Motivational InterviewingNCT03332615
Motivational Interviewing in Palliative Care
A study testing Motivational Interviewing in people with Motivational Interviewing, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Patients with advanced illness and their families confront a number of issues ranging from distressing symptoms to making complex decisions that affect quality of life and survival. Patients and family members struggle with these decisions even more when they feel ambivalence or reluctance. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Motivational Interviewing
- What is being tested?
- Motivational Interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2017to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinicians who are palliative care providers (physicians and Advanced Practice Providers).
- Patients/family caregivers must be 18 - 100 years of age.
- Patients must have an advanced illness and be receiving palliative care.
- Family caregivers must be caring for a patient who has an advanced illness who is receiving palliative care.
Who cannot join
- Patients/family caregivers who do not speak English or require interpreter services will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Motivational Interviewing to Address Reluctance and Ambivalence in Palliative Care
Patients with advanced illness and their families confront a number of issues ranging from distressing symptoms to making complex decisions that affect quality of life and survival. Patients and family members struggle with these decisions even more when they feel ambivalence or reluctance. The investigator's overarching goal is to enhance provision of high quality, patient-centered care for patients with advance illness and their families and to reduce burnout among palliative care clinicians. The investigator will apply a well-established approach to achieving clinician/patient alignment in the primary care setting, Motivational Interviewing (MI) to a new population and setting, palliative care.
Read the detailed description
The investigator will use a 2-arm randomized wait-list control design with up to 30 palliative care clinicians (15 in each arm). Clinicians in the intervention arm will be taught Motivational Interviewing (MI) via a coaching model in which a didactic session is followed by feedback through review of clinicians' audio-recorded encounters. Clinicians in both arms will audio record 4 encounters with patients with advanced illness and their family caregivers. The patients/caregivers will be provided with a 1-page information sheet about the study and will sign a HIPAA B form which will allow the study team to record a palliative care encounter and allow the research assistant to administer a short survey immediately within 1-2 days following a palliative care encounter to assess the effect of integrating MI techniques on perceived empathy and satisfaction with the encounter. The investigators will also assess clinician satisfaction with the encounter. Clinician burnout will be assessed at the time of study enrollment and following completion of all study encounter recordings. Clinicians randomized to the wait-list control arm will receive MI coaching only after they have recorded 4 study encounters. The wait-list control study design was selected to give all participating clinicians access to motivational interviewing coaching.
Intervention: The investigator is comparing standard palliative care communication skills enhanced by Motivational Interviewing coaching to standard palliative care. Given that palliative care is currently the gold standard for clinician communication in the setting of serious and advanced illness, if Motivational Interviewing coaching improves encounters for palliative care clinicians, it is even more likely to do so for other clinicians who care for people with advanced illness. The investigator has adopted a "coaching" model that includes both didactic and individual feedback. The coaching approach maps to Social Cognitive Theory in that its purpose is to build skills and improve self-efficacy or confidence to use the techniques. Participating palliative care clinicians randomized to the intervention arm will receive Motivational Interviewing coaching immediately. Those randomized to the wait-list control arm will receive Motivational Interviewing coaching after the study encounters and data collection have been completed. The intervention consists of several components: 1) 1-hour face-to-face (in person or via Skype) didactic session in which a Motivational Interviewing coach explains tenets of Motivational Interviewing and specifics, particularly addressing ambivalence and reluctance. This session will be recorded for future broader dissemination; 2) 1-hour individual session via Skype, including individualized goal-setting; 3) Clinician audio records 2 encounters, which are transcribed. The Motivational Interviewing coach then codes the encounters and meets with the clinician via Skype for 30 minutes to give feedback and coaching; 4) Clinician audio records 2 additional encounters and again receives individualized feedback and coaching. At the end of the interactive Motivational Interviewing didactic, each clinician who is randomized to the intervention arm will set an individual goal for which Motivational Interviewing technique he/she wants to try.
Each clinician will then audio record 2 palliative care encounters; audio recordings will be transcribed. The Motivational Interviewing coach will listen to the recordings and code the transcriptions paying attention to the clinician's stated goal. The coach will conduct 1:1 Skype calls to review audio-recorded encounters and provide individualized feedback and coaching. During the feedback sessions, the coach will provide positive feedback on the Motivational Interviewing techniques used, paying most attention to the technique the clinician set as his/her individual target technique. The coach will also offer feedback on parts of the encounter when Motivational Interviewing could have been applied. At the end of the session, the coach will ask the clinician to set another individual goal for which Motivational Interviewing technique they want to try and repeat the process of having them audio record 2 additional palliative care encounters and providing individualized feedback and coaching. After each clinician has finished the intervention, the investigators will obtain extensive process data from clinicians to learn what went well about the coaching and what can be improved to plan for future refinement and study. To plan for future scalability, the investigators will simultaneously be developing a coaching manual that will be used to train others to serve as Motivational Interviewing coaches.
