Ambulation DifficultyNCT03834428
IText For ICOUGH: Improving Ambulation of Surgical Patients Through Text Messaging
A study testing Text Message Intervention and ICOUGH protocol in people with Ambulation Difficulty, run by Boston Medical Center at 1 site in United States.
Trial summary
The investigators plan to conduct a study that evaluates if text messaging increases patients' adherence to ambulation (specifically reminding patients to get out of bed three or more times daily) which is one component of a protocol called ICOUGH, which is a mnemonic that stands for: Incentive spirometry (a breathing… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ambulation Difficulty
- What is being tested?
- Text Message Intervention and ICOUGH protocol
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2019to 13 Jul 2019
- 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
- Patients of all genders on any surgical service at Boston Medical Center
- English speaking
- Ability to read at 5th grade level
- Able to ambulate, with or without assistance
- Possession of a personal cell phone that can receive text messages
Who cannot join
- Visually impaired or blind
- Presence of neuromuscular disease or inability to perform all the measures in the ICOUGH protocol
- Prisoners
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
The investigators plan to conduct a study that evaluates if text messaging increases patients' adherence to ambulation (specifically reminding patients to get out of bed three or more times daily) which is one component of a protocol called ICOUGH, which is a mnemonic that stands for: Incentive spirometry (a breathing device that expands the lungs), Coughing and deep breathing, Oral hygiene (using a toothbrush for example),Understanding (patient and family education), Getting out of bed at least three times daily, and Head-of-bed elevation to prevent choking; each letter representing steps of a protocol developed at Boston Medical Center (BMC) shown to decrease lung-related complications of surgery. Other outcomes, including frequency of ambulation, pain score, number of visitors per day, head-of-bed elevation, education on importance of ambulation, and falls will also be assessed. The hypothesis is that a reminder text message to ambulate will improve these outcomes over time.
While beneficial to patients and health care facilities, the ICOUGH protocol is sometimes both difficult to implement and sustain at an acute care hospital, because: (1) patient motivation fluctuates and is the key determinant of patient ambulation (2) it relies heavily on nurses to both educate patients and then keep them accountable to the protocol, (3) an unfavorable nurse-to-patient ratio, (4) high inpatient turnover for elective surgical cases, and (5) an aging baby boomer population-a higher volume of older, higher- risk patients will require more time and attention per nurse. Therefore, utilization of text message reminders may promote better patient, family, and provider engagement and adherence to ambulation which can improve outcomes and decrease healthcare spending.
Read the detailed description
Pulmonary complications (e.g., pneumonia, unplanned intubation, and prolonged duration of ventilatory support) occur after about 1-2% of operations in the United States, leading to significant morbidity, lengths of hospital stay and cost, perhaps as much as $50,000 in expenses for the necessary additional care. However, many of these complications are preventable and the ICOUGH protocol has been demonstrated to impact pulmonary post operative complications. It has been shown to improve patient outcomes by decreasing postoperative pneumonia by 38%, unplanned intubations by 40%, and all adverse outcomes by 40%; over $5 million in cost savings for BMC in a two-year period has accompanied improved patient outcomes.
But despite its efficacy, the acute care hospital setting, specifically a safety-net hospital setting, presents challenges to ICOUGH protocol sustainability. ICOUGH requires education of patients over a number of time points and holds them accountable to adhere to the protocol. Nurses represent one source of education, although other clinical demands compete for nurses' time and attention. Acute care hospitals face high inpatient turnover for elective operations and must contend with an aging population that translates to a higher volume of older, higher-risk patients who may require more time and attention per nurse. Additionally, non-elective surgery patients, such as those admitted from the emergency department, would not have received ICOUGH protocol education. However, patients who are admitted to the hospital after emergency and trauma operations are at greatest risk of suffering pulmonary complications and stand to benefit the most from these interventions. These patients are not always optimized for surgery due to their acute circumstances, and they do not ordinarily receive the ICOUGH education that patients have prior to elective operations. In addition, patients also lack significant motivation due to the seriousness of their presentation and pain level to ambulate unless reminded.
To address these challenges within BMC and facilitate ambulation protocol implementation, sustainability, and scaling in other institutions, the research team developed a point-of-care, patient-centric way to promote better patient, family, and provider engagement with and adherence to the ICOUGH protocol, specifically ambulation. In this pilot study, patients will be randomized to receive a text message once a day to remind them to ambulate three or more times each day in addition to the ICOUGH education or to receive the ICOUGH education without text reminders. All participants will be contacted daily by a research team member to collect data on the outcome measures and each participant in the experimental text message arm will be interviewed at hospital discharge to solicit their opinion abut the text message reminders.
