Virtual Health Coaching for Reducing Alcohol Use Around Surgery

(ASPIRE-2 Trial)

Overseen By Anne Fernandez

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Severe alcohol withdrawal, others

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

Compensation: Varies

Number of Visits: Unknown

440 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

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

What data supports the effectiveness of this treatment for reducing alcohol use around surgery?

Research suggests that preoperative interventions, like virtual health coaching, can help patients reduce alcohol consumption and improve surgical outcomes. Patients are often motivated to change behaviors for short-term health benefits, and structured support can enhance their confidence and success in making these changes. ^{1 2 3 4 5}

Is virtual health coaching safe for reducing alcohol use around surgery?

The research suggests that preoperative interventions like alcohol cessation can reduce surgery-related complications, and virtual health coaching is generally considered safe as it involves remote guidance and support without direct medical procedures. ^{4 6 7 8 9}

How is the Virtual Health Coaching treatment for reducing alcohol use around surgery different from other treatments?

Virtual Health Coaching is unique because it uses digital technology to provide personalized support and guidance, helping patients reduce alcohol use before surgery. This approach is different from traditional face-to-face treatments, offering flexibility and accessibility through virtual means. ^{10 11 12 13 14}

What is the purpose of this trial?

This sequential, multiple assignment, randomized trial will test treatments designed to reduce alcohol use before and after surgery to promote surgical health and long-term wellness.

Research Team

Anne Fernandez, PhD

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for adults scheduled for major elective surgery (non-cancer) in the next 5-12 weeks, who drink alcohol at levels that may increase surgical risks (score ≥ 5 on AUDIT-C). They must be willing to follow study rules and have internet access. People already in another alcohol study or with severe alcohol withdrawal history can't join.

Inclusion Criteria

Willingness to comply with all study procedures and availability for the duration of the study

Completed consent form, baseline survey, and enrollment phone call

Score ≥ 5 on the Alcohol Use Disorders Identification Test-Concise (AUDIT-C) based on research linking this score with increased risk of surgical complications

Exclusion Criteria

Participants enrolled in another research study focused on alcohol use

Unable to speak, understand, or read English

History of severe alcohol withdrawal

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Intervention

Participants receive preoperative virtual health coaching to reduce alcohol use before surgery

4-6 weeks

Weekly virtual sessions

Postoperative Intervention

Participants receive postoperative health coaching to maintain reduced alcohol use and promote surgical health

10 months

Monthly virtual sessions

Follow-up

Participants are monitored for alcohol consumption and health outcomes after the intervention

10 months

Treatment Details

Interventions

• Enhanced Usual Care (pre-operative)
• On-Track (Post-operative)
• Postoperative Virtual Health Coaching
• Preoperative Virtual Health Coaching
• Usual surgical care (post-operative)

Trial Overview The study tests if treatments reducing alcohol use before and after surgery can improve recovery and long-term health. Participants receive either usual care or additional virtual coaching pre- and post-surgery, with assignments changing based on their progress.

Participant Groups

Group I: Preoperative Virtual Health Coaching then Usual Surgical Care Experimental Treatment 2 Interventions

Randomized two times (2 possible randomization groups each time). Responder to Preoperative Virtual Health Coaching

Group II: Preoperative Virtual Health Coaching then Postoperative Virtual Health Coaching Experimental Treatment 2 Interventions

Randomized two times (2 possible randomization groups each time). Responder to Preoperative Virtual Health Coaching

Group III: Preoperative Virtual Health Coaching then On-Track Experimental Treatment 2 Interventions

Randomized two times (2 possible randomization groups each time). Non-responder to Preoperative Virtual Health Coaching

Group IV: Preoperative Virtual Health Coaching then Combine (Postoperative Virtual Health Coaching + On-track) Experimental Treatment 3 Interventions

Randomized two times (2 possible randomization groups each time). Non-responder to Preoperative Virtual Health Coaching

Group V: Preoperative Virtual Health Coaching only Experimental Treatment 1 Intervention

Only completed first randomization. Study withdrawal prior to re-randomization.

Group VI: Enhanced Usual Care then Usual Surgical Care Experimental Treatment 2 Interventions

Randomized two times (2 possible randomization groups each time). Responder to Enhanced Usual Care

Group VII: Enhanced Usual Care then Post-operative Health Coaching Experimental Treatment 2 Interventions

Randomized two times (2 possible randomization groups each time). Responder to Enhanced Usual Care

Group VIII: Enhanced Usual Care then On-Track Experimental Treatment 2 Interventions

Randomized two times (2 possible randomization groups each time). Non-responder to Enhanced Usual Care

Group IX: Enhanced Usual Care then Combine (Postoperative Health Coaching + On-track) Experimental Treatment 3 Interventions

Randomized two times (2 possible randomization groups each time). Non-responder to Enhanced Usual Care

Group X: Enhanced Usual Care alone Experimental Treatment 1 Intervention

Only completed first randomization. Study withdrawal prior to re-randomization

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Findings from Research

In a study involving 815 patients scheduled for elective cardiothoracic surgery, 52% did not participate in a digital prehabilitation trial, highlighting significant barriers to access such as lack of internet or digital skills.

