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ATME—Needs, requirements and cross-sectoral patient journeys of patients with out-of-hospital mechanical ventilation and intensive care in outpatient settings: study protocol for an observational study
  1. Nahne-Alina Knizia1,
  2. Josefine Hirschler1,
  3. Constance Stegbauer1,
  4. Antje Schwinger2,
  5. Andreas Büscher3,
  6. Nathalie Englert3,
  7. Lara Peters3,
  8. Hakim A. Bayarassou4,
  9. Leonie Mallmann5,
  10. Gerald Willms1
  1. 1aQua Institute for Applied Quality Improvement and Research in Health Care GmbH, Göttingen, Germany
  2. 2AOK Research Institute, Berlin, Germany
  3. 3Faculty of Business Administration and Social Sciences, University of Applied Sciences, Osnabrück, Germany
  4. 4German Interdisciplinary Society for Out-of Hospital Ventilation e. V. (DIGAB), Cologne, Germany
  5. 5Federal Association of Private Social Service Providers, Berlin, Germany
  1. Correspondence to Nahne-Alina Knizia; nahne-alina.knizia{at}aqua-institut.de

Abstract

Introduction An increasing number of tracheotomised and/or ventilated patients with high-cost out-of-hospital intensive care needs and, at the same time, a decreasing number of healthcare professionals inevitably lead to challenges in the care of this patient population. In addition, little is known about this population, their health restrictions, needs, patient journeys, care structures and processes. The project ‘Needs, requirements and cross-sectoral care pathways of out-of-hospital ventilated intensive care patients’ (ATME) aims to analyse these aspects and explore current care structures to inform further development of care in line with patients’ needs and requirements.

Methods and analysis Qualitative and quantitative methods will be used. In preparation of a semistandardised survey, exploratory interviews will be conducted with tracheotomised and/or ventilated patients with out-of-hospital intensive care needs (TVPOI) (n=15), nursing care providers (n=30), outpatient medical centres, as well as outpatient medical, medical technology and therapeutic care providers (n=35). Three semistandardised survey questionnaires for TVPOI (n=2,000) will be developed and conducted with nursing care facilities (n=250) and outpatient medical centres for mechanical ventilation (n=25). Content analyses will be conducted for qualitative data; survey data will be analysed descriptively. In addition, healthcare claims data will be analysed descriptively to provide information on patient journeys. Three result workshops and one consensus conference will be carried out with representatives of the relevant target groups to analyse the suitability of care structures and to develop recommendations for action to improve TVPOI.

Ethics and dissemination The ATME study received a positive vote from the Ethics Committee of the Osnabrück University of Applied Sciences and is registered in ‘Deutsches Register Klinischer Studien (DRKS)’ (registration number: DRKS00030891). The study results will be presented at national conferences and in relevant peer-reviewed journals. Additionally, study results will be published by the funding institution (the Innovation Committee of the Federal Joint Committee) on their website.

  • INTENSIVE & CRITICAL CARE
  • Health policy
  • QUALITATIVE RESEARCH
  • Quality of Life
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Strengths and limitations of this study

  • Mixed-methods design using qualitative and primary and secondary quantitative data to generate a database for the advancement of healthcare.

  • Inclusion of different perspectives on healthcare for patients with out-of-hospital mechanical ventilation and intensive care needs.

  • Potential limitations are the selection bias of the interviewed persons and survey participants, as well as the structure of healthcare claims data as secondary data.

  • In addition, the study is being conducted at a time when regulatory changes still need to be implemented.

