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Challenges in Trying to Implement an Early Intervention Program for Infants with Congenital Heart Disease

Long, Suzanne H. BPhysio(Hons), PhD; Eldridge, Beverley J. BAppSci(Physio), PhD; Harris, Susan R. PT, PhD, FAPTA, FCAHS; Cheung, Michael M. H. BSc(Hons), MBChB, MRCP(UK)

doi: 10.1097/PEP.0000000000000101

Purpose: To describe challenges in trying to implement a physical therapy-based early intervention program for infants with congenital heart disease.

Methods: Neonates with cyanotic congenital heart disease who had elective or emergency cardiac surgery at age 28 days or less participated in the study. Families were offered hospital-based physical therapy intervention from infant age of 3 months. Feasibility and efficacy of intervention were to be evaluated at 8 months.

Results: Study recruitment was protracted and then stopped. Anticipated sample size was limited by survival (86%) and recruitment rates (75%); cardiorespiratory and neurological complications led to lengthy admissions, precluding study participation. In addition, geographic constraints and families' general take-up of the services offered limited ability of those recruited to receive intervention at planned frequency and intensity.

Conclusions: Overall, data collected demonstrated infeasibility to evaluate effectiveness of hospital-based physical therapy intervention for this cohort of infants. Nonetheless, valuable data were gathered about factors leading to nonparticipation.

The authors describe the difficulties encountered when trying to evaluate effectiveness of hospital-based PT intervention for infants with CHD. Although the study was abandoned, valuable data were gathered about factors leading to nonparticipation.

Heart Research Group (Drs Long and Cheung), Clinical Sciences, Murdoch Children's Research Institute, Melbourne, Australia; Department of Physiotherapy (Dr Eldridge), Royal Children's Hospital, Melbourne, Australia; Physiotherapy (Dr Eldridge), Melbourne School of Health Sciences, University of Melbourne, Melbourne, Australia; Department of Physical Therapy (Dr Harris), University of British Columbia, Vancouver, Canada; Department of Cardiology (Dr Cheung), Royal Children's Hospital, Melbourne, Australia; Department of Paediatrics (Dr Cheung), University of Melbourne, Melbourne, Australia.

Correspondence: Susan R. Harris, PT, PhD, FAPTA, FCAHS, Department of Physical Therapy, University of British Columbia, 212-2177 Wesbrook Mall, Vancouver, BC V6T 1Z3, Canada (

Grant support: This study was funded by the 2012 HeartKids Australia Grants-in-Aid program, which was supported by the Wilson HTM Foundation. The Murdoch Children's Research Institute is supported through a Federal Government infrastructure grant. The Heart Research Group is supported by RCH 1000, Royal Children's Hospital Foundation, and Big W.

The authors declare no conflicts of interest.

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Infants who undergo cardiac surgery for congenital heart disease (CHD) have risks for gross motor delays and musculoskeletal impairments.1 Through longitudinal, prospective research, we demonstrated that these risks become reality; infants who undergo early cardiac surgery have gross motor delays that persist through infancy, and motor impairments including lack of trunk extension and active trunk rotation, imbalance of flexor and extensor muscle control, and asymmetry in crawling.2,3 Although these infants have unique needs for developmental assessment and intervention, these needs have yet to be addressed via systematic assessment, intervention, and support resources for Australian children with CHD.4

To date, no published studies have evaluated therapeutic early intervention (EI) in infants with CHD, and efficacy of EI in other patient groups is inconclusive.5–7 Further research is required to determine whether focused, timely interventions can enhance the physical development of children with CHD. Consequently, a study was designed to evaluate the effect of physical therapy (PT) on gross motor development of infants who had undergone early cardiac surgery. Two intervention approaches were designed to examine the efficacy of PT, as well as the feasibility to participate for families living both locally and at a distance from the Royal Children's Hospital. We aimed to develop interventions that could be translated from research to clinical settings, in the event that PT was found to improve gross motor performance.

Study recruitment was abandoned after 10 months as our data collection demonstrated that it would not be feasible to evaluate the effectiveness of intervention services for our cohort of infants within the designed therapy model. This article describes the challenges faced in trying to implement an intervention program for children with CHD.

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Royal Children's Hospital provides cardiac surgical services for children in the states of Victoria, South Australia, Western Australia, Tasmania, and the Northern Territory. Neonates with cyanotic heart disease who underwent cardiac surgery were included. This patient group is well recognized to be at greater risk of motor delay.2,8,9 Exclusion criteria included chromosomal abnormalities or congenital syndromes, preterm birth (<37 weeks' gestation), and families in which the primary caregiver was unable to read and write English.

