IText For ICOUGH: Improving Ambulation of Surgical Patients Through Text Messaging
Primary Purpose
Ambulation Difficulty
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text Message Intervention
ICOUGH protocol
Sponsored by
About this trial
This is an interventional prevention trial for Ambulation Difficulty focused on measuring Text message reminder, ICOUGH protocol, IText, Safety net hospital, Inpatient
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Visually impaired or blind
- Presence of neuromuscular disease or inability to perform all the measures in the ICOUGH protocol
- Prisoners
- Pregnant women
Sites / Locations
- Boston Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
No Text Message Control
Text Message Intervention
Arm Description
Participants randomized to this arm will receive education about the ICOUGH protocol which includes the importance of ambulation.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Daily chair usage during hospitalization
Participants will be asked about the number of times they sit in the chair in their room each day.
Number of daily visitors while hospitalized
Participants will be asked how many visitors they had while hospitalized
Number of visitors who helped participants ambulate
Participants will be asked how many visitors helped them ambulate.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03834428
Brief Title
IText For ICOUGH: Improving Ambulation of Surgical Patients Through Text Messaging
Official Title
IText For ICOUGH: Improving Ambulation of Surgical Patients Through Text Messaging
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
March 21, 2019 (Actual)
Primary Completion Date
June 7, 2019 (Actual)
Study Completion Date
July 13, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ambulation Difficulty
Keywords
Text message reminder, ICOUGH protocol, IText, Safety net hospital, Inpatient
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No Text Message Control
Arm Type
Active Comparator
Arm Description
Participants randomized to this arm will receive education about the ICOUGH protocol which includes the importance of ambulation.
Arm Title
Text Message Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Text Message Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
ICOUGH protocol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the frequency of ambulation daily while hospitalized
Description
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.
Time Frame
baseline and 10 days
Secondary Outcome Measure Information:
Title
Pain Level Scale twice daily while hospitalized
Description
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.
Time Frame
Twice daily until hospital discharge or for 10 days maximum
Title
Number of participants that received ambulation education during hospitalization
Description
Participants will be asked whether they received any education on the importance of ambulation while hospitalized.
Time Frame
At hospital discharge or hospital day #10
Title
Daily chair usage during hospitalization
Description
Participants will be asked about the number of times they sit in the chair in their room each day.
Time Frame
Daily until hospital discharge or for 10 days maximum
Title
Number of daily visitors while hospitalized
Description
Participants will be asked how many visitors they had while hospitalized
Time Frame
Daily until hospital discharge or for 10 days maximum
Title
Number of visitors who helped participants ambulate
Description
Participants will be asked how many visitors helped them ambulate.
Time Frame
Daily until hospital discharge or for 10 days maximum
Title
Usefulness of the text messages in the experimental group
Description
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.
Time Frame
At hospital discharge or hospital day #10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Visually impaired or blind
Presence of neuromuscular disease or inability to perform all the measures in the ICOUGH protocol
Prisoners
Pregnant women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela Rosenkranz
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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IText For ICOUGH: Improving Ambulation of Surgical Patients Through Text Messaging
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