Introduction

In Germany, the number of tracheotomised and/or ventilated patients with out-of-hospital intensive care needs (TVPOI) is increasing due to medical and technological advances.1 Due to a lack of registration and data, the exact number of affected patients is unclear; 5,500 to 20,000 TVPOI are estimated, with an upward trend.2

TVPOI represent a very heterogeneous group, especially with regard to their age, ventilator-causing diseases and comorbidities, course of disease and care needs, therapy goals, as well as living and care situations.1–3 In Germany, different care settings for TVPOI exist: inpatient facilities and outpatient care supported by nursing care service providers (eg, in the patient’s own home or in a shared apartment). Detailed information on intensive care in Germany can be found in box 1.4 However, high costs of medical, rehabilitative-therapeutic and nursing care services,1 5 and an intransparent provider market,3 with increasing evidence of quality deficiencies4 6 7 have been criticised. Studies found indications of medical-therapeutic overuse, underuse and misuse, especially with regard to unused weaning potential,5 8 9 overload of general practitioners,10 lack of therapeutic rehabilitation services11 and qualified specialist nurses,6 7 with regionally varying availability.12 Furthermore, the basic rights to self-determination and participation of those affected are often not guaranteed.6 7 The rising shortage of skilled nurses leads to further challenges in the healthcare of TVPOI.13

Box 1

Intensive care in Germany

Persons with statutory health insurance and a high demand for medical care are entitled to intensive care in Germany (§37c Abs. 1 Social Code Book V). A high demand for medical care is given if the continuous presence of an appropriately qualified nurse is necessary due to the imminent danger of a life-threatening situation that requires nursing or medical intervention.15

Indications of challenges in care provision led to the institution of a new legal regulation for out-of-hospital intensive care, the ‘Intensive Care and Rehabilitation Strengthening Act (GKV-IPReG)’, yet also to the realisation that further analyses of healthcare are needed.2 However, there is still insufficient information about the actual number of TVPOIs, their diseases and care trajectories, as well as their needs and requirements.2 6 7 The innovation fund project ‘Needs, requirements and cross-sectoral care pathways of out-of-hospital ventilated intensive care patients’ (ATME) addresses these aspects by aiming to describe and analyse the care structures and patient journeys of out-of-hospital ventilated and/or tracheotomised intensive care patients and thus create the basis for further development of care services in line with the needs and requirements of this patient population. The main result of the project will be recommendations for action to improve healthcare for TVPOI. Standardised surveys are conducted with service providers and patients, and analyses of health insurance data form the basis of the study. The project period lasts from 1 July 2022 to 30 June 2024. It will be conducted by a consortium of the aQua Institute for Applied Quality Improvement and Research in Healthcare GmbH, the University of Applied Sciences Osnabrück, the the WIdO AOK Research Institute and the Federal Association of Private Social Service Providers (bpa). The German Interdisciplinary Society for Out-of-Hospital Ventilation e. V. (DIGAB) will support the project as a cooperation partner.

Methods and analysis

Aim

The present study aims to describe the population of TVPOI as well as their patient journeys and care structures in order to analyse the suitability of current care structures and thus lay the basis for a demand-oriented advancement of care services in Germany. The project is divided into a foundational and an applied research part.

Foundational research part

The aim of the foundational research part of the study is to describe and analyse cross-sectoral patient journeys and the current care structures of TVPOI. Therefore, the epidemiological and sociodemographic characteristics of the population in question will be described, as well as their needs and requirements with regard to their disease, patient journey and healthcare. Self-determination and patient participation rights will also be considered. Research also will take into account current and past medical, rehabilitative-therapeutic and ambulatory nursing care.

Applied research part

In this second part of the study, the analysis will explore whether current healthcare structures prevalent in Germany are suitable to cater for the needs of TVPOI. As the study will be conducted during the implementation phase of the GKV-IPReG (more information can be found in box 2), the impact of this new legal framework will be considered as well. Based on the knowledge gained, recommendations for further development of healthcare services will be provided that take the needs and requirements of TVPOI into account. With the support of the project advisory board, a prioritisation of challenges and referring suggestions for improvements in care structures will be provided. The advisory board is composed of patient and patient relative representatives, representatives of cost units, service, aid and care providers, and researchers from the field of out-of-hospital intensive care.

