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| ID | Type | Description | Link |
|---|---|---|---|
| UG3AG067593 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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. |
|
| Control Arm | No Intervention | 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conversation Guide + Clinical Support | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS-CAT Pain | Change in patient reported pain; measured on scale of 1-100. A higher score indicates a worse outcome. | Baseline (before hospital discharge), 1-,2-, and 3-Months Post-Surgery |
| PROMIS-CAT Physical Function | Change in patient reported Physical Function; measured on scale of 1-100. A higher score indicates a better outcome. | Baseline (before hospital discharge), 1-,2-, and 3-Months Post-Surgery |
| PROMIS-CAT Anxiety | Change in patient reported Anxiety; measured on scale of 1-100. A higher score indicates a worse outcome. | Baseline (before hospital discharge), 3-Months Post-Surgery |
| Use of Non-Pharmacological Pain Control Modalities | Number of participants using Non-Pharmacological Pain Control Modalities | 3 Months Post-Surgery |
| 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. | 3-Months Post-Surgery |
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Inclusion Criteria:
Exclusion Criteria:
- Patients under 18 years of age.
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| Name | Affiliation | Role |
|---|---|---|
| Andrea L Cheville | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | United States | ||
| Mayo Clinic in Rochester |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35657564 | Derived | Redmond S; Mayo Clinic NOHARM Research Team; Tilburt J, Cheville A. Non-pharmacological Options in Postoperative Hospital-Based and Rehabilitation Pain Management (NOHARM): Protocol for a Stepped-Wedge Cluster-Randomized Pragmatic Clinical Trial. Pain Ther. 2022 Sep;11(3):1037-1053. doi: 10.1007/s40122-022-00393-x. Epub 2022 Jun 3. |
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13,796 participants were excluded from the study prior to randomization and data collection due to principal investigator discretion.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 | 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. Sequence 1 went live with the intervention during Step 2: Surgical practices offered 4 months of usual care followed by 36 months of intervention. However, patients did not transition from usual care to intervention. |
| FG001 | Sequence 2 | 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. Sequence 2 went live with the intervention during Step 3. Surgical practices offered 11 months of usual care followed by 29 months of intervention. However, patients did not transition between usual care and intervention. |
| FG002 | Sequence 3 | 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. Sequence 3 went live with the intervention during Step 4. Surgical practices offered 18 months of usual care followed by 22 months of intervention. However, patients did not transition from usual care to intervention. |
| FG003 | Sequence 4 | 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. Sequence 4 went live with the intervention during Step 5. Surgical practices offered 25 months of usual care followed by 15 months of intervention. However, patients did not transition from usual care to intervention. |
| FG004 | Sequence 5 | 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. Sequence 5 went live with the intervention during Step 6. Surgical practices offered 32 months of usual care followed by 8 months of intervention. However, patients did not transition from usual care to intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Step 1: Oct 16 2020 - Feb 28 2021 |
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| Step 2: Mar 1 2021 - Sep 30 2021 |
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| Step 3: Oct 1 2021 - Apr 30 2022 |
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| Step 4: May 1 2022 - Nov 30 2022 |
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| Step 5: Dec 1 2022 - Jun 30 2023 |
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| Step 6: Jul 1 2023 - Jan 31 2024 |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 | PROMIS-CAT Pain | Change in patient reported pain; measured on scale of 1-100. A higher score indicates a worse outcome. | Number of participants who answered at least 1 pain followup survey | Posted | Mean | Standard Deviation | score on a scale | Baseline (before hospital discharge), 1-,2-, and 3-Months Post-Surgery |
|
Adverse events were collected from baseline to end of study participation for up to 3 Months Post-Surgery for all participants. Sites were monitored for the duration of the study (40 months)
All deaths and adverse events were collected irrespective of attribution. No deaths or adverse events were causally associated with the NOHARM trial intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | General disorders | Systematic Assessment | Fall during index hospitalization |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment | Rash during study period |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrea Cheville | Mayo Clinic | (507) 284-2747 | cheville.andrea@mayo.edu |
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| 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 | Sep 21, 2023 | May 22, 2025 | Prot_SAP_004.pdf |
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This is a stepped wedge cluster randomized pragmatic clinical trial.
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|
| Rochester |
| Minnesota |
| 55905 |
| United States |
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | There were two participants in the study who did not provide their gender as male/female. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Employment | Count of Participants | Participants |
|
| Marital status | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Rurality (RUCA code) | Count of Participants | Participants |
|
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. |
|
|
| Primary | PROMIS-CAT Physical Function | Change in patient reported Physical Function; measured on scale of 1-100. A higher score indicates a better outcome. | Number of participants who answered at least one physical function followup survey | Posted | Mean | Standard Deviation | score on a scale | Baseline (before hospital discharge), 1-,2-, and 3-Months Post-Surgery |
|
|
|
| Primary | PROMIS-CAT Anxiety | Change in patient reported Anxiety; measured on scale of 1-100. A higher score indicates a worse outcome. | Number of participants who answered at least one followup anxiety survey | Posted | Mean | Standard Deviation | score on a scale | Baseline (before hospital discharge), 3-Months Post-Surgery |
|
|
|
| Primary | Use of Non-Pharmacological Pain Control Modalities | Number of participants using Non-Pharmacological Pain Control Modalities | Patients who answered a questionnaire about their use of non-pharmacologic pain control modalities | Posted | Count of Participants | Participants | 3 Months Post-Surgery |
|
|
|
| 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. | Posted | Count of Participants | Participants | 3-Months Post-Surgery |
|
|
|
| 380 |
| 25,088 |
| 25 |
| 25,088 |
| 2,897 |
| 25,088 |
| EG001 | 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. | 608 | 43,054 | 104 | 43,054 | 4,766 | 43,054 |
|
| Muscle spasm | Musculoskeletal and connective tissue disorders | Systematic Assessment | Muscle spasm during study period |
|
| Failure to rescue | General disorders | Systematic Assessment | Failure to reduce pain: 3 or more consecutive severe pain scores (>= 7 on numeric rating scale out of 10) |
|
| Burn at electrode or hot pack site | Skin and subcutaneous tissue disorders | Systematic Assessment | Burn at electrode of hot pack site during study period |
|
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Not Employed or Student or Military duty |
|
| Disabled |
|
| Unknown or Not Reported |
|
| Divorced |
|
| Widowed |
|
| Life Partnership |
|
| Separated |
|
| Unknown |
|
| Some college, vocational school, or associate degree |
|
| Bachelor's degree |
|
| Master's or Doctoral degree |
|
| Unknown |
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| Small town (RUCA 7-9) |
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| Rural (RUCA 10) |
|
| Unknown |
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| Month 2 |
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| Month 3 |
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| Month 2 |
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| Month 3 |
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| Cold or Heat |
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| Relaxed Breathing |
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| Guided Imagery |
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| Massage |
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| Meditation |
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| Muscle Relaxation |
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| Music |
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| Tai Chi |
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| TENS |
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| Walking |
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| Yoga |
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| Any opioid prescription or administration associated with index surgical encounter |
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| Any opioid administered inpatient during post-hospitalization follow-up period |
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| Any opioid prescribed during post-hospitalization follow-up period |
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| Any opioid prescription written during study period |
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| Any opioid exposure (prescription or inpatient administration) during study period |
|