Nurse-Patient RelationsPINPOINTNCT06067672
The Patient's First Point of Contact
An observational study of Nurse-Patient Relations, run by University of Boras at 1 site in Sweden.
Trial summary
The overall objective of this observational study is to investigate practices of communication and decision-making during nurses' initial assessment of patients' health problems in primary care, examine working mechanisms in good practices and develop feasible solutions. The specific aims are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nurse-Patient Relations
- What is being tested?
- Observations to investigate the current practices of communication and decision-making during Nurse-patient consultations
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- 15 Aug 2023to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Audio-recorded observations from a purposive sample of 150 patient-nurse consultations, including 30 nurses and 150 patients will be recruited at primary care centres in three different geographic areas of the southwest of Sweden.
Who may be able to join
- Registered Nurses at primary care centres and patients seeking primary care for a new health concern or a new episode of a problem
Who cannot join
- Patients visiting the primary care nurse with a chronic or continuous health problem
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
University of Borås
Borås, 50190
Annelie Sundler, Professor, annelie.sundler@hb.se
About this study
Official title: The Patient's First Point of Contact (PINPOINT) - Protocol of a Prospective Multicentre Study of Communication and Decision-making During Patient Assessments by Primary Care Practice Nurses
The overall objective of this observational study is to investigate practices of communication and decision-making during nurses' initial assessment of patients' health problems in primary care, examine working mechanisms in good practices and develop feasible solutions.
The specific aims are:
Read more
- To investigate patients' expectations and experiences with the communication and decision-making during their first contact with a registered nurse (RN) in primary care.
- To investigate patient-RN communication on the level of patient involvement.
- To investigate RNs' actual communication, assessments and decision-making, value conflicts and the challenges and strategies they use in prioritizing.
- To analyse the underlying working mechanisms of good communication practices.
- To develop methodologies for facilitating efficient processes in assessing, managing, and prioritizing patients in primary care for RNs.
Project PINPOINT aims for a prospective multicenter study, using various methods for data collection and analysis.
- Conditions
- Nurse-Patient Relations
- Being tested
- Observations to investigate the current practices of communication and decision-making during Nurse-patient consultations
- Keywords
- Communication, Decision-making, Nurse, Primary care
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observations to investigate the current practices of communication and decision-making during Nurse-patient consultationsOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported expectations and experiences of the communication during consultations
Data will be gathered with the following questionaries: QUOTE-COMM, QUality Of care Through the patients' Eyes, and The COOP/WONCA, measuring functional health status. The QUOTE-COMM is used to gather patient reported data on expectations and experiences of communication aspects during consultations. At baseline the importance of (expectations) of various communication aspects are rated, and after experiences from the consultation, to evaluate to what extent RNs met patients' expectation. The COOP/WONCA is used at baseline to measure health status.
Measured: At baseline (day 1), after visit (day 1) and at 2-4 weeks
Communication processes and patient involvement as observed during consultations
Data will be gathered with audio recordings during real time consulltations. The observations with audio recordings will be coded with OPTION5, observing patient involvement in decision making, and the Verona Coding definition of emotional sequences, VR-CoDES. The OPTION5 scale is a reliable and valid instrument for investigating patient involvement in decision making. The Verona Coding Definitions on Emotional Sequences (VR-CoDES) is a reliable and valid instrument for coding of sequences of communication involving negative emotions, e.g., elicitations and expressions of patient cues and concerns, and RNs responses.
Measured: Day 1.
Secondary outcomes (1)
Assessment and decision-making processes, and related priorities and value conflicts - from observations and RN experiences
Data will be gathered with observations with audio recordings and interviews, and analysed with qualitative methods to gain insights on assessments and decision-making processes during consultations, and related priorities and value conflicts
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start15 Aug 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nurse-Patient RelationsStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Boras
- Sponsor type
- University, hospital or other
- Collaborators
- Mälardalen University, Netherlands Instititute for Health Services Research, Vastra Gotaland Region
- Responsible party
- Principal investigator, Annelie J Sundler, University of Boras
- Investigators
- Annelie Sundler, Professor, Principal investigator, University of Borås
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06067672
- Sponsor's protocol ID
- FO2023/171
- Acronym
- PINPOINT
- Status last verified
- Oct 2023
- First submitted
- 25 Sep 2023
- Last updated
- 5 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data supporting these findings are not publicly available due to the participants' privacy, the General Data Protection Regulation (GDPR) law, and the ethical approval from the Swedish Ethical Review Authority.
Publications
Ostensson S, Acuna Mora M, Darcy L, Saarnio Huttu L, Van Dulmen S, Sundler AJ. Patient-Registered Nurse Communication: Exploring Patients' Expectations and Experience in Primary Care Consultations. Health Expect. 2025 Aug;28(4):e70353. doi: 10.1111/hex.70353.