Box 2

Intensive Care and Rehabilitation Strengthening Act (GKV-IPReG)

With the introduction of the GKV-IPReG, the legal basis for the care of TVPOI is newly regulated in Germany. Due to the new law, the out-of-hospital intensive care (AKI) directive was passed by the Federal Joint Committee in November 2021 and became effective as of 18 March 2022. Since January 2023, prescriptions for services according to the AKI directive have been possible.16 Prior to the introduction of the GKV-IPReG, out-of-hospital intensive care prescriptions fell into the category of home nursing care (HKP) according to Section 37 of the German Social Code, Book V.15 The main changes to GKV-IPReG for the care of TVPOI are as follows16:

  • Only ‘specifically qualified’ doctors are allowed to prescribe out-of-hospital intensive care.

  • The weaning potential of TVPOI must be assessed before each prescription.

  • Only nursing care services that have successfully passed a quality inspection by medical boards are allowed to provide out-of-hospital intensive care.

  • Care must be audited annually by the medical service (MD).

Study design

ATME is an observational study with a descriptive and explorative part and a mixed-methods design with retrospective and cross-sectional elements. For the foundational research, TVPOI, nurses providing out-of-hospital intensive care, outpatient medical, medical technology and therapeutic providers will be consulted. The data that will be analysed in this part of the study comprises primary (interviews and surveys) and secondary (healthcare claims data); both will be analysed using quantitative and qualitative methods. Based on the observed results, three subsequent result workshops and one consensus conference will be held to develop recommendations for action for the applied research part. For further details, see figure 1.

Figure 1

Study progress. TVPOI, tracheotomised and/or ventilated patients with out-of-hospital intensive care needs.

Study population

Inclusion and exclusion criteria

Patients with tracheostoma and/or invasive or non-invasive mechanical ventilation of any age who receive permanent out-of-hospital intensive care at home (1:1 care), in a specialised shared living community or in a long-term care facility in Germany are included in the study. In cases of children under the age of 18 or patients who are cognitively unable to express themselves, relatives or carers can participate in the project.

Nursing care services can participate in the project if:

  • They have concluded a care contract according to §132a of the German Social Code Book V, including a supplementary agreement according to §4 of the relevant framework recommendation of the GKV-SV and can demonstrate care for the above-mentioned patient population.

  • They provide out-of-hospital intensive care for patients based on §37c subsection 2 of the German Social Code Book V (or, before November 2020, based on §37 subsection 2 of the Social Code Book V).

  • They have a care contract pursuant to §132l, subsection 5 of the German Social Code Book V (or prior to May 2019 based on §132a, subsection 1, sentence 5 of the German Social Code Book V).

Furthermore, healthcare providers for out-of-hospital mechanical ventilation (eg, speech therapists, occupational therapists, outpatient specialists, general practitioners and home care providers) who care for TVPOI can participate in the study.

Individuals and healthcare providers to whom the preceding criteria do not apply are excluded from the study.

Recruitment

Exploratory interviews

Participants for the exploratory interviews will be recruited by all consortium partners of the ATME project. Further measures to recruit participants will include the presentation of the project at scientific conferences, a newsletter and recruitment by members of the advisory board.

Semistandardised surveys

For the semistandardised surveys, outpatient medical, medical technology and therapeutic providers will be recruited by the DIGAB. The bpa will recruit nursing care facilities and services. Subsequently, participating nursing care facilities and outpatient medical centres will recruit TVPOI. In addition, nursing care facilities and TVPOI will be recruited through self-help groups, newsletters and a public call for participation.

Workshops and consensus conference

The participants of the three result workshops and the consensus conference will be recruited by project members and the DIGAB network.

Sample size

Exploratory interviews

Three different target groups will be addressed for the interviews. Depending on the estimated size of the total population, the following guideline values for target group-specific sample sizes were defined:

  • Approximately 15 TVPOI.

  • Approximately 30 nursing care facilities, services and outpatient medical centres.

