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. Author manuscript; available in PMC: 2025 Dec 12.
Published in final edited form as: Cleft Palate Craniofac J. 2025 Oct 3;63(8):2493–2502. doi: 10.1177/10556656251382528

Achieving and Sustaining Standardized Measurement of Treatment Outcomes in Children With Cleft Lip/Palate: Pilot Study of a Multifaced Implementation Strategy

Thomas J Sitzman 1,2,3, Jessica L Chee-Williams 1,4, Davinder J Singh 1,2,3, Kelly Nett Cordero 1,4, Patricia Beals 1, Maria T Britto 5
PMCID: PMC12696739  NIHMSID: NIHMS2126719  PMID: 41042928

Abstract

Objective:

Prior work has identified numerous barriers to standardized outcome measurement in cleft care. The objective of this study was to evaluate a multifaceted implementation strategy to collect standardized outcomes for children with cleft lip and/or palate (CL/P).

Design:

A one-armed, single-site pilot study of a multifaceted implementation strategy.

Setting:

A metropolitan children’s hospital.

Patients:

Five-year-old children with CL/P.

Interventions:

A multifaceted implementation strategy for standardized outcome measurement.

Main Outcomes Measures:

The primary outcome measure was penetration of the intervention, defined as the proportion of children for whom the standardized measures of aesthetic, dental, and speech outcomes were collected. Penetration pre-implementation and 12 months post-implementation were compared. The secondary outcome was acceptability of standardized outcome measurement among providers and staff, evaluated with the Acceptability of Intervention Measure.

Results:

The implementation strategy resulted in high penetration of standardized outcome measurement: measurement of aesthetic outcomes increased from 7% to 82% (p < .0001); measurement of dental outcomes increased from 0% to 56% (p < .0001); measurement of speech outcomes increased from 29% to 77% (p=.0001). Acceptability of standardized outcome measurement was high, with 93% of cleft team providers and staff (n =14/15) reporting that they somewhat or completely agreed that standardized outcome measurement met their approval, was appealing, was welcomed, and was liked. Penetration continued to improve after the implementation period, with high rates of outcome measure collection sustained for four years following implementation.

Conclusions:

Deployment of a multifaceted implementation strategy led to substantial increases in the collection of aesthetic, dental, and speech outcomes among children with CL/P.

Keywords: cleft lip and palate, outcome measurement, implementation science, longitudinal tracking, pilot study, implementation study

Introduction

Cleft lip and/or palate (CL/P) is the second most common congenital anomaly in the United States, occurring in more than 7000 births annually.1 CL/P affects a child’s appearance, speech, hearing, facial growth, dentition, and psychosocial development.2 While children usually undergo surgical repairs within the first 18 months of life, a substantial number of children will require secondary surgeries to improve their appearance, occlusion, or speech.3–5 Many children with CL/P will also need dental treatment,6,7 orthodontic treatment,8 speech therapy services,9,10 and psychology services11 as part of their comprehensive cleft care. Identifying children with unmet treatment needs is a core function of the cleft lip and palate team.

Evaluation of children with CL/P at 5 years of age is an ideal time to assess both unmet treatment needs and outcomes of primary lip and palate treatments.12 Researchers have demonstrated in numerous contexts that evaluation of aesthetic and speech outcomes is feasible and reliable in patients at 5 years of age.12–15 Clinicians agree that this age, coinciding with the start of kindergarten, is an ideal time to address speech and resonance issues, to correct significant aesthetic issues with the lip and/or nose, and to provide counseling about the need for future orthodontic treatment. Performing standardized aesthetic, dental, and speech evaluation of children with CL/P at age five therefore enables the team to identify and address ongoing treatment needs, while also facilitating the team’s evaluations of treatments that patients received during their infancy.

Standardized outcome measurement is a core component of interventions that improve surgical outcomes through identification and spread of best practices.16,17 Standardized outcome measurement was cited by a joint World Health Organization (WHO) and National Institute of Dental and Craniofacial Research (NIDCR) expert panel as critical for cleft research.18 The adoption of standardized outcome measurement was also a core component of the centralization of cleft care in the United Kingdom, which led to more timely primary surgery, decreased length of stay, and better surgical outcomes, for children with CL/P.19,20 While these findings provide support for standardized outcome measurement as a core component of cleft care, real and significant challenges exist to implementing standardized outcome measurement in the United States.

