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Clinician-patient Interaction During Addiction Consultation (CLiPID)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2015 by Prof G Humphris, University of St Andrews.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01769651
First Posted: January 17, 2013
Last Update Posted: February 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
NHS Fife
Information provided by (Responsible Party):
Prof G Humphris, University of St Andrews
  Purpose

Accurately predicting the risk factors of patients' suffering a drug overdose plays a crucial role in effective prevention of drug overdose. In order to investigate possible risk factors for drug overdose, the NHS Fife Research & Development Office funded this project to be carried out by a group of researchers based in the University of St Andrews, in collaboration with the NHS Fife Addiction Services.

To improve our understanding of drug misusers' risk of suffering a drug overdose, the investigators focus on the factors that are associated with the aspects of the addiction consultation process (e.g. verbal and non-verbal behaviours of clinicians and patients). The investigators are particularly interested in how clinicians recognize and manage patients' emotional concerns during consultations. Based on the empirical evidence in the area of patient-centred consultation, the investigators hypothesize that successful management of patient emotional distress is positively correlated with improved healthcare outcomes including patient's feeling more emotionally valued and satisfied with the consultation. The investigators also hypothesize, according to the research findings on the relationship between facial expressions and suicidal reattempt, that some non-verbal behaviours during consultation (e.g. patient's 'looking down' activity) are related to patient's risk of suffering a drug overdose.

After obtaining informed consent from clinicians and patients, the investigators will video record a patient's first consultation session with a key worker within the NHS Fife Addition Services. The investigators expect to collect a minimum of 16 consultations (about eight clinicians with two patients per staff member) for this one-year pilot study. A validated coding scheme will be modified to code patients' expressions of emotional distress and clinicians' responses. Additional survey method will be also employed to collect demographic information and patient satisfaction. The investigators hope the findings of the study will improve our understanding of drug overdose risk factors and contribute to the development of drug overdose prevention programmes.


Condition Intervention
Drug Dependency Other: methadone replacement therapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Clinician-patient Interaction During Addiction Consultation and Drug Overdose Risk

Resource links provided by NLM:


Further study details as provided by Prof G Humphris, University of St Andrews:

Primary Outcome Measures:
  • Number of days patients injected non-prescribed drugs [ Time Frame: one month after the video recorded consultation ]
    The primary outcome measure of the study is patient risk of suffering a drug overdose, measured by the number of days patients injected non-prescribed drugs, recorded on the Treatment Outcomes Profile Questionnaire, one month after the recorded consultation.


Secondary Outcome Measures:
  • Patient Satisfaction [ Time Frame: an expected average of 30 minutes after recorded consultation ]
    Patient satisfaction is the secondary outcome, measured by the Patient Satisfaction Survey completed by patients, an expected average of 30 minutes after the recorded consultation.


Estimated Enrollment: 16
Study Start Date: March 2015
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Drug service users
Those patients who receive Methadone replacement therapy as part of their treatment plan. In addition, those drug user patients who have a first consultation session with their Addiction Nurses.
Other: methadone replacement therapy
Patients are prescribed Methadone as part of their treatment plan, having been assessed as having opioid dependence syndrome and requiring pharmacological substitution therapy. A bio-psychosocial approach is taken in the treatment management of individuals.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All drug user patients refered to the NHS Fife Addiction Services by a Fife wide triage contact point, patient GPs or Consultant, who are to have a first session with their Addiction Nurses, are identified as potential patient participants.
Criteria

Inclusion Criteria:

  • Drug service users in NHS Fife Addiction Services
  • Have a first session with their Addiction Nurses
  • English is first language

Exclusion Criteria:

  • Mental health problems
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01769651


Contacts
Contact: Yuefang Zhou, PhD 00441334461866 yz10@st-andrews.ac.uk

Locations
United Kingdom
School of Medicine, University of St Andrews
St Andrews, Fife, Scotland, United Kingdom, KY16 9TF
Sponsors and Collaborators
University of St Andrews
NHS Fife
Investigators
Principal Investigator: Gerry M Humphris, PhD University of St Andrews
  More Information

Publications:
Responsible Party: Prof G Humphris, Chair of Health Psychology, University of St Andrews
ClinicalTrials.gov Identifier: NCT01769651     History of Changes
Other Study ID Numbers: CLiPID01
First Submitted: January 10, 2013
First Posted: January 17, 2013
Last Update Posted: February 18, 2015
Last Verified: February 2015

Keywords provided by Prof G Humphris, University of St Andrews:
drug user patients
addiction nurses
overdose risk

Additional relevant MeSH terms:
Behavior, Addictive
Compulsive Behavior
Impulsive Behavior
Methadone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents