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Clinical Trials/NCT03433729
NCT03433729CompletedNot Applicable

A Randomized Controlled Trial to Assess the Impact of an Agenda Setting Form in a Respiratory Outpatient Clinic: Are Patients More Likely to Perceive That Their Important Issues Are Discussed and Does the Form Improve Clinic Efficiency?

Cambridge University Hospitals NHS Foundation Trust2 sites in 1 country165 target enrollmentStarted: March 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
165
Locations
2
Primary Endpoint
The proportion of patients who, on leaving their outpatient appointment, strongly agree with the statement "My doctor discussed the issues that were important to me" where options are strongly agree, agree, disagree, strongly disagree.

Study Overview

Brief Summary

The purpose of the study is to determine whether patients who use a prompt sheet to identify their important issues before they see a doctor are more likely to feel that their important issues have been discussed during their consultation. The study will be conducted in a respiratory outpatient clinic.

Detailed Description

Evidence suggests that most patients come to a consultation with issues they wish to raise, but they may not actually raise them and clinicians may not elicit them. This can adversely affect the consultation outcome, e.g. through misunderstandings, unwanted prescriptions, non-adherence and unnecessary follow-ups. In a review of methods used before consultations to help patients address their information needs Kinnersely et al. (2009) found that there were small but statistically significant increases in patient satisfaction and the number of questions patients asked, and no effect on consultation length. However, they identified several gaps in the evidence including the need to assess a wider range of outcome measures, to identify the impact of the methods on the types of questions asked and the need to measure consultation length accurately.

This study aims to assess the impact of a written agenda form in a respiratory outpatient clinic. The form prompts the patient to identify their questions and issues, provides a list of frequently asked questions and invites the patient to write down the issues they wish to discuss with their doctor. We wish to identify whether use of the form increases the extent to which patients perceive that their important issues are discussed in the consultation. We will also assess whether patients feel more able to raise these issues and get the outcome they wanted, their confidence to manage their condition and consultation length.

The study is a randomised controlled trial (RCT) with a sample size of 158 patients. On arrival at the clinic patients will be randomly allocated to either the intervention group (who will receive an agenda form) or to standard practice. Patient reported outcomes will be collected after the patient has seen the doctor and consultation times will be recorded by an independent observer outside the consultation room.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • have an outpatient appointment at one of the designated clinics
  • are able to understand the Patient Information Sheet and complete the agenda form and the feedback form, or are accompanied by a person who meets this criteria and who is willing to complete the form on the patient's behalf
  • willing and able to give informed consent for participation in the study

Exclusion Criteria

  • No further criteria apply

Arms & Interventions

Patient Agenda Form

Experimental

Patient Agenda form: Patients receive an agenda form to use before their consultation.

Intervention: Patient agenda form (Other)

Usual care

No Intervention

Patients' appointment continues as usual.

Outcomes

Primary Outcomes

The proportion of patients who, on leaving their outpatient appointment, strongly agree with the statement "My doctor discussed the issues that were important to me" where options are strongly agree, agree, disagree, strongly disagree.

Time Frame: Immediately after consultation with the doctor

Secondary Outcomes

  • The proportion of patients who strongly agree with the statement "I felt able to raise issues that were important to me with my doctor" where options are strongly agree, agree, disagree, strongly disagree(Immediately after consultation with the doctor)
  • The proportion of patients who strongly agree with the statement "I got the outcome I wanted from my consultation" where options are strongly agree, agree, disagree, strongly disagree.(Immediately after consultation with the doctor)
  • Length of consultation(Immediately after consultation with the doctor)
  • Patient confidence to manage their condition following the consultation, rated on a scale of 0-10 where 0 equals no confidence and 10 equals maximum confidence(Immediately after consultation with the doctor)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr Jonathan Fuld

Consultant Physician

Cambridge University Hospitals NHS Foundation Trust

Study Sites (2)

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