Wait List Control: Clinicians who are randomized to the wait-list control arm will audio record 4 palliative care encounters, which will be transcribed, and have an individual coaching and feedback session in which the Motivational Interviewing coach will review their audio-recorded encounters following completion of study data collection.
- Conditions
- Motivational Interviewing
- Being tested
- Motivational Interviewing, Wait-list control
- Keywords
- Palliative Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingBehavioural
Clinicians in the intervention arm will be taught Motivational Interviewing via a coaching model in which a didactic session is followed by feedback through review of clinicians' audio-recorded encounters.
Wait-list controlBehavioural
After consent, clinicians in the wait-list control arm will complete a survey to self-assess their motivational interviewing skills and burnout.
| Study group | Role | What they receive |
|---|---|---|
| Clinicians with MI coaching | Active comparator | Clinicians in the intervention arm will be taught Motivational Interviewing via a coaching model in which a didactic session is followed by feedback through review of clinicians' audio-recorded encounters. Receives: Behavioral: Motivational Interviewing |
| Wait-list control | Placebo comparator | After consent, clinicians in the wait-list control arm will complete a survey to self-assess their motivational interviewing skills and burnout. Receives: Behavioral: Wait-list control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aim 1: feasibility and acceptability of learning Motivational Interviewing techniques by palliative care clinicians
To determine palliative care clinician-rated feasibility and acceptability of learning Motivational Interviewing techniques. Feasibility will be defined as the proportion of participating clinicians who successfully complete study participation (i.e. record 4 patient/caregiver encounters and provide post-test assessment).
Measured: Through study completion, an average of 1 year.
Secondary outcomes (1)
Aim 2: measure effects of the application of Motivational Interviewing techniques
To provide preliminary data on the effects of the application of Motivational Interviewing techniques on patient, caregiver and clinician perceptions of palliative care clinical encounters and on palliative care burnout. The investigator proposes to assess patient (or family caregiver)-reported Perceived Empathy and patient (or family caregiver) and clinician-reported Satisfaction with the palliative care encounter (within 2 days of the encounter). We will also assess clinician burnout prior to and following the intervention period.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start24 Oct 2017
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Motivational InterviewingStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University
- Responsible party
- Sponsor
- Investigators
- Jean S Kutner, MD, MSPH, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03332615
- Sponsor's protocol ID
- 17-1196
- Status last verified
- Nov 2019
- First submitted
- 18 Aug 2017
- Last updated
- 5 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pollak KI, Gao X, Arnold RM, Arnett K, Felton S, Fairclough DL, Kutner JS. Feasibility of Using Communication Coaching to Teach Palliative Care Clinicians Motivational Interviewing. J Pain Symptom Manage. 2020 Apr;59(4):787-793. doi: 10.1016/j.jpainsymman.2019.11.010. Epub 2019 Nov 23.
PubMed 31765759
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Interviewing to Address Reluctance and Ambivalence in Palliative Care
- ClinicalTrials.gov ID
- NCT03332615
- Acronym / sponsor ID
- 17-1196
- Conditions
- Motivational Interviewing
- Keywords
- Palliative Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Duke University
- Study start
- 24 Oct 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with advanced illness and their families confront a number of issues ranging from distressing symptoms to making complex decisions that affect quality of life and survival. Patients and family members struggle with these decisions even more when they feel ambivalence or reluctance. The investigator's overarching goal is to enhance provision of high quality, patient-centered care for patients with advance illness and their families and to reduce burnout among palliative care clinicians. The investigator will apply a well-established approach to achieving clinician/patient alignment in the primary care setting, Motivational Interviewing (MI) to a new population and setting, palliative care.
Detailed description
The investigator will use a 2-arm randomized wait-list control design with up to 30 palliative care clinicians (15 in each arm). Clinicians in the intervention arm will be taught Motivational Interviewing (MI) via a coaching model in which a didactic session is followed by feedback through review of clinicians' audio-recorded encounters. Clinicians in both arms will audio record 4 encounters with patients with advanced illness and their family caregivers. The patients/caregivers will be provided with a 1-page information sheet about the study and will sign a HIPAA B form which will allow the study team to record a palliative care encounter and allow the research assistant to administer a short survey immediately within 1-2 days following a palliative care encounter to assess the effect of integrating MI techniques on perceived empathy and satisfaction with the encounter. The investigators will also assess clinician satisfaction with the encounter. Clinician burnout will be assessed at the time of study enrollment and following completion of all study encounter recordings. Clinicians randomized to the wait-list control arm will receive MI coaching only after they have recorded 4 study encounters. The wait-list control study design was selected to give all participating clinicians access to motivational interviewing coaching.
