Clinical pathway of metabolic therapy with 131I in differentiated thyroid cancer

Abstract

Clinical Pathways are care plans that are applied to clinical processes with a predictable course, with the intention of protocolizing these processes and reducing the variability in their management. Our objective was to develop a clinical pathway for ¹³¹I metabolic therapy in its application to differentiated thyroid cancer.

A work team was organized consisting of doctors (Endocrinology and Nuclear Medicine), nursing staff (Hospitalization Unit and Nuclear Medicine), Radiophysics and the Clinical Management and Continuity of Care Support Service. For the design of the clinical pathway, several team meetings were held, in which the literature reviews were pooled and the design and development of the clinical pathway was undertaken in accordance with current clinical guidelines. This team achieved consensus on the development of the care plan, establishing its key points and drafting the different documents that make up the Clinical Pathway: Timeframe-based schedule, Clinical Pathway Variation Record Document, Patient Information Documents, Patient Satisfaction Survey, Pictogram Brochure, Quality Assessment Indicators. Finally, the clinical pathway was presented to all the clinical departments involved and to the Medical Director of the Hospital and is now being implemented in clinical practice.

Resumen

Las Vías Clínicas son planes asistenciales que se aplican a procesos clínicos de curso predecible, con la intención de protocolizarlos y disminuir la variabilidad en su manejo. Nuestro objetivo ha sido desarrollar una vía clínica para la terapia metabólica con ¹³¹I, proceso asistencial aplicado a los pacientes con carcinoma diferenciado de tiroides.

Se organizó un Equipo de Trabajo formado por médicos (Endocrinología y Medicina Nuclear), personal de enfermería (Unidad de Hospitalización y Medicina Nuclear), de Radiofísica y del Servicio de Apoyo a la Gestión Clínica y Continuidad Asistencial. Para el diseño de la vía clínica se realizaron varias reuniones del equipo, en las que se pusieron en común las revisiones bibliográficas y se abordó el diseño y desarrollo de la Vía, respetando las guías clínicas vigentes. Este equipo ha logrado mediante consenso la elaboración del plan asistencial, estableciendo sus puntos clave y redactando los distintos documentos que componen la Vía Clínica: Matriz temporal, Documento de registro de variaciones de la Vía Clínica, Documentos de Información al paciente, Encuesta de satisfacción del paciente, Folleto de pictogramas, Indicadores de Evaluación de Calidad. Por último, la Vía Clínica se ha presentado a todos los servicios clínicos involucrados y a la Dirección Médica del Hospital, procediendo a su implementación en la práctica clínica.

Introduction

Clinical pathways (CPs) are health care plans that are applied to predictable clinical processes. They describe the clinical activities carried out by each of the professionals attending the patients during their health care process as well as all the information of the care to be provided to the users.

These pathways constitute a useful tool for improving the quality of health care since they define the sequence of care a patient should receive and coordinate the multidisciplinary team by defining who, where, when and how each care should be performed. Likewise, CPs allow evaluating other dimensions of health care quality such as those estimated by the patients themselves and the care managers^1–3.

Metabolic therapy with radioiodine ¹³¹I-NaI (¹³¹I) is indicated in determined patients with differentiated thyroid cancer (DTC) after surgical treatment (thyroidectomy with/without lymph node dissection) depending on the clinical-pathological data and after evaluation of the post-surgical situation⁴. This therapy is a health care process that presents a predictable clinical course and requires good multidisciplinary coordination of various professionals from different departments (Endocrinology, Nuclear Medicine, Radiophysics) as well as the Hospitalization Nursing Unit.

This therapy makes up part of the therapeutic armamentarium of the Hospital Universitario de Navarra (HUN). With the aim of protocolizing and reducing the variability in the management of this type of patients, we proposed the implementation of a CP for the treatment of patients with DTC with ¹³¹I.

The objectives of the elaboration and implementation of the CP were to coordinate the different professionals involved in the care of these patients to ensure completion of the different phases of the process, reduce the variability of clinical practice in the approach to this treatment, optimize the use of resources and improve not only the safety but also the satisfaction of patients receiving metabolic therapy with ¹³¹I in the HUN. This would also generate an educational tool to provide accurate and updated information of treatment with ¹³¹I that would be useful in the training and management of these patients for residents, physicians in training, nurses and other professionals that participate in this clinical process (Table 1).

Table 1.

Objectives sought with clinical pathways and tools for achieving these objectives. The ultimate objective of both is improvements in health care quality.

