Are Doctors and Assistant Nurses Equally Good at Informing Patients

• ClinicalTrials.gov Identifier: NCT03893968
• Recruitment Status: Completed
• First Posted: March 28, 2019
• Last Update Posted: March 28, 2019
• Sponsor: Umeå University
• Information provided by (Responsible Party): Aleksandra McGrath, Umeå University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Patient Care	Behavioral: Information by an assistant nurse; Behavioral: Information by a doctor	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Patients are assigned to either a group informed by doctors or assistance nurses in parallel.
• Masking: Single (Investigator)
• Masking Description: The investigator is blinded to group allocation.
• Primary Purpose: Health Services Research
• Official Title: Are Doctors and Assistant Nurses Equally Good at Informing Patients: A Randomized Controlled Trial Comparing Information Recall Regarding Postoperative Self-care
• Actual Study Start Date: February 1, 2018
• Actual Primary Completion Date: June 30, 2018
• Actual Study Completion Date: June 30, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Informed by a doctor; Information by a doctor	Behavioral: 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	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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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).
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Sweden

Norrland's University Hospital

Umeå, Sverige, Sweden, 90956

Sponsors and Collaborators

Umeå University

Investigators

• Study Chair: Martin Fahlström; Umea University

More Information

• Responsible Party: Aleksandra McGrath, Senior Consultant, Umeå University
• ClinicalTrials.gov Identifier: NCT03893968
• Other Study ID Numbers: 2017/446-31
• First Posted: March 28, 2019
• Last Update Posted: March 28, 2019
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No