Trial Outcomes & Findings for Non-pharmacological Pain Management After Surgery (NCT NCT04570371)
NCT ID: NCT04570371
Last Updated: 2025-11-13
Results Overview
Change in patient reported pain; measured on scale of 1-100. A higher score indicates a worse outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
81938 participants
Primary outcome timeframe
Baseline (before hospital discharge), 1-,2-, and 3-Months Post-Surgery
Results posted on
2025-11-13
Participant Flow
13,796 participants were excluded from the study prior to randomization and data collection due to principal investigator discretion.
Unit of analysis: Surgical departments
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Step 1: Oct 16 2020 - Feb 28 2021
STARTED
|
1899 5
|
2378 5
|
1265 4
|
721 4
|
840 4
|
|
Step 1: Oct 16 2020 - Feb 28 2021
COMPLETED
|
1899 5
|
2378 5
|
1265 4
|
721 4
|
840 4
|
|
Step 1: Oct 16 2020 - Feb 28 2021
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Step 2: Mar 1 2021 - Sep 30 2021
STARTED
|
3228 5
|
3854 5
|
2112 4
|
1147 4
|
1726 4
|
|
Step 2: Mar 1 2021 - Sep 30 2021
COMPLETED
|
3228 5
|
3854 5
|
2112 4
|
1147 4
|
1726 4
|
|
Step 2: Mar 1 2021 - Sep 30 2021
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Step 3: Oct 1 2021 - Apr 30 2022
STARTED
|
3130 5
|
3660 5
|
1902 4
|
1157 4
|
1500 4
|
|
Step 3: Oct 1 2021 - Apr 30 2022
COMPLETED
|
3130 5
|
3660 5
|
1902 4
|
1157 4
|
1500 4
|
|
Step 3: Oct 1 2021 - Apr 30 2022
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Step 4: May 1 2022 - Nov 30 2022
STARTED
|
3394 5
|
4038 5
|
2035 4
|
1145 4
|
1715 4
|
|
Step 4: May 1 2022 - Nov 30 2022
COMPLETED
|
3394 5
|
4038 5
|
2035 4
|
1145 4
|
1715 4
|
|
Step 4: May 1 2022 - Nov 30 2022
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Step 5: Dec 1 2022 - Jun 30 2023
STARTED
|
3486 5
|
4328 5
|
2054 4
|
1233 4
|
1715 4
|
|
Step 5: Dec 1 2022 - Jun 30 2023
COMPLETED
|
3486 5
|
4328 5
|
2054 4
|
1233 4
|
1715 4
|
|
Step 5: Dec 1 2022 - Jun 30 2023
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Step 6: Jul 1 2023 - Jan 31 2024
STARTED
|
3526 5
|
4131 5
|
2017 4
|
1171 4
|
1635 4
|
|
Step 6: Jul 1 2023 - Jan 31 2024
COMPLETED
|
3526 5
|
4131 5
|
2017 4
|
1171 4
|
1635 4
|
|
Step 6: Jul 1 2023 - Jan 31 2024
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
There were two participants in the study who did not provide their gender as male/female.
Baseline characteristics by cohort
| Measure |
Control Arm
n=25088 Participants
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).
|
Intervention
n=43054 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.
|
Total
n=68142 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age (category) · <=40
|
3681 Participants
n=25088 Participants
|
7695 Participants
n=43054 Participants
|
11376 Participants
n=68142 Participants
|
|
Age, Customized
Age (category) · 41-50
|
2878 Participants
n=25088 Participants
|
4464 Participants
n=43054 Participants
|
7342 Participants
n=68142 Participants
|
|
Age, Customized
Age (category) · 51-60
|
4507 Participants
n=25088 Participants
|
7039 Participants
n=43054 Participants
|
11546 Participants
n=68142 Participants
|
|
Age, Customized
Age (category) · 61-70
|
7236 Participants
n=25088 Participants
|
12052 Participants
n=43054 Participants
|
19288 Participants
n=68142 Participants
|
|
Age, Customized
Age (category) · 71-80
|
5271 Participants
n=25088 Participants
|
9302 Participants
n=43054 Participants
|
14573 Participants
n=68142 Participants
|
|
Age, Customized
Age (category) · 80+
|
1515 Participants
n=25088 Participants
|
2502 Participants
n=43054 Participants
|
4017 Participants
n=68142 Participants
|
|
Sex: Female, Male
Female
|
10429 Participants
n=25087 Participants • There were two participants in the study who did not provide their gender as male/female.
|
16819 Participants
n=43053 Participants • There were two participants in the study who did not provide their gender as male/female.