  • Approximately 35 outpatient medical, medical technology and therapeutic providers.

The different sample sizes for the interviews are based on the number of different perspectives represented. While interviews with TVPOI are expected to reach a thematic saturation in a smaller sample already, more interviews with nursing care facilities and services and outpatient medical centres, as well as outpatient medical, medical technology and therapeutic providers, are considered necessary to be able to explore the perceptions of all professions involved.

Semistandardised surveys

Based on the interviews, semistandardised surveys of three target groups will be conducted. As it is the goal of the semistandardised surveys to describe current care structures on a greater quantitative data basis, 5,000 TVPOI would need to be reached at an expected response rate of 40%. In addition, employees of 500 nursing care facilities and services and 50 outpatient medical centres will be encouraged to participate in the survey, with an expected response rate of 50%.

Healthcare claims data analysis

For the analysis of healthcare claims data, all available data on TVPOI of all 11 regional statutory health insurance funds (AOK) will be used to describe current healthcare structures and patient journeys. Data on approximately 6,000–8,000 insured individuals per year from 2017 to 2022 will be included in the analysis.

Workshops and consensus conference

The result workshops will be conducted with TVPOI, medical and therapeutic providers, and nursing facilities. The consensus conference will be attended by the members of the advisory board and other stakeholders as appropriate. Recommendations for action shall be consented to and objectified in a transparent and structured manner.

Data collection and database

To reach the objectives of the study, qualitative and quantitative data will be assessed and analysed.

Exploratory interviews

The interviews aim at exploring the field of investigation and will support the development of the semistandardised surveys. Moreover, the perspectives of different healthcare providers, that is, nursing professionals, general practitioners, resident medical specialists and home care providers, will be considered. This is all the more desirable, as little is known concerning their involvement in the healthcare provision of TVPOI. Therefore, three specific interview guidelines have been developed.

TVPOI will be asked questions regarding their living situation, out-of-hospital mechanical ventilation and the organisation of their healthcare. Furthermore, experiences concerning individual patient journeys and assessments of the legal changes due to the GKV-IPReG are inquired. Topics of the interviews with partners from nursing facilities and services, outpatient medical centres, as well as outpatient medical, medical technology and therapeutic providers will be, for example, their tasks in the provision of healthcare, usual symptoms and patient journeys of TVPOI. Additionally, they will be asked to give an assessment of the current care structures of TVPOI and interdisciplinary cooperation between different healthcare providers.

All target groups will be asked for their assessment of the change in the legal framework. The exploratory interviews will be conducted via video, telephone or face-to-face interviews, depending on the preferences of the interview partner.

Based on the findings from the interviews, semistandardised surveys will be developed. Furthermore, the results will be incorporated into the development of recommendations for action.

Semistandardised surveys

Three different surveys will be conducted to describe the patient population in a semistandardised way.

The aim of surveying TVPOI is to describe the target population using primary data. For this purpose, the survey instrument will contain questions on sociodemographic data (eg, age group, gender and marital status), underlying diseases and comorbidities, the experienced course of illness and care, as well as the care structures used and the living situation of the participants.

The aim of surveying nursing facilities and outpatient medical centres is to collect information about healthcare (therapies, weaning, medical and ambulatory nursing care, and hospitalisation) for TVPOI in addition to the structural aspects. The survey will contain items about structural characteristics (eg, number, type and severity of disease in TVPOI, number and qualification of staff, and existing cooperations), items on conducive and obstructive factors of guideline-based and needs-based care, as well as the hospital interface.

The developed questionnaires will be pretested by representatives of the relevant target groups and revised depending on feedback before the start of the survey. The surveys for employees of nursing care facilities and outpatient medical centres for mechanical ventilation will be conducted as online surveys. TVPOI can use an online survey or a paper-and-pencil version of the survey.