- Conditions
- Ambulation Difficulty
- Being tested
- Text Message Intervention, ICOUGH protocol
- Keywords
- Text message reminder, ICOUGH protocol, IText, Safety net hospital, Inpatient
- Medical subject headings
- Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text Message InterventionBehavioural
A text message will be sent once daily (between noon and 3p) to remind participants to ambulate at least 3 times each day while hospitalized.
ICOUGH protocolBehavioural
Education will be provided about the ICOUGH protocol which includes: Incentive spirometry (a breathing device that expands the lungs), Coughing and deep breathing, Oral hygiene (for example using a toothbrush), Understanding (patient and family education), Getting out of bed at least three times daily, and Head-of-bed elevation to prevent choking.
| Study group | Role | What they receive |
|---|---|---|
| No Text Message Control | Active comparator | Participants randomized to this arm will receive education about the ICOUGH protocol which includes the importance of ambulation. Receives: Behavioral: ICOUGH protocol |
| Text Message Intervention | Experimental | Participants randomized to this arm will receive daily text message reminders to ambulate in the hospital in addition to education about the ICOUGH protocol which includes the importance of ambulation. Receives: Behavioral: Text Message Intervention; Behavioral: ICOUGH protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the frequency of ambulation daily while hospitalized
The frequency of ambulation will be tracked for each participant each day of their hospitalization after ICOUGH education. Ambulation is defined as leaving a patient's room.
Measured: baseline and 10 days
Secondary outcomes (6)
Pain Level Scale twice daily while hospitalized
Participants will be asked twice daily (in the morning and evening) until discharge, "On a scale of 1-10, with 10 being the worst pain imaginable, what is your pain now?" Lower scores are more favorable.
Measured: Twice daily until hospital discharge or for 10 days maximum
Number of participants that received ambulation education during hospitalization
Participants will be asked whether they received any education on the importance of ambulation while hospitalized.
Measured: At hospital discharge or hospital day #10
Daily chair usage during hospitalization
Participants will be asked about the number of times they sit in the chair in their room each day.
Measured: Daily until hospital discharge or for 10 days maximum
Number of daily visitors while hospitalized
Participants will be asked how many visitors they had while hospitalized
Measured: Daily until hospital discharge or for 10 days maximum
Number of visitors who helped participants ambulate
Participants will be asked how many visitors helped them ambulate.
Measured: Daily until hospital discharge or for 10 days maximum
Usefulness of the text messages in the experimental group
At discharge participants in the experimental arm will be interviewed as to their opinions about the text messages. The qualitative answers will be analyzed for themes and content.
Measured: At hospital discharge or hospital day #10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start21 Mar 2019
- Primary completion7 Jun 2019
- Study completion13 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ambulation DifficultyStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pamela Rosenkranz, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03834428
- Sponsor's protocol ID
- H-38265
- Status last verified
- Jul 2019
- First submitted
- 5 Feb 2019
- Last updated
- 16 Jul 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 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IText For ICOUGH: Improving Ambulation of Surgical Patients Through Text Messaging
- ClinicalTrials.gov ID
- NCT03834428
- Acronym / sponsor ID
- H-38265
- Conditions
- Ambulation Difficulty
- Keywords
- Text message reminder, ICOUGH protocol, IText, Safety net hospital, Inpatient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- 21 Mar 2019 (actual)
- Primary completion
- 7 Jun 2019 (actual)
- Study completion
- 13 Jul 2019 (actual)
- First posted
- 8 Feb 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.
The investigators plan to conduct a study that evaluates if text messaging increases patients' adherence to ambulation (specifically reminding patients to get out of bed three or more times daily) which is one component of a protocol called ICOUGH, which is a mnemonic that stands for: Incentive spirometry (a breathing device that expands the lungs), Coughing and deep breathing, Oral hygiene (using a toothbrush for example),Understanding (patient and family education), Getting out of bed at least three times daily, and Head-of-bed elevation to prevent choking; each letter representing steps of a protocol developed at Boston Medical Center (BMC) shown to decrease lung-related complications of surgery. Other outcomes, including frequency of ambulation, pain score, number of visitors per day, head-of-bed elevation, education on importance of ambulation, and falls will also be assessed. The hypothesis is that a reminder text message to ambulate will improve these outcomes over time.
While beneficial to patients and health care facilities, the ICOUGH protocol is sometimes both difficult to implement and sustain at an acute care hospital, because: (1) patient motivation fluctuates and is the key determinant of patient ambulation (2) it relies heavily on nurses to both educate patients and then keep them accountable to the protocol, (3) an unfavorable nurse-to-patient ratio, (4) high inpatient turnover for elective surgical cases, and (5) an aging baby boomer population-a higher volume of older, higher- risk patients will require more time and attention per nurse. Therefore, utilization of text message reminders may promote better patient, family, and provider engagement and adherence to ambulation which can improve outcomes and decrease healthcare spending.