|
27248 Participants
n=68140 Participants • There were two participants in the study who did not provide their gender as male/female.
|
|
Sex: Female, Male
Male
|
14658 Participants
n=25087 Participants • There were two participants in the study who did not provide their gender as male/female.
|
26234 Participants
n=43053 Participants • There were two participants in the study who did not provide their gender as male/female.
|
40892 Participants
n=68140 Participants • There were two participants in the study who did not provide their gender as male/female.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
990 Participants
n=25088 Participants
|
1505 Participants
n=43054 Participants
|
2495 Participants
n=68142 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24024 Participants
n=25088 Participants
|
41340 Participants
n=43054 Participants
|
65364 Participants
n=68142 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
74 Participants
n=25088 Participants
|
209 Participants
n=43054 Participants
|
283 Participants
n=68142 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
185 Participants
n=25088 Participants
|
314 Participants
n=43054 Participants
|
499 Participants
n=68142 Participants
|
|
Race (NIH/OMB)
Asian
|
547 Participants
n=25088 Participants
|
1009 Participants
n=43054 Participants
|
1556 Participants
n=68142 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
30 Participants
n=25088 Participants
|
62 Participants
n=43054 Participants
|
92 Participants
n=68142 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1044 Participants
n=25088 Participants
|
1652 Participants
n=43054 Participants
|
2696 Participants
n=68142 Participants
|
|
Race (NIH/OMB)
White
|
22682 Participants
n=25088 Participants
|
38971 Participants
n=43054 Participants
|
61653 Participants
n=68142 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=25088 Participants
|
0 Participants
n=43054 Participants
|
0 Participants
n=68142 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
600 Participants
n=25088 Participants
|
1046 Participants
n=43054 Participants
|
1646 Participants
n=68142 Participants
|
|
Region of Enrollment
United States
|
25088 participants
n=25088 Participants
|
43054 participants
n=43054 Participants
|
68142 participants
n=68142 Participants
|
|
Employment
Employed
|
11229 Participants
n=25088 Participants
|
20549 Participants
n=43054 Participants
|
31778 Participants
n=68142 Participants
|
|
Employment
Retired
|
10310 Participants
n=25088 Participants
|
16528 Participants
n=43054 Participants
|
26838 Participants
n=68142 Participants
|
|
Employment
Not Employed or Student or Military duty
|
2341 Participants
n=25088 Participants
|
4294 Participants
n=43054 Participants
|
6635 Participants
n=68142 Participants
|
|
Employment
Disabled
|
1189 Participants
n=25088 Participants
|
1573 Participants
n=43054 Participants
|
2762 Participants
n=68142 Participants
|
|
Employment
Unknown or Not Reported
|
19 Participants
n=25088 Participants
|
110 Participants
n=43054 Participants
|
129 Participants
n=68142 Participants
|
|
Marital status
Married
|
17015 Participants
n=25088 Participants
|
29673 Participants
n=43054 Participants
|
46688 Participants
n=68142 Participants
|
|
Marital status
Single
|
3772 Participants
n=25088 Participants
|
6449 Participants
n=43054 Participants
|
10221 Participants
n=68142 Participants
|
|
Marital status
Divorced
|
1936 Participants
n=25088 Participants
|
3263 Participants
n=43054 Participants
|
5199 Participants
n=68142 Participants
|
|
Marital status
Widowed
|
1891 Participants
n=25088 Participants
|
2825 Participants
n=43054 Participants
|
4716 Participants
n=68142 Participants
|
|
Marital status
Life Partnership
|
245 Participants
n=25088 Participants
|
458 Participants
n=43054 Participants
|
703 Participants
n=68142 Participants
|
|
Marital status
Separated
|
163 Participants
n=25088 Participants
|
247 Participants
n=43054 Participants
|
410 Participants
n=68142 Participants
|
|
Marital status
Unknown
|
66 Participants
n=25088 Participants
|
139 Participants
n=43054 Participants
|
205 Participants
n=68142 Participants
|
|
Education
