Health, SubjectiveNCT03549403
Effects of Patient-centered Telephone Education in Day Surgery
A study testing Patient-centered telephone education in people with Health, Subjective and Cost Effectiveness, run by University of Oulu at 1 site in Finland.
Trial summary
This study describe and evaluate the effectiveness of patient-centered telephone education in day surgery. The aim is to evaluate the effects of patient-centered telephone education on the experienced health of adult patients and the costs of healthcare in day surgery. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Health, Subjective, Cost Effectiveness
- What is being tested?
- Patient-centered telephone education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFinland
- Study dates
- 1 Sep 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- arrive at the surgery from home
- leave latest at the next morning of the surgery
- leave home after surgery
- is 18-64 years old
- be able to respond to the questionnaire independently.
Who cannot join
- over 65 years old patients
- patients who need institutional care after surgery
- patients who arrive to surgery from a institutional care unit
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Patient-centered Pre- and Postoperative Telephone Education on the Experienced Health and Health-care Costs in Day Surgery by Adult Patients: A Randomized Controlled Trial.
This study describe and evaluate the effectiveness of patient-centered telephone education in day surgery. The aim is to evaluate the effects of patient-centered telephone education on the experienced health of adult patients and the costs of healthcare in day surgery. Telephone education intervention is planned in co-operation with the day surgery unit´s healthcare staff.
Half of participants will receive current education in day surgery, while the other half will receive developed patient-centered telephone education before and after day surgery.
Read the detailed description
Research is an experimental randomized controlled trial -study and it will be carried out in a Finnish day surgery unit.
Research questions are as follows:
- What are the implications of patient-centered pre- and postoperative telephone education for the experienced health of day surgery adult patients? Hypothesis 1: The experimental health of the trial group is better than the control group.
- What is the impact of patient-centered pre- and postoperative telephone education on the costs of healthcare in day surgery adult patients? Hypothesis 1: The costs of healthcare in the trial group is lower than in the control group.
The aim is to produce new information that is used in the design and implementation of patient-centered and cost-effective patient education as well as develop patient education more patient-centered.
Patients are randomized to the trial (n = 60) and the control group (n = 60) in the order in which they receive the surgery time. The sample size is verified by force analysis.
Intervention group´s education: The nurse will call the preoperative call to the patient home one week before the day surgery and postoperatively within 3-8 days after the day surgery. The intervention will be carried out in accordance with the guidelines and the contents of the developed patient-centered telephone education intervention in the same way in each patient. The call duration is approximately 15 to 30 minutes. Telephone education is carried out by a nurse responsible for preoperative telephone education in day surgery unit and 2-3 anesthesia nurses who have also participated in the intervention planning. The researcher provides them with guidance on patient-centered telephone education prior to intervention.
Control group´s education: The control group's education is carried out by nurses responsible for patient education in the day surgery unit who have not been involved in the planning and implementation of the intervention. Education is implemented in accordance with current practice, where day surgery adult patients receive preoperative education over the phone one week prior to day surgery and postoperative education during the day surgery.
The collection of the data is done by the modified Oldwellactive Oulu -instrument, whose reliability has been found to be acceptable in the previous studies.The preliminary questionnaire is sent before surgery to the patient and returns the questionnaire is upon arrival in the day surgery. Nurses receive the questionnaires and put them in a sealed mailbox placed in the department. The investigator is responsible for clearing the mailbox. The questionnaire for the final measurement is given by nurses to the day surgery patient in connection with discharge education. The questionnaire is requested to fill in two weeks after the surgery and return it with a supplied postage stamped addressed envelope.
The costs of health-care are calculated in the number and duration of postoperative patient´s phone calls to the day surgery unit of the patient documents as well as separate book counts. Additionally calculated the number of emergency / polyclinic / hospital department visits and laboratory examinations / X-ray images after the day surgery of patient documents for 3 months. The costs of the trial group are compared to the control group before and after the surgery.
Patient randomization is performed by various nurses than by the intervention itself, thus avoiding the risk of selective randomization. A randomizing nurse will share day surgery adult patients meeting the criteria for entry into the trial and control groups in the order in which they receive the surgery time. Patients are provided with a Register Statement and an identification code list to ensure the intervention´s planned implementation of the study. The Register Statement of the patients is stored on the researcher's computer behind the password. Questionnaires are encoded that the identity of the patients is not disclosed. In the health-care cost´s calculation, markings from patient documents are processed without personal identifiers, so the issues being processed can not be combined with a particular patient.
