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PRINCE Primary: Integrated GP Care for Persistent Physical Symptoms - a Feasibility & Cluster Randomised Controlled Trial (PRINCE Primary)

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.
 
ClinicalTrials.gov Identifier: NCT02444520
Recruitment Status : Completed
First Posted : May 14, 2015
Last Update Posted : May 9, 2019
Sponsor:
Collaborator:
South London and Maudsley NHS Foundation Trust
Information provided by (Responsible Party):
King's College London

Brief Summary:
PRINCE primary is cluster randomised waiting list controlled trial to evaluate the feasibility of an integrated approach to care in general practice for adults with persistent physical symptoms (PPS). PPS is defined as physical symptoms with no obvious underlying organic. 240 patients with PPS recruited from 8-12 GP practices in London will be randomised to the integrated care approach plus treatment as usual (TAU) or TAU alone. The integrated GP approach consists of providing GPs with a short cognitive behaviour therapy (CBT) skills training, ongoing supervision, as well as written and audio-visual materials/guidelines. In addition, participants randomised to the intervention group will receive tailored CBT-based self-help materials (i.e. written and audio-visual materials).

Condition or disease Intervention/treatment Phase
Persistent Physical Symptoms Behavioral: Integrated GP Care Not Applicable

Detailed Description:

Patients with PPS are often severely functionally impaired and. They consume large amounts of healthcare and welfare benefits. There is an accumulating body of evidence showing that cognitive behavioural interventions can reduce levels of symptoms and improve overall functioning in patients with PPS. CBT has demonstrated both short-term and long-term efficacy with small to medium effect sizes for PPS. Larger treatment effects have been reported for specific PPS syndromes, including non-cardiac chest pain, Irritable Bowel Syndrome (IBS), and Chronic Fatigue Syndrome (CFS).

General practitioners (GPs) play a major role in identifying and managing patients with PPS. A previous randomised parallel group pilot trial investigated the feasibility (i.e. recruitment, retention and acceptability) of implementing a primary care Symptoms Clinic for patients with PPS). The Symptoms Clinic comprised a structured set of consultations delivered by a specially trained GP with a strong interest in PPS. The intervention included exploring potential biological mechanisms underlying the PPS condition, empathetic support, and training patients in symptom-management (i.e. medication or cognitive behavioural techniques). The results indicated that the Symptoms Clinic was acceptable to the majority of patients randomised to the intervention group, and may have the potential to generate clinically significant benefits. However, this pilot study did not assess feasibility parameters referring to GPs' willingness to participate in the study and undergo specialised psychological training. Moreover, the intervention was carried out by only one GP, raising questions about the generalizability of the study.

Managing patients with PPS can be highly challenging in general practice. Although GPs recognise the treatment of PPS as a responsibility of primary care, previous studies show that GPs often feel powerless, frustrated and helpless when encountering these patients. Furthermore, GPs frequently report that factors such as time constraints and the lack of psychological training prevents them from effectively addressing patients' psychosocial needs and developing appropriate doctor-patient communication skills.

The aim of this study is to assess whether it is feasible to conduct an adequately powered future trial to evaluate the efficacy and cost-effectiveness of a CBT-based integrated GP care approach for treating patients with PPS (please refer to arms and interventions for more details).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 161 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: PRINCE Primary is a cluster randomised waiting list controlled trial to evaluate the acceptability and feasibility of an integrated approach to care in general practice for adults with PPS.
Masking: Single (Outcomes Assessor)
Masking Description: Patients and GPs will not be blind to treatment allocation due to the nature of the trial (i.e. therapy trial). The trial team member responsible for treatment allocation will be unblind. All outcome data are based on self-report and will be collected either by post or email. The research assistant(s) responsible for contacting participants who have not returned or completed follow-up questionnaires will be unblind. Moreover, the Data Monitoring and Ethics Committee (DMEC), research workers and trial statisticians will remain blind to treatment allocation.
Primary Purpose: Other
Official Title: Persistent Physical Symptoms Reduction Intervention: a Systems Change and Evaluation (PRINCE) - Integrated GP Care for Persistent Physical Symptoms: a Feasibility & Cluster Randomised Controlled Trial
Study Start Date : May 2015
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Experimental: Integrated GP Care
  • GP training in utilising cognitive behavioural skills during 10-minute consultations;
  • GP Supervision;
  • Audio-visual and written materials/guidelines for GP's;
  • Copies of self-help materials for patients;• Integrated case management discussion prior to secondary care referral. GPs will be encouraged to consult with a colleague before making a referral;
  • Booklets for patients once consent gained.
Behavioral: Integrated GP Care

The overall aims of the intervention are to help the patient:

  1. develop an understanding of the relationship between cognitive, emotional, physiological and behavioral aspects of their problem;
  2. understand factors that may be maintaining the problem;
  3. learn how to modify the behavioral and cognitive responses which may be maintaining the problem;
  4. adopt a healthy sleep routine which can promote healthy living.

Hand-outs will be available for GPs to give to patients, but the structure of the intervention allows for treatment to be formulation-based so that particular issues raised in the consultation that might be maintaining symptom severity (e.g. avoidance) can be addressed.


