Trial Outcomes & Findings for Strategies for Prescribing Analgesics Comparative Effectiveness Trial (NCT NCT01583985)
NCT ID: NCT01583985
Last Updated: 2019-03-06
Results Overview
Measure of pain-related functional interference (range 0-10; higher score is worse)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
265 participants
Primary outcome timeframe
3 months, 6 months, 9 months, and 12 months
Results posted on
2019-03-06
Participant Flow
25 patients withdrew prior to randomization. 10 were excluded by the study team and 15 declined to be randomized.
Participant milestones
| Measure |
Opioid
The opioid prescribing strategy included 3 levels of opioid analgesics. Medications were individually adjusted according to patient preferences and responses.
|
Non-opioid
The non-opioid prescribing strategy included 3 levels of non-opioid medications from several drug classes. Medications were individually adjusted according to patient preferences and responses.
|
|---|---|---|
|
Overall Study
STARTED
|
120
|
120
|
|
Overall Study
Included in Primary Analysis
|
119
|
119
|
|
Overall Study
COMPLETED
|
117
|
117
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Strategies for Prescribing Analgesics Comparative Effectiveness Trial
Baseline characteristics by cohort
| Measure |
Opioid
n=120 Participants
The opioid prescribing strategy included 3 levels of opioid analgesics. Medications were individually adjusted according to patient preferences and responses.
|
Non-opioid
n=120 Participants
The non-opioid prescribing strategy included 3 levels of non-opioid medications from several drug classes. Medications were individually adjusted according to patient preferences and responses.
|
Total
n=240 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
72 Participants
n=39 Participants
|
64 Participants
n=41 Participants
|
136 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
48 Participants
n=39 Participants
|
56 Participants
n=41 Participants
|
104 Participants
n=35 Participants
|
|
Age, Continuous
|
56.8 years
STANDARD_DEVIATION 13.3 • n=39 Participants
|
59.7 years
STANDARD_DEVIATION 14.0 • n=41 Participants
|
58.3 years
STANDARD_DEVIATION 13.7 • n=35 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=39 Participants
|
36 Participants
n=41 Participants
|
72 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
84 Participants
n=39 Participants
|
84 Participants
n=41 Participants
|
168 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
White
|
105 Participants
n=39 Participants
|
102 Participants
n=41 Participants
|
207 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Black
|
7 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
18 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Other or Multiple
|
7 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
13 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Missing
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
120 Participants
n=39 Participants
|
120 Participants
n=41 Participants
|
240 Participants
n=35 Participants
|
|
Brief Pain Inventory Interference
|
5.4 units on a scale
STANDARD_DEVIATION 1.5 • n=39 Participants
|
5.5 units on a scale
STANDARD_DEVIATION 2.0 • n=41 Participants
|
5.5 units on a scale
STANDARD_DEVIATION 1.9 • n=35 Participants
|
|
Brief Pain Inventory Severity
|
5.4 units on a scale
STANDARD_DEVIATION 1.5 • n=39 Participants
|
5.4 units on a scale
STANDARD_DEVIATION 1.2 • n=41 Participants
|
5.4 units on a scale
STANDARD_DEVIATION 1.4 • n=35 Participants
|
|
Primary Pain Location
Back pain
|
78 Participants
n=39 Participants
|
78 Participants
n=41 Participants
|
156 Participants
n=35 Participants
|
|
Primary Pain Location
Hip/knee osteoarthritis pain
|
42 Participants
n=39 Participants
|
42 Participants
n=41 Participants
|
84 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 3 months, 6 months, 9 months, and 12 monthsPopulation: Patients with at least one follow-up outcome assessment
Measure of pain-related functional interference (range 0-10; higher score is worse)
Outcome measures
| Measure |
Opioid
n=119 Participants
The opioid prescribing strategy included 3 levels of opioid analgesics. Medications were individually adjusted according to patient preferences and responses.
|
Non-opioid
n=119 Participants
The non-opioid prescribing strategy included 3 levels of non-opioid medications from several drug classes. Medications were individually adjusted according to patient preferences and responses.
|
|---|---|---|
|
Brief Pain Inventory Interference Scale
3 months
|
3.7 units on a scale
Standard Deviation 2.1
|
3.7 units on a scale
Standard Deviation 2.2
|
|
Brief Pain Inventory Interference Scale
6 months
|
3.4 units on a scale
Standard Deviation 2.1
|
3.6 units on a scale
Standard Deviation 2.4
|
|
Brief Pain Inventory Interference Scale
9 months
|
3.6 units on a scale
Standard Deviation 2.2
|
3.3 units on a scale
Standard Deviation 2.4
|
|
Brief Pain Inventory Interference Scale
12 months
|
3.4 units on a scale
Standard Deviation 2.5
|
3.3 units on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: 3 months, 6 months, 9 months, and 12 monthsPopulation: patients with at least one follow-up assessment
Measure of pain intensity (range 0-10; higher score is worse)
Outcome measures
| Measure |
Opioid
n=119 Participants
The opioid prescribing strategy included 3 levels of opioid analgesics. Medications were individually adjusted according to patient preferences and responses.
