The Effect of Spouses' Involvement Through Case Management in Older Patients' Fast-track Program

NCT ID: NCT02561637

Last Updated: 2015-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2015-06-30

Brief Summary

Patients in fast-track programmes are required to take an active part in their treatment and rehabilitation. Spouses of older patients can often provide valued practical and emotional support, reducing stress, pain and length of stay - yet they are seldom invited to participate in a supporting role. The aim of this study is to investigate the effect of spouses' involvement in older patients fast-track treatment programs using case management as intervention. A two-group quasi-experimental design with pre-test and repeated post-test measures (protocol approved in November 2012) was used. Patients aged 65 years or older going through a fast-track programme for a total hip replacement and their spouses was recruited in dyads from one Danish orthopaedic ward for the intervention group (n=15) and for the control group (n=14). Data was collected from both groups at baseline, two weeks and three months after surgery. Outcome measures for patients include: functional status, nutrition, pain, depression and healthcare consumptions; and for spouses: caregiver satisfaction and difficulties and anxiety.

Conditions

Arthroplasty, Replacement, Hip

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Case management

Before admission the spouse-patient dyads will take part in an interview with the case manager assessing the spouses' needs during admission through an individual care plan. During admission the case manager will follow-up and assess the goals and actions of the individual care plan and coordinate with other health professionals. During the discharge meeting the case manager will provide additional information to the spouse according to needs assessed in the care plan. After discharge the case manager will conduct a follow-up telephone call for the spouse 3-4 days and 10 days after the patient's discharge consisting of information similar to that provided at the discharge meeting.

Group Type: EXPERIMENTAL

Case management

Intervention Type: BEHAVIORAL

Control group

Spouses and patients in the control group will receive usual care and written and oral information about the fast-track program and principles in general from the nursing staff. The usual care and information is provided before admission in the out-patient facilities and during admission

Group Type: OTHER

Control group

Intervention Type: BEHAVIORAL

Interventions

Case management

Intervention Type: BEHAVIORAL

Control group

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 65 years of age or older
• undergoing a total hip replacement due to arthritis
• live with their spouses
• speak, read and understand Danish without an interpreter
• have their spouses present at the mandatory pre-information meeting in the outpatient facilities.

• presence at the pre-information meeting

Exclusion Criteria

• They cannot receive home care, be placed in a nursing home or be permanent users of wheelchairs

• Index score at >24 assessed on the Mini-Mental Stats Examination (MMSE)
• Index score of <6 assessed on the Charlson Comorbidity Index

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lund University

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Connie Berthelsen

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Connie B Berthelsen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Aarhus

Other Identifiers

SICAM2015

Identifier Type: -

Identifier Source: org_study_id