Supporting Self-management of Chronic Pain

NCT03119896 | Completed

• 1 other identifier: 223092
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 5

Brief Summary

Does the Navigator Tool Intervention improve communication regarding self-management during consultations between healthcare professionals and people with chronic pain? As there is usually no cure for chronic pain, healthcare professionals are increasingly turning to methods of treatment that emphasise management of symptoms rather than elimination of pain. However, as Pain Concern's previous research has shown, there are several barriers to self-management that both healthcare professionals and people with pain face in their consultations in primary care. The Navigator Tool Intervention has been designed to overcome the majority of these barriers through improving the quality of communication regarding self-management during consultations. In line with the House of Care Model, where care relies on engaged and informed patients, healthcare professionals committed to partnership working, and organisational processes that support this, our intervention prepares both the healthcare professionals and patients for their consultation. By providing a training session for the healthcare professionals in how supported self-management can be brought into the consultation room, and by providing the patients with a paper-based tool that allows them to organise their concerns and questions prior to the consultation, the intervention aims to steer the conversation toward the aspects that the patient needs to discuss in order to better manage their pain. This study will launch the intervention and evaluate its effectiveness in improving self-management support through conversation. It will be launched over a 3 month period in 4 sites across Scotland; 24 patients will be using the tool with a trained healthcare professional and 24 will act as a control group, receiving standard care without the tool. Questionnaires assessing the satisfaction with the consultation(s) and communication, as well as confidence in managing one's pain, will be analysed and compared between the two groups. Interviews will be carried out with healthcare professionals and a sample of patients having used the tool to gain a deeper understanding of the usefulness of the intervention and how it may be improved in the future.

Conditions

Chronic Pain Syndrome; Chronic Pain; Chronic Pain Due to Injury; Chronic Pain Due to Trauma; Chronic Pain Due to Malignancy (Finding); Chronic Pain Post-Procedural; Chronic Pain Hip; Chronic Pain, Widespread

Keywords

chronic pain; self-management; pain management; doctor patient communication; primary care

Outcome Measures

Primary Outcomes (1)

• Transcripts of semi-structured interviews with healthcare professionals and patients from Intervention group

  Transcripts will be analysed and coded for themes and attitudes, similar concerns and experiences regarding the experience of using the intervention.

  Interviews will be carried out 1-2 months after the intervention has finished (the last consultation has taken place).

Secondary Outcomes (3)

• Consultation Quality Index - 2 (CQI-2)

  Distributed to participants 1 week after the intervention has finished, they will return the filled in questionnaire within 1-2 weeks of having received it.

• Pain Self-Efficacy Questionnaire (PSEQ)

  First one distributed 1 week before the intervention starts, to be completed and submitted within 1 week. Second will be distributed 1 week after the intervention has ended, to be returned within 1-2 weeks after having received it.

• CARE measure

  Distributed to participants 1 week after the intervention has finished, they will return the filled in questionnaire within 1-2 weeks of having received it.

Other Outcomes (1)

• Transcripts of semi structured interviews with healthcare professionals and patients from the intervention group.

  Interviews will be carried out 1-2 months after the intervention has finished (the last consultation has taken place).

Study Arms (2)

Intervention Group (using Navigator Tool)

EXPERIMENTAL

The participants will receive a copy of the Navigator Tool Intervention, a paper-based information pack including the My Pain Concerns Form, suggested questions to ask your healthcare professional, a goal setting sheet and information on common self-management strategies. They will be encouraged to fill in some of the forms before the consultation, and some during the consultation. They will have consultations with a healthcare professional who has undergone a Self-management Awareness Training with the Thistle Foundation.

Other: The Navigator Tool Intervention

Control Group (not using Navigator Tool)

NO INTERVENTION

These participants will not have access to the Navigator Tool Intervention, and will have consultations with a healthcare professional who has not undergone the Self-management Awareness Training.

Interventions

The Navigator Tool Intervention OTHER

The intervention consists of two parts; a training session on self-management of chronic conditions for the healthcare professionals, and a paper-based tool for the patients. Both parts aim to inform and prepare the two parties as to what self-management entails in order to facilitate a constrictive consultation.

Intervention Group (using Navigator Tool)

Eligibility Criteria

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

You may qualify if:

• Be over 18 years of age
• Have experienced pain for more than 3 months

You may not qualify if:

• Being unable to communicate in English
• Being unable to attend consultations with a healthcare professional for the duration of the project
• Being currently participating in another research project regarding chronic pain

Sponsors & Collaborators

• Pain Concern: lead
• The Thistle Foundation: collaborator
• Health and Social Care Alliance Scotland (the ALLIANCE): collaborator
• Edinburgh and Lothians Health Foundation: collaborator

Study Sites (5)

St Margaret's Health Centre

Auchterarder, Scotland, PH3 1JH, United Kingdom

Location

Whitesands Medical Practice

Dunbar, Scotland, EH42 1EE, United Kingdom

Location

St Triduana's Medical Practice

Edinburgh, Scotland, 6RU, United Kingdom

Location

Milngavie Clinic

Milngavie, Scotland, G62 7AA, United Kingdom

Location

Muirhead Medical Centre

Muirhead, Scotland, DD2 5NH, United Kingdom

Location

MeSH Terms

Conditions

Chronic Pain; Signs and Symptoms; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Pamela F Bell, MB FFARCSI FFPMCAI FFPMRCA

  Pain Concern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two groups; one "active group" receiving the intervention, and one "control group" receiving standard care without the intervention.

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: April 19, 2017
• Study Start: August 28, 2017
• Primary Completion: March 19, 2018
• Study Completion: March 19, 2018
• Last Updated: April 5, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (5)