Surgical Procedure, Unspecified
Conditions
Brief summary
The purpose of this study is to test the impact of a bundled NOHARM Conversation Guide with clinical decision support intervention embedded within an Electronic Health Record (EHR) on pain and function 3 months following surgery.
Interventions
BEHAVIORALConversation Guide + Clinical Support
The intervention is a bundled intervention (conversation guide + clinician decision support tools) which promotes the solicitation and use of patient preferences for post-surgical, non-pharmacological pain management strategies.
Sponsors
National Institute on Aging (NIA)
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
This is a stepped wedge cluster randomized pragmatic clinical trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* All patients 18 years of age and older. * Must be undergoing qualifying surgeries at participating sites. * Patients under 18 years of age.
Exclusion criteria
\- Patients under 18 years of age.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS-CAT Pain | Baseline (before hospital discharge), 1-,2-, and 3-Months Post-Surgery | Change in patient reported pain; measured on scale of 1-100. A higher score indicates a worse outcome. |
| PROMIS-CAT Physical Function | Baseline (before hospital discharge), 1-,2-, and 3-Months Post-Surgery | Change in patient reported Physical Function; measured on scale of 1-100. A higher score indicates a better outcome. |
| PROMIS-CAT Anxiety | Baseline (before hospital discharge), 3-Months Post-Surgery | Change in patient reported Anxiety; measured on scale of 1-100. A higher score indicates a worse outcome. |
| Use of Non-Pharmacological Pain Control Modalities | 3 Months Post-Surgery | Number of participants using Non-Pharmacological Pain Control Modalities |
| Opioid Use | 3-Months Post-Surgery | Binary variables indicating presence or absence of opioid administration and prescription during the hospital encounter associated with the index surgery and during the post-discharge follow-up period. |
Countries
United States
Participant flow
Pre-assignment details
13,796 participants were excluded from the study prior to randomization and data collection due to principal investigator discretion.
Participants by arm
| Arm | Count |
|---|---|
| Control Arm Per a stepped-wedge cluster randomized pragmatic clinical trial design, all patients within whole surgical practices will be randomized to implementation tranches. The control arm consists of all patients receiving surgery in implementation tranches in which the intervention has not been implemented yet (per the study schedule). | 25,088 |
| Intervention Per a stepped-wedge cluster randomized pragmatic clinical trial design, all patients within whole surgical practices will be randomized to implementation tranches in which the intervention will be implemented per the study schedule.
Conversation Guide + Clinical Support: The intervention is a bundled intervention (conversation guide + clinician decision support tools) which promotes the solicitation and use of patient preferences for post-surgical, non-pharmacological pain management strategies. | 43,054 |
| Total | 68,142 |
Baseline characteristics
| Characteristic | Control Arm | Intervention | Total |
|---|---|---|---|
| Age, Customized Age (category) <=40 | 3681 Participants | 7695 Participants | 11376 Participants |
| Age, Customized Age (category) 41-50 | 2878 Participants | 4464 Participants | 7342 Participants |
| Age, Customized Age (category) 51-60 | 4507 Participants | 7039 Participants | 11546 Participants |
| Age, Customized Age (category) 61-70 | 7236 Participants | 12052 Participants | 19288 Participants |
| Age, Customized Age (category) 71-80 | 5271 Participants | 9302 Participants | 14573 Participants |
