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The influence of Patient Reported Outcome Measures on patient empowerment, physical function and satisfaction.


- candidate number22831
- NTR NumberNTR5452
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-sep-2015
- Secondary IDsMEC: WO 15.042 
- Public TitleThe influence of Patient Reported Outcome Measures on patient empowerment, physical function and satisfaction.
- Scientific TitleThe influence of Patient Reported Outcome Measures on patient empowerment, physical function and satisfaction.
- ACRONYM
- hypothesisPrimary: There is no difference in satisfaction between patients who filled out their PROMs and received feedback compared to patients who did not.
Secondary: There is no difference in illness behavior (empowerment), patient-physician relationship and physical function between patients who filled out their PROMs and received feedback compared to patient who did not.
- Healt Condition(s) or Problem(s) studiedOsteoarthritis, Knee, Hip
- Inclusion criteriaadults ¡Ý18 years old, Dutch fluency and literacy and the ability to give informed consent.
- Exclusion criteriapatients not able to fill out the questionnaires, due to mental problems or language difficulties.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 22-jun-2015
- planned closingdate26-sep-2015
- Target number of participants128
- InterventionsStudy Design
This study used a pre and after implementation of the intervention design Patient allocated in the intervention group were asked to fill out digital questionnaires about physical function (HOOS-PS or KOOS-PS) and pain (NRS-Pain) [6]. After filling out the questionnaires, patients received the final scores on a print out. The results were visualized by a color scale ranging ____. Afterwards the patient could take the results to the physician, who discussed them during the consult. Before the start of the intervention period, the physicians received description on how to interpret the scores and how to discuss them with their patient. After the consult both cohorts filled a web-based questionnaires about: 1) disability, either hip disability and Osteoarthritis Outcome Score (HOOS-ps) or Knee injury and Osteoarthritis Outcome Score (KOOS-ps) [1], 2) Pain Self Efficacy Questionnaire (PSEQ) [2], 3) Patient-Doctor Relationship Questionnaire (PDRQ-9) [3], 4) Satisfaction with care, 0-10 ordinal scale, satisfaction with information, 0-10 ordinal scale, satisfaction with doctor, 0-10 ordinal scale, and 5) Patient Activation Measure (PAM) [4]. Patients were also asked for demographic information.
- Primary outcomepatient satisfaction
- Secondary outcome• Patient: age, gender, marital status, income, work status, education, diagnosis, previous operations/treatment
• Patient Activation Measure (PAM)
• Patient-doctor relationship Questionnaire
• Disability
o Hip: Hip disability and Osteoarthritis Outcome Score (HOOS-ps)
o Knee: Knee injury and Osteoarthritis Outcome Score (KOOS-ps)
• Pain
- Timepointst=0; before for the intervention group and after the consult with orthopedic surgeon at thein outpatient clinic for both cohorts.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES L. Ackermans
- CONTACT for SCIENTIFIC QUERIES M. Hageman
- Sponsor/Initiator Onze Lieve Vrouwe Gasthuis (OLVG)
- Funding
(Source(s) of Monetary or Material Support)
Onze Lieve Vrouwe Gasthuis (OLVG)
- Publications
- Brief summaryOur research will focus on assessing the effect of providing PROMs to the patients regarding physical function, pain and on patients¡¯ satisfaction, patient-physician relation illness behavior (empowerment) and physical function.
Countries of recruitment: Netherlands
- Main changes (audit trail)
- RECORD3-sep-2015 - 22-nov-2015


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