PainmCareNCT03430960
Post Operative Survey Through a Bi-Directional Secure Mobile Messaging System
A study testing Phone Call and Mobile App Survey in people with Pain, run by Defense and Veterans Center for Integrative Pain Management at 1 site in United States.
Trial summary
Purpose The general purpose of this project is to assess the utility of the mCare application and MHCE (Mobile Healthcare Environment) system - a secure, mobile, smartphone app based platform - for same day surgery postoperative follow up of patients receiving peripheral nerve blocks. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Phone Call and Mobile App Survey
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2016to 30 Aug 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 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female military health care beneficiaries age 18 and 89 years old
- Receive peripheral nerve block affecting their limb(s)
- Same day surgery
- Owns a personal cell phone with the following features:
- A 320 x 240 screen display resolution or greater
- ii. Text messaging capabilities
Show all 12Show fewer
- iii. Data service capabilities
- iv. Service provided by either: AT\&T, AllTel, Sprint, T-Mobile, or Verizon
- Ability to use their personal cell phone
- Ability to read and respond to a message in English as the app is only in English.
- Receives reliable cell phone service in their home.
- DEERS eligibility
Who cannot join
- Under age 18 and over 89 years old
- Non-English speaking-App will only be in English as this is an app developed just for this study.
- Active participation in other research studies involving mobile devices
- Inability to interact with a touch screen mobile device
- Receive Exparel(which is a pain medication drug they can receive during surgery since these patients will be called 48 hour post discharge)
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
About this study
Official title: Defense and Veterans Pain Rating Scale (DVPRS)and Post Operative Survey Through a Bi-Directional Secure Mobile Messaging System - A Randomized Feasibility Study (mCare)
- Purpose The general purpose of this project is to assess the utility of the mCare application and MHCE (Mobile Healthcare Environment) system - a secure, mobile, smartphone app based platform - for same day surgery postoperative follow up of patients receiving peripheral nerve blocks.
- Research Design Randomized open-label study, comparing the satisfaction of the two groups with the method of follow up, which is either over the phone or via a mCare application. A separate group made up of nurses and physicians will have the opportunity to take a short anonymous survey to rank their opinion on the use of the smartphone application for patient feedback.
Read the detailed description
The primary objective of the study is to evaluate the feasibility of the implementation of the mCare system for postoperative follow-up and querying of patients receiving peripheral nerve blocks during their perioperative care. The investigators intend to perform a randomized pilot study comparing mCare with the current standard of care. Participants will be randomized into 2 groups: a) standard of care groups and b) mCare group. In the standard of care group, the participants will be followed-up via a phone call by an Acute Pain Service (APS) nurse, according to current standards. During the past year there have been 375 calls made, 64 of which have not been answered (17%). In the mCare group participants will be followed-up via mCare application. 48 hours after discharge an APS nurse is going to call the participants in group a) and the mCare system will notify participants in group b) to answer follow-up questions about their pain and peripheral nerve block. If necessary (based on the follow-up algorithm), participants in either group will be contacted (via phone call or the app, depending on group assignment) 7 days after their surgery to assess resolution of the peripheral nerve block. At the end of follow-up, on postoperative day 8, each patient will be asked to complete the satisfaction and convenience surveys. 10 days after their surgery participants in the mCare group will complete the System Usability Survey (SUS).At the end of the study, APS nurses and medical providers will be asked to complete the satisfaction and convenience surveys, and follow-up response data will be summarized and analyzed. Our research question is whether the use of the mCare system would result in improved patient compliance, satisfaction, and convenience on both the patient and the provider side, while being at least as safe as the standard of care.
Research question 1: Does the use of mCare app improve postoperative follow-up response rate of patients receiving perioperative peripheral nerve blocks who are discharged the same day?
Research question 2: Does satisfaction, convenience and ease of use differ between the mCare system and current standards a) in the patient population and b) among health care providers?
The pain assessment tool adapted for the mCare app will be the Defense and Veterans Pain Rating Scale(DVPRS),which is a 6 item questionnaire for assessing current pain, average and worst pain over the last 24 hours, and physical and emotional function. The DVPRS has been validated at Walter Reed National Military Medical Center (WRNMMC), but the administration has been paper based during rounds by the Acute Pain Service.