Less than high school
|
4590 Participants
n=25088 Participants
|
7143 Participants
n=43054 Participants
|
11733 Participants
n=68142 Participants
|
|
Education
High school graduate
|
737 Participants
n=25088 Participants
|
1230 Participants
n=43054 Participants
|
1967 Participants
n=68142 Participants
|
|
Education
Some college, vocational school, or associate degree
|
7365 Participants
n=25088 Participants
|
11660 Participants
n=43054 Participants
|
19025 Participants
n=68142 Participants
|
|
Education
Bachelor's degree
|
5786 Participants
n=25088 Participants
|
9175 Participants
n=43054 Participants
|
14961 Participants
n=68142 Participants
|
|
Education
Master's or Doctoral degree
|
4356 Participants
n=25088 Participants
|
7068 Participants
n=43054 Participants
|
11424 Participants
n=68142 Participants
|
|
Education
Unknown
|
2254 Participants
n=25088 Participants
|
6778 Participants
n=43054 Participants
|
9032 Participants
n=68142 Participants
|
|
Rurality (RUCA code)
Urban (RUCA 1-3)
|
18150 Participants
n=25088 Participants
|
29743 Participants
n=43054 Participants
|
47893 Participants
n=68142 Participants
|
|
Rurality (RUCA code)
Micropolitan (RUCA 4-6)
|
2661 Participants
n=25088 Participants
|
5297 Participants
n=43054 Participants
|
7958 Participants
n=68142 Participants
|
|
Rurality (RUCA code)
Small town (RUCA 7-9)
|
2284 Participants
n=25088 Participants
|
4217 Participants
n=43054 Participants
|
6501 Participants
n=68142 Participants
|
|
Rurality (RUCA code)
Rural (RUCA 10)
|
1835 Participants
n=25088 Participants
|
3555 Participants
n=43054 Participants
|
5390 Participants
n=68142 Participants
|
|
Rurality (RUCA code)
Unknown
|
158 Participants
n=25088 Participants
|
242 Participants
n=43054 Participants
|
400 Participants
n=68142 Participants
|
PRIMARY outcome
Timeframe: Baseline (before hospital discharge), 1-,2-, and 3-Months Post-SurgeryPopulation: Number of participants who answered at least 1 pain followup survey
Change in patient reported pain; measured on scale of 1-100. A higher score indicates a worse outcome.
Outcome measures
| Measure |
Control Arm
n=16819 Participants
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).
|
Intervention
n=30349 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.
|
|---|---|---|
|
PROMIS-CAT Pain
Baseline
|
59.32 score on a scale
Standard Deviation 9.92
|
59.96 score on a scale
Standard Deviation 9.68
|
|
PROMIS-CAT Pain
Month 1
|
56.94 score on a scale
Standard Deviation 9.10
|
56.06 score on a scale
Standard Deviation 8.97
|
|
PROMIS-CAT Pain
Month 2
|
53.08 score on a scale
Standard Deviation 9.42
|
53.29 score on a scale
Standard Deviation 9.39
|
|
PROMIS-CAT Pain
Month 3
|
52.14 score on a scale
Standard Deviation 9.43
|
52.43 score on a scale
Standard Deviation 9.45
|
PRIMARY outcome
Timeframe: Baseline (before hospital discharge), 1-,2-, and 3-Months Post-SurgeryPopulation: Number of participants who answered at least one physical function followup survey
Change in patient reported Physical Function; measured on scale of 1-100. A higher score indicates a better outcome.
Outcome measures
| Measure |
Control Arm
n=16543 Participants
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).
|
Intervention
n=29973 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.
|
|---|---|---|
|
PROMIS-CAT Physical Function
Baseline
|
40.50 score on a scale
Standard Deviation 9.04
|
39.50 score on a scale
Standard Deviation 8.54
|
|
PROMIS-CAT Physical Function
Month 1
|
38.44 score on a scale
Standard Deviation 9.06
|
39.68 score on a scale
Standard Deviation 9.19
|
|
PROMIS-CAT Physical Function
Month 2
|
42.44 score on a scale
Standard Deviation 9.75
|
40.79 score on a scale
Standard Deviation 10.26
|
|
PROMIS-CAT Physical Function
Month 3
|
43.84 score on a scale
Standard Deviation 9.74
|
41.85 score on a scale
Standard Deviation 10.41
|
PRIMARY outcome
Timeframe: Baseline (before hospital discharge), 3-Months Post-SurgeryPopulation: Number of participants who answered at least one followup anxiety survey
Change in patient reported Anxiety; measured on scale of 1-100. A higher score indicates a worse outcome.
