Patient Anxiety and Concern as Predictors for the Perceived Quality and Efficacy of Treatment

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Kolding Sygehus.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Odense University Hospital
University of Southern Denmark
Information provided by:
Kolding Sygehus
ClinicalTrials.gov Identifier:
NCT01205295
First received: September 13, 2010
Last updated: June 22, 2011
Last verified: September 2010
  Purpose

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.


Condition Intervention
Anxiety
Orthopedic Surgery
Other: Cognitive behavioural therapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient Anxiety and Concern as Predictors for the Perceived Quality and Efficacy of Treatment

Resource links provided by NLM:


Further study details as provided by Kolding Sygehus:

Primary Outcome Measures:
  • Mental disorders. [ Time Frame: Baseline(preoperative) ] [ Designated as safety issue: Yes ]
    CMD-SQ contains 38 items and was prepared as a tool for general practitioners to increase the focus on patient anxiety and concern. The questionnaire was translated into Danish and then validated without the test-retest. CMD-SQ consists of the following six subscales, each of them has been validated: SCL-AS, Whiteley-7, SCL-ANX4, SCL-8, SCL-DEF6 and CAGE. The patients respond on a Likert scale. A normal score is lower than four in the SCL-AS scale and no more than two in the remaining scales. A manual for assessing and validating the score of CMD-SQ is available.

  • Quality of life [ Time Frame: Baseline (preoperative) ] [ Designated as safety issue: Yes ]
    EQ-5D is designed to assess the quality of life with no reference to a specific diagnosis. The questionnaire has been translated into Danish and validated. The scale includes five broad areas and a visual analogue scale. The self-reported health situation is reported on a scale from 0 to 100. The score 100 corresponds to the best self-reported health situation.

  • Self-reported health perception [ Time Frame: Baseline (preoperative) ] [ Designated as safety issue: Yes ]
    SF-12 is an internationally and nationally validated questionnaire that evaluates patients' self-reported health perception. SF-12 is an abbreviated version of SF-36 and it contains 12 items, which are divided into physical and mental items. The patients respond on a Likert scale.

  • Function of the shoulder [ Time Frame: Baseline (preoperative) ] [ Designated as safety issue: Yes ]
    The UK questionnaire Oxford Shoulder Score (OSS) are initially and similar, but related to two different categories of patients, namely shoulder - operated patients. The questionnaires are compiled in Oxford. Each questionnaire contains 12 items. The OSS has been translated into Danish and validated. The patients respond on a Likert scale from 1 - 5. The calculated scores can be between 12 and 60 points. 12 points reflects the best possible effect of treatment, and a score above 36 is categorized as an expression of a poor patient-assessed efficacy of treatment.

  • Function of the hip [ Time Frame: Baseline (preoperative) ] [ Designated as safety issue: Yes ]
    The UK questionnaires Oxford Hip Score (OHS) are initially and similar, but related to two different categories of patients, namely THA operated patients. The questionnaires are compiled in Oxford. Each questionnaire contains 12 items. The OHS has been translated into Danish and is undergoing a validation process in a parallel project. The patients respond on a Likert scale from 1 - 5. The calculated scores can be between 12 and 60 points.


Secondary Outcome Measures:
  • Satisfaction with treatment [ Time Frame: 3 day postoperative ] [ Designated as safety issue: Yes ]

    The Danish questionnaire HVOK deals with patients' priorities and satisfaction with treatment and is included in a revised form. Ten of the highest prioritised items were selected for this study. The patients respond on a Likert scale.

    The Royal College of Surgeons of England has developed the "Questionnaire for patients who have had hip surgery". The aim was to investigate patients´ satisfaction with surgery. It is relevant to select three items and use them as supplementary questions in this study. The patients respond on a Likert scale.


  • Mental disorders. [ Time Frame: 3 months postoperative ] [ Designated as safety issue: Yes ]
    CMD-SQ contains 38 items and was prepared as a tool for general practitioners to increase the focus on patient anxiety and concern. The questionnaire was translated into Danish and then validated without the test-retest. CMD-SQ consists of the following six subscales, each of them has been validated: SCL-AS, Whiteley-7, SCL-ANX4, SCL-8, SCL-DEF6 and CAGE. The patients respond on a Likert scale. A normal score is lower than four in the SCL-AS scale and no more than two in the remaining scales. A manual for assessing and validating the score of CMD-SQ is available.

  • Quality of life [ Time Frame: 3 months postoperative ] [ Designated as safety issue: Yes ]
    EQ-5D is designed to assess the quality of life with no reference to a specific diagnosis. The questionnaire has been translated into Danish and validated. The scale includes five broad areas and a visual analogue scale. The self-reported health situation is reported on a scale from 0 to 100. The score 100 corresponds to the best self-reported health situation.

  • Self-reported health perception [ Time Frame: 3 months postoperative ] [ Designated as safety issue: Yes ]
    SF-12 is an internationally and nationally validated questionnaire that evaluates patients' self-reported health perception. SF-12 is an abbreviated version of SF-36 and it contains 12 items, which are divided into physical and mental items. The patients respond on a Likert scale.

  • Function of the shoulder [ Time Frame: 3 months postoperative ] [ Designated as safety issue: Yes ]
    The UK questionnaire Oxford Shoulder Score (OSS) are initially and similar, but related to two different categories of patients, namely shoulder - operated patients. The questionnaires are compiled in Oxford. Each questionnaire contains 12 items. The OSS has been translated into Danish and validated. The patients respond on a Likert scale from 1 - 5. The calculated scores can be between 12 and 60 points. 12 points reflects the best possible effect of treatment, and a score above 36 is categorized as an expression of a poor patient-assessed efficacy of treatment.

