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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03893968
Other study ID # 2017/446-31
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2018
Est. completion date June 30, 2018

Study information

Verified date March 2019
Source Umeå University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date June 30, 2018
Est. primary completion date June 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.
Information by a doctor
Information received by patients after ambulatory hand surgery under local anaesthetic about postoperative self care given by a doctor.

Locations

Country Name City State
Sweden Norrland's University Hospital Umeå Sverige

Sponsors (1)

Lead Sponsor Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Information recall 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 Stress and satisfaction 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
Secondary Additional healthcare contacts Compare differences in the number of healthcare contacts due to not being able to recall or having understood information. 30 days after surgery
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