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

Trial Summary

What is the purpose of this trial?

The purpose of this single-blind, randomized, controlled study is to assess the efficacy of "informative text messages" vs "traditional handouts" provided to lumbar spine surgery patients post-operatively.

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 data supports the effectiveness of the treatment Text Message Group, SMS Intervention, Informative Text Messages for lumbar spine surgery recovery?

Text message-based interventions have been shown to be valuable for monitoring and supporting patients in various medical conditions, including spine surgery and colorectal surgery, by improving patient engagement and tracking symptoms. ^{1 2 3 4 5}

Is text messaging safe for use in medical interventions?

Text message-based interventions have been used safely in various medical settings, such as monitoring symptoms in spine surgery patients and providing educational content in first aid courses, without any reported safety concerns. ^{1 3 6 7 8}

How does text messaging for lumbar spine surgery recovery differ from other treatments?

This treatment is unique because it uses text messages to help patients manage their recovery after lumbar spine surgery, providing a simple and scalable way to track symptoms and offer support, unlike traditional methods that rely on in-person follow-ups or written instructions. ^{1 8 9 10 11}

Research Team

Oren N Gottfried, MD FAANS

Principal Investigator

Duke Neurosurgery

Eligibility Criteria

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 am 18 years old or older.

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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 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 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]

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]

References

1. United States 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Development of a telehealth monitoring service after colorectal surgery: A feasibility study. [2020]

3. England 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. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Improving patient health engagement with mobile texting: A pilot study in the head and neck postoperative setting. [2018]

5. United States 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. [2022]

6. Peru 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]. [2017]

7. Switzerland 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. [2023]

8. United States 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. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Perceived self-care information needs and information--seeking behaviors before and after elective spinal procedures. [2019]

10. Canada pubmed.ncbi.nlm.nih.gov

Use of mobile phone text message reminders in health care services: a narrative literature review. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

A qualitative assessment of a text message intervention for people with low back pain. [2023]