The non-participating patients were often older, had lower socioeconomic status, were more likely to be current smokers, and had a higher EuroSCORE II, indicating they had more modifiable risk factors and could benefit the most from prehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reasons and predictors of non-participation in a personalized digital prehabilitation care trial for patients undergoing elective cardiothoracic surgery. Scheenstra, B., Bongers, BC., Broeders, B., et al.[2023]

Preoperative multimodal prehabilitation programs can enhance surgical outcomes by improving patients' nutritional, functional, and psychological states before surgery, which is especially important for the elderly and those with multiple health issues.

Evidence supports various preoperative interventions, such as exercise training and psychosocial support, but further research is needed to determine the most effective components and their ideal timing for optimal patient recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preparing the patient for surgery to improve outcomes. Levett, DZ., Edwards, M., Grocott, M., et al.[2022]

A study involving 38 postoperative patients revealed that 98% of participants demonstrated high levels of patient activation, indicating strong engagement in their recovery process, regardless of socio-economic status.

The analysis identified key themes such as 'self-efficacy,' 'resilience,' and 'social support' as important factors driving patient engagement, suggesting that a tailored model for surgical patients could enhance their recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Surgical Patient Engagement Model: A Qualitative Study of Postoperative Patients. Yun, PS., MacDonald, CL., Orne, J., et al.[2020]

Redesigning elective surgical pathways can enhance patient care by focusing on individual needs, leading to improved patient satisfaction, health outcomes, and overall healthcare value.

Anaesthetists are uniquely positioned to lead these changes, implementing risk-adapted interventions before, during, and after surgery, which can reduce errors and promote better health practices like lifestyle modifications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peri-operative care pathways: re-engineering care to achieve the 'triple aim'. Grocott, MPW., Edwards, M., Mythen, MG., et al.[2019]

A study involving 299 surgical patients revealed a high prevalence of risk behaviors, with 42.1% of participants exhibiting multiple risk factors such as physical inactivity and unhealthy weight, indicating a significant opportunity for prehabilitation interventions.

Patients showed greater motivation and confidence to change health behaviors for short-term peri-operative benefits compared to long-term health improvements, highlighting the potential for targeted support during the 'pre-operative teachable moment' to enhance surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring patient attitudes to behaviour change before surgery to reduce peri-operative risk: preferences for short- vs. long-term behaviour change. McDonald, S., Yates, D., Durrand, JW., et al.[2020]

Implementing a Stop/Go preoperative checklist significantly reduced adverse events in surgeries from 1.5% to nearly 0%, highlighting its effectiveness in enhancing patient safety.

The study emphasizes the importance of a safety culture within the surgical team, suggesting that structured checklists can prevent many errors that occur during surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a STOP/GO protocol in the preoperative area to increase patient safety. Harris, AM., Preece, K., Harris, C.[2018]

The Enhanced Recovery after Surgery (ERAS) model aims to improve surgical recovery and reduce hospital stays, but currently does not include exercise prehabilitation (PREHAB), which could enhance patients' functional capacity before surgery.

This review highlights the conflicting evidence on the effectiveness of PREHAB for patients undergoing various surgeries, such as coronary artery bypass graft and lung resection, and emphasizes the need for further research to clarify its potential benefits and integration into ERAS protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise prehabilitation in elective intra-cavity surgery: A role within the ERAS pathway? A narrative review. Orange, ST., Northgraves, MJ., Marshall, P., et al.[2018]

The use of a safe surgery checklist (CL) led to a slight reduction in adverse events (AEs) from 13.6% to 11.8%), but this change was not statistically significant, indicating that the checklist alone may not be sufficient to reduce AEs.

However, there was a significant reduction in patient deaths (p=0.007) associated with the use of the checklist, suggesting that while the checklist did not significantly lower AEs, it may contribute to improved patient outcomes when combined with other safety strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of the Surgical Safety Checklist on the incidence of adverse events: contributions from a national study. Faria, LR., Moreira, TR., Carbogim, FDC., et al.[2023]

Prehabilitation, including preoperative exercise and smoking cessation 6-8 weeks before surgery, can significantly reduce postoperative complications and shorten hospital stays for surgical patients.

