Text Messaging for Lumbar Spine Surgery Recovery

(NOTICE Trial)

Overseen By Claudia E Pamanes, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Prior lumbar fusions, Tumors, Infection, Trauma, Non-English, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

224 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether daily text messages can aid recovery from lumbar spine surgery more effectively than standard printed instructions. The researchers aim to determine if these messages, which provide recovery tips and video links, can reduce hospital visits and improve overall recovery. They seek patients who have recently undergone a specific type of spine surgery due to degenerative spine issues and who regularly use text messaging. Participants should have a mobile phone and be comfortable with texting. As an unphased trial, this study offers a unique opportunity to contribute to innovative recovery methods that could enhance patient care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that informative text messages are safe for lumbar spine surgery recovery?

Research has shown that using text messages to aid patient recovery after surgery is generally safe. Studies have found that sending messages like SMS in healthcare settings has not caused any serious safety issues. For instance, text messages have successfully supported patients after surgeries, with no known major side effects from receiving them.

In this study, patients will receive structured text messages after lumbar spine surgery. These messages will provide important recovery information and advice, including links to helpful videos. This method is non-invasive, meaning it doesn't physically affect the body, which further reduces any risk. Overall, using text messages in this way is well-tolerated and considered safe for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it tests a new approach to aiding recovery from lumbar spine surgery using automated text messages. Unlike the standard of care, which typically includes post-op packets and direct communication with healthcare providers, this method provides patients with regular, structured guidance through their phones. The use of pre-defined text scripts with video links offers a unique way to reinforce recovery instructions and potentially reduces the need for emergency visits or hospital readmissions. This innovative communication strategy might make recovery smoother and more efficient by keeping patients informed and engaged without overwhelming healthcare resources.

What evidence suggests that informative text messages are effective for lumbar spine surgery recovery?

This trial will compare the effectiveness of text messaging with standard post-operative care for lumbar spine surgery recovery. Research has shown that text messages can effectively aid recovery after lower back surgery. In one study, patients who received text messages had better outcomes than those who only received traditional handouts. These messages provided reminders and encouraged more physical activity, aiding recovery. Another study found that mobile apps and messaging improved post-surgery care, making it easier for patients to follow recovery steps. Overall, digital tools like text messaging have shown promise in aiding recovery and reducing complications after spinal surgery. Participants in this trial will be assigned to either the Text Message Group, receiving automated messages, or the Control Group, receiving standard post-op instructions. ^{1 2 3 4 6}

Who Is on the Research Team?

Oren N Gottfried, MD FAANS

Principal Investigator

Duke Neurosurgery

Are You a Good Fit for This Trial?

This trial is for adults over 18 with degenerative spine conditions who are having lumbar fusion surgery. Participants must own and be comfortable using a mobile phone for daily texting. It's not for non-English speakers, smokers, those with uncontrolled diabetes, or anyone previously having lumbar fusions or certain other health issues.

Inclusion Criteria

I have been diagnosed with a degenerative spine condition.

I had a spinal fusion surgery in my lower back involving 1 to 4 levels.

Answers YES to all the following screening questions: Do you own a mobile phone that is capable of sending and receiving text messages? Do you know how to text and feel comfortable texting? Are you a regular (at least once a day) text-message user? Are you agreeable to regular contact?

Exclusion Criteria

Prisoners or institutionalized patients

I have a tumor, infection, or trauma.

I will be removed from the study if I go to a rehab center or stay in the hospital for more than 7 days after surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Assessment

Participants complete standard of care outcomes questionnaires at the pre-operative clinic visit for baseline comparison

1 visit

Treatment

Participants undergo spinal fusion surgery and receive either standard post-surgery handouts or informative text messages for 2 weeks post-operatively

2 weeks

Daily text messages for 1 week, every other day for the second week (experimental group)

Follow-up

Participants are monitored for safety and effectiveness, including a phone interview at 30 days post-discharge to assess outcomes

30 days

1 phone interview

What Are the Treatments Tested in This Trial?

