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Accepted for/Published in: JMIR Research Protocols

Date Submitted: Feb 21, 2023
Date Accepted: Jun 7, 2023

The final, peer-reviewed published version of this preprint can be found here:

Digital Outpatient Services for Adults: Development of an Intervention and Protocol for a Multicenter Non–Randomized Controlled Trial

Holmen H, Holm AM, Kilvær TK, Ljoså TM, Granan LP, Ekholdt C, Larsen LS, Fosse E

Digital Outpatient Services for Adults: Development of an Intervention and Protocol for a Multicenter Non–Randomized Controlled Trial

JMIR Res Protoc 2023;12:e46649

DOI: 10.2196/46649

PMID: 37428533

PMCID: 10366969

Digital outpatient services for adults: development of an intervention and description of a multicenter non-randomized controlled trial

  • Heidi Holmen; 
  • Are Martin Holm; 
  • Thomas Karsten Kilvær; 
  • Tone Marte Ljoså; 
  • Lars Petter Granan; 
  • Christopher Ekholdt; 
  • Lotte Sandberg Larsen; 
  • Erik Fosse

ABSTRACT

Background:

Healthcare services are challenged by an increasing number of patients and limited resources. Therefore, research investigating options to reduce costs and increase effectivity is warranted. Digital outpatient services can provide flexible and tailored follow-up, improve patients’ health literacy, and facilitate the identification of adverse courses of diseases.

Objective:

This article aims to describe the “digital outpatient service” intervention and to present the protocol for the ongoing multicenter, non-randomized trial evaluating this intervention.

Methods:

Based on previous experiences and evidence-based knowledge, this intervention has been developed through patient-journey maps in collaboration with each clinical specialty. The patients gain access to a mobile app for self-monitoring and patient-reported outcomes, and chat for contact between the patients and healthcare workers. The healthcare workers’ dashboard includes a traffic-light system to draw attention to the most urgent patient report. In this multicenter, non-randomized controlled trial, patients are allocated to the control group receiving standard care or the 6-months intervention. Eligible patients are aged 18 years or older, who receive outpatient care at the neurology, lung, pain, or cancer department at two university hospitals in Norway. The evaluation will include patient-reported outcomes, qualitative interviews, and clinical measures. The primary outcome will be health literacy using the Health Literacy Questionnaire (HLQ). A sample size of 165 participants is split into a 1:2 ratio in favor of the intervention. Quantitative data will be analyzed in SPSS using descriptive statistics and logistic regression. Qualitative data will be analyzed using thematic analysis.

Results:

This trial started in September 2021 and the intervention started in January 2022. It is expected to end in July 2023 with results in December 2023.

Conclusions:

This study will evaluate an intervention facilitated by an already certified digital multicomponent solution, with intervention content based on patient-reported outcomes, health literacy, and self-monitoring. The intervention is specifically tailored to each participating center and the needs of their patients, using patient journey maps. The comprehensive and generic evaluation of this digital outpatient service intervention is a strength as it targets a heterogeneous sample of patients. Thus, this study will provide important knowledge about the applicability and effects of digital healthcare services. As a result, patients and healthcare workers will gain a new and evidence-based understanding of whether and how digital tools may be used in clinical care. Clinical Trial: NCT05068869


 Citation

Please cite as:

Holmen H, Holm AM, Kilvær TK, Ljoså TM, Granan LP, Ekholdt C, Larsen LS, Fosse E

Digital Outpatient Services for Adults: Development of an Intervention and Protocol for a Multicenter Non–Randomized Controlled Trial

JMIR Res Protoc 2023;12:e46649

DOI: 10.2196/46649

PMID: 37428533

PMCID: 10366969

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