Objective	Tools
Reduce the variability in clinical practice and provide legal protection for professionals.	Establish the sequence of activities (matrix), standardize the actions and unify criteria of action for all the patients based on scientific evidence, with commitment to patient care and protection for professionals on behalf of the institution.
Improve the coordination among different professionals	Precise definition of the different activities to perform and the responsibilities of each professional from a multidisciplinary point of view
Increase patient satisfaction	Transmit simple and comprehensible information making patients part of the expectations of the health care actions and being committed to their care
Improve patient safety	Registry of the complications and adverse events that occur during treatment and their posterior analysis with the aim of reducing the incidence.
Optimize the use of resources	Perform all the activities and complementary tests necessary in each patient according to the scientific evidence available and only those necessary.
Generate an educational tool for the professionals involved	Precise and up to date information of the management of these patients, while also facilitating a global view of the process and the sequential decision making.

In contrast to other health care processes, such as thyroidectomy^5,6 and other multiple unrelated clinical processes^7–9, in which the development and implementation of their corresponding CP have been described, we found no reference to the design of a CP in the metabolic treatment of DTC with ¹³¹I in a review of the literature.

The present study describes the process of elaboration, design and development of a CP for ¹³¹I treatment in patients with DTC.

Setting of the clinical application. Current state of the subject

The CP developed will be applied in all patients diagnosed with DTC previously treated with total thyroidectomy (with or without cervical lymph node dissection, according to the indication) requiring admission to the HUN for complementary treatment with ¹³¹I as indicated according to the currently prevailing clinical guidelines.

Postoperative treatment with ¹³¹I in patients with DTC has been the subject of many studies and clinical guidelines in the last years^11–15. Postsurgical evaluation of the patient following initial surgical treatment is essential for deciding the need for treatment with ¹³¹I as well as the most adequate dose and the ultimate indication of the treatment (ablation of the remnant, adjuvant therapy or treatment of persistent disease). There is no universal recommendation for all patients with DTC and, thus, it is essential for each patient to be individually evaluated.

The recommendations of the guidelines of the American Thyroid Association¹¹ have the general acceptation of most work groups. Within the context of these guidelines and, in general, the current globally prevailing recommendations¹⁶, and after exhaustive postsurgical evaluation of the patients (clinical manifestations, histopathology and analyses), the Multidisciplinary Thyroid Committee of the HUN has established the indications for treatment with ¹³¹I and the appropriate dose to thereby apply the most adequate individualized therapeutic plan in each patient. These therapeutic recommendations are periodically revised by the committee and updated according to the scientific evidence available.

Before initiating treatment, the patient should present thyroid stimulating hormone (TSH) values >30 mIU/L. These levels can be achieved by discontinuing thyroid hormone treatment for 3–4 weeks or by the use of recombinant human thyroid-stimulating hormone (rhTSH), which improves the quality of life and reduces hospital stay for patients. The preparation with rhTSH is recommended in patients with a low or intermediate risk of recurrence or high risk and comorbidities. In high risk patients there are no recommendations for its use due to the lack of sufficient evidence. In addition, preparation for the treatment also requires an iodine-poor diet for 1–2 weeks.

Due to the radiological characteristics of ¹³¹I and its metabolic incorporation and elimination, patients must be hospitalized for the first days after the administration of treatment. This hospitalization is based on radiological protection¹⁷ of their environment (family members and persons participating in their care), health care workers and the general public. Urine, saliva and perspiration are the main pathways of elimination of ¹³¹I and therefore this type of residue should be adequately treated. Specifically, the urine eliminated during hospitalization is collected and stored in a special waste container for management as radioactive residue. The length of hospital stay depends on the rate of dose emitted by the patient, which is monitored with radiation detectors. In order to maintain the exposure of persons within the patient’s environment below safe dose limits, when this dose rate is below the appropriate value¹⁸, the patient should be discharged following a radiological protection scheme which includes hygiene measures to prevent radioactive contamination by saliva, perspiration and urine and distancing measures.

Objectives

The different Guidelines and Protocols currently in prevailing for the treatment with 131I in DTC, however, do not guarantee a protocolized and standardized care in all patients, which ensures the fulfillment with all the recommendations established in these Guidelines.

Thus, there is a need for the development of CPs with the final objective of improving health care quality and the secondary objectives as shown in Table 1. CPs are tools for the coordination of all the dimensions of the health care process¹⁹, not only in regard to those related to the professionals involved (optimized and coordinated care adjusted to the indication, from a multidisciplinary perspective) but also those associated with the patient (knowledge of the process, participation and adjustment to expectations) and the health care institution (management, optimization of resources, guarantees of health care quality).

Up to now, CPs have been described for the surgical treatment of DTC and for many other clinical processes, but not for metabolic therapy with ¹³¹I in DTC. Treatment with ¹³¹I was chosen for being a health care process that requires good multidisciplinary coordination and present a predictable clinical course. The selection of this process was made in consensus with the members of the different departments that participate in the same, including radiophysicists and physicians and nurses.