Previous work has shown that barriers to standardized outcome measurement in children with CL/P include the absence of a system for recalling patients for evaluation, inconsistent evaluation methods, and difficulty performing facial photographs and dental evaluations in young children.21,22 Challenges with data collection are problematic as outcomes cannot be assessed unless there are processes in place to obtain standardized assessments. Therefore, the first step cleft teams need to take to assess their outcomes is implementation of methods and strategies that achieve consistent collection of standardized outcomes.23

The purpose of the present study was to test a multifaceted implementation strategy for achieving standardized measurement of aesthetic, dental, and speech outcomes in children with CL/P. This multifaceted implementation strategy was composed of multiple discrete strategies, with each discrete strategy selected from the Expert Recommendations for Implementing Change compilation.24 Based on prior research exploring barriers and facilitators to standardized outcome measurement in this population,21 the multifaceted approach incorporated strategies focusing on provider education, developing and implementing tools for quality monitoring, conducting small tests of change, and facilitating relay of clinical data to clinicians. This multifaceted implementation strategy was tested within a cleft team at a large-volume metropolitan hospital. It was hypothesized that deployment of the multifaceted implementation strategy would lead to measurement of aesthetic, dental, and speech outcomes in 75% of children with CL/P, and that the system developed to achieve that outcome would be acceptable to clinicians.23,25

Methods

Institutional Review Board (IRB) approval was obtained from the Phoenix Children’s Hospital (PCH-IRB 17-058) prior to the onset of this study. This study adhered to the Standards for Reporting Implementation Studies (StaRI) guidelines for accurate reporting.26,27 The STaRI checklist for this study can be found in Appendix 1 in the supplementary materials.

Study Design

This was a one-armed, single-site pilot study of a multifaceted implementation strategy with a pre-post analysis. The implementation strategy was executed over eight months, from April 2020 through November 2020. Thereafter, implementation activities were limited to reporting of study results to cleft team members. Implementation outcomes were assessed 12-months following deployment of the implementation strategy. All engagement by the intervention team stopped in March 2022. Sustainability of the implementation strategy was assessed through March 2025.

Study Context

This study was conducted at a large metropolitan children’s hospital in the Southwest United States. The children’s hospital had a single cleft team. The cleft team was approved by the American Cleft Palate-Craniofacial Association (ACPA). At the onset of the study the cleft team lacked consistent records, had limited ability to track patient progress over time, and was unable to comprehensively evaluate the quality of care they delivered. The team wanted consistent evaluations, follow-up, and continuous monitoring of quality of care provided.

At study launch, the team included plastic surgeons (4), speech-language pathologists (3), an orthodontist (1), and behavioral health providers (two psychologists and one social worker). All members of the team were hospital employees, except for two of the plastic surgeons who were in solo private practice. The number of providers was stable during the implementation period. During the 4 years after implementation, the team added two speech-language pathologists and one orthodontist.

Professional offices and clinic facilities for all providers were co-located in a single facility dedicated exclusively to children with cleft and craniofacial conditions. Most clinical visits were conducted at this facility, although surgeons and speech-language pathologists did conduct a limited number of clinical visits at satellite facilities in the metropolitan area. All clinics, both at the primary facility and at satellite facilities, were run by the same providers and support staff. Clinical visits with the plastic surgeons were supported by medical assistants, and clinical visits with orthodontists were supported by orthodontic assistants. Both groups of assistants worked almost exclusively with cleft team providers. Scheduling of clinic visits was performed by both support staff within the cleft clinic and a hospital-wide scheduling team.

The cleft team was led by a four-member leadership team consisting of the clinical leader for each of the four core disciplines: surgery, orthodontics, speech language pathology, and psychology. Prior to initiation of the pilot study, members of this leadership team selected the outcome measures to be collected and agreed to be champions for standardized outcome measurement within their discipline.

Target Population

Assessment was completed for 5-year-old children (5.0–5.99 years) with CL/P treated at one metropolitan children’s hospital from March 2017 to December 2022. Children with medical conditions that prevented evaluation, such as profound developmental delay or severe hearing impairment, were excluded.