|
Non-opioid
n=119 Participants
The non-opioid prescribing strategy included 3 levels of non-opioid medications from several drug classes. Medications were individually adjusted according to patient preferences and responses.
|
|---|---|---|
|
Brief Pain Inventory Severity Scale
3 months
|
4.3 units on a scale
Standard Deviation 1.8
|
4.0 units on a scale
Standard Deviation 1.7
|
|
Brief Pain Inventory Severity Scale
6 months
|
4.1 units on a scale
Standard Deviation 1.8
|
4.1 units on a scale
Standard Deviation 1.9
|
|
Brief Pain Inventory Severity Scale
9 months
|
4.2 units on a scale
Standard Deviation 1.7
|
3.6 units on a scale
Standard Deviation 1.7
|
|
Brief Pain Inventory Severity Scale
12 months
|
4.0 units on a scale
Standard Deviation 2.0
|
3.5 units on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: 3 months, 6 months, 9 months, and 12 monthsPopulation: those with any follow-up outcomes
Checklist of bothersome medication-related symptoms (0-19, higher number = more symptoms)
Outcome measures
| Measure |
Opioid
n=119 Participants
The opioid prescribing strategy included 3 levels of opioid analgesics. Medications were individually adjusted according to patient preferences and responses.
|
Non-opioid
n=119 Participants
The non-opioid prescribing strategy included 3 levels of non-opioid medications from several drug classes. Medications were individually adjusted according to patient preferences and responses.
|
|---|---|---|
|
Medication-related Symptom Checklist
3 months
|
2.3 symptoms
Standard Deviation 2.5
|
1.3 symptoms
Standard Deviation 1.8
|
|
Medication-related Symptom Checklist
6 months
|
2.1 symptoms
Standard Deviation 2.7
|
1.3 symptoms
Standard Deviation 2.3
|
|
Medication-related Symptom Checklist
9 months
|
1.9 symptoms
Standard Deviation 2.8
|
0.9 symptoms
Standard Deviation 1.9
|
|
Medication-related Symptom Checklist
12 months
|
1.8 symptoms
Standard Deviation 2.6
|
0.9 symptoms
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Patients reporting falls at any outcome timepoint
Number of falls in 12 months after enrollment
Outcome measures
| Measure |
Opioid
n=118 Participants
The opioid prescribing strategy included 3 levels of opioid analgesics. Medications were individually adjusted according to patient preferences and responses.
|
Non-opioid
n=119 Participants
The non-opioid prescribing strategy included 3 levels of non-opioid medications from several drug classes. Medications were individually adjusted according to patient preferences and responses.
|
|---|---|---|
|
Falls
No falls
|
63 Participants
|
63 Participants
|
|
Falls
1 fall
|
26 Participants
|
17 Participants
|
|
Falls
2 or more falls
|
29 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: All randomized participants
All cause, EMR-confirmed hospitalizations
Outcome measures
| Measure |
Opioid
n=120 Participants
The opioid prescribing strategy included 3 levels of opioid analgesics. Medications were individually adjusted according to patient preferences and responses.
|
Non-opioid
n=120 Participants
The non-opioid prescribing strategy included 3 levels of non-opioid medications from several drug classes. Medications were individually adjusted according to patient preferences and responses.
|
|---|---|---|
|
Hospitalizations
No hospitalizations
|
99 Participants
|
99 Participants
|
|
Hospitalizations
1 hospitalization
|
15 Participants
|
16 Participants
|
|
Hospitalizations
2 or more hospitalizations
|
6 Participants
|
5 Participants
|
Adverse Events
Opioid
Serious events: 19 serious events
Other events: 58 other events
Deaths: 0 deaths
Non-opioid
Serious events: 22 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Opioid
n=120 participants at risk
The opioid prescribing strategy included 3 levels of opioid analgesics. Medications were individually adjusted according to patient preferences and responses.
|
Non-opioid
n=120 participants at risk
The non-opioid prescribing strategy included 3 levels of non-opioid medications from several drug classes. Medications were individually adjusted according to patient preferences and responses.
|
|---|---|---|
|
General disorders
Hospitalization
|
15.8%
19/120 • Number of events 23 • 1 year
|
18.3%
22/120 • Number of events 26 • 1 year
|
Other adverse events
| Measure |
Opioid
n=120 participants at risk
The opioid prescribing strategy included 3 levels of opioid analgesics. Medications were individually adjusted according to patient preferences and responses.
|
Non-opioid
n=120 participants at risk
The non-opioid prescribing strategy included 3 levels of non-opioid medications from several drug classes. Medications were individually adjusted according to patient preferences and responses.
|
|---|---|---|
|
General disorders
Emergency Department visits
|
48.3%
58/120 • Number of events 110 • 1 year
|
40.8%
49/120 • Number of events 81 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place