During 12 months, 30 infants were to be recruited and matched to a historical control group2 on the basis of residential proximity to the Royal Children's Hospital, sex, and diagnostic categories. Remaining participants (n = 20) would be those residing outside Victoria for which a control group was not available. These participants were included to examine the feasibility of providing interventions to families living at a distance from the hospital.

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Physical Therapy Intervention

Families were invited to begin an intervention program for their baby at 3 months of age, coinciding with the usual commencement of voluntary active movement.10 Families gave signed, informed consent before starting the intervention. The goals of intervention were to (1) correct musculoskeletal impairments and gross motor delays2 and (2) provide individualized, developmental advice and support to caregivers. Where possible, PT sessions were scheduled in conjunction with existing hospital-based appointments. In line with this, infants more likely to be attending the hospital on a regular basis because of ongoing medical and surgical management (palliative cardiac surgical group) were offered intervention on an “as-needs” basis (Table 1). This approach formalized and standardized existing PT outpatient practices for other groups of children under medical/surgical care at Royal Children's Hospital. Infants less likely to be attending the hospital on a regular basis (corrective cardiac surgical group) were invited to participate in a single educational PT session. Home-based strategies aimed at preventing musculoskeletal impairments and gross motor delays were provided to this group.11



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Outcome Measures

Assessment and intervention procedures were documented on a standard template that included attendance frequency and/or reasons for nonattendance. During the study period, data on perioperative variables and inpatient and outpatient PT patient contact hours were collected from hospital databases.

Standardized outcome measures were to be administered by an assessor blinded to diagnoses, history, and the intervention group at 8 and 12 months of age. These measures included the Alberta Infant Motor Scale, assessing infant gross motor performance, and the Ages and Stages Questionnaire, 3rd Edition, a parent-completed screening questionnaire for identification of developmental delay or disorders.12,13

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Study recruitment was ceased after approximately 10 months (41 weeks). During this period, 42 neonates with cyanotic heart disease underwent cardiac surgery; 19 (45%) were residents of another state (Table 2). Seven patients (17%) were excluded: 3 with congenital syndromes, 3 born preterm, and 1 from a non–English-speaking family. Six patients (14%) died at a median age of 23 days (range, 17-40 days). Two families (5%) were unable to participate because their children had complicated and lengthy intensive care admissions.



We had planned to begin intervention as close to the age of 3 months as possible, but this was not feasible for some families. We were unable to approach 11 families (26%) for study participation because they were discharged back to their state of residence before the intended commencement of the intervention program (median age at discharge, 20 days; range, 15-42 days). The information to be delivered therefore was not yet appropriate for their clinical condition, and seemed at odds with the families' focus during the acute/subacute phase of recovery. In addition, monitoring plans for discharge—in order to provide the intervention as late as possible—was more difficult and time-consuming than anticipated, as communication avenues between medical/nursing and allied health staff regarding discharge planning were not well established.

Of 16 families (38%) approached to participate in this study, 4 declined: 1 to pursue alternate therapies (energetic healing and chiropractic services), another who preferred not to attend what they felt were “unnecessary” appointments at the hospital, and a third for unknown reasons. The fourth family verbally consented to study participation, but declined after another allied health appointment in which the infant was extremely irritable. Characteristics of study participants, nonparticipants, and the historical control group are shown in Table 2.

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Physiotherapy Intervention

Six infants who had undergone palliative cardiac surgery were recruited to this study. One participant died unexpectedly from a respiratory illness (age 7.3 months), and another had not yet commenced intervention at the point the study was stopped. The PT intervention provided to participants and nonparticipants is outlined in Tables 3 and 4. Two participants suffered postoperative cerebrovascular events, thereby receiving more inpatient and outpatient intervention than other participants (ID 1 and 2, Table 4). One participant (ID 2, Table 4) was offered a local EI placement at age 8 months, however the family elected not to participate.





PT appointments were not scheduled at the frequency suggested in the study protocol for several reasons: physical therapist illness (2 occasions), PT department workload (1 occasion), study participant surgical event (1 occasion), family unable to attend (1 occasion), transfer to local services (1 occasion), and transfer back to state of residence (1 occasion). Families attended the hospital for other outpatient appointments more frequently than for PT sessions (Table 4).

Six infants who had undergone corrective cardiac surgery were recruited for this study. Five of the 6 lived within 100 km of the hospital, and 1 in rural Victoria. Four participants had returned to the hospital for their intervention session at the time recruitment was stopped.

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This project was designed to evaluate the feasibility and efficacy of providing PT interventions to reduce morbidity in children who had undergone early cardiac surgery. Study recruitment was stopped prematurely as several barriers to participation arose from both the families and service providers. Overall, the data being collected demonstrated that it would be unfeasible to evaluate the effectiveness of intervention services for the available cohort of infants with the designed therapy model. It was evident, however, that valuable data had been gathered about factors leading to nonparticipation, and that resources should be redirected to designing an alternate therapy model.

