Digital Outpatient Services

Digital Outpatient Services - a Controlled Multicenter Study

More people are living with chronic or long-term disorders together and they live longer, which gives an increase in patients who need health services. Seen in the context of the shorter lengths of stay, and the outpatient clinics' increasing responsibility, there is a need to increase outpatient capacity without leading to more patient readmissions. Further, new services should take into account the patients capacity to benefit from the services, and their level of health literacy is crucial. By developing new services using technology, patients will be able to be followed up closely in their own home with adapted treatment and information, a closer dialogue with the health service where there is a need, and the utilization of scarce resources in the health care system can increase.

The aim of the current study is to evaluate a digital outpatient clinic, and assess any differences over time in health literacy, digital health literacy, quality of life and overall satisfaction with the outpatient services. Furthermore, the investigators will assess the intervention group's satisfaction with the digital outpatient clinic. In addition, the digital services will be tailored and revised throughout the study based on continuous feedback and iterative processes.

The current study is a pragmatic controlled multicenter study with two study arms; one control arm and one intervention arm. In total, eligible participants will be recruited from one of four centers.

Study Overview

• Status: Active, not recruiting
• Conditions: Epilepsy; Cancer; Interstitial Lung Disease; Long Term Pain
• Intervention / Treatment: Other: Dignio Digital Remote Care intervention group; Other: Usual Care Control group

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heidi Holmen, PhD; Phone Number: 004723070000; Email: heidho@ous-hf.no

Study Locations

• Norway
  • Oslo, Norway
    • Oslo University Hospital
  • Tromsø, Norway
    • University Hospital of North Norway

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients attending the study centers that are cognitively able to use a digital outpatient service with no major conflicting disorders, with one of the following disorders:
• cancer
• epilepsy
• interstitial lung disease
• long-term complex pain conditions

Exclusion Criteria:

• under the age of 18
• any mental or cognitive conditions interfering with their ability to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Dignio Digital Remote Care intervention group; Participants will receive the MyDignio app for individualized follow-up for 6 months.	Other: Dignio Digital Remote Care intervention group; The intervention consists of Dignio Prevent (for healthcare professionals) and MyDignio (for patients). The system is CE marked and the system satisfies all regulatory requirements for privacy and information security. Various components can be added for an individualized follow-up of the patients. Elements of the digital outpatient service in Dignio include patient reported outcomes and other questionnaires, tasks, objective measures, reminders and information, in addition to a chat function for asynchronous contact with healthcare personnel and video consultations for real-time consultations.
Other: Usual Care Control group; Participants in the control group will receive follow-up at the outpatient clinic as per their needs.	Other: Usual Care Control group; Participants in the control group will receive follow-up at the outpatient clinic as per their needs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Health literacy	The HLQ is a standardized measure of health literacy, and the investigators will apply five of the nine domains; 1 Feeling understood and supported by healthcare providers; 2 Having sufficient information to manage my health; 3 Actively managing my health; 6 Ability to actively engage with healthcare providers; and 9 Understanding health information well enough to know what to do. the HLQ is is translated and validated in Norwegian. (Osborne et al. 2013; Wahl et al. 2020)	Baseline, 3 months, and 6 months follow-up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Digital health literacy	The investigators will apply the eHLQ to measure level of digital health literacy. The eHLQ contains 35 items summarized in seven domains: 1) using technology to process health information, 2) understanding of health concepts and language, 3) ability to actively engage with digital services, 4) feel safe and in control, 5) motivated to engage with digital services, 6) access to digital services that work, and 7) digital services that suit individual needs. Higher scores indicate better digital health literacy. Domains 1-5 consist of 5 items, domain 6 consists of 6 items, and domain 7 consists of 4 items. (Kayser et al. 2018)	Baseline, 3 months, and 6 months months follow-up.
Change in Health/ quality of life	To assess the patient reported health or quality of life the investigators will use the 12-Item Short Form Survey from the RAND Medical Outcomes Study (RAND-12) (Ware et al. 1996). The items summarizes into two scales; mental component score and Physical component score. Higher scores indicate better health, and the instruments is translated and validated in Norwegian.	Baseline, 3 months, and 6 months follow-up.
Change in Perceived safety in a pandemic	To assess the participants self-perceived safety in the pandemic the investigators will apply the item: "How anxious are you to be infected with Covid-19 (corona)?" with responses on a 5 point Likert scale from "Not anxious" to "Very anxious" .	Baseline, 3 months, and 6 months follow-up.
Change in Satisfaction with digital services	The Service User Technology Acceptability Questionnaire (SUTAQ) is an instrument that can be used to measure user beliefs about the acceptability of digital services, and has the ability to discriminate and predict individual differences in beliefs and behaviour. (Hirani et al 2016; Torbjørnsen et al. 2018)	3 months, and 6 months follow-up.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Experiences with digital outpatient services	Qualitative interviews with patients and healthcare personnel will be conducted to assess their experiences with the new services.	After 6 moths of study follow-up, the investigators will conduct the interviews

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: University Hospital of North Norway
• Investigators: Study Director: Erik Fosse, PhD, Oslo University Hospital; Principal Investigator: Heidi Holmen, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2021
• Primary Completion (Actual): July 1, 2023
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: September 19, 2021
• First Submitted That Met QC Criteria: September 24, 2021
• First Posted (Actual): October 6, 2021

Study Record Updates

• Last Update Posted (Actual): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Satisfaction; mHealth; eHealth; Controlled trial; Health literacy; Digital outpatient services
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial
• Other Study ID Numbers: 21/06826

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No