Home-based management of hypoxaemic COVID-19 patients : design of the Therapy@Home pilot study
© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ..
INTRODUCTION: During the COVID-19 pandemic, hospital capacity was strained. Home-based care could relieve the hospital care system and improve patient well-being if safely organised.We designed an intervention embedded in a regional collaborative healthcare network for the home-based management of acutely ill COVID-19 patients requiring oxygen treatment. Here, we describe the design and pilot protocol for the evaluation of the feasibility of this complex intervention.
METHODS AND ANALYSIS: Following a participatory action research approach, the intervention was designed in four consecutive steps: (1) literature review and establishment of an expert panel; (2) concept design of essential intervention building blocks (acute medical care, acute nursing care, remote monitoring, equipment and technology, organisation and logistics); (3) safety assessments (prospective risk analysis and a simulation patient evaluation) and (4) description of the design of the pilot (feasibility) study aimed at including approximately 15-30 patients, sufficient for fine-tuning for a large-scale randomised intervention.
ETHICS AND DISSEMINATION: All patients will provide written, informed consent. The study was approved by the Medical Ethics Review Committee of the University Medical Center Utrecht, the Netherlands (protocol NL77421.041.21). The preparatory steps (1-4) needed to perform the pilot are executed and described in this paper. The findings of the pilot will be published in academic journals. If we consider the complex intervention feasible, we aim to continue with a large-scale randomised controlled study evaluating the clinical effectiveness, safety and implementation of the complex intervention.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2024 |
|---|---|
| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:14 |
|---|---|
| Enthalten in: |
BMJ open - 14(2024), 1 vom: 30. Jan., Seite e079778 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Boeijen, Josi A [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
COVID-19 |
|---|
| Anmerkungen: |
Date Completed 05.02.2024 Date Revised 09.02.2024 published: Electronic Citation Status MEDLINE |
|---|
| doi: |
10.1136/bmjopen-2023-079778 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM367900629 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM367900629 | ||
| 003 | DE-627 | ||
| 005 | 20240210233210.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 240202s2024 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1136/bmjopen-2023-079778 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1287.xml |
| 035 | |a (DE-627)NLM367900629 | ||
| 035 | |a (NLM)38296291 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Boeijen, Josi A |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Home-based management of hypoxaemic COVID-19 patients |b design of the Therapy@Home pilot study |
| 264 | 1 | |c 2024 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 05.02.2024 | ||
| 500 | |a Date Revised 09.02.2024 | ||
| 500 | |a published: Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. | ||
| 520 | |a INTRODUCTION: During the COVID-19 pandemic, hospital capacity was strained. Home-based care could relieve the hospital care system and improve patient well-being if safely organised.We designed an intervention embedded in a regional collaborative healthcare network for the home-based management of acutely ill COVID-19 patients requiring oxygen treatment. Here, we describe the design and pilot protocol for the evaluation of the feasibility of this complex intervention | ||
| 520 | |a METHODS AND ANALYSIS: Following a participatory action research approach, the intervention was designed in four consecutive steps: (1) literature review and establishment of an expert panel; (2) concept design of essential intervention building blocks (acute medical care, acute nursing care, remote monitoring, equipment and technology, organisation and logistics); (3) safety assessments (prospective risk analysis and a simulation patient evaluation) and (4) description of the design of the pilot (feasibility) study aimed at including approximately 15-30 patients, sufficient for fine-tuning for a large-scale randomised intervention | ||
| 520 | |a ETHICS AND DISSEMINATION: All patients will provide written, informed consent. The study was approved by the Medical Ethics Review Committee of the University Medical Center Utrecht, the Netherlands (protocol NL77421.041.21). The preparatory steps (1-4) needed to perform the pilot are executed and described in this paper. The findings of the pilot will be published in academic journals. If we consider the complex intervention feasible, we aim to continue with a large-scale randomised controlled study evaluating the clinical effectiveness, safety and implementation of the complex intervention | ||
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a COVID-19 | |
| 650 | 4 | |a Feasibility Studies | |
| 650 | 4 | |a Organisation of health services | |
| 650 | 4 | |a Patient-Centered Care | |
| 650 | 4 | |a Telemedicine | |
| 700 | 1 | |a van de Pol, Alma C |e verfasserin |4 aut | |
| 700 | 1 | |a van Uum, Rick T |e verfasserin |4 aut | |
| 700 | 1 | |a Venekamp, Roderick P |e verfasserin |4 aut | |
| 700 | 1 | |a Smit, Karin |e verfasserin |4 aut | |
| 700 | 1 | |a Kaasjager, Karin A H |e verfasserin |4 aut | |
| 700 | 1 | |a van den Broek, Robert |e verfasserin |4 aut | |
| 700 | 1 | |a Bijsterbosch, Wilma |e verfasserin |4 aut | |
| 700 | 1 | |a Schoonhoven, Lisette |e verfasserin |4 aut | |
| 700 | 1 | |a Rutten, Frans H |e verfasserin |4 aut | |
| 700 | 1 | |a Zwart, Dorien L M |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t BMJ open |d 2012 |g 14(2024), 1 vom: 30. Jan., Seite e079778 |w (DE-627)NLM215724372 |x 2044-6055 |7 nnns |
| 773 | 1 | 8 | |g volume:14 |g year:2024 |g number:1 |g day:30 |g month:01 |g pages:e079778 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1136/bmjopen-2023-079778 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 14 |j 2024 |e 1 |b 30 |c 01 |h e079778 | ||