Geographic constraints to service provision are not unique to Australia. Surgical management of children with CHD is usually coordinated through tertiary hospitals that are catchment centers for large geographic regions. Centralization of services enables providers a concentrated exposure to congenital heart disease, leading to decreased mortality.14,15 Beyond the perioperative period, this creates unique challenges to successful management of subacute and chronic aspects of CHD. Perhaps as a consequence, coordinated developmental follow-up of infants with CHD that have undergone cardiac surgery is not part of current practice in Australia.4 Our study reviewed participants from Tasmania, Western and South Australia; however, the provision of intervention to patients from these states was minimal. Further studies should explore the potential for home-based or local intervention provision.

Soto and colleagues instituted a developmental follow-up clinic for infants with CHD, focusing on those who had surgery at less than 30 days, had a cyanotic lesion, or were otherwise at risk for developmental delay because of comorbidities or complications.16 All infants younger than 30 days at surgery were routinely referred for local EI; at follow-up, however, only 52% were receiving intervention, with 31% of infants meeting EI criteria not receiving services. Follow-up included medical/developmental history, physical examination, and developmental evaluation. Of 193 infants initially participating, 109 returned to the clinic at a mean age of 7.2 months (56% attendance rate). Authors reflected that “establishing a consistent system to refer eligible patients was more difficult than expected, but improved over time,” and amended the attendance rate to 73% after removing 43 “‘missed” patients from the dataset. Outcomes from this clinic were consistent with previous research,17 in that gross motor skills were delayed. Despite this, only 24% of the cohort was receiving PT services. This suggests that other centers experience similar difficulties with referral and uptake of developmental services, despite their demonstrable need.

In 2012, the American Heart Association released a scientific statement containing an algorithm for surveillance, screening, evaluation, reevaluation, and management of developmental disorder or disability, aimed to optimize neurodevelopmental outcome in children with CHD.18 Beyond identifying developmental delay, routine surveillance is valuable, as seen by identification of an infant with acute stroke by a research physical therapist in the abandoned study. Similarly, in our historical study, detection of a leg-length discrepancy by the research team led to medical review and discovery of a large femoral clot requiring treatment.2 Although the American Heart Association recommendations in identifying and diagnosing developmental delays are commendable, they do not address the provision of intervention for identified problems. As seen in our study, and that by Soto et al, disparity exists between identification of delay through developmental surveillance and actual EI provision.16 Existing studies are not able to discern whether the lack of intervention provision is a result of service availability, or family availability and interest; further exploration is required.

Stieber et al19 designed a 10-week, play- and home-based therapy program for 12- to 24-month-old infants with CHD. This program involved five 2-week sessions, with each session comprising 2 individualized patient goals. Each goal was addressed with 6 play-based activities; families were directed to complete 1 or more activities for at least 10 minutes per day, and were phoned biweekly to assess progress and modify activities as needed. Interestingly, despite being home-based, only 2 families totally adhered to the program, with remaining families citing illness, lack of interest, and limited time as factors for nonparticipation. Parents reported most “success” if therapy was incorporated into the child's day, rather than performed as separate sessions; families self-selected whether to perform activities in 10-minute sessions, or in a more relaxed manner. This highlights the difference in intervention dosage (frequency, intensity, and duration) that may occur even in closely monitored intervention programs. Although we provided some structure to guide the frequency of intervention in the abandoned study, PT appointments were not scheduled at the frequency suggested and most certainly not at a dosage that would elicit change in outcome. To truly evaluate intervention effectiveness, a closely directed program that has strategies to maximize participation, in light of the described challenges that are specific to this population, is required.

One major issue that arose in the foregoing studies, as in the abandoned study, is families' perceived need for therapy. Anecdotally, placing high priority on EI services when families have recently faced life-and-death situations is difficult. To promote PT intervention as a preventative strategy for morbidity, sound scientific evidence is needed that EI changes outcomes. However, to obtain this evidence, one needs buy-in from clinicians and study participants such that intervention can be provided at appropriate frequency, intensity, and duration to be evaluated objectively. This study has shown that when PT services are offered in a tertiary setting under the current model of care, family acceptance is limited. In light of ongoing calls for increased intervention services for this at-risk population, alternate, innovative methods of delivering EI programs should be considered.

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The authors thank physical therapists, Tristan Melchiori and Stacy Kelly, for their assistance with PT assessment and intervention provision.

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acceptability of health care; congenital heart disease; early intervention; feasibility study; infant; patient participation; physical therapy; research subject recruitment

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