NCT06067672

Brief 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. 1.To investigate patients' expectations and experiences with the communication and decision-making during their first contact with a registered nurse (RN) in primary care.
  2. 2.To investigate patient-RN communication on the level of patient involvement.
  3. 3.To investigate RNs' actual communication, assessments and decision-making, value conflicts and the challenges and strategies they use in prioritizing.
  4. 4.To analyse the underlying working mechanisms of good communication practices.
  5. 5.To develop methodologies for facilitating efficient processes in assessing, managing, and prioritizing patients in primary care for RNs.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
20mo left

Started Aug 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Aug 2023Dec 2027

Study Start

First participant enrolled

August 15, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 25, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 5, 2023

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

October 5, 2023

Status Verified

October 1, 2023

Enrollment Period

4.4 years

First QC Date

September 25, 2023

Last Update Submit

October 2, 2023

Conditions

Keywords

CommunicationDecision-makingNursePrimary care

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Day 1.

Secondary Outcomes (1)

  • Assessment and decision-making processes, and related priorities and value conflicts - from observations and RN experiences

    Through study completion, an average of 1 year

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Registered Nurses at primary care centres and patients seeking primary care for a new health concern or a new episode of a problem

You may not qualify if:

  • Patients visiting the primary care nurse with a chronic or continuous health problem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Borås

Borås, 50190, Sweden

RECRUITING

Related Publications (2)

  • 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.

  • Sundler 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.

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Annelie Sundler, Professor

    University of Borås

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Annelie Sundler, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 25, 2023

First Posted

October 5, 2023

Study Start

August 15, 2023

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

October 5, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

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.

Locations