NCT04060329

Brief Summary

The purpose of this study is to identify new methods of measuring and improving collaborative goal setting between patients and clinicians in adult cystic fibrosis care.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

9 active sites

Status
terminated

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 15, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 19, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

December 2, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2020

Completed
Last Updated

July 9, 2020

Status Verified

July 1, 2020

Enrollment Period

4 months

First QC Date

August 15, 2019

Last Update Submit

July 7, 2020

Conditions

Cystic FibrosisChronic Disease

Outcome Measures

Primary Outcomes (1)

  • Collaborative goal setting

    A new 3-item patient-reported measure under evaluation to assess collaborative goal setting between a patient and their clinician during the health care visit. Each item is rated on a 4-point scale ranging from 0 ('Strongly disagree') to 3 ('Strongly agree'), with an additional 'Not sure' option. Scoring method is to be determined.

    Immediately after the health care visit (Day 0)

Secondary Outcomes (3)

  • Shared decision-making

    Immediately after the health care visit (Day 0)

  • Interpersonal and communication skills

    Immediately after the health care visit (Day 0)

  • Self-efficacy to manage chronic disease

    Immediately after the health care visit (Day 0)

Other Outcomes (15)

  • Description of goals discussed during the visit

    Immediately after the health care visit (Day 0)

  • Preference for discussing goals

    Immediately after the health care visit (Day 0)

  • Use of coopeRATE Prompt

    Immediately after the health care visit (Day 0) - Phase 2 only

  • +12 more other outcomes

Study Arms (3)

Phase 1

NO INTERVENTION

Usual care

Phase 2

EXPERIMENTAL

Usual care + coopeRATE Prompt intervention

Behavioral: coopeRATE Prompt

Clinicians

OTHER

After Phase 2, clinicians will be asked about their experiences with, and views about, the coopeRATE Prompt intervention.

Behavioral: coopeRATE Prompt

Interventions

coopeRATE PromptBEHAVIORAL

The coopeRATE Prompt intervention is a set of two questions delivered to patients immediately before the clinical encounter that elicit their concerns and goals.

CliniciansPhase 2

Eligibility Criteria

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

You may qualify if:

  • Have a diagnosis of cystic fibrosis
  • Are 18 years of age or older
  • Can read and write in English
  • Are attending a participating site for a routine cystic fibrosis care visit
  • Have already consented to participate in the Cystic Fibrosis Foundation Patient Registry
  • Allow study researchers to access their Cystic Fibrosis Foundation Patient Registry information and link it to their study data
  • Have not previously participated in the study

You may not qualify if:

  • Do not have a diagnosis of cystic fibrosis
  • Are less than 18 years of age
  • Cannot read and write in English
  • Are not attending a participating site for a routine cystic fibrosis care visit
  • Have not already consented to participate in the Cystic Fibrosis Foundation Patient Registry
  • Do not allow study researchers to access their Cystic Fibrosis Foundation Patient Registry information and link it to their study data
  • Have previously participated in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

University of California San Diego

San Diego, California, 92103, United States

Location

National Jewish Health

Denver, Colorado, 80206, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Nebraska Medical Center / Nebraska Medical Center

Omaha, Nebraska, 68106, United States

Location

Dartmouth-Hitchcock Medical Center / Dartmouth-Hitchcock Manchester

Lebanon, New Hampshire, 03756, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15224, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Publications (5)

  • Elwyn G, Barr PJ, Grande SW, Thompson R, Walsh T, Ozanne EM. Developing CollaboRATE: a fast and frugal patient-reported measure of shared decision making in clinical encounters. Patient Educ Couns. 2013 Oct;93(1):102-7. doi: 10.1016/j.pec.2013.05.009. Epub 2013 Jun 12.

    PMID: 23768763BACKGROUND

  • Barr PJ, Thompson R, Walsh T, Grande SW, Ozanne EM, Elwyn G. The psychometric properties of CollaboRATE: a fast and frugal patient-reported measure of the shared decision-making process. J Med Internet Res. 2014 Jan 3;16(1):e2. doi: 10.2196/jmir.3085.

    PMID: 24389354BACKGROUND

  • Makoul G, Krupat E, Chang CH. Measuring patient views of physician communication skills: development and testing of the Communication Assessment Tool. Patient Educ Couns. 2007 Aug;67(3):333-42. doi: 10.1016/j.pec.2007.05.005. Epub 2007 Jun 18.

    PMID: 17574367BACKGROUND

  • Ritter PL, Lorig K. The English and Spanish Self-Efficacy to Manage Chronic Disease Scale measures were validated using multiple studies. J Clin Epidemiol. 2014 Nov;67(11):1265-73. doi: 10.1016/j.jclinepi.2014.06.009. Epub 2014 Aug 3.

    PMID: 25091546BACKGROUND

  • Dalcin AT, Jerome GJ, Fitzpatrick SL, Louis TA, Wang NY, Bennett WL, Durkin N, Clark JM, Daumit GL, Appel LJ, Coughlin JW. Perceived helpfulness of the individual components of a behavioural weight loss program: results from the Hopkins POWER Trial. Obes Sci Pract. 2015 Oct;1(1):23-32. doi: 10.1002/osp4.6. Epub 2015 Sep 9.

    PMID: 27668085BACKGROUND

MeSH Terms

Conditions

Cystic FibrosisChronic Disease

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Glyn Elwyn

    Dartmouth College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Model Details: In Phase 1, participants receive usual care only. In Phase 2, a different group of participants receive the coopeRATE Prompt intervention in addition to usual care.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 15, 2019

First Posted

August 19, 2019

Study Start

December 2, 2019

Primary Completion

March 16, 2020

Study Completion

March 16, 2020

Last Updated

July 9, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

US(9)