No Intervention: Waiting List Control Group
Patients in the waiting list control group will continue to receive treatment as usual (TAU), and will be crossed over to receive 'Integrated GP Care' at 6 months post randomization.



Primary Outcome Measures :
  1. Feasibility: Willingness of clinicians to participate in the study (proportion of GPs that register within the study out of the GPs that are registered with the eligible practice) [ Time Frame: 24 weeks post randomization ]
    The following definition of a feasibility study has been agreed by the Efficacy and Mechanism Evaluation (EME), Public Health Research (PHR), Health Technology Assessment (HTA) and Research for Patient Benefit (RfPB) programme: "Feasibility Studies are pieces of research done before a main study in order to answer the question "Can this study be done?". They are used to estimate important parameters that are needed to design the main study".

  2. Feasibility: Willingness of patients to use the provided material given in 'integrated GP care' (self-help material). [ Time Frame: 24 weeks post randomization ]
    The following definition of a feasibility study has been agreed by the Efficacy and Mechanism Evaluation (EME), Public Health Research (PHR), Health Technology Assessment (HTA) and Research for Patient Benefit (RfPB) programme: "Feasibility Studies are pieces of research done before a main study in order to answer the question "Can this study be done?". They are used to estimate important parameters that are needed to design the main study".

  3. Feasibility: Willingness of practices and participants to be contacted about the study (Number (No.) of reply slips sent via the post to ask if the practice/participants would like to participate further information v No. of reply slips received back) [ Time Frame: 24 weeks post randomization ]
    The following definition of a feasibility study has been agreed by the Efficacy and Mechanism Evaluation (EME), Public Health Research (PHR), Health Technology Assessment (HTA) and Research for Patient Benefit (RfPB) programme: "Feasibility Studies are pieces of research done before a main study in order to answer the question "Can this study be done?". They are used to estimate important parameters that are needed to design the main study".

  4. Feasibility: Willingness of practices to be randomised (No. of eligible GP practices agreed consent v No. of GP practices not agreed to consent) [ Time Frame: 24 weeks post randomization ]
    The following definition of a feasibility study has been agreed by the Efficacy and Mechanism Evaluation (EME), Public Health Research (PHR), Health Technology Assessment (HTA) and Research for Patient Benefit (RfPB) programme: "Feasibility Studies are pieces of research done before a main study in order to answer the question "Can this study be done?". They are used to estimate important parameters that are needed to design the main study".

  5. Feasibility: Willingness of GP practices to be consent and be randomized as assessed by No. of eligible GP practices agreed consent v No. of GP practices not agreed to consent [ Time Frame: 24 weeks post randomization ]
    The following definition of a feasibility study has been agreed by the Efficacy and Mechanism Evaluation (EME), Public Health Research (PHR), Health Technology Assessment (HTA) and Research for Patient Benefit (RfPB) programme: "Feasibility Studies are pieces of research done before a main study in order to answer the question "Can this study be done?". They are used to estimate important parameters that are needed to design the main study".

  6. Feasibility: Follow-up rates and response rates to questionnaires (Sent questionnaires v completed questionnaires received at 12 and 24 weeks). [ Time Frame: 24 weeks post randomization ]
    The following definition of a feasibility study has been agreed by the Efficacy and Mechanism Evaluation (EME), Public Health Research (PHR), Health Technology Assessment (HTA) and Research for Patient Benefit (RfPB) programme: "Feasibility Studies are pieces of research done before a main study in order to answer the question "Can this study be done?". They are used to estimate important parameters that are needed to design the main study".

  7. Feasibility: Rate of eligible trial participants (Consort). The number of patients per practice that are initially screened for eligibility and the number per practice meeting the inclusion and exclusion criteria. [ Time Frame: 24 weeks post randomization ]
    The following definition of a feasibility study has been agreed by the Efficacy and Mechanism Evaluation (EME), Public Health Research (PHR), Health Technology Assessment (HTA) and Research for Patient Benefit (RfPB) programme: "Feasibility Studies are pieces of research done before a main study in order to answer the question "Can this study be done?". They are used to estimate important parameters that are needed to design the main study".

  8. Feasibility: Availability of data required and the usefulness and limitations of GP databases assessed qualitatively [ Time Frame: 24 weeks post randomization ]
    The following definition of a feasibility study has been agreed by the Efficacy and Mechanism Evaluation (EME), Public Health Research (PHR), Health Technology Assessment (HTA) and Research for Patient Benefit (RfPB) programme: "Feasibility Studies are pieces of research done before a main study in order to answer the question "Can this study be done?". They are used to estimate important parameters that are needed to design the main study".

  9. Feasibility: Willingness of participants to be consented and randomised (No. of positive reply slips received V No. of patients agreed to be screened, No. of eligible patients agreed consent v No. of eligible patients not agreed to consent) [ Time Frame: 24 weeks post randomization ]
    The following definition of a feasibility study has been agreed by the Efficacy and Mechanism Evaluation (EME), Public Health Research (PHR), Health Technology Assessment (HTA) and Research for Patient Benefit (RfPB) programme: "Feasibility Studies are pieces of research done before a main study in order to answer the question "Can this study be done?". They are used to estimate important parameters that are needed to design the main study".


