Clinical trial NCT01205295: Patient Anxiety and Concern as Predictors for the Perceived Quality and Efficacy of Treatment
Official title: Patient Anxiety and Concern as Predictors for the Perceived Quality and Efficacy of Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anxiety
Orthopedic Surgery
Keywords: hip
shoulder
mental disorders
anxiety
concern
efficacy of treatment
Lead sponsor: Kolding Sygehus
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
name: University of Southern Denmark
First posted: 2010-09-20
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hip and shoulder patients from the Department of Orthopaedic Surgery, Kolding Hospital, a part of Lillebaelt Hospital, Denmark and Department of Orthopaedics and Traumatology, Odense University Hospital, Denmark.

Brief summary: Background: Previous studies have shown that anxiety and dissatisfaction with patient progress are predictors for increased postoperative pain and reduced impact and efficacy of pain treatment. However, it remains to be shown whether patient anxiety and concern are predictors for the perceived quality of patient progress and the perceived efficacy of treatment.

The aim of this study is to investigate whether there is a correlation between preoperative anxiety and concern, and the perceived quality and efficacy of postoperative treatment. The hypothesis is that anxious and concerned patients are less satisfied with treatment and have a poorer response of their treatment.

Methods/design: This PhD-project consists of four coherent studies. 1) A methodological study evaluating the CMD-SQ (Common Mental Disorder - Screening Questionnaire) questionnaire by a test-retest study. 2) The main study, a prospective follow-up study, has the aim of investigating the correlation between patient anxiety and concern, their perceived quality of patient progress and the perceived efficacy of treatment. This correlation will be detected by means of five questionnaires: CMD-SQ, EQ-5D, SF-12, HVOK, OHS or OSS. 3) A study consisting of an explicit internal medical audit with the aim to investigate whether the medical assessment of patient efficacy of treatment is consistent with their own self-reported efficacy of treatment. 4) An intervention study designed as a randomized clinical trial. The aim is to investigate whether a targeted effort towards patients with a high score of CMD-SQ, i.e. patients with anxiety and concern, can increase their self-reported efficacies of treatment and their perceived quality of progress. A total of 800 hip- and shoulder-patients will be included.

Discussion: If a correlation between patient anxiety and concern, their perceived quality of progress and the perceived efficacy of treatment is found, it will be relevant to screen all hip- and shoulder-patients for anxiety and concern preoperatively and deal with this before their operation. This study will provide a proposition of how these patients can be taken care of through cognitive behavioural therapy as a targeted effort towards their anxiety and concern.

Aim and hypothesis: The aim of this study is to investigate whether there is a correlation between patient anxiety and concern, and their perceived quality and efficacy of treatment. The overall hypothesis is that patients who are anxious and concerned are less satisfied with their treatment and have a poorer overall efficacy of their treatment.


Eligibility criteria: Inclusion Criteria:

* All hip- and shoulder-patients, who are referred for the first time to the Outpatient Department of Orthopaedic Surgery at Kolding Hospital, a part of Lillebaelt Hospital and Department of Orthopaedic Surgery, Odense University Hospital, Denmark are included.
* The patients must be able to speak and read Danish and must be at least 18 years old.
* To be included, they must enter a patient programme that implies an operation.

Exclusion Criteria:

* Patients with cancer or who are registered as terminal are excluded.
* Patients who have experienced a trauma within the past four weeks and those with a psychotic diagnosis are excluded, e.g. severe mental disorders such as schizophrenia, paranoid psychosis and bipolar affective disorders (DSM IV, F 20-29, F 30, 31).

Primary outcomes:
measure: Mental disorders.
timeFrame: Baseline(preoperative)
measure: Quality of life
timeFrame: Baseline (preoperative)
measure: Self-reported health perception
timeFrame: Baseline (preoperative)
measure: Function of the shoulder
timeFrame: Baseline (preoperative)
measure: Function of the hip
timeFrame: Baseline (preoperative)
Secondary outcomes:
measure: Satisfaction with treatment
timeFrame: 3 day postoperative
measure: Mental disorders.
timeFrame: 3 months postoperative
measure: Quality of life
timeFrame: 3 months postoperative
measure: Self-reported health perception
timeFrame: 3 months postoperative
measure: Function of the shoulder
timeFrame: 3 months postoperative
measure: Function of the hip
timeFrame: 3 months postoperative
measure: Satisfaction with treatment
timeFrame: 3 months postoperative
measure: Mental disorders.
timeFrame: 12 months postoperative
measure: Quality of life
timeFrame: 12 months postoperative
measure: Self-reported health perception
timeFrame: 12 months postoperative
measure: Function of the shoulder
timeFrame: 12 months postoperative
measure: Function of the hip
timeFrame: 12 months postoperative
measure: Satisfaction with treatment
timeFrame: 12 months postoperative
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Department of Orthopaedics and Traumatology, Odense University Hospital
Study officials:
affiliation: Kolding Sygehus
name: Randi M Bilberg, Ph.d. stud.
role: STUDY_CHAIR
References:
citation: Bilberg R, Norgaard B, Roessler KK, Overgaard S. Test-retest reliability of Common Mental Disorders Questionnaire (CMDQ) in patients with total hip replacement (THR). BMC Psychol. 2014 Sep 8;2(1):32. doi: 10.1186/s40359-014-0032-5. eCollection 2014.
citation: Bilberg R, Norgaard B, Overgaard S, Roessler KK. Patient anxiety and concern as predictors for the perceived quality of treatment and patient reported outcome (PRO) in orthopaedic surgery. BMC Health Serv Res. 2012 Aug 8;12:244. doi: 10.1186/1472-6963-12-244.