IText For ICOUGH: Improving Ambulation of Surgical Patients Through Text Messaging

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.

Study Overview

• Status: Completed
• Conditions: Ambulation Difficulty
• Intervention / Treatment: Behavioral: ICOUGH protocol; Behavioral: Text Message Intervention

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 Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: No Text Message Control; Participants randomized to this arm will receive education about the ICOUGH protocol which includes the importance of ambulation.	Behavioral: ICOUGH protocol; 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.
EXPERIMENTAL: Text Message Intervention; 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.	Behavioral: ICOUGH protocol; 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.; Behavioral: Text Message Intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline and 10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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	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.	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.	At hospital discharge or hospital day #10

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Investigators: Principal Investigator: Pamela Rosenkranz, Boston University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 21, 2019
• Primary Completion (ACTUAL): June 7, 2019
• Study Completion (ACTUAL): July 13, 2019

Study Registration Dates

• First Submitted: February 5, 2019
• First Submitted That Met QC Criteria: February 6, 2019
• First Posted (ACTUAL): February 8, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 16, 2019
• Last Update Submitted That Met QC Criteria: July 14, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Inpatient; Safety net hospital; Text message reminder; ICOUGH protocol; IText
• Additional Relevant MeSH Terms: Mobility Limitation
• Other Study ID Numbers: H-38265

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No