| Age, Customized Age (category) 80+ | 1515 Participants | 2502 Participants | 4017 Participants |
| Education Bachelor's degree | 5786 Participants | 9175 Participants | 14961 Participants |
| Education High school graduate | 737 Participants | 1230 Participants | 1967 Participants |
| Education Less than high school | 4590 Participants | 7143 Participants | 11733 Participants |
| Education Master's or Doctoral degree | 4356 Participants | 7068 Participants | 11424 Participants |
| Education Some college, vocational school, or associate degree | 7365 Participants | 11660 Participants | 19025 Participants |
| Education Unknown | 2254 Participants | 6778 Participants | 9032 Participants |
| Employment Disabled | 1189 Participants | 1573 Participants | 2762 Participants |
| Employment Employed | 11229 Participants | 20549 Participants | 31778 Participants |
| Employment Not Employed or Student or Military duty | 2341 Participants | 4294 Participants | 6635 Participants |
| Employment Retired | 10310 Participants | 16528 Participants | 26838 Participants |
| Employment Unknown or Not Reported | 19 Participants | 110 Participants | 129 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 990 Participants | 1505 Participants | 2495 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24024 Participants | 41340 Participants | 65364 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 74 Participants | 209 Participants | 283 Participants |
| Marital status Divorced | 1936 Participants | 3263 Participants | 5199 Participants |
| Marital status Life Partnership | 245 Participants | 458 Participants | 703 Participants |
| Marital status Married | 17015 Participants | 29673 Participants | 46688 Participants |
| Marital status Separated | 163 Participants | 247 Participants | 410 Participants |
| Marital status Single | 3772 Participants | 6449 Participants | 10221 Participants |
| Marital status Unknown | 66 Participants | 139 Participants | 205 Participants |
| Marital status Widowed | 1891 Participants | 2825 Participants | 4716 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 185 Participants | 314 Participants | 499 Participants |
| Race (NIH/OMB) Asian | 547 Participants | 1009 Participants | 1556 Participants |
| Race (NIH/OMB) Black or African American | 1044 Participants | 1652 Participants | 2696 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 30 Participants | 62 Participants | 92 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 600 Participants | 1046 Participants | 1646 Participants |
| Race (NIH/OMB) White | 22682 Participants | 38971 Participants | 61653 Participants |
| Region of Enrollment United States | 25088 participants | 43054 participants | 68142 participants |
| Rurality (RUCA code) Micropolitan (RUCA 4-6) | 2661 Participants | 5297 Participants | 7958 Participants |
| Rurality (RUCA code) Rural (RUCA 10) | 1835 Participants | 3555 Participants | 5390 Participants |
| Rurality (RUCA code) Small town (RUCA 7-9) | 2284 Participants | 4217 Participants | 6501 Participants |
| Rurality (RUCA code) Unknown | 158 Participants | 242 Participants | 400 Participants |
| Rurality (RUCA code) Urban (RUCA 1-3) | 18150 Participants | 29743 Participants | 47893 Participants |
| Sex: Female, Male Female | 10429 Participants | 16819 Participants | 27248 Participants |
| Sex: Female, Male Male | 14658 Participants | 26234 Participants | 40892 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 380 / 25,088 | 608 / 43,054 |
| other Total, other adverse events | 2,897 / 25,088 | 4,766 / 43,054 |
| serious Total, serious adverse events | 25 / 25,088 | 104 / 43,054 |
Outcome results
Primary
Opioid Use
Binary variables indicating presence or absence of opioid administration and prescription during the hospital encounter associated with the index surgery and during the post-discharge follow-up period.
