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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

United States1 site
  • University of Colorado

    Aurora, Colorado, 80045

Other trials in United States

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.

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 groups in NCT03332615
Study groupRoleWhat they receive
Clinicians with MI coachingActive comparatorClinicians 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 controlPlacebo comparatorAfter 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.

  1. 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)
  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.

  1. First posted6 Nov 2017
  2. Study start24 Oct 2017
  3. Primary completion30 Jun 2019
  4. Study completion30 Jun 2019

Resources

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)
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

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.

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