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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01466140
Other study ID # EffectsPS1
Secondary ID
Status Completed
Phase N/A
First received October 21, 2011
Last updated November 4, 2011
Start date January 2011
Est. completion date May 2011

Study information

Verified date November 2011
Source Medical Research Foundation, The Netherlands
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to determine whether exploring the request for help more thoroughly improves patient satisfaction in general practice (primary care).


Description:

Patient satisfaction has been an important topic of interest in primary health care during the last decade(s). Many factors during the consultation influence patient satisfaction. One of the aspects in a consultation is the request for help; especially in primary care the request for help has been recognised as an important aspect influencing patient satisfaction. The investigators hypothesized that exploring the request for help more thoroughly would improve patient satisfaction in general practice.


Recruitment information / eligibility

Status Completed
Enrollment 209
Est. completion date May 2011
Est. primary completion date March 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- All patients with a new request for help.

Exclusion Criteria:

- Dementia

- Mental disability

- No or little knowledge of the Dutch language

- Illiteracy

- Limited vision

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research


Intervention

Other:
Writing down request for help
Patients in the intervention group could write down their request for help on a request card (with a maximum of 2 questions).

Locations

Country Name City State
Netherlands Isala Clinics Zwolle Overijssel

Sponsors (1)

Lead Sponsor Collaborator
Nanne Kleefstra

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient satisfaction measured with the Consultation Satisfaction Questionnaire The primary endpoint is the 'Professional Care' (PC) scale of the 'Consultation Satisfaction Questionnaire' (CSQ). In a previous study the score on the PC were 88.2 en 80.9 in the intervention and control groups, respectively. The standard deviations were 11.8 en 16.1. For our sample size calculation we used an expected standard deviation of 15. The sample size required to detect a difference of 7 on the PC scale between the intervention and control group, with a power of 90%, and alpha of 5% (two-tailed), and a standard deviation of 15, was 196 patients. We rounded this number off to 200. 15-30 minutes (after the consultation patients filled in the questionnaire) No
Secondary Patient satisfaction measured with the Visual Analog Scale On a scale of 0-10 patients could fill in the Visual Analog Scale with regard to the patient satisfaction during the consultation 15-30 minutes (patients filled in the Visual Analog Scale after the consultation) No
Secondary Doctor satisfaction measured with the Visual Analog Scale On a scale from 0-10 general practitioners could fill in the Visual Analog Scale with regard to their own satisfaction about the consultation 15-30 minutes (general pracitioners filled in the Visual Analog Scale after the consultation) No
Secondary Duration of the consultation Duration of the consultation was compared between both groups 15-30 minutes (after the consultation the doctor measured the time with a stopwatch) No
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