Maintaining perioperative normoglycemia is crucial for preventing surgical site infections, while allowing clear fluids up to 2 hours before surgery is safe and beneficial for patient hydration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative patient preparation in enhanced recovery pathways. Iqbal, U., Green, JB., Patel, S., et al.[2020]

The Birmingham OwnHealth telephone health coaching service, designed to support patients with chronic conditions, did not reduce hospital admissions or secondary care costs as intended; in fact, it was associated with an increase in emergency admissions and outpatient visits over 12 months.

Among 2,698 patients with conditions like heart failure and diabetes, the intervention group experienced a statistically significant rise in emergency admissions (0.05 more per head) and outpatient attendances (0.37 more per head) compared to matched controls, indicating that the coaching may not have been effective in improving health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of telephone health coaching (Birmingham OwnHealth) on hospital use and associated costs: cohort study with matched controls. Steventon, A., Tunkel, S., Blunt, I., et al.[2021]

Health coaching significantly reduced outpatient and total healthcare expenditures for high-risk participants, with estimated savings of $286 and $412 per person per month, respectively.

While health coaching did not impact emergency room costs, it did lead to a significant decrease in the probability of incurring inpatient expenditures, highlighting its potential effectiveness in managing healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How effective is health coaching in reducing health services expenditures? Jonk, Y., Lawson, K., O'Connor, H., et al.[2022]

In a study involving 14,584 patients with prediabetes, the highest uptake rate for wellness coaching appointments was achieved through secured email messages (3.0%), compared to letters and telephone messages, indicating that digital outreach may be more effective.

Overall, only 1.9% of patients engaged with wellness coaching, but factors such as age and gender influenced participation, with older patients and women being more likely to make appointments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wellness Coaching for People With Prediabetes: A Randomized Encouragement Trial to Evaluate Outreach Methods at Kaiser Permanente, Northern California, 2013. Xiao, H., Adams, SR., Goler, N., et al.[2019]

A longitudinal study with 671 smokers interacting with a virtual coach revealed that the perceived usefulness of behaviors, such as being informative and motivating, is crucial for user adherence to eHealth applications for behavior change.

The study identified 14 key themes related to user needs, including the importance of timing, personal motivation, and support from others, which can guide the design of more effective health behavior change applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Users' needs for a digital smoking cessation application and how to address them: A mixed-methods study. Albers, N., Neerincx, MA., Penfornis, KM., et al.[2023]

The feasibility study aimed to test the recruitment and retention of participants for an alcohol-specific digital health intervention (DHI) but only managed to recruit 7 out of 64 eligible participants, highlighting significant challenges in participant engagement and preference for face-to-face treatment.

Feedback from alcohol counsellors indicated that many potential participants preferred traditional treatment methods, and there were logistical issues in data collection and follow-up, suggesting that future trials may need to explore alternative recruitment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

DIAMOND (DIgital Alcohol Management ON Demand): a mixed methods feasibility RCT and embedded process evaluation of a digital health intervention to reduce hazardous and harmful alcohol use. Hamilton, FL., Hornby, J., Sheringham, J., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Reasons and predictors of non-participation in a personalized digital prehabilitation care trial for patients undergoing elective cardiothoracic surgery. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Preparing the patient for surgery to improve outcomes. [2022]

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

A Novel Surgical Patient Engagement Model: A Qualitative Study of Postoperative Patients. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Peri-operative care pathways: re-engineering care to achieve the 'triple aim'. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Exploring patient attitudes to behaviour change before surgery to reduce peri-operative risk: preferences for short- vs. long-term behaviour change. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Using a STOP/GO protocol in the preoperative area to increase patient safety. [2018]

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

Exercise prehabilitation in elective intra-cavity surgery: A role within the ERAS pathway? A narrative review. [2018]

8. Brazil pubmed.ncbi.nlm.nih.gov

Effect of the Surgical Safety Checklist on the incidence of adverse events: contributions from a national study. [2023]

9. India pubmed.ncbi.nlm.nih.gov

Preoperative patient preparation in enhanced recovery pathways. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Effect of telephone health coaching (Birmingham OwnHealth) on hospital use and associated costs: cohort study with matched controls. [2021]

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

How effective is health coaching in reducing health services expenditures? [2022]

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

Wellness Coaching for People With Prediabetes: A Randomized Encouragement Trial to Evaluate Outreach Methods at Kaiser Permanente, Northern California, 2013. [2019]

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

Users' needs for a digital smoking cessation application and how to address them: A mixed-methods study. [2023]

14. England pubmed.ncbi.nlm.nih.gov

DIAMOND (DIgital Alcohol Management ON Demand): a mixed methods feasibility RCT and embedded process evaluation of a digital health intervention to reduce hazardous and harmful alcohol use. [2022]