Detailed description
Pulmonary complications (e.g., pneumonia, unplanned intubation, and prolonged duration of ventilatory support) occur after about 1-2% of operations in the United States, leading to significant morbidity, lengths of hospital stay and cost, perhaps as much as $50,000 in expenses for the necessary additional care. However, many of these complications are preventable and the ICOUGH protocol has been demonstrated to impact pulmonary post operative complications. It has been shown to improve patient outcomes by decreasing postoperative pneumonia by 38%, unplanned intubations by 40%, and all adverse outcomes by 40%; over $5 million in cost savings for BMC in a two-year period has accompanied improved patient outcomes.
But despite its efficacy, the acute care hospital setting, specifically a safety-net hospital setting, presents challenges to ICOUGH protocol sustainability. ICOUGH requires education of patients over a number of time points and holds them accountable to adhere to the protocol. Nurses represent one source of education, although other clinical demands compete for nurses' time and attention. Acute care hospitals face high inpatient turnover for elective operations and must contend with an aging population that translates to a higher volume of older, higher-risk patients who may require more time and attention per nurse. Additionally, non-elective surgery patients, such as those admitted from the emergency department, would not have received ICOUGH protocol education. However, patients who are admitted to the hospital after emergency and trauma operations are at greatest risk of suffering pulmonary complications and stand to benefit the most from these interventions. These patients are not always optimized for surgery due to their acute circumstances, and they do not ordinarily receive the ICOUGH education that patients have prior to elective operations. In addition, patients also lack significant motivation due to the seriousness of their presentation and pain level to ambulate unless reminded.
To address these challenges within BMC and facilitate ambulation protocol implementation, sustainability, and scaling in other institutions, the research team developed a point-of-care, patient-centric way to promote better patient, family, and provider engagement with and adherence to the ICOUGH protocol, specifically ambulation. In this pilot study, patients will be randomized to receive a text message once a day to remind them to ambulate three or more times each day in addition to the ICOUGH education or to receive the ICOUGH education without text reminders. All participants will be contacted daily by a research team member to collect data on the outcome measures and each participant in the experimental text message arm will be interviewed at hospital discharge to solicit their opinion abut the text message reminders.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Text Message Control | Active comparator | Behavioral: ICOUGH protocolParticipants randomized to this arm will receive education about the ICOUGH protocol which includes the importance of ambulation. |
| Text Message Intervention | Experimental | Behavioral: Text Message Intervention, Behavioral: ICOUGH protocolParticipants randomized to this arm will receive daily text message reminders to ambulate in the hospital in addition to education about the ICOUGH protocol which includes the importance of ambulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients of all genders on any surgical service at Boston Medical Center
- English speaking
- Ability to read at 5th grade level
- Able to ambulate, with or without assistance
- Possession of a personal cell phone that can receive text messages
Key exclusion criteria (4 listed)
- Visually impaired or blind
- Presence of neuromuscular disease or inability to perform all the measures in the ICOUGH protocol
- Prisoners
- Pregnant women
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 |
|---|---|---|
| Text Message InterventionA text message will be sent once daily (between noon and 3p) to remind participants to ambulate at least 3 times each day while hospitalized. | Behavioural | Text Message Intervention |
| ICOUGH protocolEducation will be provided about the ICOUGH protocol which includes: Incentive spirometry (a breathing device that expands the lungs), Coughing and deep breathing, Oral hygiene (for example using a toothbrush), Understanding (patient and family education), Getting out of bed at least three times daily, and Head-of-bed elevation to prevent choking. | Behavioural | No Text Message Control, Text Message Intervention |
Primary outcome
Change in the frequency of ambulation daily while hospitalized
Time frame: baseline and 10 days
The frequency of ambulation will be tracked for each participant each day of their hospitalization after ICOUGH education. Ambulation is defined as leaving a patient's room.
6 secondary outcomes
Pain Level Scale twice daily while hospitalized
Time frame: Twice daily until hospital discharge or for 10 days maximum
Number of participants that received ambulation education during hospitalization
Time frame: At hospital discharge or hospital day #10
Daily chair usage during hospitalization
Time frame: Daily until hospital discharge or for 10 days maximum
Number of daily visitors while hospitalized
Time frame: Daily until hospital discharge or for 10 days maximum
Number of visitors who helped participants ambulate
Time frame: Daily until hospital discharge or for 10 days maximum
Usefulness of the text messages in the experimental group
Time frame: At hospital discharge or hospital day #10
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 16 Jul 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.
Pamela Rosenkranz principal investigator
Boston 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 Text Message Intervention and ICOUGH protocol in people with Ambulation Difficulty, run by Boston Medical Center 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 5 inclusion and 4 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 16 Jul 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 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?
Change in the frequency of ambulation daily while hospitalized (time frame: baseline and 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 16 Jul 2019.