Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 5K23AA023869 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
This study aims to learn more about how to improve patients' health before and after a scheduled surgery by examining acceptability and initial efficacy of pre-operative alcohol use reduction interventions.
The study is a randomized clinical pilot trial that assesses preliminary intervention efficacy of a two-session health coaching intervention relative to brief advice among pre-operative elective surgical patients and evaluates intervention acceptability. Study subjects will be outpatients at a large health system in the midwestern United States and fulfill the study's inclusion criteria. Subjects will be randomized to one of two intervention conditions: Health Coaching or Brief Advice.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brief advice | Active Comparator | One brief advice session, resource brochure, standard of care, and an infographic about alcohol and surgical health at patient's pre-existing pre-operative clinical visit. |
|
| Health coaching | Experimental | Two health coaching sessions, resource brochure, standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief advice | Behavioral | One 10-minute brief advice session |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Alcohol Weekly Use | Average (i.e. mean) weekly alcohol use was assessed using the timeline followback measure. The timeline followback assesses alcohol use using a calendar format on which participants report the number of standard drinks they consumed each day during the assessment period. In the United States, one standard drink (or one alcoholic drink equivalent), is defined as any beverage containing 0.6 oz or 14 grams of pure alcohol. | Baseline through 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of Intervention as Measured by the Post-intervention Evaluation. | Interventions will be considered 'acceptable' if the average acceptability rating reaches a threshold of 3 or more on a 4-point Likert scale where a score of 4 is most acceptable. Satisfaction
| Weeks 1-6, Immediately following intervention |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anne Fernandez | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37494103 | Derived | Chapman L, Ren T, Solka J, Bazzi AR, Borsari B, Mello MJ, Fernandez AC. Reducing Alcohol Use Before and After Surgery: Qualitative Study of Two Treatment Approaches. JMIR Perioper Med. 2023 Jul 26;6:e42532. doi: 10.2196/42532. |
Not provided
Not provided
The researchers will plan to share individual participant data that underlies the results reported in an article, after deidentification (text, tables, figures, and appendices), Study protocol, and Informed Consent Form.
Beginning 9 months and ending 36 months following article publication.
Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.
Not provided
14 of 65 enrolled participants were not assigned to groups because they did not meet eligibility requirements after enrollment (i.e. surgery cancelation).
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Brief Advice | One 10-minute educational and feedback intervention delivered 4 weeks prior to surgery. |
| FG001 | Health Coaching | Two 45-minute Health Coaching sessions delivered 4 weeks and 2 weeks prior to surgery, respectively. The sessions were based on the principles of collaborative care, motivational interviewing, and the Health Belief Model. Intervention delivery included education about alcohol use and surgical risk, providing feedback linking alcohol use and health (related to surgery and general health), advising the patient regarding abstinence or alcohol use reduction, and working with the patient to set a drinking goal if he/she was ready to change. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| From Baseline to 1 Month Follow Up |
|
| |||||||||||||||||||||
| 1 Month Follow Up to 4 Month Follow Up |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Brief Advice | One 10-minute brief advice session. |
| BG001 | Health Coaching | Two 45-minute Health Coaching sessions delivered 4 weeks and 2 weeks prior to surgery, respectively. The sessions were based on the principles of collaborative care, motivational interviewing, and the Health Belief Model. Intervention delivery included education about alcohol use and surgical risk, providing feedback linking alcohol use and health (related to surgery and general health), advising the patient regarding abstinence or alcohol use reduction, and working with the patient to set a drinking goal if he/she was ready to change. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Alcohol Weekly Use | Average (i.e. mean) weekly alcohol use was assessed using the timeline followback measure. The timeline followback assesses alcohol use using a calendar format on which participants report the number of standard drinks they consumed each day during the assessment period. In the United States, one standard drink (or one alcoholic drink equivalent), is defined as any beverage containing 0.6 oz or 14 grams of pure alcohol. | Posted | Mean | Standard Deviation | Drinks consumed/week | Baseline through 4 months |
|
4 Months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Brief Advice | One 10-minute brief advice session. | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post-op Surgical complications, Surgical and Medical Procedures | Injury, poisoning and procedural complications | Non-systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne C. Fernandez | University of Michigan | 734-232-0521 | acfernan@med.umich.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 7, 2021 | Jul 14, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 21, 2020 | Jul 14, 2022 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D003419 | Crisis Intervention |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Health coaching |
| Behavioral |
Two 45-minute health coaching sessions will use a non-confrontation motivational interviewing (MI) style. Intervention delivery will include expressing concern about unhealthy drinking, providing feedback linking alcohol use and health (related to surgery and general health), advising the patient regarding abstinence or alcohol use reduction, and working with the patient to set a drinking goal if he/she is ready to change. We will also include a personalized feedback component to address the links between pre-operative alcohol use and postoperative morbidity/mortality. |
|
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| Highest Education | Count of Participants | Participants |
|
| Surgical Stay | Count of Participants | Participants |
|
| Surgical Service | Count of Participants | Participants |
|
| Alcohol Use Disorders Identification Test (AUDIT-C) Score | The three-item AUDIT-C assessed alcohol quantity, frequency, and heavy drinking days. The overall score ranges from 0 to 12, with zero reflecting no alcohol use and higher scores reflecting higher levels of alcohol use. | Mean | Standard Deviation | units on a scale |
|
| Drinks consumed per week | Mean | Standard Deviation | Drinks consumed/week |
|
| Percentage of Days Abstinent | Mean | Standard Deviation | Percentage |
|
| Percentage of Weeks Exceeding Moderate Drinking | Mean | Standard Deviation | Percentage |
|
|
|
| Secondary | Acceptability of Intervention as Measured by the Post-intervention Evaluation. | Interventions will be considered 'acceptable' if the average acceptability rating reaches a threshold of 3 or more on a 4-point Likert scale where a score of 4 is most acceptable. Satisfaction
| Among the Brief Advice participants only 23 completed this survey. | Posted | Count of Participants | Participants | Weeks 1-6, Immediately following intervention |
|
|
|
| 26 |
| 1 |
| 26 |
| 0 |
| 26 |
| EG001 | Health Coaching | Two 45-minute Health Coaching sessions delivered 4 weeks and 2 weeks prior to surgery, respectively. The sessions were based on the principles of collaborative care, motivational interviewing, and the Health Belief Model. Intervention delivery included education about alcohol use and surgical risk, providing feedback linking alcohol use and health (related to surgery and general health), advising the patient regarding abstinence or alcohol use reduction, and working with the patient to set a drinking goal if he/she was ready to change. | 0 | 25 | 3 | 25 | 0 | 25 |
Not provided
Not provided
Not provided