Thus, the multidisciplinary team has developed and applied the CP of ¹³¹I in all patients attended in the HUN diagnosed with DTC previously treated with total thyroidectomy and require complementary administration of ¹³¹I with ablative intent as adjuvant or therapeutic treatment. A guideline has been redacted by consensus and includes all the steps to follow in the present CP as well as the different documents that make up the CP, which have also been elaborated by the multidisciplinary team.

Timeline of the design and development of the clinical pathway

For the development of the CP we used the FOCUS-PDCA model¹⁰, which is a methodology of continuing improvement of processes, implemented by the Hospital Corporation of America that includes the phase of action shown in Table 2.

Table 2.

FOCUS-PDCA model modified by Plsek, PE. Quality Management in Health Care, 1993; 1: 69-81.

Find a process improvement opportunity

Organize a team who understands the process

Clarify the current knowledge of the process

Understand variations in the process

Select a Strategy for improvement:

Plan the process improvement

Do the data collection, analysis and improvement

Check the results

Act by adopting, adjusting or abandoning the change

The process of design, development and implementation of the CP for treatment with ¹³¹I followed the Timeline shown below.

First, treatment with ¹³¹I was selected as the ideal clinical process for the development of the CP and the theoretical aspects of the process of development of the CP, objectives, project, stages of development and implementation were described in an educational session in the corresponding clinical departments. In the first department meeting, the clinical process was approved and the Work Group was selected with the aim of designing and implementing the CP in the HUN. This Work Group was made up of physicians of Endocrinology and Nuclear Medicine, nurses in the Hospitalization Unit and Nuclear Medicine, specialists in Radiophysics and the Department of Support to Clinical Management and Health Care Continuity of the HUN.

In the first meeting of the team, the results of bibliographic reviews (manuals of clinical practice, articles, guidelines of clinical practice, CPs and systematic reviews published) on treatment with ¹³¹I in electronic databases (PubMed, Medline, Cochrane Library Plus) describing the types of studies (observational,…) and clinical trials from which the scientific evidence of the recommendations was derived were selected and reviewed.

Based on this review of the literature, a draft of the CP and of all the documents from which it was derived was elaborated. To extract the recommendations described in the document of the CP, consensus was achieved among the different professionals in relation to the health care plan and the key points of the CP.

In the following meetings, this draft was revised, incorporating suggestions, until the redaction of the definitive guideline document, which was finally presented and approved by the different departments. A pilot timeline for the CP was proposed and was presented to all the clinical department involved and the Medical Administration of the HUN before beginning the implementation of the CP.

A six-month pilot period coordinated by the Work Group was established in which a follow-up and registration of the variations and complications presented during the launch period of PC were reported and opportune measures for improvement were taken.

Finally, after the presentation of the results of the pilot study and the opportune modifications of the definitive CP document arising during the pilot study, the CP was implemented with the creation of Record 2.0 in the electronic clinical history (ECH), and the first patient with an electronic report was registered in June 2021.

Taking into account that the CP is a dynamic tool, it is important to collect information of the evaluation of the indicators as well as the variations detected over a period of time. To do this, the CP will undergo periodic evaluation and revision based on the findings observed and the new scientific evidence available. These revisions will also be made by the Work group.

Once the CP has been launched, the Work Group will periodically meet (annually) to evaluate the indicators of quality, by analyzing the variations registered, evaluating the surveys of patient satisfaction, collecting and reporting the suggestions of the peers participating in the CP and to update the scientific evidence available on treatment with 131I. ¹³¹I This analysis aims to detect possible areas of improvement of the CP and, accordingly, propose pertinent modifications to the CP.

Documents of the clinical pathway

The “Guideline Document” of the CP has been entered in the servers of the different clinical departments and units participating in treatment with ¹³¹I so that it is available to all the professionals involved in the management of the process and can be consulted at any time and by any health care professional related to the process.

The specific documentation generated by each patient is digitalized and includes their clinical history (informed consent). The verification sheets and/or the data log from the pilot phase as well as the satisfaction survey of all the patients have been collected by the owners of the CP in order to extract the necessary information for obtaining the indicators of quality of the pathway.

The CP of treatment with ¹³¹I in the HUN is made up of the documents described below.

Time matrix of the clinical pathway

The time matrix of the Source Document or Work Log (Fig. 1), which sequentially and chronologically collects and details all the activities to be carried out by each of the professionals involved in the treatment of DTC with ¹³¹I treatment as well as the professionals responsible for each activity, the site where it is performed and the verification list of these activities thereby serving as a check list of the whole process.

Figure 1.

Time matrix.

Time matrix of the CP with the successive chronological “times” of patient care. Endocrinology outpatient consultation (A), Nuclear Medicine outpatient consultation (B); Pre-admission (C), Admission (D), Admission and Discharge follow-up (E) and Post-treatment evaluation (F). Include all the activities carried out in detail, the professional in charge of each activity and its location as well as the verification list.

