Total Joint ArthroplastyNCT03301610
Mobile Educations Effect on Pain Outcomes
A study testing Mobile Education Delivery and Standard Verbal and Written Education in people with Total Joint Arthroplasty and Pain, Postoperative, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to explore the clinical impact of pain management education using a mobile web-based education delivery system compared to standard education delivery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Total Joint Arthroplasty, Pain, Postoperative
- What is being tested?
- Mobile Education Delivery and Standard Verbal and Written Education
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 133 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2017to 28 Feb 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients
- over the age of 18 years
- undergoing surgical intervention and inpatient care for one of the following procedures:
- total hip arthroplasty (THA) (primary, bilateral, and revision)
- total knee arthroplasty (TKA) (primary, bilateral, unicompartmental, and revision)
- Fluent in the English language
Who cannot join
- Undergoing more complex hip and knee procedures such as:
- implant resections with or without spacer placement
- liner exchange
- THA or unipolar hip arthroplasty related to repair of hip fracture.
- Preexisting physical or cognitive limitations that would hinder their ability to use the mobile application
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: The Impact of Mobile Education Delivery on Postoperative Pain Outcomes
The purpose of this study is to explore the clinical impact of pain management education using a mobile web-based education delivery system compared to standard education delivery. This study seeks to understand the difference between two different education delivery methodologies and the effect on the postoperative pain experience, including participation in treatment plan, knowledge, pain outcomes, and opioid requirements in patients undergoing major hip (THA) and knee (TKA) arthroplasty. It is hypothesized that a real-time, interactive, mobile education system will demonstrate improved pain associated outcomes and higher patient participation when compared to the current standard education delivery method.
- Conditions
- Total Joint Arthroplasty, Pain, Postoperative
- Being tested
- Mobile Education Delivery, Standard Verbal and Written Education
- Keywords
- Pain Education, Information Delivery, Mobile Application
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Education DeliveryOther
Patients will be provided with an iPad on admission to the post-surgical unit and will remain with the patient until discharge. The patient, independently or with the nurse, may use the program at any point during the inpatient care experience. The RN will use the iPad to engage patients in their pain management.
Standard Verbal and Written EducationOther
Patients will be provided with two pamphlets on pain management on admission to the post-surgical unit. Nurses will follow-up with verbal instruction based on patient need. This will continue through hospital stay. Additional printed education materials are available through the department of patient education and verbal instruction may be tailored based on nursing assessment and patient need.
| Study group | Role | What they receive |
|---|---|---|
| Mobile Education Delivery | Experimental | The participants in the study arm will receive comprehensive pain management education delivered using mobile iPads at the point of care. The mobile based education modules will be inclusive of the use of the pain rating scale and assessment of pain; communication with healthcare providers; daily expectations for pain and pain management; pharmacologic and non-pharmacologic treatment options; medication side effects and safety; and discharge instructions including safe handling of opioids, disposal, tapering, and when to call the provider. It will also include an interactive pain and discomfort menu, knowledge based questions, and medication tracking log. Receives: Other: Mobile Education Delivery |
| Standard verbal and written education | Placebo comparator | The control group will receive the current standard of care which consists of verbal instruction and pain management educational pamphlets. At a minimum, the patients will receive two educational pamphlets titled Your Pain and Discomfort Management Menu and Communicating About Your Pain. Verbal instruction is nurse dependent. At a minimum the nurse will provide the two pamphlets to the patient and follow-up with the patient to address any questions. Receives: Other: Standard Verbal and Written Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in self-reported pain scores
Scores are measured using a 10 point (Lickert) pain rating scale. The scale ranges from 0 to 10 with the lower score indicating less pain and the higher score indicating greater pain.
Measured: Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)
Secondary outcomes (5)
Change in pain management knowledge
Scores are measured using a modified Patient Pain Questionnaire; 9 knowledge based questions use a ten-point (0-10) ordinal scale to assess patients' agreement or disagreement with specific statements. All items have been formatted so that zero indicates the most positive outcome and a ten indicates the most negative outcome.
Measured: Pre-intervention (between 1 and 5 days before surgical procedure) and post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)
Difference in self-reported participation in pain management
Scores are measured using a 10 point Lickert scale measuring patients perception of participation in pain management/treatment decisions. The scale ranges from 0 to 10 with the lower score indicating less perceived participation and the higher score indicating greater perceived participation.
Measured: Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)
Difference in post-operative opioid requirements
Total opioid requirements, converted to morphine milligram equivalents
Measured: Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)
Difference in usefulness of education
Scores are measured using a 10 point Lickert rating scale. The scale ranges from 0 to 10 with the lower score indicating lower perceived usefulness and the higher score indicating greater perceived usefulness.
Measured: Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)
Difference in use of non-pharmacologic pain modalities
Results are tabulated for a descriptive selection list for patients to report what interventions were used.
Measured: Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start23 Oct 2017
- Primary completion24 Jan 2018
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Joint ArthroplastyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This prospective study has been designed as quasi-experimental study. This study seeks to explore both a treatment and control group in efforts to compare outcomes which are dependent on the type of intervention. Study participants will be assigned into one of two study arms, intervention or control, based on random assignment determined by the location they are bedded in hospital. One of two patient care units will offer standard education, the other unit will offer the mobile, iPad based education. The patient care unit to offer the mobile, iPad based education will be selected at random.