In 2022, more than 1 year after implementation activities were completed, the cleft team revised their timeline of comprehensive team visits. The revised timeline moved the comprehensive team visit conducted at 5 years of age; this team visit was thereafter conducted at 6 years of age. Due to this change, the target population was changed to 6-year-old children (6.0-6.99 years) for the period from January 2023 to March 2025.

Outcomes

The primary outcome measure was penetration or reach of the intervention,25 defined as the proportion of all 5-year-old children for whom the standardized measures of aesthetic, dental, and speech outcomes were collected. The standardized measure for aesthetic outcomes included collection of facial photographs in frontal, lateral, and submental views for all children with a history of cleft lip +/− cleft palate. Collection of standardized dental outcomes included occlusal photographs and Decayed, Missing, and Filled Teeth (DMFT) index of caries burden28 for children with cleft lip and/or palate. Standardized measurement of speech for children with cleft palate +/− cleft lip included assessment of hypernasality and nasal air emission rated using the Cleft Audit Protocol for Speech–Augmented–Americleft Modification (CAPS-A-AM),29 assessment of nasalance using the Simplified Nasometric Assessment Procedures Revised (SNAP-R)30 test, and evaluation of articulation using the Goldman-Fristoe Test of Articulation Third Edition (GFTA-3).31

The secondary outcome was acceptability of the intervention25 among providers and staff, evaluated with the Acceptability of Intervention Measure.32 All members of the cleft team participated in the implementation of standardized outcome measurement and provided feedback using the Acceptability of Intervention Measure.

Implementation Strategy

The implementation strategy being evaluated was multifaceted and included the following discrete strategies:33

  1. Conduct educational meetings
    • Brief educational sessions were implemented for providers and staff.
    • The education sessions were held during existing staff meetings each month and each session lasted 5 to 10 min.
    • During the sessions, the benefits of standardized outcome measurement were highlighted and results of the team’s effort to improve were discussed.
  2. Develop and implement tools for quality monitoring
    • Created a patient registry
    • Included all patients with CL/P treated by providers on the cleft team
    • Included results from all outcome measurements
  3. Conduct cyclical small tests of change targeted at improving patient recall and integrating outcome measure collection into routine clinic workflows
    • Plan-Do-Study-Act (PDSA) cycles were completed with scheduling staff to address barriers to patient recall.
    • PDSA cycles were completed with clinic staff to streamline measure collection during clinic.
  4. Facilitate relay of clinical data to providers
    • Results of outcome measurement were relayed to providers in real-time.
  5. Development of a formal implementation blueprint
    • Created a blueprint that included (available from authors upon request):
      • The purpose of implementing standardized outcome measurement
      • Definitions of the outcomes being measured
      • Expectations of each clinical team leader
      • Descriptions of the discrete strategies to be executed during implementation
      • Timeline of implementation activities
      • Description of theoretical framework guiding implementation

The discrete implementation strategies that were utilized are further described in supplemental Table 1 including the actor, action, temporality, dose, outcome affected, and theoretical justification.

Analysis and Process Evaluation

Penetration was measured as the proportion of children cared for at the cleft center for whom the standardized measures of aesthetic, dental, and speech outcomes were collected. Data were monitored using run charts for each outcome measure and reported quarterly.34,35 Penetration pre-implementation (March 31, 2020) was compared to penetration 12 months post-implementation (June 30, 2021) for each standardized outcome measure using Fisher’s exact test. A priori power calculations were conducted: setting the Type I error rate at 0.10 (as positive results would be confirmed in future studies) and estimating the sample size at forty patients per year from historical data at the site, the study had a power of 0.9 to detect an increase from a baseline performance of 25% to a performance of 75% following deployment of the implementation strategy. To measure acceptability, providers and staff completed surveys 12 months after implementation; results were summarized using frequency and proportions.

Fidelity refers to the degree of adherence to the described implementation strategy and intervention. Fidelity to delivery of the implementation strategy was assessed qualitatively based on documentation review and adherence to core components as outlined in the implementation blueprint.36 Although no quantitative fidelity metrics were collected, descriptive data was used to report if the intervention was delivered as intended.