All this information is collected for each of the six times that sequentially make up the health care process, from the time the patient is received in the Endocrinology consultation to finalization with the acquisition of the post-therapy scan in Nuclear Medicine. This matrix is created for each patient attended and is successively filled out by the different professionals that attend the patient.

In the initial phase of the pilot study, the document (in paper) was physically taken to the successive locations. At present, a file in version 2.0 has been created in the ECH of the patient.

Document for the registry of variations in the clinical pathway

This document registers any variation that may occur during the health care process, whether in relation to the patient, the professionals or the institution (Fig. 2). It registers and describes the type of deviation from the CP as well as the measures adopted in each case.

Figure 2.

Variations.

Document of notification and registry of the variations occurring and the actions taken to resolve these variations.

Documents of patient information

These documents aim to facilitate comprehension of the process by the patient and their family members. All the information is structured into six different documents that are given and explained to the patient during the pre-treatment consultation in the Department of Nuclear Medicine, available in the supplementary files (see appendix):

• •

  Treatment plan: planning time of the whole process.

• •

  Diet low in iodine for treatment with ¹³¹I.

• •

  Appointment for the administration of rhTSH prior to admission.

• •

  Admission to ¹³¹I treatment room: detailed description of the metabolic therapy room and the particular characteristics of admission.

• •

  Informed consent.

• •

  Document of care or advice at discharge: provides a precise description of the recommendations to follow at home after medical and radiological discharge in relation to radioprotection of the patient, family members and environment.

Additionally, two forms will be completed during the first visit in Nuclear Medicine: pre-admission nursing evaluation (psycho-socio-health care and autonomy assessment of the patient) and survey of evaluation of socio-occupational circumstances and the residence of the patient for the estimation of radiological discharge, which allows previous planning of the possible requirements or particular needs of each patient during admission as well as the duration of posterior isolation.

Pamphlet of pictograms

This pamphlet (Fig. 3) is clearly and concisely schematized with simple self-explanatory illustrations to explain the recommendations for the patient with respect to medication, alimentation, exercise and diagnostic tests throughout the whole procedure of ¹³¹I treatment. It is a simplified graphic version of the time matrix aimed at the patient to facilitate comprehension.

Figure 3.

Pictograms.

Pamphlet of pictograms with a graphic representation of the recommendations for the patient in each step of the procedure in relation to both pre-treatment preparation (A) and during admission and after hospital discharge (B).

Patient satisfaction survey

This is a questionnaire that is given to the patient at the end of the whole procedure (Fig. 4), after the acquisition of the post-treatment scintigraphic study in the Nuclear Medicine Department. The objective is for the patient to anonymously provide a detailed description of their perception of the quality of the care received, evaluating not only the hospital infrastructure but also the information and care received by all the personnel directly involved in their treatment.

Figure 4.

Satisfaction survey.

This includes anonymous assessment of the information and care received (A), the installations, equipment and professional competence (B) as well as a section of suggestions (C).

Indicators of evaluation of the clinical pathway

Indicators of quality (Fig. 5) constitute a key element for evaluating the implementation of the CP and finally verify its impact on the health and well-being of the patients. The indicators were developed by the Work Group and attempt to cover the different areas of health care quality. These indicators will be calculated annually during the period of implementation to identify possible areas of improvement and the measures taken in these areas.

Figure 5.

Indicators of quality.

Indicators of quality for dynamic evaluation of the CP, regarding those related to patient inclusion and waiting time (A) and mean stay and variation that occurred during the process (B).

Conclusions

The time matrix of the CP is essential for achieving the objective of standardizing treatment of DTC with ¹³¹I to guarantee complete care of all the patients as well as the safety of this treatment. It is of special relevance when new professionals or residents in training incorporate in the different departments.

On the other hand, different documents are given to the patient in the Nuclear Medicine consultation (global planning of the process, particular characteristics of admission, recommendations of radioprotection during admission and after discharge home). These simple, detailed explanatory pictograms allow the systematization of information for the patient and family members, thereby facilitating their participation in the process and comprehension of the particular characteristics of their treatment and, consequently, increasing their satisfaction with the care received.

In this sense, the satisfaction survey is a key tool for knowing possible areas of improvement and the measures to be taken in these areas and is one of the indicators of quality which will allow constant evaluation of the CP and thus, progressive improvement in health care quality.

Since its implementation, the CP has been routinely applied in health care practice in the HUN and is currently undergoing an assessment process of achievement of the indicators proposed.

Funding

The present study has received no funding from the public, commercial or not for profit sectors.

Conflict of interests

The authors declare having no conflict of interests.