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

NCT02444520 | Completed DMC

• 1 other identifier: STR130202 (Primary)
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

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).

Conditions

Persistent Physical Symptoms

Keywords

Medically unexplained symptoms; Primary care; Cognitive behaviour therapy skills; Cluster randomised controlled trial; Feasibility

Outcome Measures

Primary Outcomes (9)

• 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)

  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".

  24 weeks post randomization

• Feasibility: Willingness of patients to use the provided material given in 'integrated GP care' (self-help material).

  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".

  24 weeks post randomization

• 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)

  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".

  24 weeks post randomization

• Feasibility: Willingness of practices to be randomised (No. of eligible GP practices agreed consent v No. of GP practices not agreed to consent)

  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".

  24 weeks post randomization

• 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

  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".

  24 weeks post randomization

• Feasibility: Follow-up rates and response rates to questionnaires (Sent questionnaires v completed questionnaires received at 12 and 24 weeks).

  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".

  24 weeks post randomization

• 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.

  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".

  24 weeks post randomization

• Feasibility: Availability of data required and the usefulness and limitations of GP databases assessed qualitatively

  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".

  24 weeks post randomization

• 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)

  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".

  24 weeks post randomization

Other Outcomes (10)

• Work and Social Adjustment Scale (WSAS)

  24 weeks post randomization

• Patient Health Questionnaire-15 (PHQ-15)

  24 weeks post randomization

• Patient Health Questionnaire-9 (PHQ-9)

  24 weeks post randomization

Study Arms (2)

Integrated GP Care

EXPERIMENTAL

* 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

Waiting List Control Group

NO INTERVENTION

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.

Interventions

Integrated GP Care BEHAVIORAL

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.

Integrated GP Care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• King's College London: lead
• South London and Maudsley NHS Foundation Trust: collaborator

Study Sites (1)

Kings College London

London, SE5 8AF, United Kingdom

Location

Related Publications (23)

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  BACKGROUND

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  PMID: 33028243 DERIVED

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MeSH Terms

Conditions

Medically Unexplained Symptoms

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Trudie Chader, PhD

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 22, 2015
• First Posted: May 14, 2015
• Study Start: May 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: May 9, 2019

Record last verified: 2018-08

Locations

GB (1)