Adaptation refers to alteration of the implementation strategy or intervention to fit the context of the intervention such as local workflow or to facilitate provider engagement.37 Adaptations made during the study period were reported.

After the implementation strategy was executed and its results tested, penetration of standardized outcome measurement continued to be measured and reported quarterly. Sustainability of the intervention was assessed by calculating the average proportion of children with standardized outcome measures collected during each quarter of the post-intervention period, June 30, 2021 to March 31, 2025.

Results

Penetration of the Intervention

The implementation strategy resulted in high penetration of standardized outcome measurement as shown in Figure 1. Measurement of aesthetic outcomes increased from 7% (n =2/28) to 82% (n =18/22) during the intervention period (p<.0001). Figure 2 shows the proportion of aesthetic outcomes collected quarterly from March 2017 through March 2025.

Figure 1.

Figure 1.

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The implementation strategy resulted in high penetration of standardized outcome measurement. Measurement of aesthetic outcomes significantly (p < .0001) increased from 7% to 82%, measurement of dental outcomes significantly (p < .0001) increased from 0% to 56%, and measurement of speech outcomes significantly (p =.0001) increased from 29% to 77% of children.

Figure 2.

Figure 2.

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Measurement of aesthetic outcomes increased during the intervention period from 7% to 82%. In the 16 quarters following the intervention period, aesthetic outcomes were collected for an average of 90% of children. The lightly shaded box shows the quarters the intervention was implemented.

Measurement of dental outcomes increased from 0% (n =0/55) to 56% (n =20/36; p<.0001). Figure 3 shows the proportion of children with dental assessments completed quarterly. Measurement of speech outcomes increased from 29% (n =12/42) to 77% (n =20/26; p=.0001) as shown in Figure 1, and the proportion of children with completion quarterly is shown in Figure 4.

Figure 3.

Figure 3.

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Collection of dental assessments increased from 0% to 56% during the intervention period. In the 16 quarters following the intervention period, dental outcomes were collected for an average of 78% of children.

Figure 4.

Figure 4.

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Speech assessment completion increased from 29% to 77% during the intervention period. In the 16 quarters following the intervention period, speech outcomes were collected for an average of 93% of children.

Acceptability of Standardized Outcome Measurement

Nearly all cleft team providers and staff (n =14/15; 93%) reported that they somewhat or completely agreed that standardized outcome measurement met their approval, was appealing, was welcomed, and was liked. Figure 5 shows the proportion of providers that were neutral, agreed, or strongly agreed about the acceptability of outcome measurement.

Figure 5.

Figure 5.

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Acceptability of standardized outcome measurement to providers and staff. Nearly all (93%; n=14/15) cleft team providers and staff reported that they somewhat or completely agreed that standardized outcome measurement met their approval, was appealing, was welcomed, and was liked.

Fidelity

Fidelity to the implementation strategy was high. Fidelity was as follows for each discrete strategy:

  1. Educational presentations were given monthly for the first five months. These presentations were augmented by also providing education on the difference between process improvement and research, as providers voiced some confusion over this issue during the early stages of implementation.

  2. The registry was built prior to implementation efforts and officially launched at the start of the implementation period. The registry was updated with results from new evaluations continuously, and reports of patients due for evaluation were produced quarterly.

  3. PDSA cycles were held as planned, with parallel PDSA ramps focused on patient recall, collection of dental outcome measures during orthodontic clinic visits, and collection of facial photographs during plastic surgery clinic visits. Each ramp included 3-6 PDSA cycles.

  4. Data collection was integrated into clinical documentation templates within each discipline.

  5. A blueprint of the implementation strategy was provided at the start of implementation.

There were no changes during the study period to discipline-specific outcome measures.

Adaptation

No adaptations occurred during the implementation period (i.e., April 2020 through June 2021). Three adaptations occurred after the implementation period. In 2022, the Electronic Health Record (EHR) software changed for each discipline. During this EHR change, discipline leads worked with implementation team members to ensure fields for data collection persisted.