Interventions

• Text Message Group

Trial Overview The study is testing if sending informative text messages to patients after their lumbar spine surgery helps better than traditional handouts. Patients will randomly receive either texts or handouts and the effectiveness of these methods will be compared.

How Is the Trial Designed?

Group I: ARM 1: Text Message Group Experimental Treatment 1 Intervention

The intervention group will receive automated text messages every day for the first week, and every other day for the second week post-operatively. The text messages will follow a series of pre-defined standardized scripts (Appendix 3) with embedded hyperlinks to a video from the providers with further advice. The patient is directed not to respond to the text messages, but to call for any questions or concerns. The text message group will receive a 30-day post-operative phone call to evaluate: number of ED visits, hospital readmissions, and to re-administer the questionnaires completed at baseline visit. Other data to be collected may include the following: number of phone calls to provider, MyChart messages to provider, pain medications, and new problems like pain and infection.

Group II: ARM 2: Control group Active Control 1 Intervention

The control group will be given the standard post-op packet that includes detailed instructions on proper wound care and signs and symptoms of infection. They will not receive text messages. The same outcomes will be assessed in both groups through a 30-day post-operative phone call.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Published Research Related to This Trial

In a study involving 83 overweight/obese pregnant women, sending educational SMS about nutrition and physical activity did not significantly reduce excessive gestational weight gain (GWG) compared to a control group receiving general health messages.

Both groups had similar rates of exceeding the Institute of Medicine guidelines for GWG, suggesting that the timing and duration of the intervention may need to be adjusted for more effective outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a Short Message Service Intervention on Excessive Gestational Weight Gain in a Low-Income Population: A Randomized Controlled Trial. Holmes, H., Palacios, C., Wu, Y., et al.[2023]

The TEXT4myBACK intervention, which delivers text messages to support self-management of low back pain, was found to be useful and well-accepted by participants, with many reporting improvements in their condition and increased physical activity.

Participants suggested that the intervention could be effectively scaled up, potentially delivered by healthcare professionals, and recommended enhancements such as longer message duration and more information about low back pain and exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A qualitative assessment of a text message intervention for people with low back pain. Fritsch, CG., Abdel-Shaheed, C., Mohamed, R., et al.[2023]

A pilot study involving 101 patients scheduled for elective spine surgery demonstrated that a text message-based platform effectively monitored patient symptoms, with 71.2% responding to preoperative questionnaires.

The study found that pain scores collected via the text message platform correlated well with traditional electronic medical record pain rates, indicating the platform's reliability in tracking patient symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of an Automated Text Message-Based System for Tracking Patient-Reported Outcomes in Spine Surgery: An Overview of the Concept and Our Early Experience. Perdomo-Pantoja, A., Alomari, S., Lubelski, D., et al.[2022]

The implementation of SMS text messaging significantly increased patient awareness of cleft lip-palate surgical services in Zimbabwe, with 64% of patients reporting they learned about the services through their mobile phones after the messaging system was introduced.

Following the SMS notifications, the average age of patients seeking surgery increased, indicating that older patients may have been more likely to respond to the information, while the distance traveled to the clinic remained unchanged.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of mobile health on patient enrollment for cleft lip-palate surgery: A comparative study using SMS blast text messaging in zimbabwe. Gadkaree, SK., Tollefson, TT., Fuller, JC., et al.[2022]

A study involving 15 adult patients revealed that most expected their neurosurgeon to provide all necessary self-care information before surgery, highlighting a gap in patient awareness of nurses' roles in education.

Post-surgery, over half of the patients struggled to recall discharge instructions due to sedation and pain, emphasizing the need for written discharge materials to support oral instructions and improve patient understanding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceived self-care information needs and information--seeking behaviors before and after elective spinal procedures. Holmes, KL., Lenz, ER.[2019]

A text-messaging system called FLO was successfully used by 16 out of 17 patients after elective colorectal surgery, demonstrating its feasibility for remote monitoring and support during recovery.