Intervention: The investigator is comparing standard palliative care communication skills enhanced by Motivational Interviewing coaching to standard palliative care. Given that palliative care is currently the gold standard for clinician communication in the setting of serious and advanced illness, if Motivational Interviewing coaching improves encounters for palliative care clinicians, it is even more likely to do so for other clinicians who care for people with advanced illness. The investigator has adopted a "coaching" model that includes both didactic and individual feedback. The coaching approach maps to Social Cognitive Theory in that its purpose is to build skills and improve self-efficacy or confidence to use the techniques. Participating palliative care clinicians randomized to the intervention arm will receive Motivational Interviewing coaching immediately. Those randomized to the wait-list control arm will receive Motivational Interviewing coaching after the study encounters and data collection have been completed. The intervention consists of several components: 1) 1-hour face-to-face (in person or via Skype) didactic session in which a Motivational Interviewing coach explains tenets of Motivational Interviewing and specifics, particularly addressing ambivalence and reluctance. This session will be recorded for future broader dissemination; 2) 1-hour individual session via Skype, including individualized goal-setting; 3) Clinician audio records 2 encounters, which are transcribed. The Motivational Interviewing coach then codes the encounters and meets with the clinician via Skype for 30 minutes to give feedback and coaching; 4) Clinician audio records 2 additional encounters and again receives individualized feedback and coaching. At the end of the interactive Motivational Interviewing didactic, each clinician who is randomized to the intervention arm will set an individual goal for which Motivational Interviewing technique he/she wants to try.
Each clinician will then audio record 2 palliative care encounters; audio recordings will be transcribed. The Motivational Interviewing coach will listen to the recordings and code the transcriptions paying attention to the clinician's stated goal. The coach will conduct 1:1 Skype calls to review audio-recorded encounters and provide individualized feedback and coaching. During the feedback sessions, the coach will provide positive feedback on the Motivational Interviewing techniques used, paying most attention to the technique the clinician set as his/her individual target technique. The coach will also offer feedback on parts of the encounter when Motivational Interviewing could have been applied. At the end of the session, the coach will ask the clinician to set another individual goal for which Motivational Interviewing technique they want to try and repeat the process of having them audio record 2 additional palliative care encounters and providing individualized feedback and coaching. After each clinician has finished the intervention, the investigators will obtain extensive process data from clinicians to learn what went well about the coaching and what can be improved to plan for future refinement and study. To plan for future scalability, the investigators will simultaneously be developing a coaching manual that will be used to train others to serve as Motivational Interviewing coaches.
Wait List Control: Clinicians who are randomized to the wait-list control arm will audio record 4 palliative care encounters, which will be transcribed, and have an individual coaching and feedback session in which the Motivational Interviewing coach will review their audio-recorded encounters following completion of study data collection.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinicians with MI coaching | Active comparator | Behavioral: Motivational InterviewingClinicians in the intervention arm will be taught Motivational Interviewing via a coaching model in which a didactic session is followed by feedback through review of clinicians' audio-recorded encounters. |
| Wait-list control | Placebo comparator | Behavioral: Wait-list controlAfter consent, clinicians in the wait-list control arm will complete a survey to self-assess their motivational interviewing skills and burnout. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinicians who are palliative care providers (physicians and Advanced Practice Providers).
- Patients/family caregivers must be 18 - 100 years of age.
- Patients must have an advanced illness and be receiving palliative care.
- Family caregivers must be caring for a patient who has an advanced illness who is receiving palliative care.
Key exclusion criteria (1 listed)
- Patients/family caregivers who do not speak English or require interpreter services will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational InterviewingClinicians in the intervention arm will be taught Motivational Interviewing via a coaching model in which a didactic session is followed by feedback through review of clinicians' audio-recorded encounters. | Behavioural | Clinicians with MI coaching |
| Wait-list controlAfter consent, clinicians in the wait-list control arm will complete a survey to self-assess their motivational interviewing skills and burnout. | Behavioural | Wait-list control |
Primary outcome
Aim 1: feasibility and acceptability of learning Motivational Interviewing techniques by palliative care clinicians
Time frame: Through study completion, an average of 1 year.
To determine palliative care clinician-rated feasibility and acceptability of learning Motivational Interviewing techniques. Feasibility will be defined as the proportion of participating clinicians who successfully complete study participation (i.e. record 4 patient/caregiver encounters and provide post-test assessment).
1 secondary outcome
Aim 2: measure effects of the application of Motivational Interviewing techniques
Time frame: Through study completion, an average of 1 year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
- Derived from this study: PubMed 31765759Pollak KI, Gao X, Arnold RM, Arnett K, Felton S, Fairclough DL, Kutner JS. Feasibility of Using Communication Coaching to Teach Palliative Care Clinicians Motivational Interviewing. J Pain Symptom Manage. 2020 Apr;59(4):787-793. doi: 10.1016/j.jpainsymman.2019.11.010. Epub 2019 Nov 23.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean S Kutner, MD, MSPH principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing in people with Motivational Interviewing, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aim 1: feasibility and acceptability of learning Motivational Interviewing techniques by palliative care clinicians (time frame: Through study completion, an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03332615, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2019.