Trial Outcomes & Findings for Development/Testing of SUMMIT: a Tool to Help Patients Manage Pain While Tapering Opioids (NCT NCT04746833)
NCT ID: NCT04746833
Last Updated: 2025-09-12
Results Overview
Morphine milligram equivalents per day based on participant self report.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
9-months
Results posted on
2025-09-12
Participant Flow
Participant milestones
| Measure |
SUMMIT
Participants randomized to the experimental intervention will participate in a Motivational Interviewing (MI) session lasting between 30 and 60 minutes with study psychologist. All MI sessions will be audiotaped using a VA-approved digital recorder and transcribed verbatim. Participants will subsequently be shown how to access SUMMIT via a set of unique anonymized login credentials and to navigate the components of SUMMIT on one or more devices, depending on their preference. They will then be trained on how to complete the outcome surveys.
SUMMIT: multicomponent web-based application focused on pain self-management skills
|
Control
Participants randomized to the control intervention will use an eHealth comparator: My Pain Diary: Chronic Pain Management (iPhone, Android). This app includes a pain monitoring functioning only, and thus will only minimally overlap, if at all, with SUMMIT's components. Control participants will not participate in a MI session. Participants will download the app and be shown how to use the My Pain Diary app and trained how to complete the outcome surveys
control: My Pain Diary app
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
20
|
|
Overall Study
COMPLETED
|
24
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Development/Testing of SUMMIT: a Tool to Help Patients Manage Pain While Tapering Opioids
Baseline characteristics by cohort
| Measure |
SUMMIT
n=24 Participants
Participants randomized to the experimental intervention will participate in a Motivational Interviewing (MI) session lasting between 30 and 60 minutes with study psychologist. All MI sessions will be audiotaped using a VA-approved digital recorder and transcribed verbatim. Participants will subsequently be shown how to access SUMMIT via a set of unique anonymized login credentials and to navigate the components of SUMMIT on one or more devices, depending on their preference. They will then be trained on how to complete the outcome surveys.
SUMMIT: multicomponent web-based application focused on pain self-management skills
|
Control
n=20 Participants
Participants randomized to the control intervention will use an eHealth comparator: My Pain Diary: Chronic Pain Management (iPhone, Android). This app includes a pain monitoring functioning only, and thus will only minimally overlap, if at all, with SUMMIT's components. Control participants will not participate in a MI session. Participants will download the app and be shown how to use the My Pain Diary app and trained how to complete the outcome surveys
control: My Pain Diary app
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Age, Continuous
|
62.7 years
STANDARD_DEVIATION 8.9 • n=99 Participants
|
68.8 years
STANDARD_DEVIATION 9.3 • n=107 Participants
|
65.4 years
STANDARD_DEVIATION 9.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
24 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Prescribed Opioids Difficulties Scale - Opioid Control Concerns
|
6.3 units on a scale
STANDARD_DEVIATION 3.4 • n=99 Participants
|
7.5 units on a scale
STANDARD_DEVIATION 4.1 • n=107 Participants
|
6.9 units on a scale
STANDARD_DEVIATION 3.7 • n=206 Participants
|
|
Prescribed Opioids Difficulties Scale - Psychosocial Problems
|
7.5 units on a scale
STANDARD_DEVIATION 6.7 • n=99 Participants
|
7.1 units on a scale
STANDARD_DEVIATION 6.0 • n=107 Participants
|
7.3 units on a scale
STANDARD_DEVIATION 6.4 • n=206 Participants
|
PRIMARY outcome
Timeframe: 9-monthsMorphine milligram equivalents per day based on participant self report.
Outcome measures
| Measure |
SUMMIT
n=20 Participants
Participants randomized to the experimental intervention will participate in a Motivational Interviewing (MI) session lasting between 30 and 60 minutes with study psychologist. All MI sessions will be audiotaped using a VA-approved digital recorder and transcribed verbatim. Participants will subsequently be shown how to access SUMMIT via a set of unique anonymized login credentials and to navigate the components of SUMMIT on one or more devices, depending on their preference. They will then be trained on how to complete the outcome surveys.
SUMMIT: multicomponent web-based application focused on pain self-management skills
|
Control
n=19 Participants
Participants randomized to the control intervention will use an eHealth comparator: My Pain Diary: Chronic Pain Management (iPhone, Android). This app includes a pain monitoring functioning only, and thus will only minimally overlap, if at all, with SUMMIT's components. Control participants will not participate in a MI session. Participants will download the app and be shown how to use the My Pain Diary app and trained how to complete the outcome surveys
control: My Pain Diary app
|
|---|---|---|
|
Daily Morphine Milligram Equivalents (MME)
|
25.1 Morphine milligram equivalents per day
Standard Deviation 44.7
|
21.9 Morphine milligram equivalents per day
Standard Deviation 28.6
|
PRIMARY outcome
Timeframe: 6 monthsTotal number of minutes of use of the Summit app over the 6 month intervention
Outcome measures
| Measure |
SUMMIT
n=24 Participants
Participants randomized to the experimental intervention will participate in a Motivational Interviewing (MI) session lasting between 30 and 60 minutes with study psychologist. All MI sessions will be audiotaped using a VA-approved digital recorder and transcribed verbatim. Participants will subsequently be shown how to access SUMMIT via a set of unique anonymized login credentials and to navigate the components of SUMMIT on one or more devices, depending on their preference. They will then be trained on how to complete the outcome surveys.
SUMMIT: multicomponent web-based application focused on pain self-management skills
|
Control
Participants randomized to the control intervention will use an eHealth comparator: My Pain Diary: Chronic Pain Management (iPhone, Android). This app includes a pain monitoring functioning only, and thus will only minimally overlap, if at all, with SUMMIT's components. Control participants will not participate in a MI session. Participants will download the app and be shown how to use the My Pain Diary app and trained how to complete the outcome surveys
control: My Pain Diary app
|
|---|---|---|
|
Minutes of Summit App Use
|
20.9 Minutes of use
Standard Deviation 19.8
|
—
|
SECONDARY outcome
Timeframe: six monthsThe BIRS is a 24-item validated measure of an intervention's acceptability and perceived effectiveness scored on 5-point agreement scales. The total score is divided by the total number of completed items and this ranges from 1 to 5. Higher mean item scores represent higher acceptability.
Outcome measures
| Measure |
SUMMIT
n=19 Participants
Participants randomized to the experimental intervention will participate in a Motivational Interviewing (MI) session lasting between 30 and 60 minutes with study psychologist. All MI sessions will be audiotaped using a VA-approved digital recorder and transcribed verbatim. Participants will subsequently be shown how to access SUMMIT via a set of unique anonymized login credentials and to navigate the components of SUMMIT on one or more devices, depending on their preference. They will then be trained on how to complete the outcome surveys.
SUMMIT: multicomponent web-based application focused on pain self-management skills
|
Control
n=17 Participants
Participants randomized to the control intervention will use an eHealth comparator: My Pain Diary: Chronic Pain Management (iPhone, Android). This app includes a pain monitoring functioning only, and thus will only minimally overlap, if at all, with SUMMIT's components. Control participants will not participate in a MI session. Participants will download the app and be shown how to use the My Pain Diary app and trained how to complete the outcome surveys
control: My Pain Diary app
|
|---|---|---|
|
Behavior Intervention Rating Scale (BIRS)
|
4.4 score on a scale
Standard Deviation 0.4
|
4.5 score on a scale
Standard Deviation 0.4
|
Adverse Events
SUMMIT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place