PubMed 40696861Sundler AJ, Heden L, Holmstrom IK, van Dulmen S, Bergman K, Ostensson S, Ostman M. The patient's first point of contact (PINPOINT) - protocol of a prospective multicenter study of communication and decision-making during patient assessments by primary care registered nurses. BMC Prim Care. 2023 Nov 29;24(1):249. doi: 10.1186/s12875-023-02208-0.
PubMed 38031004
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Patient's First Point of Contact (PINPOINT) - Protocol of a Prospective Multicentre Study of Communication and Decision-making During Patient Assessments by Primary Care Practice Nurses
- ClinicalTrials.gov ID
- NCT06067672
- Acronym / sponsor ID
- PINPOINT / FO2023/171
- Conditions
- Nurse-Patient Relations
- Keywords
- Communication, Decision-making, Nurse, Primary care
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of BorasUniversity, hospital or other
- Collaborators
- Mälardalen University, Netherlands Instititute for Health Services Research, Vastra Gotaland Region
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Oct 2023 (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 overall objective of this observational study is to investigate practices of communication and decision-making during nurses' initial assessment of patients' health problems in primary care, examine working mechanisms in good practices and develop feasible solutions.
The specific aims are:
- To investigate patients' expectations and experiences with the communication and decision-making during their first contact with a registered nurse (RN) in primary care.
- To investigate patient-RN communication on the level of patient involvement.
- To investigate RNs' actual communication, assessments and decision-making, value conflicts and the challenges and strategies they use in prioritizing.
- To analyse the underlying working mechanisms of good communication practices.
- To develop methodologies for facilitating efficient processes in assessing, managing, and prioritizing patients in primary care for RNs.
Project PINPOINT aims for a prospective multicenter study, using various methods for data collection and analysis.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Audio-recorded observations from a purposive sample of 150 patient-nurse consultations, including 30 nurses and 150 patients will be recruited at primary care centres in three different geographic areas of the southwest of Sweden.
Key inclusion criteria (1 listed)
- Registered Nurses at primary care centres and patients seeking primary care for a new health concern or a new episode of a problem
Key exclusion criteria (1 listed)
- Patients visiting the primary care nurse with a chronic or continuous health problem
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 |
|---|---|---|
| Observations to investigate the current practices of communication and decision-making during Nurse-patient consultationsNo intervention | Other | – |
Primary outcome
Patient-reported expectations and experiences of the communication during consultations
Time frame: At baseline (day 1), after visit (day 1) and at 2-4 weeks
Data will be gathered with the following questionaries: QUOTE-COMM, QUality Of care Through the patients' Eyes, and The COOP/WONCA, measuring functional health status. The QUOTE-COMM is used to gather patient reported data on expectations and experiences of communication aspects during consultations. At baseline the importance of (expectations) of various communication aspects are rated, and after experiences from the consultation, to evaluate to what extent RNs met patients' expectation. The COOP/WONCA is used at baseline to measure health status.
Communication processes and patient involvement as observed during consultations
Time frame: Day 1.
Data will be gathered with audio recordings during real time consulltations. The observations with audio recordings will be coded with OPTION5, observing patient involvement in decision making, and the Verona Coding definition of emotional sequences, VR-CoDES. The OPTION5 scale is a reliable and valid instrument for investigating patient involvement in decision making. The Verona Coding Definitions on Emotional Sequences (VR-CoDES) is a reliable and valid instrument for coding of sequences of communication involving negative emotions, e.g., elicitations and expressions of patient cues and concerns, and RNs responses.
1 secondary outcome
Assessment and decision-making processes, and related priorities and value conflicts - from observations and RN experiences
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Derived from this study: PubMed 40696861Ostensson S, Acuna Mora M, Darcy L, Saarnio Huttu L, Van Dulmen S, Sundler AJ. Patient-Registered Nurse Communication: Exploring Patients' Expectations and Experience in Primary Care Consultations. Health Expect. 2025 Aug;28(4):e70353. doi: 10.1111/hex.70353.
- Derived from this study: PubMed 38031004Sundler AJ, Heden L, Holmstrom IK, van Dulmen S, Bergman K, Ostensson S, Ostman M. The patient's first point of contact (PINPOINT) - protocol of a prospective multicenter study of communication and decision-making during patient assessments by primary care registered nurses. BMC Prim Care. 2023 Nov 29;24(1):249. doi: 10.1186/s12875-023-02208-0.
- Individual participant dataSharing planned: No. Data supporting these findings are not publicly available due to the participants' privacy, the General Data Protection Regulation (GDPR) law, and the ethical approval from the Swedish Ethical Review Authority.
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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.
Annelie Sundler, Professor principal investigator
University of Borås
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nurse-Patient Relations, run by University of Boras at 1 site in Sweden.
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 1 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: looking for participants now, as of the sponsor's last update on 5 Oct 2023. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annelie Sundler, Professor (+4633 4354000, annelie.sundler@hb.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported expectations and experiences of the communication during consultations (time frame: At baseline (day 1), after visit (day 1) and at 2-4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06067672, which also lists 2 linked publications.
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 5 Oct 2023.