The system helped identify potential complications early, as it flagged two patients who were unwell before they were readmitted, indicating that telehealth can enhance patient safety and recovery management post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a telehealth monitoring service after colorectal surgery: A feasibility study. Bragg, DD., Edis, H., Clark, S., et al.[2020]

A randomized controlled trial involving 150 patients showed that a mobile-based educational program significantly improved knowledge, attitudes, and practices regarding postoperative care for lumbar disk herniation surgery compared to a control group.

The intervention group, using the LUmbar CAring Training app, had notably higher scores in these areas immediately after the program and 8 weeks later, indicating the program's effectiveness and feasibility in enhancing patient education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a mobile-application educational intervention on the knowledge, attitude, and practice of patients in postoperative care for lumbar disk herniation surgery: A randomized control trial. Sadeghpour Ezbarami, S., Zarei, F., Haghani, S.[2023]

A study involving 2752 patients with acute low back pain found that providing standardized written information (the 'back book') reduced the rate of persistent low back pain after three months by 3.6% compared to a control group, indicating a modest but significant benefit.

Patients who received the information booklet reported higher satisfaction regarding guidance on physical activities and prevention, although the intervention did not significantly affect sick leave duration or disability levels among those with ongoing pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a simple information booklet on pain persistence after an acute episode of low back pain: a non-randomized trial in a primary care setting. Coudeyre, E., Tubach, F., Rannou, F., et al.[2022]

A study involving 23 postoperative patients showed that daily automated text messages about recovery were well-received, with a high satisfaction rating of 3.8 out of 4, indicating that patients found the platform helpful.

All participants engaged with their healthcare providers through texting, with those facing complications or who were unmarried texting more frequently, suggesting that this method could enhance patient engagement in recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving patient health engagement with mobile texting: A pilot study in the head and neck postoperative setting. Sosa, A., Heineman, N., Thomas, K., et al.[2018]

An educational intervention using text messages (SMS) significantly improved the final grades of students in a first aid course, with the intervention group scoring higher than the control group (PR = 4.82; 95% CI: 1.58 to 14.72).

The SMS content was designed to be educational, motivational, and included multiple-choice questions, indicating that well-structured text messages can enhance learning outcomes for undergraduate medical students.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Academic application of text messages in a first aid course: a pilot study in a private university in Lima, Peru]. Carrillo-Larco, RM., Shu-Yip, SB., Pérez-Lu, JE.[2017]

A systematic review of 60 studies found that mobile text message reminders significantly improved health outcomes, with 77% of studies reporting benefits such as better medication adherence and reduced missed appointments.

Despite the positive results, the use of SMS reminders in healthcare lacks rigorous randomized controlled trials, indicating a need for more systematic research to validate their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of mobile phone text message reminders in health care services: a narrative literature review. Kannisto, KA., Koivunen, MH., Välimäki, MA.[2022]

Citations

1. withpower.com withpower.com/trial/phase-spondylosis-9-2021-11dbe

Text Messaging for Lumbar Spine Surgery Recovery Trial Overview The study is testing if sending informative text messages to patients after their lumbar spine surgery helps better than traditional handouts.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8212000/

TEXT4myBACK – The Development Process of a Self ... A text message intervention was developed to support recovery from low back pain. An iterative process with clinicians, researchers, and consumers was ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6778274/

Mobile messaging and smartphone apps for patient ... Postoperative monitoring with a mobile application after ambulatory lumbar discectomy: an effective tool for spine surgeons. Eur Spine J 2016;25:3536-42.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2468781223000243

A qualitative assessment of a text message intervention for ... The TEXT4myBACK intervention was useful and well-accepted. It provided reminders and supported increases in physical activity.

5. journals.sagepub.com journals.sagepub.com/doi/full/10.1177/20552076251328549

Digital health interventions for spinal surgery patients A systematic review assessing the quality of digital health interventions for spinal surgery patients and the potential effects on these patients is lacking.

6. atm.amegroups.org atm.amegroups.org/article/view/28527/html

Mobile messaging and smartphone apps for patient ... These interventions utilize simple mobile messaging (SMS) and software applications on mobile devices for a variety of purposes. In the surgical population ...