Multiple Chronic ConditionsDignityCareNCT07142616
Digitally Supported Person-centered Care Systems
A study testing 03 - Summaries of and clinical notes from several providers, 01 - Clinical notes from one provider and 02 - Access to notes from primary and secondary care in people with Multiple Chronic Conditions, run by University Hospital of North Norway at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Multiple Chronic Conditions
- What is being tested?
- 03 - Summaries of and clinical notes from several providers, 01 - Clinical notes from one provider and 02 - Access to notes from primary and secondary care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteNorway
- Study dates
- 18 Jun 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- There is no exclusion criterium.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dignity Care - Digitally Supported Person-centered Care Systems
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
- Being tested
- 03 - Summaries of and clinical notes from several providers, 01 - Clinical notes from one provider, 02 - Access to notes from primary and secondary care
- Keywords
- Patient-Centered Care, Prevention, Integrated care, Electronic Health Records, Randomized controlled trial, Patient summary, Treatment plan, Decision Making, Shared
- Medical subject headings
- Multiple Chronic Conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
03 - Summaries of and clinical notes from several providersOther
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.
01 - Clinical notes from one providerOther
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.
02 - Access to notes from primary and secondary careOther
Access to all clinical notes across three providers: General practitioner, Social services and Specialist care.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: 03 - Summaries of and clinical notes from several providers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after completing the the task for each patient
Secondary outcomes (4)
Time spent completeing the patient case overviews and follow-up plans
Time from start of case to delivery of answer as measured by participant reported start and stop time.
Measured: Immediately after completing the the task for each patient
System Usability Scale
The usability of the intervention to do the work needed for each patient will be measured with the System Usability Scale which contains ten items scored from one (strongly disagree) to five (strongly agree) that are transformed to a 0 to 100 scale and translated into a curved grading scale from A-F
Measured: Immediately after completing the the task for each patient
Information support for solving tasks
To compare how the different interventions helped to solve the task described under primary outcome, the following questions will be asked:
On a scale of 1 to 5 (1 Poor 2 Fair 3 Good 4 Very good 5 Excellent), how did the information you had access to support you to find information about
- Current medical status?
- Social or personal circumstances that contribute to the current status?
- What is important to the patient?
- What should be followed up further?
- Who should be involved in the follow-up?
Measured: Immediately after completing the the task for each patient
Experience with conducting the task
To compare the experience with the digital tool used to conduct the tasks, the following questions will be used:
On a scale of 1 to 5 (1 Poor 2 Fair 3 Good 4 Very good 5 Excellent)
- What do you think about the tool overall?
- How good was the support in the tool to find the information you needed?
- How useful was the training in using the tool?
- How did the tool work compared to tools you use daily for similar tasks?
- How would such a tool fit into your daily work?
Would you recommend the tool to colleagues? (Yes Unsure No)
Measured: Immediately after completing the the task for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start18 Jun 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Chronic ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Gro KR Berntsen, Prof, Principal investigator, Norwegian Center for E-health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07142616
- Sponsor's protocol ID
- 2024/ 251632
- Acronym
- DignityCare
- Status last verified
- Aug 2025
- First submitted
- 17 Jun 2024
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized questionnaire data
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dignity Care - Digitally Supported Person-centered Care Systems
- ClinicalTrials.gov ID
- NCT07142616
- Acronym / sponsor ID
- DignityCare / 2024/ 251632
- Conditions
- Multiple Chronic Conditions
- Keywords
- Patient-Centered Care, Prevention, Integrated care, Electronic Health Records, Randomized controlled trial, Patient summary, Treatment plan, Decision Making, Shared
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 26 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 01 Usual care with clinical notes from one provider | Active comparator | Other: 01 - Clinical notes from one providerAccess 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. |
| 02 Clinical notes from several providers | Active comparator | Other: 02 - Access to notes from primary and secondary careAccess to all clinical notes across three providers: General practitioner, Social services and Specialist care. |
| 03 - DigiTeam - Summaries of and clinical notes from several providers | Experimental | Other: 03 - Summaries of and clinical notes from several providersAccess 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- There is no exclusion criterium.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 03 - Summaries of and clinical notes from several providersAccess 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 - DigiTeam - Summaries of and clinical notes from several providers |
| 01 - Clinical notes from one providerAccess 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 Usual care with clinical notes from one provider |
| 02 - Access to notes from primary and secondary careAccess to all clinical notes across three providers: General practitioner, Social services and Specialist care. | Other | 02 Clinical notes from several providers |
Primary outcome
Quality of patient summary and follow-up plan
Time frame: Immediately after completing the the task for each patient
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.
4 secondary outcomes
Time spent completeing the patient case overviews and follow-up plans
Time frame: Immediately after completing the the task for each patient
System Usability Scale
Time frame: Immediately after completing the the task for each patient
Information support for solving tasks
Time frame: Immediately after completing the the task for each patient
Experience with conducting the task
Time frame: Immediately after completing the the task for each patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: Yes. Anonymized questionnaire data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gro KR Berntsen, Prof principal investigator
Norwegian Center for E-health Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 03 - Summaries of and clinical notes from several providers, 01 - Clinical notes from one provider and 02 - Access to notes from primary and secondary care in people with Multiple Chronic Conditions, run by University Hospital of North Norway at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of patient summary and follow-up plan (time frame: Immediately after completing the the task for each patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.