Healthcare claims data

A retrospective longitudinal claims data analysis will also be part of the study. Anonymised claims data from 11 regional statutory health insurance funds (AOK) will be used. Information on ambulatory nursing care, hospital admission, physician’s visits, physiotherapy and occupational therapy, as well as prescriptions for drugs and medical devices, will be included. Data of approximately 6000–8000 TVPOI per year from 2017 to 2022 can be included in the sample.

Workshops and consensus conference

Based on the results of the interviews, the semistandardised survey and the routine data analysis, three result workshops will be held. The aim of these workshops is to prioritise relevant care problems and options for the further development of care structures. Based on the result workshops, a consensus conference will be conducted to discuss the recommendations for the improvement of care and to investigate the feasibility of the further development of care structures. In the consensus conference, care-related problems and possible solutions identified in the course of the project are evaluated in an anonymous vote.

Analyses

Exploratory interviews

Exploratory interviews with TVPOI, nursing facilities and outpatient medical, medical technology and therapeutic providers will be recorded and transcribed. Interview transcripts will be pseudonymised and analysed in MAXQDA using qualitative content analysis, according to Mayring.14

Semistandardised surveys

The survey data collected will be analysed descriptively. Depending on the scaling, frequency distributions or mean values, including SD, will be evaluated. Appropriate statistical tests will be used to test for significant differences between the different types of service providers (outpatient medical centres vs. nursing facilities). Free-text data from the surveys will be summarised in terms of content and presented narratively.

Healthcare claims data analysis

The claims data analysis will focus on the epidemiological and sociodemographic description of the study population and will provide information about the underlying diseases, comorbidities, age and gender, as well as the living and care situation of TVPOI. In addition, a description of the medical, rehabilitative-therapeutic and nursing care of the sample is aimed at. A focus will be placed on patient journeys, especially where discontinuity of care. for example, from inpatient to outpatient care, is expected. Derived from this broad perspective, the course of the illness and therapy, the care and the housing situation of these patients will be described. To the best of our knowledge, no comparable analyses exist to date that allow extrapolations on the number of insured TVPOI for Germany.

Workshops and consensus conference

The workshops will be recorded, and the results will be documented in a protocol. The votes from the result workshops are evaluated quantitatively, and the scientific advisory board prioritises the developed solution approaches in the consensus conference. The recommendations for action identified in the consensus conference are assessed quantitatively from the point of view of practicability.

Patient and public involvement

Patients were not involved in the study design but played an important part in the development of the questionnaires. Their needs as well as their care and living situation will be assessed in interviews. The information thus gathered will then be incorporated into the development of the questionnaire. Patients will also be asked to give feedback on the questionnaire and to distribute the survey within their networks. In addition, patients will be represented on the advisory board and will thus be involved in all parts of the study. In the result workshops and consensus conference at the end of the study, recommendations for action are developed, again with active patient support.

Ethics and dissemination

The study received a positive vote from the Ethics Committee of the Hochschule Osnabrück, University of Applied Sciences (document number: HSOS/2022/1/6). The study results will be presented at national conferences and in relevant peer-reviewed journals. Additionally, study results will be published by the funding institution (Innovation Committee of the Federal Joint Committee) on their website.

Ethics statements

Patient consent for publication

References

Footnotes

  • Contributors GW, CS, AS, AB, HAB and LM designed the concept of the study. N-AK and JH drafted the manuscript. CS, GW, LM, AS, AB, NE and LP contributed to manuscript drafting, editing and reviewing. All authors read and approved the final manuscript.

  • Funding This work is funded by the Innovation Committee of the Federal Joint Committee (G-BA), grant number: 01VSF21027.

  • Competing interests Dr HAB declares to work as a physician working with tracheotomised and/or ventilated patients with out-of-hospital intensive care needs. In addition, he holds the position of President of the DIGAB e. V. Dr LM declares no competing interests besides working for the bpa. The other authors declare no competing interests.

  • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

  • Provenance and peer review Not commissioned; externally peer reviewed.