NCT03893968

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 28, 2019

Completed
Last Updated

March 28, 2019

Status Verified

March 1, 2019

Enrollment Period

5 months

First QC Date

December 17, 2018

Last Update Submit

March 26, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Stress and satisfaction

    1 week after surgery

  • Additional healthcare contacts

    30 days after surgery

Study Arms (2)

Informed by a doctor

EXPERIMENTAL

Information by a doctor

Behavioral: Information by a doctor

Informed by an assistant nurse

EXPERIMENTAL

Information by an assistant nurse

Behavioral: Information by an assistant nurse

Interventions

Information received by patients after ambulatory hand surgery under local anaesthetic about postoperative self care given by an assistent nurse.

Informed by an assistant nurse

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

Informed by a doctor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • about to undergo elective hand surgical procedure in local anaesthesia
  • years or older.

You may not qualify if:

  • does not speak Swedish
  • dementia or other form av cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norrland's University Hospital

Umeå, Sverige, 90956, Sweden

Location

Study Officials

  • Martin Fahlström

    Umea University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The investigator is blinded to group allocation.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Patients are assigned to either a group informed by doctors or assistance nurses in parallel.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Consultant

Study Record Dates

First Submitted

December 17, 2018

First Posted

March 28, 2019

Study Start

February 1, 2018

Primary Completion

June 30, 2018

Study Completion

June 30, 2018

Last Updated

March 28, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations