamic shift of agency from healthcare providers to themselves, through a pathway of increasing experience and learning through the support of other more expert parents and HCPs (Genna et al., 2022). Moreover, parents' competence in recognizing and communicating signs of critical illness develops with increasing experience with their child, education, peer‐to‐peer support and other contextual factors (Genna et al., 2022). A similar process of shift of agency and associated factors has been reported for parents and children or young adults with complex diseases, gradually engaging in their own care along a pathway of increasing developmental stage, cognitive level and age (Dall'Oglio et al., 2021). However, parents of CMC have a lifelong responsibility and ownership of the care of CMC, which will never shift to the child due to their major functional limitations and cognitive impairment. When parents of CMC become expert caregivers, the agency of care can be flexibly renegotiated with HCPs when CMC severely deteriorate or a new condition arises, requiring a different level of partnership (Allshouse et al., 2018; Genna et al., 2022). Self‐care processes are reported to be more challenging for parents at the onset of a complex condition in their children, particularly in early childhood, when parents are still learning how to care for their CMC (Spitaletta et al., 2023). Less expert parents of CMC are reported to be relying more on vital signs as opposed to signs of behaviour change in their CMC (Genna et al., 2022). The PAT CMC may be a relevant tool to support families in acquiring the skills to recognize and care for their CMC at home in case of deterioration. This is the first trigger tool developed for parents of CMC. The development process was rigorous in line with the COSMIN guidelines (Terwee et al., 2018).

Other tools have been developed for children with acute or chronic conditions, including the SIGNS‐for‐Kids illness recognition tool (Gilleland et al., 2019), written action plans for asthma (MacGillivray & Flavin, 2014), tools to facilitate the delivery of information and communication on respiratory diseases (Van Horck et al., 2017) or parent education and early recognition of deterioration of infants with complex congenital heart diseases (Gaskin et al., 2018; Rudd et al., 2020). An initial retrospective evaluation of the SIGNS‐for‐Kids tool showed a potential utility of those screening criteria (Gray et al., 2022). Parents' appreciation, particularly when information on recognizing signs of serious illness and the usual duration of illness is included, has been reported (Francis et al., 2013). A clear description of signs of deterioration is essential for parents' ability to recognize signs of illness, as performed by the Canadian Healthcare Excellence (Healthcare Excellence Canada, 2022).

The PAT‐CMC is based on 7 clusters of clinical indicators (Breathing, Heart, Devices, Behaviour, Neuro‐Muscular, Nutrition/Hydration and Other) and 23 items, which are triggers for potential clinical deterioration for CMC. Five clusters overlap with the SIGNS tool (including Behaviour, Respiratory, Skin, Hydration/Feeding and Intervention has no effect), the CHAT tool (including Baby's skin colour, activity, breathing, circulation, feeding and other issues), and the items are similar to the ten warning signs reported for rapidly deteriorating patients by the Canadian Patient Safety Institute (Gaskin et al., 2018; Gilleland et al., 2019; Hallisy, 2011). The added value of the PAT‐CMC for CMC is the inclusion of additional items specific to CMC, such as device functioning and neuromuscular signs of deterioration; the individual baseline vital sign thresholds of these children reported on the tool by the HCP, allowing for the personalization of vital sign triggers according to their condition; an additional open field where to identify other critical indicators customized to the individual CMC.

Finally, the PAT‐CMC reports triggers differentiated by their potential severity and level of recommended intervention. Signs of potentially critical deterioration requiring immediate attention are identified in red, while signs of clinical deterioration requiring further observation are identified in yellow, to facilitate their interpretation. The plurality of parents of children with different significant congenital or acquired chronic health problems affecting multiple organ systems, involved in the tool's comprehensiveness and face validation process supports the generalizability of the PAT‐CMC, to serve the needs of CMC with different aetiology. A trigger tool such as the PAT‐CMC could be useful in empowering parents in seeking appropriate help, such as Paediatric Early Warning System Scores (PEWS) for nurses in the healthcare context (Parshuram et al., 2009).

6.1. Strengths and limitations

The rigorous methodology and parent's involvement in the development of the tool are the strengths of this study. Parent's contribution to the development of the PAT‐CMC tool, in addition to healthcare providers, ensures the tool's comprehensiveness and comprehensibility. Future development of this tool will entail thorough information on symptom recognition to increase parent's trust in the intervention and self‐efficacy (Neill et al., 2015).

There are some limitations to this study. Beyond content validity, there is still no evidence of internal or external validity of the PAT‐CMC tool. Future studies will be needed to describe the tool's screening power and criterion validity among subgroups of children in need (or not) of emergency care. Moreover, the tool's face validity and usability could be strengthened by adding additional visual and written information to support the recognition of indicators of deterioration in CMC, including information related to device malfunctioning potentially affecting critical deterioration. Usability needs to be explored, including an understanding of the priority indicators of illness included and the escalation process.

6.2. Implications for policy and practice

The PAT‐CMC trigger tool has been devised to educate parents and other lay caregivers on the priority indicators of deterioration of CMC to increase patient safety and prevent morbidity and mortality by initiating the early escalation of care. This tool has the potential to empower parents at home in the communication with healthcare providers on indicators of deterioration of their children to establish appropriate responses to the child's condition. Early recognition of priority indicators of deterioration could reduce unplanned hospital and emergency room admissions or increase appropriate healthcare services utilization. However, these hypotheses need to be confirmed by further research. The PAT‐CMC trigger tool could be used to educate parents on general and personalized indicators of clinical deterioration of their child, according to the child's age, condition and devices used.

7. CONCLUSION

This study reports on the development and content validation of the PAT‐CMC trigger tool for parents and lay caregivers of CMC at home. This tool has the potential to support parents in the recognition of indicators of critical deterioration and urgent care needs in CMC. Further validation is warranted to report the effect of its use on children's outcomes and healthcare services utilization.

AUTHOR CONTRIBUTIONS

OG conceived the study protocol, designed the study and developed the study methods. OG, CG, KT, conducted the data collection, performed the data analysis and interpretation. OG and CG drafted the manuscript. All authors contributed to the study coordination, critically reviewed the manuscript and approved the final version.

FUNDING INFORMATION

This study received funding from the Italian Ministry of Health.

CONFLICT OF INTEREST STATEMENT

The authors declare that there is no conflict of interest.

PEER REVIEW

The peer review history for this article is available at https://www.webofscience.com/api/gateway/wos/peer‐review/10.1111/jan.16201.

STATISTICS

The authors affirm that the methods used in the data analyses are suitably applied to their data within their study design and context, and the statistical findings have been implemented and interpreted correctly.

The authors agree to take responsibility for ensuring that the choice of statistical approach is appropriate and is conducted and interpreted correctly as a condition to submit to the Journal.

Supporting information

Supplementary File S1:

Supplementary File S2:

Supplementary File S3:

Supplementary File S4:

Supplementary File S5:

Supplementary File S6:

Genna, C. , Thekkan, K. R. , Geremia, C. , Di Furia, M. , Cecchetti, C. , Rufini, E. , Salata, M. , Perrotta, D. , Dall’Oglio, I. , Tiozzo, E. , Raponi, M. , & Gawronski, O. (2025). Parents' Trigger Tool for Children with Medical Complexity – PAT‐CMC: Development of a recognition tool for clinical deterioration at home. Journal of Advanced Nursing, 81, 383–398. 10.1111/jan.16201

DATA AVAILABILITY STATEMENT

Data available on request from the authors.