Feasibility of a Goal-based Agenda Setting Intervention

NCT04696484 | Completed

• 1 other identifier: Pro00047666
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 4

Brief Summary

This study aims to assess the feasibility of a new, brief intervention, the 'coopeRATE Prompt', for informing conversations between patients and physicians in routine tele-health and in-person adult Cystic Fibrosis (CF) care. The coopeRATE Prompt is two questions designed to elicit patients' concerns and goals to facilitate collaborative goal setting within the health care visit. This is a prospective single arm study that will be conducted at four CF care centers in the United States.

Conditions

Cystic Fibrosis; Chronic Disease

Outcome Measures

Primary Outcomes (1)

• Use of intervention responses with physician (patient-reported)

  Patient-reported discussion of intervention responses (concerns and goals) in the visit with physician, assessed using two items with multiple choice (single answer) format. The first item assesses how many of the patient concerns were discussed and the second item assesses how many of the patient goals were discussed. Item response options are 'None of them', 'Some of them', or 'All of them'.

  Within 24 hours after completion of the healthcare visit

Secondary Outcomes (22)

• Intervention completion (patient-reported)

  1-4 days before the healthcare visit

• Intervention acceptability (patient-reported)

  1-4 days before the healthcare visit

• Utility of intervention (patient-reported)

  Within 24 hours after completion of the healthcare visit

• Way(s) in which intervention was helpful (patient-reported)

  Within 24 hours after completion of the healthcare visit

• Initiator of discussion (patient-reported)

  Within 24 hours after completion of the healthcare visit

Other Outcomes (6)

• Concerns and goals (patient-reported)

  1-4 days before the healthcare visit and within 24 hours after completion of the healthcare visit

• Additional intervention feedback (patient-reported)

  1-4 days before the healthcare visit and within 24 hours after completion of the healthcare visit

• Type of routine healthcare visit (patient-reported)

  Within 1 month following completion of patient data collection

Study Arms (1)

Intervention

EXPERIMENTAL

coopeRATE Prompt

Behavioral: coopeRATE Prompt

Interventions

coopeRATE Prompt BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• have a diagnosis of CF
• are 18 years of age or older
• can read and write English
• have a scheduled in-person or tele-health routine CF care visit
• have access to internet and email

You may not qualify if:

• does not have a diagnosis of CF
• is less than 18 years of age
• cannot read and write English
• does not have a scheduled in-person or tele-health routine CF care visit
• does have access to internet and email

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Cystic Fibrosis Foundation: collaborator

Study Sites (4)

National Jewish Health

Denver, Colorado, 80206, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Dartmouth-Hitchcock

Lebanon, New Hampshire, 03756, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Publications (4)

• Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.

  PMID: 28851459 BACKGROUND

• 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: 27668085 BACKGROUND

• 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: 23768763 BACKGROUND

• 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: 24389354 BACKGROUND

MeSH Terms

Conditions

Cystic Fibrosis; Chronic Disease

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Glyn Elwyn

  Dartmouth College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 6, 2021
• Study Start: January 14, 2021
• Primary Completion: September 3, 2021
• Study Completion: September 19, 2021
• Last Updated: November 24, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: The data and supporting information will be available after December 2021 and for an indefinite period of time.
• Access Criteria: Requests must include sufficient justification for the data which does not duplicate any current or planned data use. All requests will be subject to Investigator approval.

Locations

US (4)