  • Function of the hip [ Time Frame: 3 months postoperative ] [ Designated as safety issue: Yes ]
    The UK questionnaires Oxford Hip Score (OHS) are initially and similar, but related to two different categories of patients, namely THA operated patients. The questionnaires are compiled in Oxford. Each questionnaire contains 12 items. The OHS has been translated into Danish and is undergoing a validation process in a parallel project. The patients respond on a Likert scale from 1 - 5. The calculated scores can be between 12 and 60 points.

  • Satisfaction with treatment [ Time Frame: 3 months postoperative ] [ Designated as safety issue: Yes ]

    The Danish questionnaire HVOK deals with patients' priorities and satisfaction with treatment and is included in a revised form. Ten of the highest prioritised items were selected for this study. The patients respond on a Likert scale.

    The Royal College of Surgeons of England has developed the "Questionnaire for patients who have had hip surgery". The aim was to investigate patients´ satisfaction with surgery. It is relevant to select three items and use them as supplementary questions in this study. The patients respond on a Likert scale.


  • Mental disorders. [ Time Frame: 12 months postoperative ] [ Designated as safety issue: Yes ]
    CMD-SQ contains 38 items and was prepared as a tool for general practitioners to increase the focus on patient anxiety and concern. The questionnaire was translated into Danish and then validated without the test-retest. CMD-SQ consists of the following six subscales, each of them has been validated: SCL-AS, Whiteley-7, SCL-ANX4, SCL-8, SCL-DEF6 and CAGE. The patients respond on a Likert scale. A normal score is lower than four in the SCL-AS scale and no more than two in the remaining scales. A manual for assessing and validating the score of CMD-SQ is available.

  • Quality of life [ Time Frame: 12 months postoperative ] [ Designated as safety issue: Yes ]
    EQ-5D is designed to assess the quality of life with no reference to a specific diagnosis. The questionnaire has been translated into Danish and validated. The scale includes five broad areas and a visual analogue scale. The self-reported health situation is reported on a scale from 0 to 100. The score 100 corresponds to the best self-reported health situation.

  • Self-reported health perception [ Time Frame: 12 months postoperative ] [ Designated as safety issue: Yes ]
    SF-12 is an internationally and nationally validated questionnaire that evaluates patients' self-reported health perception. SF-12 is an abbreviated version of SF-36 and it contains 12 items, which are divided into physical and mental items. The patients respond on a Likert scale.

  • Function of the shoulder [ Time Frame: 12 months postoperative ] [ Designated as safety issue: Yes ]
    The UK questionnaire Oxford Shoulder Score (OSS) are initially and similar, but related to two different categories of patients, namely shoulder - operated patients. The questionnaires are compiled in Oxford. Each questionnaire contains 12 items. The OSS has been translated into Danish and validated. The patients respond on a Likert scale from 1 - 5. The calculated scores can be between 12 and 60 points. 12 points reflects the best possible effect of treatment, and a score above 36 is categorized as an expression of a poor patient-assessed efficacy of treatment.

  • Function of the hip [ Time Frame: 12 months postoperative ] [ Designated as safety issue: Yes ]
    The UK questionnaires Oxford Hip Score (OHS) are initially and similar, but related to two different categories of patients, namely THA operated patients. The questionnaires are compiled in Oxford. Each questionnaire contains 12 items. The OHS has been translated into Danish and is undergoing a validation process in a parallel project. The patients respond on a Likert scale from 1 - 5. The calculated scores can be between 12 and 60 points.

  • Satisfaction with treatment [ Time Frame: 12 months postoperative ] [ Designated as safety issue: Yes ]

    The Danish questionnaire HVOK deals with patients' priorities and satisfaction with treatment and is included in a revised form. Ten of the highest prioritised items were selected for this study. The patients respond on a Likert scale.

    The Royal College of Surgeons of England has developed the "Questionnaire for patients who have had hip surgery". The aim was to investigate patients´ satisfaction with surgery. It is relevant to select three items and use them as supplementary questions in this study. The patients respond on a Likert scale.



Estimated Enrollment: 800
Study Start Date: September 2010
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Mental disorders
Preoperative and postoperative screening of mental disorders and efficacy of treatment in hip and shoulder patient.
Other: Cognitive behavioural therapy
Cognitive behavioural therapy Psychologist Preoperative Efficacy of treatment
Other Names:
  • Cognitive behavioural therapy
  • Psychologist
  • Preoperative
  • Efficacy of treatment
  • Hip
  • Shoulder

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01205295

Contacts
Contact: Randi Bilberg M Bilberg, Ph.d. Stud. 0045-76363026 randi.madsen@slb.regionsyddanmark.dk

Locations
Denmark
Department of Orthopaedics and Traumatology, Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Randi M Bilberg, Ph.d. Stud.    0045-76363026    randi.madsen@slb.regionsyddanmark.dk   
Sponsors and Collaborators
Kolding Sygehus
Odense University Hospital
University of Southern Denmark
Investigators
Study Chair: Randi M Bilberg, Ph.d. stud. Kolding Sygehus
  More Information

No publications provided by Kolding Sygehus

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ph.d. Stud. Randi Bilberg, Kolding Hospital
ClinicalTrials.gov Identifier: NCT01205295     History of Changes
Other Study ID Numbers: TBH-12-1106
Study First Received: September 13, 2010
Last Updated: June 22, 2011
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Kolding Sygehus:
hip
shoulder
mental disorders
anxiety
concern
efficacy of treatment

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 19, 2014