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- George Washington University
- Responsible party
- Principal investigator, Amber M. Stitz, Mayo Clinic
- Investigators
- Amber M Stitz, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03301610
- Sponsor's protocol ID
- 17-004771
- Status last verified
- Feb 2018
- First submitted
- 13 Sep 2017
- Last updated
- 1 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Mobile Education Delivery on Postoperative Pain Outcomes
- ClinicalTrials.gov ID
- NCT03301610
- Acronym / sponsor ID
- 17-004771
- Conditions
- Total Joint Arthroplasty, Pain, Postoperative
- Keywords
- Pain Education, Information Delivery, Mobile Application
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- George Washington University
- Study start
- 23 Oct 2017 (actual)
- Primary completion
- 24 Jan 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 4 Oct 2017 (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.
The purpose of this study is to explore the clinical impact of pain management education using a mobile web-based education delivery system compared to standard education delivery. This study seeks to understand the difference between two different education delivery methodologies and the effect on the postoperative pain experience, including participation in treatment plan, knowledge, pain outcomes, and opioid requirements in patients undergoing major hip (THA) and knee (TKA) arthroplasty. It is hypothesized that a real-time, interactive, mobile education system will demonstrate improved pain associated outcomes and higher patient participation when compared to the current standard education delivery method.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This prospective study has been designed as quasi-experimental study. This study seeks to explore both a treatment and control group in efforts to compare outcomes which are dependent on the type of intervention. Study participants will be assigned into one of two study arms, intervention or control, based on random assignment determined by the location they are bedded in hospital. One of two patient care units will offer standard education, the other unit will offer the mobile, iPad based education. The patient care unit to offer the mobile, iPad based education will be selected at random.
| Arm | Type | Receives |
|---|---|---|
| Mobile Education Delivery | Experimental | Other: Mobile Education DeliveryThe participants in the study arm will receive comprehensive pain management education delivered using mobile iPads at the point of care. The mobile based education modules will be inclusive of the use of the pain rating scale and assessment of pain; communication with healthcare providers; daily expectations for pain and pain management; pharmacologic and non-pharmacologic treatment options; medication side effects and safety; and discharge instructions including safe handling of opioids, disposal, tapering, and when to call the provider. It will also include an interactive pain and discomfort menu, knowledge based questions, and medication tracking log. |
| Standard verbal and written education | Placebo comparator | Other: Standard Verbal and Written EducationThe control group will receive the current standard of care which consists of verbal instruction and pain management educational pamphlets. At a minimum, the patients will receive two educational pamphlets titled Your Pain and Discomfort Management Menu and Communicating About Your Pain. Verbal instruction is nurse dependent. At a minimum the nurse will provide the two pamphlets to the patient and follow-up with the patient to address any questions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients
- over the age of 18 years
- undergoing surgical intervention and inpatient care for one of the following procedures:
- total hip arthroplasty (THA) (primary, bilateral, and revision)
- total knee arthroplasty (TKA) (primary, bilateral, unicompartmental, and revision)
Key exclusion criteria (5 listed)
- Undergoing more complex hip and knee procedures such as:
- implant resections with or without spacer placement
- liner exchange
- THA or unipolar hip arthroplasty related to repair of hip fracture.
- Preexisting physical or cognitive limitations that would hinder their ability to use the mobile application
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 |
|---|---|---|
| Mobile Education DeliveryPatients will be provided with an iPad on admission to the post-surgical unit and will remain with the patient until discharge. The patient, independently or with the nurse, may use the program at any point during the inpatient care experience. The RN will use the iPad to engage patients in their pain management. | Other | Mobile Education Delivery |
| Standard Verbal and Written EducationPatients will be provided with two pamphlets on pain management on admission to the post-surgical unit. Nurses will follow-up with verbal instruction based on patient need. This will continue through hospital stay. Additional printed education materials are available through the department of patient education and verbal instruction may be tailored based on nursing assessment and patient need. | Other | Standard verbal and written education |
Primary outcome
Difference in self-reported pain scores
Time frame: Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)
Scores are measured using a 10 point (Lickert) pain rating scale. The scale ranges from 0 to 10 with the lower score indicating less pain and the higher score indicating greater pain.
5 secondary outcomes
Change in pain management knowledge
Time frame: Pre-intervention (between 1 and 5 days before surgical procedure) and post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)
Difference in self-reported participation in pain management
Time frame: Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)
Difference in post-operative opioid requirements
Time frame: Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)
Difference in usefulness of education
Time frame: Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)
Difference in use of non-pharmacologic pain modalities
Time frame: Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-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 1 Mar 2018.
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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.
Amber M Stitz principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Education Delivery and Standard Verbal and Written Education in people with Total Joint Arthroplasty and Pain, Postoperative, run by Mayo Clinic at 1 site in United States.
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 6 inclusion and 5 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 1 Mar 2018. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Difference in self-reported pain scores (time frame: Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-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 1 Mar 2018.