Questionnaires are stored in a locked locker and all material on the researcher's computer behind the password. The researcher is responsible for the retention and proper disposal of the material, questionnaires, registration descriptions and identification code lists. Research findings are set to scientific criticism at the publishing stage and possible criticism is taken into account. The results are not generalized or prettify. Reporting aims at open, clear and accurate.
The data is analyzed using descriptive parameters and regression analysis for preliminary and final status by testing the difference between the trial and control groups by the Mann-Whitney U-test. The Consort checklist is used to evaluate and report the intervention implementation.
- Conditions
- Health, Subjective, Cost Effectiveness
- Being tested
- Patient-centered telephone education
- Keywords
- Telephone education, Effectiveness, Health, Cost, Day surgery, Adult patient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-centered telephone educationBehavioural
The intervention will be carried out in accordance with the guidelines and the contents of the patient-centered telephone education intervention in the same way with every patient. The education call duration is approximately 15 to 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Patient-centered telephone education | Experimental | Patients receive the preoperative call home one week before the day surgery and postoperatively 3-8 days after the day surgery. On the day of surgery patients receive current education. Receives: Behavioral: Patient-centered telephone education |
| Current education practice | No intervention | Patient´s education is implemented in accordance with current practice, where day surgery adult patients receive preoperative education over the phone one week prior to day surgery and postoperative education during on the day of surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Experienced health
The questionnaire assess the impact of patient-centered telephone education to the day surgery patients´ experienced health, such as mobility, sleep, normal functions of survival, intellectual activities, ailments and symptoms, anxiety and energetic aspects.
Measured: Up to two weeks after surgery
Health-care costs
Patient-centered telephone education´s measures to the number of patient´s postoperative treatment
Measured: Up to three months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start1 Sep 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health, SubjectiveStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Collaborators
- Oulu University Hospital
- Responsible party
- Principal investigator, Mira Rajala, University of Oulu
- Investigators
- Maria Kääriäinen, PhD, Study director, University of Oulu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03549403
- Sponsor's protocol ID
- 152/2017
- Status last verified
- Nov 2023
- First submitted
- 23 Apr 2018
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rajala M, Kaakinen P, Fordell M, Kaariainen M. The Quality of Patient Education in Day Surgery by Adult Patients. J Perianesth Nurs. 2018 Apr;33(2):177-187. doi: 10.1016/j.jopan.2016.02.013. Epub 2017 Mar 30.
PubMed 29580597
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Patient-centered Pre- and Postoperative Telephone Education on the Experienced Health and Health-care Costs in Day Surgery by Adult Patients: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03549403
- Acronym / sponsor ID
- 152/2017
- Conditions
- Health, Subjective, Cost Effectiveness
- Keywords
- Telephone education, Effectiveness, Health, Cost, Day surgery, Adult patient
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Collaborators
- Oulu University Hospital
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Jun 2018 (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.
This study describe and evaluate the effectiveness of patient-centered telephone education in day surgery. The aim is to evaluate the effects of patient-centered telephone education on the experienced health of adult patients and the costs of healthcare in day surgery. Telephone education intervention is planned in co-operation with the day surgery unit´s healthcare staff.
Half of participants will receive current education in day surgery, while the other half will receive developed patient-centered telephone education before and after day surgery.
Detailed description
Research is an experimental randomized controlled trial -study and it will be carried out in a Finnish day surgery unit.
Research questions are as follows:
- What are the implications of patient-centered pre- and postoperative telephone education for the experienced health of day surgery adult patients? Hypothesis 1: The experimental health of the trial group is better than the control group.
- What is the impact of patient-centered pre- and postoperative telephone education on the costs of healthcare in day surgery adult patients? Hypothesis 1: The costs of healthcare in the trial group is lower than in the control group.
The aim is to produce new information that is used in the design and implementation of patient-centered and cost-effective patient education as well as develop patient education more patient-centered.
Patients are randomized to the trial (n = 60) and the control group (n = 60) in the order in which they receive the surgery time. The sample size is verified by force analysis.
Intervention group´s education: The nurse will call the preoperative call to the patient home one week before the day surgery and postoperatively within 3-8 days after the day surgery. The intervention will be carried out in accordance with the guidelines and the contents of the developed patient-centered telephone education intervention in the same way in each patient. The call duration is approximately 15 to 30 minutes. Telephone education is carried out by a nurse responsible for preoperative telephone education in day surgery unit and 2-3 anesthesia nurses who have also participated in the intervention planning. The researcher provides them with guidance on patient-centered telephone education prior to intervention.
