Text Messaging for Lumbar Spine Surgery Recovery

(NOTICE Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Oren N Gottfried, MD FAANS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Duke University

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

No Placebo Group

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.

Trial 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 (Behavioural Intervention)

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Duke Neurosurgery and Duke Orthopedics Durham, NC

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2495

Patients Recruited

5,912,000+

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] Text message-based interventions have been demonstrated to be a valuable monitoring tool across various conditions. Here, we aimed to describe our early experience using a newly developed text message-based platform designed to track symptoms in spine surgery patients.

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

Development of a telehealth monitoring service after colorectal surgery: A feasibility study. [2020] To evaluate the feasibility of a text-messaging system to remotely monitor and support patients after discharge following elective colorectal surgery, within an enhanced recovery protocol.

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] We aimed to evaluate the impact of a mobile-based educational program on patients' postoperative care for lumbar disk herniation surgery.

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] Cell phone ownership is nearly universal. Messaging is one of its most widely used features. Texting-based interventions may improve patient engagement in the postoperative setting, but remain understudied.

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] Mass-media campaigns have been known to modify the outcome of low back pain (LBP). We assessed the impact on outcome of standardized written information on LBP given to patients with acute LBP.

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] The aim of the study was to develop and evaluate the impact of an educational intervention with the use of text messages (SMS) in a first aid course. A prospective study and intervention was conducted. Two steps were implemented: 1) a qualitative study to design the SMS and 2) the intervention with the sending of the SMS messages. The outcome variable was the final grade of students. Multivariate models were constructed, prevalence ratios and confidence intervals at 95% were calculated. The first phase revealed that the SMS should be educational-theoretical, motivational, and multiple choice. In the intervention there were 66 participants in the control and intervention group. The average age was 17.7 (± 1.2) years. The intervention group obtained higher scores compared with the control group (PR = 4.82; 95% CI: 1.58 to 14.72). In conclusion, SMS with informative and motivational content is useful in the formation of undergraduate medicine.

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] The objective of this trial was to investigate the effect of educational short message service (SMS), or text messages, on excessive gestational weight gain (GWG) in a low-income, predominantly overweight/obese population.

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] Patients' lack of awareness of available services is a significant barrier to delivering surgical care in resource-limited settings. Short message service (SMS) text messaging is a potential means to disseminate this information in resource-limited settings, where rates of mobile phone usage are high.

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

Perceived self-care information needs and information--seeking behaviors before and after elective spinal procedures. [2019] Patients undergoing elective lumbar spinal surgical procedures pose a challenge to nurses who provide discharge instruction, because the decreased length of stay (LOS) severely limits time for comprehensive discharge instruction. The perspectives of 15 adult patients on their perceived self-care information needs and information seeking behaviors following elective spinal surgical procedures were examined. Content analytic techniques were used to categorize responses. Preoperatively, a majority of the subjects (93.3%) indicated that the neurosurgeon rather than the nurse, was anticipated to be the sole source of information related to self-care needs. Postdischarge, more than half of the subjects reported that they had difficulty describing the teaching session because they were either too sedated due to the analgesia, or were experiencing extreme pain at the time the discharge instruction was being delivered. Results substantiate the importance of supplementing oral discharge instruction with comprehensive written discharge instruction and of increasing public awareness of the teaching expertise of nurses.

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

Use of mobile phone text message reminders in health care services: a narrative literature review. [2022] Mobile text messages are a widely recognized communication method in societies, as the global penetration of the technology approaches 100% worldwide. Systematic knowledge is still lacking on how the mobile telephone text messaging (short message service, SMS) has been used in health care services.

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

A qualitative assessment of a text message intervention for people with low back pain. [2023] Text messages represent a simple and scalable strategy to provide self-management to people with low back pain (LBP), yet their usefulness is unknown.