Time frame: 3-Months Post-Surgery
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Arm | Opioid Use | Any opioid prescription or administration associated with index surgical encounter | 22299 Participants |
| Control Arm | Opioid Use | Any opioid prescribed during post-hospitalization follow-up period | 7348 Participants |
| Control Arm | Opioid Use | Any opioid administered inpatient during post-hospitalization follow-up period | 4972 Participants |
| Control Arm | Opioid Use | Any opioid prescription written during study period | 20173 Participants |
| Control Arm | Opioid Use | Any opioid prescribed at discharge following index surgery | 19082 Participants |
| Control Arm | Opioid Use | Any opioid exposure (prescription or inpatient administration) during study period | 23034 Participants |
| Control Arm | Opioid Use | Any opioid administered in hospital associated with index surgery (excluding day of surgery) | 16158 Participants |
| Intervention | Opioid Use | Any opioid exposure (prescription or inpatient administration) during study period | 38654 Participants |
| Intervention | Opioid Use | Any opioid administered inpatient during post-hospitalization follow-up period | 7238 Participants |
| Intervention | Opioid Use | Any opioid administered in hospital associated with index surgery (excluding day of surgery) | 26035 Participants |
| Intervention | Opioid Use | Any opioid prescribed at discharge following index surgery | 30414 Participants |
| Intervention | Opioid Use | Any opioid prescribed during post-hospitalization follow-up period | 10422 Participants |
| Intervention | Opioid Use | Any opioid prescription written during study period | 31738 Participants |
| Intervention | Opioid Use | Any opioid prescription or administration associated with index surgical encounter | 37639 Participants |
Primary
PROMIS-CAT Anxiety
Change in patient reported Anxiety; measured on scale of 1-100. A higher score indicates a worse outcome.
Time frame: Baseline (before hospital discharge), 3-Months Post-Surgery
Population: Number of participants who answered at least one followup anxiety survey
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Arm | PROMIS-CAT Anxiety | Baseline | 50.72 score on a scale | Standard Deviation 9.2 |
| Control Arm | PROMIS-CAT Anxiety | Month 1 | 51.93 score on a scale | Standard Deviation 9.34 |
| Control Arm | PROMIS-CAT Anxiety | Month 2 | 51.21 score on a scale | Standard Deviation 9.54 |
| Control Arm | PROMIS-CAT Anxiety | Month 3 | 47.19 score on a scale | Standard Deviation 9.55 |
| Intervention | PROMIS-CAT Anxiety | Month 3 | 47.48 score on a scale | Standard Deviation 9.62 |
| Intervention | PROMIS-CAT Anxiety | Baseline | 51.85 score on a scale | Standard Deviation 9.17 |
| Intervention | PROMIS-CAT Anxiety | Month 2 | 51.75 score on a scale | Standard Deviation 9.49 |
| Intervention | PROMIS-CAT Anxiety | Month 1 | 51.63 score on a scale | Standard Deviation 9.59 |
Primary
PROMIS-CAT Pain
Change in patient reported pain; measured on scale of 1-100. A higher score indicates a worse outcome.
Time frame: Baseline (before hospital discharge), 1-,2-, and 3-Months Post-Surgery
Population: Number of participants who answered at least 1 pain followup survey
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Arm | PROMIS-CAT Pain | Baseline | 59.32 score on a scale | Standard Deviation 9.92 |
| Control Arm | PROMIS-CAT Pain | Month 1 | 56.94 score on a scale | Standard Deviation 9.1 |
| Control Arm | PROMIS-CAT Pain | Month 2 | 53.08 score on a scale | Standard Deviation 9.42 |
| Control Arm | PROMIS-CAT Pain | Month 3 | 52.14 score on a scale | Standard Deviation 9.43 |
| Intervention | PROMIS-CAT Pain | Month 3 | 52.43 score on a scale | Standard Deviation 9.45 |
| Intervention | PROMIS-CAT Pain | Baseline | 59.96 score on a scale | Standard Deviation 9.68 |
| Intervention | PROMIS-CAT Pain | Month 2 | 53.29 score on a scale | Standard Deviation 9.39 |
| Intervention | PROMIS-CAT Pain | Month 1 | 56.06 score on a scale | Standard Deviation 8.97 |
Primary
PROMIS-CAT Physical Function
Change in patient reported Physical Function; measured on scale of 1-100. A higher score indicates a better outcome.
