- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03893968
Are Doctors and Assistant Nurses Equally Good at Informing Patients
Are Doctors and Assistant Nurses Equally Good at Informing Patients: A Randomized Controlled Trial Comparing Information Recall Regarding Postoperative Self-care
Objectives: to compare patients' recall of information regarding postoperative self-care when being informed by either doctors or assistant nurses.
Methods: a non-blinded randomized single-center controlled trial being conducted at a hand-surgical unit in Northern Sweden. Included are adult ambulatory patients about to undergo surgery in local anesthesia. Patients are randomized into two parallel groups, with the control-group being informed by doctors and the intervention-group by assistant nurses. Patients will be telephoned one week after surgery for assessment of information recall via a structured telephone-interview.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study was conducted within the hand-surgical unit at Norrland's University Hospital in Umeå, county of Västerbotten, in Sweden. There are three hospitals in this sparsely populated county of 55432〖km〗^2 with about 268000 in population. The hand-surgery unit serves both the local population and is a tertiary referral center.
As the healthcare in Sweden is funded by taxpayers, the healthcare for patients is free, apart from a small nominal fee. There was a total of seven doctors and seven assistant nurses participating in the study, all having several years of experience working with hand-surgical care. Prior to the study, doctors had the formal responsibility of informing patients about their postoperative care. However, despite it being the surgeons' responsibility, the task of informing patients was at times performed by assistant nurses. After receiving the information, patients were discharged and left the clinic. Normally patients receive a complementary written information after being informed verbally. Patients included in the study did not receive the written information, since it might have been a confounding factor in understanding of information.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sverige
-
Umeå, Sverige, Sweden, 90956
- Norrland's University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- about to undergo elective hand surgical procedure in local anaesthesia
- 18 years or older.
Exclusion Criteria:
- does not speak Swedish
- dementia or other form av cognitive impairment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Informed by a doctor
Information by a doctor
|
Information received by patients after ambulatory hand surgery under local anaesthetic about postoperative self care given by a doctor.
|
|
Experimental: Informed by an assistant nurse
Information by an assistant nurse
|
Information received by patients after ambulatory hand surgery under local anaesthetic about postoperative self care given by an assistent nurse.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Information recall
Time Frame: 1 week after surgery
|
A telephone-interviews were performed seven days after the surgery using a structured questionnaire.
For the main objective, seven questions were asked testing patients recall/knowledge of their postoperative self-care.
Each question evaluated the patients' knowledge of a unique aspect of postoperative self-care.
The questionnaire is designed based on the postoperative info sheet received by patients after hand surgery.
|
1 week after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stress and satisfaction
Time Frame: 1 week after surgery
|
During the telephone interview the patients could rate on a 1-10 scale their level of "feeling of understood the information", stress, and satisfaction.
"Feeling of having understood the information" means the patients perception of having fully understood all the information and knowing fully what to do when leaving the hospital.
For assessing "stress", the interviewer asked about the level of stress that the patient had experienced during the week following the surgery.
Regarding "satisfaction", the interviewer asked and assessed how satisfied the patients were with the way the personnel had informed the patient (e.g.
not used difficult or confusing language, had given the patient time to ask questions etc).
|
1 week after surgery
|
|
Additional healthcare contacts
Time Frame: 30 days after surgery
|
Compare differences in the number of healthcare contacts due to not being able to recall or having understood information.
|
30 days after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Martin Fahlström, Umeå University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2017/446-31
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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