Persistent Physical Symptoms Reduction Intervention: a Systems Change and Evaluation (PRINCE) - Integrated GP Care for Persistent Physical Symptoms: a Feasibility & Cluster Randomised Controlled Trial

King's College London2 个研究点分布在 1 个国家目标入组 161 人开始时间: 2015年5月最近更新: 2019年5月9日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: King's College London
入组人数: 161
试验地点: 2
主要终点: Feasibility: Follow-up rates and response rates to questionnaires (Sent questionnaires v completed questionnaires received at 12 and 24 weeks).

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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).

详细描述

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).

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Other
盲法: Single (Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

未提供

排除标准

未提供

研究组 & 干预措施

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.

干预措施: Integrated GP Care (Behavioral)

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.

结局指标

主要结局

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