The current standard for follow up with patients who receive regional anesthesia for same day surgery is that the APS nurse contacts them 48 hours after the procedure and asks about their pain, qualities and duration of the nerve block, and their satisfaction with the service. If the patient's answers make it necessary (e.g. the block doesn't wear off, the numbness still persists) then the APS nurse calls them again one week after the surgery. If the numbness still persists at that point, then the APS nurse escalates their case by informing the regional anesthesia provider who decides further steps.
In this study, the investigators intend to substitute the phone call by the APS nurse with the use of the mCare app. Our research question is whether the app is at least as safe as the standard of care, and at least as easy to use and convenient as the phone call.
- Conditions
- Pain
- Being tested
- Phone Call, Mobile App Survey
- Keywords
- mCare, post surgery, mobile, healthcare, application
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone CallOther
Participants will be followed-up via phone call by Acute Pain Research Nurse
Mobile App SurveyOther
Participants will be followed-up via mCare mobile app
| Study group | Role | What they receive |
|---|---|---|
| Group A - Standard of Care | Other | Not described Receives: Other: Phone Call |
| Group B - mCare group | Experimental | Not described Receives: Other: Mobile App Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Burden of Contact Method
This will be measured by comparing the proportion of patients who completed clinical measures at initial contact attempt and any contact attempt. The initial contact method is a phone call for the SOC group, and an initial text reminder for mCare group. Patients who do not respond to the initial contact attempt are subsequently re-contacted, which is a clinical burden.
Measured: 10 days
Secondary outcomes (2)
Participant-Reported Contact-Method Evaluations
A contact-method satisfaction survey asked participants the degree to which they were satisfied with their contact method (phone or mCare app) (1=not satisfied at all, 5=completely satisfied), whether they would like to use their respective contact method for follow-up after a future surgery (yes/no), and the degree to which the contact method was convenient (1=not convenient at all, 5=very convenient). An 8-item system usability survey was completed by mCare participants. Participants rated the degree to which they agreed with statements of app usability on a 5-point scale (1=strongly disagree, 5=strongly agree).
Measured: 10 days
Nurse Satisfaction and Preferences
A 5-item nurse satisfaction survey assessed nurse satisfaction and preferences for each contact method. This included which method they gave more accurate information, was easier to understand and use, was more convenient, was safer, and preferred for post-surgical follow-up for regional anesthesia. Response options included: phone call, mCare, and both methods equally.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start16 Jun 2016
- Primary completion15 Jun 2018
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Defense and Veterans Center for Integrative Pain Management
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- COL (ret) Chester C Buckenmaier, MD, Principal investigator, Defense and Veterans Center for Integrative Pain Management
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03430960
- Sponsor's protocol ID
- 500249
- Acronym
- mCare
- Status last verified
- Sep 2018
- First submitted
- 28 Nov 2017
- Last updated
- 19 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defense and Veterans Pain Rating Scale (DVPRS)and Post Operative Survey Through a Bi-Directional Secure Mobile Messaging System - A Randomized Feasibility Study (mCare)
- ClinicalTrials.gov ID
- NCT03430960
- Acronym / sponsor ID
- mCare / 500249
- Conditions
- Pain
- Keywords
- mCare, post surgery, mobile, healthcare, application
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Defense and Veterans Center for Integrative Pain ManagementUniversity, hospital or other
- Study start
- 16 Jun 2016 (actual)
- Primary completion
- 15 Jun 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 13 Feb 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.
- Purpose The general purpose of this project is to assess the utility of the mCare application and MHCE (Mobile Healthcare Environment) system - a secure, mobile, smartphone app based platform - for same day surgery postoperative follow up of patients receiving peripheral nerve blocks.
- Research Design Randomized open-label study, comparing the satisfaction of the two groups with the method of follow up, which is either over the phone or via a mCare application. A separate group made up of nurses and physicians will have the opportunity to take a short anonymous survey to rank their opinion on the use of the smartphone application for patient feedback.
