Patient Agenda Setting and Clinic Efficiency in Outpatients
Primary Purpose
Respiratory Tract Diseases
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Patient agenda form
Sponsored by
About this trial
This is an interventional other trial for Respiratory Tract Diseases focused on measuring Outpatient Clinics, Hospital, Humans, Outcome Assessment (Health Care), Patient Outcome Assessment, Patient satisfaction, Hospitalists, Secondary care
Eligibility Criteria
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
Sites / Locations
- Cambridge University Hospitals NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Patient Agenda Form
Usual care
Arm Description
Patient Agenda form: Patients receive an agenda form to use before their consultation.
Patients' appointment continues as usual.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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
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
Length of consultation
Full Information
NCT ID
NCT03433729
First Posted
February 8, 2018
Last Updated
February 8, 2018
Sponsor
Cambridge University Hospitals NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT03433729
Brief Title
Patient Agenda Setting and Clinic Efficiency in Outpatients
Official Title
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?
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cambridge University Hospitals NHS Foundation Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Tract Diseases
Keywords
Outpatient Clinics, Hospital, Humans, Outcome Assessment (Health Care), Patient Outcome Assessment, Patient satisfaction, Hospitalists, Secondary care
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
165 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient Agenda Form
Arm Type
Experimental
Arm Description
Patient Agenda form: Patients receive an agenda form to use before their consultation.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Patients' appointment continues as usual.
Intervention Type
Other
Intervention Name(s)
Patient agenda form
Intervention Description
On arrival at the clinic patients are given an agenda form to prompt them to think about what issues they wished to discuss with their doctor. The form contains a prompt list of items they can tick, free space to write their own items, and a prompt to consider what is the most important issue for them and what they would like to happen before they leave their clinic appointment.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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.
Time Frame
Immediately after consultation with the doctor
Title
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
Time Frame
Immediately after consultation with the doctor
Title
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
Time Frame
Immediately after consultation with the doctor
Title
Length of consultation
Time Frame
Immediately after consultation with the doctor
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan P Fuld, MD ChB, PhD
Organizational Affiliation
Cambridge University Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cambridge University Hospitals NHS Foundation Trust
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
12. IPD Sharing Statement
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Patient Agenda Setting and Clinic Efficiency in Outpatients
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