Control group´s education: The control group's education is carried out by nurses responsible for patient education in the day surgery unit who have not been involved in the planning and implementation of the intervention. Education is implemented in accordance with current practice, where day surgery adult patients receive preoperative education over the phone one week prior to day surgery and postoperative education during the day surgery.
The collection of the data is done by the modified Oldwellactive Oulu -instrument, whose reliability has been found to be acceptable in the previous studies.The preliminary questionnaire is sent before surgery to the patient and returns the questionnaire is upon arrival in the day surgery. Nurses receive the questionnaires and put them in a sealed mailbox placed in the department. The investigator is responsible for clearing the mailbox. The questionnaire for the final measurement is given by nurses to the day surgery patient in connection with discharge education. The questionnaire is requested to fill in two weeks after the surgery and return it with a supplied postage stamped addressed envelope.
The costs of health-care are calculated in the number and duration of postoperative patient´s phone calls to the day surgery unit of the patient documents as well as separate book counts. Additionally calculated the number of emergency / polyclinic / hospital department visits and laboratory examinations / X-ray images after the day surgery of patient documents for 3 months. The costs of the trial group are compared to the control group before and after the surgery.
Patient randomization is performed by various nurses than by the intervention itself, thus avoiding the risk of selective randomization. A randomizing nurse will share day surgery adult patients meeting the criteria for entry into the trial and control groups in the order in which they receive the surgery time. Patients are provided with a Register Statement and an identification code list to ensure the intervention´s planned implementation of the study. The Register Statement of the patients is stored on the researcher's computer behind the password. Questionnaires are encoded that the identity of the patients is not disclosed. In the health-care cost´s calculation, markings from patient documents are processed without personal identifiers, so the issues being processed can not be combined with a particular patient.
Questionnaires are stored in a locked locker and all material on the researcher's computer behind the password. The researcher is responsible for the retention and proper disposal of the material, questionnaires, registration descriptions and identification code lists. Research findings are set to scientific criticism at the publishing stage and possible criticism is taken into account. The results are not generalized or prettify. Reporting aims at open, clear and accurate.
The data is analyzed using descriptive parameters and regression analysis for preliminary and final status by testing the difference between the trial and control groups by the Mann-Whitney U-test. The Consort checklist is used to evaluate and report the intervention implementation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient-centered telephone education | Experimental | Behavioral: Patient-centered telephone educationPatients receive the preoperative call home one week before the day surgery and postoperatively 3-8 days after the day surgery. On the day of surgery patients receive current education. |
| Current education practice | No intervention | –Patient´s education is implemented in accordance with current practice, where day surgery adult patients receive preoperative education over the phone one week prior to day surgery and postoperative education during on the day of surgery. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- arrive at the surgery from home
- leave latest at the next morning of the surgery
- leave home after surgery
- is 18-64 years old
- be able to respond to the questionnaire independently.
Key exclusion criteria (3 listed)
- over 65 years old patients
- patients who need institutional care after surgery
- patients who arrive to surgery from a institutional care unit
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 |
|---|---|---|
| Patient-centered telephone educationThe intervention will be carried out in accordance with the guidelines and the contents of the patient-centered telephone education intervention in the same way with every patient. The education call duration is approximately 15 to 30 minutes. | Behavioural | Patient-centered telephone education |
Primary outcome
Experienced health
Time frame: Up to two weeks after surgery
The questionnaire assess the impact of patient-centered telephone education to the day surgery patients´ experienced health, such as mobility, sleep, normal functions of survival, intellectual activities, ailments and symptoms, anxiety and energetic aspects.
Health-care costs
Time frame: Up to three months after surgery
Patient-centered telephone education´s measures to the number of patient´s postoperative treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Background: PubMed 29580597Rajala M, Kaakinen P, Fordell M, Kaariainen M. The Quality of Patient Education in Day Surgery by Adult Patients. J Perianesth Nurs. 2018 Apr;33(2):177-187. doi: 10.1016/j.jopan.2016.02.013. Epub 2017 Mar 30.
- 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.
Maria Kääriäinen, PhD study director
University of Oulu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient-centered telephone education in people with Health, Subjective and Cost Effectiveness, run by University of Oulu at 1 site in Finland.
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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 29 Nov 2023. 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 Finland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mira M Rajala, McS (+358414545371, mira.rajala@student.oulu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experienced health (time frame: Up to two weeks after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03549403, which also lists 1 linked publication.
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 29 Nov 2023.