Detailed description
The primary objective of the study is to evaluate the feasibility of the implementation of the mCare system for postoperative follow-up and querying of patients receiving peripheral nerve blocks during their perioperative care. The investigators intend to perform a randomized pilot study comparing mCare with the current standard of care. Participants will be randomized into 2 groups: a) standard of care groups and b) mCare group. In the standard of care group, the participants will be followed-up via a phone call by an Acute Pain Service (APS) nurse, according to current standards. During the past year there have been 375 calls made, 64 of which have not been answered (17%). In the mCare group participants will be followed-up via mCare application. 48 hours after discharge an APS nurse is going to call the participants in group a) and the mCare system will notify participants in group b) to answer follow-up questions about their pain and peripheral nerve block. If necessary (based on the follow-up algorithm), participants in either group will be contacted (via phone call or the app, depending on group assignment) 7 days after their surgery to assess resolution of the peripheral nerve block. At the end of follow-up, on postoperative day 8, each patient will be asked to complete the satisfaction and convenience surveys. 10 days after their surgery participants in the mCare group will complete the System Usability Survey (SUS).At the end of the study, APS nurses and medical providers will be asked to complete the satisfaction and convenience surveys, and follow-up response data will be summarized and analyzed. Our research question is whether the use of the mCare system would result in improved patient compliance, satisfaction, and convenience on both the patient and the provider side, while being at least as safe as the standard of care.
Research question 1: Does the use of mCare app improve postoperative follow-up response rate of patients receiving perioperative peripheral nerve blocks who are discharged the same day?
Research question 2: Does satisfaction, convenience and ease of use differ between the mCare system and current standards a) in the patient population and b) among health care providers?
The pain assessment tool adapted for the mCare app will be the Defense and Veterans Pain Rating Scale(DVPRS),which is a 6 item questionnaire for assessing current pain, average and worst pain over the last 24 hours, and physical and emotional function. The DVPRS has been validated at Walter Reed National Military Medical Center (WRNMMC), but the administration has been paper based during rounds by the Acute Pain Service.
The current standard for follow up with patients who receive regional anesthesia for same day surgery is that the APS nurse contacts them 48 hours after the procedure and asks about their pain, qualities and duration of the nerve block, and their satisfaction with the service. If the patient's answers make it necessary (e.g. the block doesn't wear off, the numbness still persists) then the APS nurse calls them again one week after the surgery. If the numbness still persists at that point, then the APS nurse escalates their case by informing the regional anesthesia provider who decides further steps.
In this study, the investigators intend to substitute the phone call by the APS nurse with the use of the mCare app. Our research question is whether the app is at least as safe as the standard of care, and at least as easy to use and convenient as the phone call.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - Standard of Care | Other | Other: Phone Call |
| Group B - mCare group | Experimental | Other: Mobile App Survey |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male and female military health care beneficiaries age 18 and 89 years old
- Receive peripheral nerve block affecting their limb(s)
- Same day surgery
- Owns a personal cell phone with the following features:
- A 320 x 240 screen display resolution or greater
Key exclusion criteria (5 listed)
- Under age 18 and over 89 years old
- Non-English speaking-App will only be in English as this is an app developed just for this study.
- Active participation in other research studies involving mobile devices
- Inability to interact with a touch screen mobile device
- Receive Exparel(which is a pain medication drug they can receive during surgery since these patients will be called 48 hour post discharge)
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 |
|---|---|---|
| Phone CallParticipants will be followed-up via phone call by Acute Pain Research Nurse | Other | Group A - Standard of Care |
| Mobile App SurveyParticipants will be followed-up via mCare mobile app | Other | Group B - mCare group |
Primary outcome
Clinical Burden of Contact Method
Time frame: 10 days
This will be measured by comparing the proportion of patients who completed clinical measures at initial contact attempt and any contact attempt. The initial contact method is a phone call for the SOC group, and an initial text reminder for mCare group. Patients who do not respond to the initial contact attempt are subsequently re-contacted, which is a clinical burden.
2 secondary outcomes
Participant-Reported Contact-Method Evaluations
Time frame: 10 days
Nurse Satisfaction and Preferences
Time frame: 10 days
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 19 Sep 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.
COL (ret) Chester C Buckenmaier, MD principal investigator
Defense and Veterans Center for Integrative Pain Management
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phone Call and Mobile App Survey in people with Pain, run by Defense and Veterans Center for Integrative Pain Management 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 12 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 19 Sep 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. 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?
Clinical Burden of Contact Method (time frame: 10 days). 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 19 Sep 2018.