Patient CareNCT03893968
Are Doctors and Assistant Nurses Equally Good at Informing Patients
A study testing Information by an assistant nurse and Information by a doctor in people with Patient Care, run by Umeå University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Care
- What is being tested?
- Information by an assistant nurse and Information by a doctor
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2018to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- about to undergo elective hand surgical procedure in local anaesthesia
- 18 years or older.
Who cannot join
- does not speak Swedish
- dementia or other form av cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Patient Care
- Being tested
- Information by an assistant nurse, Information by a doctor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Information by an assistant nurseBehavioural
Information received by patients after ambulatory hand surgery under local anaesthetic about postoperative self care given by an assistent nurse.
Information by a doctorBehavioural
Information received by patients after ambulatory hand surgery under local anaesthetic about postoperative self care given by a doctor.
| Study group | Role | What they receive |
|---|---|---|
| Informed by a doctor | Experimental | Information by a doctor Receives: Behavioral: Information by a doctor |
| Informed by an assistant nurse | Experimental | Information by an assistant nurse Receives: Behavioral: Information by an assistant nurse |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week after surgery
Secondary outcomes (2)
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).
Measured: 1 week after surgery
Additional healthcare contacts
Compare differences in the number of healthcare contacts due to not being able to recall or having understood information.
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start1 Feb 2018
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient CareStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients are assigned to either a group informed by doctors or assistance nurses in parallel.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleksandra McGrath, Umeå University
- Investigators
- Martin Fahlström, Study chair, Umea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03893968
- Sponsor's protocol ID
- 2017/446-31
- Status last verified
- Mar 2019
- First submitted
- 17 Dec 2018
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Doctors and Assistant Nurses Equally Good at Informing Patients: A Randomized Controlled Trial Comparing Information Recall Regarding Postoperative Self-care
- ClinicalTrials.gov ID
- NCT03893968
- Acronym / sponsor ID
- 2017/446-31
- Conditions
- Patient Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 28 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Patients are assigned to either a group informed by doctors or assistance nurses in parallel.
| Arm | Type | Receives |
|---|---|---|
| Informed by a doctor | Experimental | Behavioral: Information by a doctorInformation by a doctor |
| Informed by an assistant nurse | Experimental | Behavioral: Information by an assistant nurseInformation by an assistant nurse |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- about to undergo elective hand surgical procedure in local anaesthesia
- 18 years or older.
Key exclusion criteria (2 listed)
- does not speak Swedish
- dementia or other form av cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Information by an assistant nurseInformation received by patients after ambulatory hand surgery under local anaesthetic about postoperative self care given by an assistent nurse. | Behavioural | Informed by an assistant nurse |
| Information by a doctorInformation received by patients after ambulatory hand surgery under local anaesthetic about postoperative self care given by a doctor. | Behavioural | Informed by a doctor |
Primary outcome
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.
2 secondary outcomes
Stress and satisfaction
Time frame: 1 week after surgery
Additional healthcare contacts
Time frame: 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Fahlström study chair
Umea University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Information by an assistant nurse and Information by a doctor in people with Patient Care, run by Umeå University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Information recall (time frame: 1 week after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2019.