Person-Centred Information and Communication for Patients Undergoing Colo-Rectal Surgery - the PINCORE Project

Göteborg University

Status: Completed

Conditions: Colorectal Neoplasms

Treatments: Other: person-centred communication

Study type: Interventional

Funder types: Other

Identifiers

NCT03587818

GPCC core project PINCORE

Details and patient eligibility

About

An overarching aim is to create prerequisites for person-centred information and communication. The specific aim is to evaluate if an intervention with a written information and communication support tool and person-centred dialogues can increase patients' health-related quality of life and preparedness and well-being pre-surgery and during recovery in connection to colorectal cancer (CRC) surgery. Further, the aim is to explain variations in patients' recovery trajectories during the six months following CRC surgery in order to identify particularly vulnerable sub-groups of patients.

The hypothesis is that person-centred information and communication supported by an interactive patient information and education material (PEM) for patients undergoing CRC surgery will lead to improved preparedness for surgery and recovery during recovery 6 months following surgery. Secondary outcomes were decreased length of stay at hospital in relation to surgery, changed behaviour pertaining when and how to seek health care for recovery support, and improved emotional, role and social function, general health status and distress.

The study is performed at three surgical departments in Sweden. A combination of quantitative and qualitative methods will be applied. The project started with analysis of existing patient written information and education materials aimed for the patient group at Swedish surgical departments and analyses of conversations between patients and providers in consultations occurring over time before and following surgery. These results provided the basis for the development of the person-centred communication intervention developed in collaboration between people who had undergone CRC surgery, professionals from CRC surgery clinics and researchers with expertise in patient education, person-centred care and CRC surgery.

The design is quasi-experimental and longitudinal. Patients are consecutively sampled. Types of data:

• patient reported answers in validated questionnaires
• information about diagnosis, type of treatments and course of care obtained from patients' records
• recorded consultation conversations with patients between patients and health care providers
• narrative interviews with patients 6 months following discharge regarding their recovery after surgery
• focus group discussions and individual interviews with professionals regarding how they have perceived using the intervention and how it has functioned.

Full description

Background In Sweden, approximately 3,900 people are diagnosed with colon cancer and 1,900 with rectal cancer annually, split almost equally between women and men. The primary treatment for colorectal cancer (CRC) is surgery. A particular challenge in CRC care is meeting patients' information needs over time in order to improve their recovery. There is a need for comprehensive considerations and person-centred communication supporting patients to be prepared for the surgery and the following recovery.

Aim An overarching aim is to create prerequisites for person-centred information and communication. The specific aim is to evaluate if an intervention with a written information and communication support tool and person-centred dialogues can increase patients' health-related quality of life and preparedness and well-being pre-surgery and during recovery in connection to colorectal cancer surgery. The hypothesis is that person-centred information and communication supported by an interactive patient information and education material (PEM) for patients undergoing CRC surgery will lead to improved preparedness for surgery and recovery during recovery 6 months following surgery. Secondary outcomes were decreased length of stay at hospital in relation to surgery, changed behaviour pertaining when and how to seek health care for recovery support, and improved emotional, role and social function, general health status and distress. Further, the aim is to explain variations in patients' recovery trajectories during the six months following CRC surgery in order to identify particularly vulnerable sub-groups of patients.

Communication in consultations will be supported by a innovative written interactive PEM with the goal to enhance the patient's knowledge seeking in order to be prepared for "the next step" in his/her care process. Here, person-centred communication refers to the patient-provider conversations where the patient is encouraged to tell about personal experiences, perceptions and worries in a dialogue format. An assumption is that dialogues unfolds when the two partners together are seeking to make sense of what is shared to each others.

Method Three hospitals. The study is performed at three surgical departments; university, regional and local hospitals; including public and private non-profit. Health care providers and patients from the three hospitals will be included in the development and evaluation of the intervention. A combination of quantitative and qualitative methods will be applied.

Initial analyses before the development of the intervention The project started with analysis of existing patient written information and education materials aimed for the patient group at Swedish surgical departments and analyses of conversations between patients and providers in consultations occurring over time before and following surgery. These results provided the basis for the development of the person-centred communication intervention developed in collaboration between people who had undergone CRC surgery, professionals from CRC surgery clinics and researchers with expertise in patient education, person-centred care and CRC surgery.

Evaluation in a quasi-experimental design

The design of the clinical intervention study is quasi-experimental and longitudinal; one group of patients before the introduction of the intervention will be compared to one group who have been part of the intervention (consecutively sampled). For the evaluation several types of data will be used:

• patient reported answers in validated questionnaires
• clinical and treatment data obtained from patients' records
• recorded consultation conversations with patients between patients and health care providers
• narrative interviews with patients 6 months following discharge regarding their recovery after surgery
• focus group discussions and individual interviews with professionals regarding how they have perceived using the intervention and how it has functioned

Expected result The project will contribute a model for the enabling of person-centred communication in connection to CRC surgery. There are many people who will benefit of improved support for the specific group of patients, since CRC is a common type of cancer affecting women and men and where surgery is the most common treatment. Evaluations with a combination of methods increase the possibility to explain the significance of the intervention and how it can be implemented. The design of the intervention model, including a video and workshop outline for the introduction of the intervention model to health care professionals, facilitates direct clinical implementation if the evaluation will be proved effective. The written interactive PEM developed and tested is general for the Swedish context and include a generic approach for how to design the interactive PEM to other groups of patients.

Enrollment: 488 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• undergoing planned surgery for cancer in colon or rectum

Exclusion criteria

• receiving preoperative chemotherapy
• receiving long-term preoperative radiation
• diagnosed metastasis
• post-surgical diagnosis of benign tumors
• undergoing emergency surgery
• having reduced cognitive function
• lacking ability to communicate in Swedish

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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488 participants in 2 patient groups

Control group

No Intervention group

Description:

Conventional care. Patients were receiving several written patient education materials (PEMs), mostly related to specific parts or procedures related to the surgery and the recovery. Communication between patients and professionals during consultations occurred according to conventional care practice.

Intervention group

Experimental group

Description:

I. Written interactive PEM structured into chapters/phases of the care process. Designed to serve three purposes: 1. generic information of the surgery and recovery process on a group level to promote high readability, suitability and comprehensibility 2. arena of dialogues between patient and professionals; voicing concerns, share perspectives 3. for the patient to personally reflect on generic information. II. Person-centred communication in dialogues using the PEM as a supportive tool, facilitated by four communication strategies: 1. professionals guiding the patient through the care process 2. communicating an introduction, agenda and closing 3. being sensitive to the patient's questions, beliefs, experiences and resources 4. dialogue based on story, posing open-ended questions, and following up.

Treatment:

Other: person-centred communication