Other Outcome Measures:
  1. Work and Social Adjustment Scale (WSAS) [ Time Frame: 24 weeks post randomization ]
    a five-item scale with a range of scores from 0 to 40 (a higher score indicates more severe impairment) that is used to measure patients' own perceptions of the impact of PPS on their functioning in terms of work, home management, social leisure and private leisure activities, family and other relationships.

  2. Patient Health Questionnaire-15 (PHQ-15) [ Time Frame: 24 weeks post randomization ]
    a 15-item scale measuring somatic symptoms and taking values from 0 to 30.

  3. Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: 24 weeks post randomization ]
    a 9-item scale measuring depressive symptoms taking values from 0 to 27, with scores of scores of 5, 10, 15, and 20 representing mild, moderate, moderately severe, and severe depression respectively (Kroenke, Spitzer & Williams, 2001).

  4. Clinical Global Impression (CGI) [ Time Frame: 24 weeks post randomization ]
    a nine-point scale measuring patient's perceived improvement, where 1 is completely recovered and 9 is could not get any worse

  5. Satisfaction (Measure patients' self-rated satisfaction of the intervention) [ Time Frame: 24 weeks post randomization ]
    Measure patients' self-rated satisfaction of the intervention.

  6. Client Service Receipt Inventory (Measures health care service receipt, direct and indirect costs of illness, and cost effectiveness of intervention) [ Time Frame: 24 weeks post randomization ]

    questionnaire detailing patient's use of services, including:

    • Use of care providers (yes/no and type)
    • Attendance at accident and emergency (yes/no)
    • Use of diagnostic tests (yes/no and type)
    • Working hours, occupation and days absent from work
    • Receipt of benefits (yes/no and type)

  7. GPs knowledge Questionnaire [ Time Frame: 24 weeks post randomization ]
    Measures GP knowledge: 10 true of false statements testing the GP's knowledge of PPS (maximum score of 11)

  8. GP's Confidence Questionnaire [ Time Frame: 24 weeks post randomization ]
    Measures GP confidence: and a ten-item scale testing their confidence treating PPS (minimum score 10 and maximum score 70)

  9. Cognitive Behavioural Responses Questionnaire (CBRQ) [ Time Frame: 24 weeks post randomization ]

    measure of putative mediators of cognitive change including:

    • fear avoidance (range 0-24),
    • catastrophizing (range 0-16),
    • damage avoidance (range 0-20),
    • embarrassment avoidance (range 0-24),
    • symptom focusing (range 0-24),
    • all or nothing behaviour (range 0-20) and avoidance behaviour (range 0-32) (Reme, Stahl & Chalder, 2011)

  10. EuroQol - 5 Dimensions - 5 Levels (EuroQol-5D-5L) [ Time Frame: 24 weeks post randomization ]
    a 5-item scale measuring health, taking from 5 to 25. Additionally, patients rate their own perceptions of their current health on a scale of 0 to 100 (Brooks, 1996).



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Patients that fit the eligibility criteria will be invited to take part in the study. Patients will be considered eligible for inclusion in this study if they fulfil all of the following criteria:

(i) have a PPS diagnosis (which are medically unexplained) (ii) are greater than or equal to 18 and less than or equal to 65 years old (iii) are registered with a GP practice in South London that has consented to taking part in PRINCE Primary (iv) have had 6 or more consultations in the last year (not necessarily for the same symptom or directly related to PPS (v) have given written informed consent, provided baseline data before randomisation and can speak and read English at a level adequate for participation in the.

Patients will be excluded from the study if the patient has:

(i) active psychosis (ii) drug or alcohol addiction as indicated in the patient's medical notes (iii) current benzodiazepine use exceeding the equivalent of 10mg diazepam per day (iv) had any psychotherapy treatment within the last year (not inclusive of general visits from community psychiatric teams) (v) dissociative seizures (vi) if they are at imminent risk of self-harm, after psychiatric/ psychological assessment (vii) taking part in the PRINCE Secondary study or the ACTIB Study (Everitt et al., 2015).


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): NCT02444520


Locations
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United Kingdom
Kings College London
London, United Kingdom, SE5 8AF
Sponsors and Collaborators
King's College London
South London and Maudsley NHS Foundation Trust
Investigators
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Principal Investigator: Trudie Chader, PhD King's College London
Publications:
Chalder T, Wallace P, Wessely S. Self-help treatment of chronic fatigue in the community: A randomized controlled trial. British Journal of Health Psychology 1997;2(3):189-97. doi: https://doi.org/10.1111/j.2044-8287.1997.tb00535.x

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT02444520    
Other Study ID Numbers: STR130202 (Primary)
First Posted: May 14, 2015    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: August 2018
Keywords provided by King's College London:
Medically unexplained symptoms
Primary care
Cognitive behaviour therapy skills
Cluster randomised controlled trial
Feasibility