Time frame: Baseline (before hospital discharge), 1-,2-, and 3-Months Post-Surgery
Population: Number of participants who answered at least one physical function followup survey
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Arm | PROMIS-CAT Physical Function | Baseline | 40.50 score on a scale | Standard Deviation 9.04 |
| Control Arm | PROMIS-CAT Physical Function | Month 1 | 38.44 score on a scale | Standard Deviation 9.06 |
| Control Arm | PROMIS-CAT Physical Function | Month 2 | 42.44 score on a scale | Standard Deviation 9.75 |
| Control Arm | PROMIS-CAT Physical Function | Month 3 | 43.84 score on a scale | Standard Deviation 9.74 |
| Intervention | PROMIS-CAT Physical Function | Month 3 | 41.85 score on a scale | Standard Deviation 10.41 |
| Intervention | PROMIS-CAT Physical Function | Baseline | 39.50 score on a scale | Standard Deviation 8.54 |
| Intervention | PROMIS-CAT Physical Function | Month 2 | 40.79 score on a scale | Standard Deviation 10.26 |
| Intervention | PROMIS-CAT Physical Function | Month 1 | 39.68 score on a scale | Standard Deviation 9.19 |
Primary
Use of Non-Pharmacological Pain Control Modalities
Number of participants using Non-Pharmacological Pain Control Modalities
Time frame: 3 Months Post-Surgery
Population: Patients who answered a questionnaire about their use of non-pharmacologic pain control modalities
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Arm | Use of Non-Pharmacological Pain Control Modalities | Aromatherapy | 58 Participants |
| Control Arm | Use of Non-Pharmacological Pain Control Modalities | Massage | 303 Participants |
| Control Arm | Use of Non-Pharmacological Pain Control Modalities | Tai Chi | 7 Participants |
| Control Arm | Use of Non-Pharmacological Pain Control Modalities | Meditation | 166 Participants |
| Control Arm | Use of Non-Pharmacological Pain Control Modalities | Cold or Heat | 721 Participants |
| Control Arm | Use of Non-Pharmacological Pain Control Modalities | Muscle Relaxation | 183 Participants |
| Control Arm | Use of Non-Pharmacological Pain Control Modalities | Acupressure | 23 Participants |
| Control Arm | Use of Non-Pharmacological Pain Control Modalities | TENS | 58 Participants |
| Control Arm | Use of Non-Pharmacological Pain Control Modalities | Relaxed Breathing | 278 Participants |
| Control Arm | Use of Non-Pharmacological Pain Control Modalities | Walking | 630 Participants |
| Control Arm | Use of Non-Pharmacological Pain Control Modalities | Music | 184 Participants |
| Control Arm | Use of Non-Pharmacological Pain Control Modalities | Yoga | 27 Participants |
| Control Arm | Use of Non-Pharmacological Pain Control Modalities | Guided Imagery | 23 Participants |
| Intervention | Use of Non-Pharmacological Pain Control Modalities | Yoga | 1237 Participants |
| Intervention | Use of Non-Pharmacological Pain Control Modalities | Music | 7545 Participants |
| Intervention | Use of Non-Pharmacological Pain Control Modalities | Acupressure | 752 Participants |
| Intervention | Use of Non-Pharmacological Pain Control Modalities | Aromatherapy | 2549 Participants |
| Intervention | Use of Non-Pharmacological Pain Control Modalities | Cold or Heat | 16058 Participants |
| Intervention | Use of Non-Pharmacological Pain Control Modalities | Relaxed Breathing | 10709 Participants |
| Intervention | Use of Non-Pharmacological Pain Control Modalities | Guided Imagery | 1024 Participants |
| Intervention | Use of Non-Pharmacological Pain Control Modalities | Massage | 6848 Participants |
| Intervention | Use of Non-Pharmacological Pain Control Modalities | Meditation | 4254 Participants |
| Intervention | Use of Non-Pharmacological Pain Control Modalities | Tai Chi | 257 Participants |
| Intervention | Use of Non-Pharmacological Pain Control Modalities | TENS | 1359 Participants |
| Intervention | Use of Non-Pharmacological Pain Control Modalities | Walking | 17886 Participants |
| Intervention | Use of Non-Pharmacological Pain Control Modalities | Muscle Relaxation | 5436 Participants |