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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06067672
Other study ID # FO2023/171
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 15, 2023
Est. completion date December 31, 2027

Study information

Verified date October 2023
Source University of Boras
Contact Annelie Sundler, Professor
Phone +4633 4354000
Email annelie.sundler@hb.se
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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. To investigate patient-RN communication on the level of patient involvement. 3. To investigate RNs' actual communication, assessments and decision-making, value conflicts and the challenges and strategies they use in prioritizing. 4. To analyse the underlying working mechanisms of good communication practices. 5. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date December 31, 2027
Est. primary completion date December 31, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Registered Nurses at primary care centres and patients seeking primary care for a new health concern or a new episode of a problem Exclusion Criteria: - Patients visiting the primary care nurse with a chronic or continuous health problem

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Observations to investigate the current practices of communication and decision-making during Nurse-patient consultations
No intervention

Locations

Country Name City State
Sweden University of Borås Borås

Sponsors (4)

Lead Sponsor Collaborator
University of Boras Mälardalen University, Netherlands Instititute for Health Services Research, Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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 Through study completion, an average of 1 year
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