Outcome measures
| Measure |
Control Arm
n=11195 Participants
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).
|
Intervention
n=15227 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.
|
|---|---|---|
|
PROMIS-CAT Anxiety
Baseline
|
50.72 score on a scale
Standard Deviation 9.20
|
51.85 score on a scale
Standard Deviation 9.17
|
|
PROMIS-CAT Anxiety
Month 1
|
51.93 score on a scale
Standard Deviation 9.34
|
51.63 score on a scale
Standard Deviation 9.59
|
|
PROMIS-CAT Anxiety
Month 2
|
51.21 score on a scale
Standard Deviation 9.54
|
51.75 score on a scale
Standard Deviation 9.49
|
|
PROMIS-CAT Anxiety
Month 3
|
47.19 score on a scale
Standard Deviation 9.55
|
47.48 score on a scale
Standard Deviation 9.62
|
PRIMARY outcome
Timeframe: 3 Months Post-SurgeryPopulation: Patients who answered a questionnaire about their use of non-pharmacologic pain control modalities
Number of participants using Non-Pharmacological Pain Control Modalities
Outcome measures
| Measure |
Control Arm
n=958 Participants
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).
|
Intervention
n=25142 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.
|
|---|---|---|
|
Use of Non-Pharmacological Pain Control Modalities
Relaxed Breathing
|
278 Participants
|
10709 Participants
|
|
Use of Non-Pharmacological Pain Control Modalities
Guided Imagery
|
23 Participants
|
1024 Participants
|
|
Use of Non-Pharmacological Pain Control Modalities
Massage
|
303 Participants
|
6848 Participants
|
|
Use of Non-Pharmacological Pain Control Modalities
Meditation
|
166 Participants
|
4254 Participants
|
|
Use of Non-Pharmacological Pain Control Modalities
Muscle Relaxation
|
183 Participants
|
5436 Participants
|
|
Use of Non-Pharmacological Pain Control Modalities
Music
|
184 Participants
|
7545 Participants
|
|
Use of Non-Pharmacological Pain Control Modalities
Tai Chi
|
7 Participants
|
257 Participants
|
|
Use of Non-Pharmacological Pain Control Modalities
TENS
|
58 Participants
|
1359 Participants
|
|
Use of Non-Pharmacological Pain Control Modalities
Walking
|
630 Participants
|
17886 Participants
|
|
Use of Non-Pharmacological Pain Control Modalities
Aromatherapy
|
58 Participants
|
2549 Participants
|
|
Use of Non-Pharmacological Pain Control Modalities
Cold or Heat
|
721 Participants
|
16058 Participants
|
|
Use of Non-Pharmacological Pain Control Modalities
Yoga
|
27 Participants
|
1237 Participants
|
|
Use of Non-Pharmacological Pain Control Modalities
Acupressure
|
23 Participants
|
752 Participants
|
PRIMARY outcome
Timeframe: 3-Months Post-SurgeryBinary 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.
Outcome measures
| Measure |
Control Arm
n=25088 Participants
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).
|
Intervention
n=43054 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.
|
|---|---|---|
|
Opioid Use
Any opioid exposure (prescription or inpatient administration) during study period
|
23034 Participants
|
38654 Participants
|
|
Opioid Use
Any opioid prescription or administration associated with index surgical encounter
|
22299 Participants
|
37639 Participants
|
|
Opioid Use
Any opioid administered inpatient during post-hospitalization follow-up period
|
4972 Participants
|
7238 Participants
|
|
Opioid Use
Any opioid prescribed during post-hospitalization follow-up period
|
7348 Participants
|
10422 Participants
|
|
Opioid Use
Any opioid prescription written during study period
|
20173 Participants
|
31738 Participants
|
|
Opioid Use
Any opioid administered in hospital associated with index surgery (excluding day of surgery)
|
16158 Participants
|
26035 Participants
|
|
Opioid Use
Any opioid prescribed at discharge following index surgery
|
19082 Participants
|
30414 Participants
|
Adverse Events
Control Arm
Serious events: 25 serious events
Other events: 2897 other events
Deaths: 380 deaths
Intervention
Serious events: 104 serious events
Other events: 4766 other events
Deaths: 608 deaths
Serious adverse events
| Measure |
Control Arm
n=25088 participants at risk
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).
|
Intervention
n=43054 participants at risk
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.
|
|---|---|---|
|
General disorders
Fall
|
0.10%
25/25088 • 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.
|
0.24%
104/43054 • 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.
|
Other adverse events
| Measure |
Control Arm
n=25088 participants at risk
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).
|
Intervention
n=43054 participants at risk
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.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
2.1%
521/25088 • 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.
|
2.1%
886/43054 • 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.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm
|
1.3%
338/25088 • 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.
|
1.4%
612/43054 • 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.
|
|
General disorders
Failure to rescue
|
8.0%
2012/25088 • 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.
|
7.5%
3234/43054 • 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.
|
|
Skin and subcutaneous tissue disorders
Burn at electrode or hot pack site
|
0.10%
26/25088 • 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.
|
0.08%
34/43054 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place