NCT03332615

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

October 24, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

November 5, 2019

Status Verified

November 1, 2019

Enrollment Period

1.7 years

First QC Date

August 18, 2017

Last Update Submit

November 1, 2019

Conditions

Keywords

Palliative Care

Outcome Measures

Primary Outcomes (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).

    Through study completion, an average of 1 year.

Secondary Outcomes (1)

  • Aim 2: measure effects of the application of Motivational Interviewing techniques

    Through study completion, an average of 1 year.

Study Arms (2)

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.

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.

Behavioral: Wait-list control

Interventions

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.

Clinicians with MI coaching

After consent, clinicians in the wait-list control arm will complete a survey to self-assess their motivational interviewing skills and burnout.

Wait-list control

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients/family caregivers who do not speak English or require interpreter services will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Motivational Interviewing

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Jean S Kutner, MD, MSPH

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2017

First Posted

November 6, 2017

Study Start

October 24, 2017

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

November 5, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations