Digitally Supported Person-centered Care Systems

NCT07142616 | Completed

• 1 other identifier: 2024/ 251632
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

The case history of patients with complex and long-term needs is often stored in fragments across many different care providers, each with a separate electronic health record. Even when the notes are stored in the same organization, the large volume of information makes it difficult for practitioners to grasp the full overview of the patient's situation. The DigiTeam tool, combines information management features to present notes from across the care pathway from the three main providers: General Practice, Health and Social care Services, and Secondary care. It also includes summaries of the patient's concerns, conditions, and treatment plan. It provides links to the source documents that are the basis for the summaries. The overarching aim is to examine the effect of physicians' use of the DigiTeam for three patient cases derived from real-world pseudonymized notes, on the quality of the physcians' ensuing case summary and treatment plan. In the comparator arms, physicians use usual care tools, i.e. only one or three sources of notes and no information management features.

Conditions

Multiple Chronic Conditions

Keywords

Patient-Centered Care; Prevention; Integrated care; Electronic Health Records; Randomized controlled trial; Patient summary; Treatment plan; Decision Making, Shared

Outcome Measures

Primary Outcomes (1)

• Quality of patient summary and follow-up plan

  The primary outcome is the quality of the patient summary and follow-up plan Participants are asked to create a summary as preparation for a care planning meeting with colleagues, using the information available in the digital tool to write 1) a Comprehensive summary of the patient's situation and 2. A care plan. Quality of summaries and care plans will be measured by Microsoft Copilot. An expert group of three clinicians will create gold-standard summaries. These will be converted into a list of clear, mutually exclusive items using standardized rules. Copilot will be prompted to identify whether each item is present in participant responses. The item list will be validated by comparing scoring consistency (Kappa statistics) between researchers and Copilot, aiming for ≥0.7 agreement with researchers and ≥0.9 between Copilot runs. Final scores will reflect the number of items included per response.

  Immediately after completing the the task for each patient

Secondary Outcomes (4)

• Time spent completeing the patient case overviews and follow-up plans

  Immediately after completing the the task for each patient

• System Usability Scale

  Immediately after completing the the task for each patient

• Information support for solving tasks

  Immediately after completing the the task for each patient

• Experience with conducting the task

  Immediately after completing the the task for each patient

Other Outcomes (3)

• Technical problems

  Immediately after completing the the task for each patient

• Experience with the type of patients

  Immediately after completing the the task for each patient

• Time spent on various activities

  Immediately after completing the the task for each patient

Study Arms (3)

01 Usual care with clinical notes from one provider

ACTIVE COMPARATOR

Access to all clinical notes available to the provider in the patient's case. The provider is General practice in two patient cases, and hospital in one patient case.

Other: 01 - Clinical notes from one provider

02 Clinical notes from several providers

ACTIVE COMPARATOR

Access to all clinical notes across three providers: General practitioner, Social services and Specialist care.

Other: 02 - Access to notes from primary and secondary care

03 - DigiTeam - Summaries of and clinical notes from several providers

EXPERIMENTAL

Access to all clinical notes across three providers: General practitioner, Social services and Specialist care, like in arm 02. In addition, access to information management features, such as summaries of patient's priorities, and clinical summaries of key health problems, including links to source documents.

Other: 03 - Summaries of and clinical notes from several providers

Interventions

03 - Summaries of and clinical notes from several providers OTHER

Access to all clinical notes across three providers: General practitioner, Social services and Specialist care, like in arm 02. In addition, access to information management features, such as summaries of patient's priorities, and clinical summaries of key health problems, including links to source documents.

03 - DigiTeam - Summaries of and clinical notes from several providers

01 - Clinical notes from one provider OTHER

Access to all clinical notes available to the provider in the patient's case. The provider is General practice in two patient cases, and hospital in one patient case.

01 Usual care with clinical notes from one provider

02 - Access to notes from primary and secondary care OTHER

Access to all clinical notes across three providers: General practitioner, Social services and Specialist care.

02 Clinical notes from several providers

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• General practitioner OR
• Physician who has graduated within the last five years.
• If the recruitment is difficult, medical students and other physicians may be included.
• To recruit participants, the trial will be announced through known networks, social media, the researchers' network, and general announcements.

Sponsors & Collaborators

• University Hospital of North Norway: lead
• Norwegian University of Science and Technology: collaborator

Study Sites (1)

University hospital North Norway

Tromsø, Troms, 9037, Norway

Location

MeSH Terms

Conditions

Multiple Chronic Conditions

Interventions

Secondary Care

Condition Hierarchy (Ancestors)

Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Referral and Consultation; Professional Practice; Organization and Administration; Health Services Administration; Delivery of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Gro KR Berntsen, Prof

  Norwegian Center for E-health Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The Outcome Assessor of the primary outcome is a large language model, which assesses the answers provided by the participants without any information about group allocation.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are block randomized to balance the three arms (Usual care, 3 sources, Summaries). The sizes of the blocks are set by a trial service office, and not known to those involved in the trial.

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: August 26, 2025
• Study Start: June 18, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: At publication of planned papers from the RCT
• Access Criteria: Contact authors.

Locations

NO (1)