Also in 2022, the team moved the comprehensive team visit conducted at 5 years of age to 6 years of age to better align with when patients started orthodontic treatment planning. Due to this change, the target population was changed to 6-year-old children (6.0-6.99 years) starting in January 2023. The speech-language pathology team continued to conduct a full speech and resonance evaluation at age five, followed by a repeat evaluation at age six for coordinated treatment planning with the other relevant disciplines. This change aligned with practices in other clinical outcomes studies that have expanded the age window to age six.38 The decision was also driven by the need to allow more targeted, patient-specific discussions about orthodontic treatment timing rather than broader, anticipatory orthodontic counseling typically offered at earlier ages.

Third, in 2023, team orthodontists reported challenges with documenting the number of teeth with treated carries due to the increased prevalence of ceramic fillings. In response to this concern, an additional field for “untreated carries-Y/N” was added to document unmet needs for carries control.

Sustainability of the Intervention

Penetration of outcome measurement increased during the 12 months following the implementation strategy across all three disciplines, despite the absence of active process monitoring. In the 16 quarters following the intervention period, collection of aesthetic outcomes was collected for an average of 90% of children, dental assessment for an average of 78%, and speech assessments for an average of 93%.

Discussion

In the present study, a multifaceted implementation strategy was implemented to address known barriers to standardized outcome measurement. Collection of standardized outcome measurement significantly increased across all three target areas. Collection of aesthetic outcomes increased from 7% of children to 82% of children; collection of dental outcomes increased from 0% to 56%, and speech outcomes increased from 29% to 77% over the 1-year intervention period. Following the intervention period, outcome collection was sustained over the next 4 years at an average of 90% for aesthetic assessments, 78% for dental assessments, and 93% for speech assessments. Most staff reported that standardized outcome measurement met their approval. This pilot study showed collection of aesthetic, dental, and speech outcomes during clinic is feasible, sustainable, and acceptable. These findings support the need for future research to evaluate whether these results generalize to other cleft teams in the United States.

Strategies were implemented in the present study that were tailored to the setting39 and incorporated known facilitators of implementation success.33 The implementation strategy included provider engagement in selecting outcomes, securing leadership support,22 developing a patient registry, and using iterative Plan-Do-Study-Act (PDSA) cycles40,41 to improve patient recall. These implementation activities led to staff buy-in and integration of standardized outcome measurement into existing clinic workflows. Findings in the present study mirror prior work showing that successful implementation is more likely when clinical staff are involved early and when strategies are responsive to the context they are being implemented.25,39

Implementation strategies are inherently context dependent. Strategies in the present study were selected based on an assessment of the clinic’s resources, personnel, and patient population. Other teams may need to consider different approaches, such as revising professional roles, changing equipment available in rooms, and integrating digital health tools into clinical documentation.24 One discrete implementation strategy that appears essential for achieving high penetration of standardized outcome measurement–regardless of context–is the creation of a patient registry to support longitudinal tracking of patient outcomes. Implementing standardized outcome measurement tracked with a registry facilitates objective evaluation of clinical outcomes and enables participation in quality improvement and comparative effectiveness research.

The United Kingdom’s cleft care centralization activities in the 1990s and early 2000s included a government mandate to collect standardized outcome measurements, create a population registry, and to regularly audit treatment outcomes.38 This systematic outcome monitoring led to measurable improvements in speech, dental, and aesthetic outcomes.13 Additionally, cleft providers in the United Kingdom strengthened patient and public involvement in cleft care by disseminating findings and completing workshops that included patient involvement.13 Standardized assessment and outcome monitoring has helped cleft care in the United Kingdom align with patient-centered outcomes principles and support research that reflects patients’ needs and concerns.42 While standardized reporting and outcomes assessment is not mandated in the United States, aspects of a standardized framework exist.

Cleft teams in the United States can follow and reference already established guidelines and professional standards such as the American Cleft Palate-Craniofacial Association (ACPA) Parameters of Care.2 The ACPA calls for teams to longitudinally assess all patients with cleft conditions, monitor outcomes, and change practice when outcomes are not meeting benchmarks. However, without consensus on which outcomes to monitor, the impact of standardization efforts remains limited and difficult to scale. Prior work on standardization of cleft treatment protocols has called for establishing criteria for protocol selection and converging outcome collection across teams.43 Future research should include conducting a multi-site clinical trial testing the penetration, fidelity, sustainability, and cost of implementing standardized measurement of outcomes for children with cleft conditions. Policymakers in the United States should also consider supporting a national registry to enable cross-institutional comparison and define a core set of outcomes for ongoing, mandated monitoring of cleft outcomes.

The results of this pilot study provide evidence that standardized outcome measurement was not only feasible at a cleft team based in the United States, but also demonstrated that outcome measurement was sustainable over time. Integration of outcome measurement into existing clinical workflows may have contributed to the sustainability of outcomes measurement found in this study. Despite completion of active implementation work in March 2022, collection of standardized outcome measures continued to increase. This finding suggests that the cleft team fully integrated standardized outcome measurement into their standard daily workflow, developing a system that did not rely on external support from the implementation team.

Success in sustaining these efforts may also be attributed to the team’s efforts to incorporate training on outcome measurement collection in onboarding of providers and staff. For example, newly hired medical assistants were trained and given feedback on capturing photographs as a part of their new-hire training and new speech-language pathologists were trained on administering and documenting standardized speech assessments. Finally, the team’s culture and leadership may also partly explain the success in sustaining penetration.44 The team has a culture of transparency and a focus on reporting outcomes. The team also had stable leadership with consistent support for the intervention throughout the study period. These features—training of new team members, culture of transparency and reporting, and stable supportive leadership—were also key components leading to implementation and sustaining of standardized speech outcome measurements across cleft centers in the United Kingdom,12 suggesting they may have broad applicability for sustaining outcome measurement in cleft care.

Limitations

This was a pilot study conducted at a single center and may not generalize to other settings. Implementation strategies are context dependent and cleft teams must evaluate which strategies align with their specific needs, stakeholders, and resources, which may be different than the strategies selected for this study. In the present study, no new equipment was required to collect standardized outcome measures. Only minimal supplies were needed such as hair pins and cheek retractors to aid in photo collection. All outcome measures were reported in routine clinical documentation from the start of implementation. The registry was initially a part of the implementation leader’s duties but was transitioned to team members as a part of their routine responsibilities. Other centers may require additional resources to support standardized outcome measurement, including procurement of necessary equipment and supplies, and the development and maintenance of a clinical registry.

The present study elected to collect standardized outcomes measurements—aesthetic, dental, speech—that aligned with WHO recommendations. The study did not include collection of psychosocial outcomes, which is a crucial area to assess in cleft care. Implementation of a psychosocial outcome measurement into the clinic workflow is currently in progress. Future work should also assess the implementation of patient (and caregiver) reported health-related quality of life measures such as the CLEFT-Q—derived from the FACE-Q—that measures appearance45 and speech-related measures such as the Velopharyngeal Insufficiency Effects on Life Outcomes (VELO) questionnare.46 Finally, this study highlights the importance of a champion to select the strategies, lead implementation, and get stakeholder buy-in. It may be difficult for teams to sustain this role in environments constrained by productivity expectations or limited financial support.

Conclusions

Collection of aesthetic, dental, and speech outcomes increased substantially following deployment of a multifaceted implementation strategy addressing known barriers and facilitators to outcome measurement in cleft care. Collection of outcomes continued at a high rate for the 4 years following the intervention period. The acceptability of standardized outcome measurement was high with nearly all providers reporting that they somewhat or completely agreed that standardized outcome measurement met their approval, was welcomed, and was liked. These findings support the feasibility and sustainability of collecting standardized outcome measures that can be used to assess and improve treatment outcomes for children with cleft conditions.

Supplementary Material

Supplemental Table 1
Appendix 1

Supplemental material for this article is available online.

Funding

The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: Research reported in this publication was supported by the National Institute of Dental and Craniofacial Research (NIDCR) and the Office of the Director, National Institutes of Health (OD) under awards K23DE025023 and U01DE029750. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Footnotes

Declaration of Conflicting Interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

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Associated Data

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Supplementary Materials

Supplemental Table 1
NIHMS2126719-supplement-Supplemental_Table_1.docx (17.7KB, docx)
Appendix 1
NIHMS2126719-supplement-Appendix_1.docx (84.9KB, docx)

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