Thoracic Surgery
Conditions
Keywords
Family Nursing
Brief summary
Elective open-heart surgery involves physical and psychological strain for the person undergoing surgery. Family plays a significant part in care before and after surgery, and the family has care needs of their own. Health services need to address the family-caregiver burden as an essential aspect of care. Different methods aiming at stress reduction and involvement of patients and family members in care exist. The evidence is conflicting concerning which way is the most effective. Health-promoting conversations are an intervention model promoting family well-being and alleviation of illness and illness-related suffering for the whole family. Families´ in the intervention group in this trial will, before and after one family member's elective open-heart surgery, participate in Health-promoting conversations. Health-promoting conversation is an intervention model based on the Family Systems Nursing theory. The person undergoing surgery decides which family members should be asked to participate in 1-3 conversations whit a family nurse. Effects on postoperative recovery, health-related quality of life, stress, and patient and family involvement in care will be evaluated with patient- and family-reported outcome measures. The aim is to evaluate Health-promoting conversation's effect on family wellbeing, functioning, and involvement in care. The cost-effectiveness of the intervention will also be evaluated. The study will follow the ethical guidelines of the Declaration of Helsinki. The Swedish National Committee on Health Research Ethics reviewed and accepted the study in march 2020 (nr 2019-06315)
Interventions
BEHAVIORALHealth promoting conversations
The Health-promoting conversations intervention is a conversation model between the patient, family members, and a trained nurse. Patients and families included in the study will, after submitting base-line-data, be randomized to
Sponsors
Örebro University, Sweden
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients: * Patients =/\>18 years of age * undergoing elective, open-heart surgery * having a minimum of one family member willing to participate in Health-promoting conversations Family members * Family member of a patient undergoing elective, open-heart surgery * willing to participate in Health-promoting conversations \*=/\> 15 years of age
Exclusion criteria
patient and family member: * Inability to speak or understand Swedish to the extent of giving informed consent * Cognitive and/or psychiatric disorder to the extent of not being able to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Family-Sense Of Coherence (F-SOC) | A statistically significant change in F-SOC from baseline at three months after hospital discharge between the trial patient groups. | Person-reported outcome measure, questionnaire measuring sense of coherence at family level. 12 items. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Family Involvement in Care Questionnaire (FICQ) | Family members only: 2 weeks after hospital discharge | Person-reported outcome measure, questionnaire measuring family members perceived Instrument measuring family members experiences of involvement in care of the family member who is a patient. 16 items on a 4-point Likert-scale and 2 open ended questions. |
| Cost-Effectiveness of Heath promoting conversations | Baseline (before randomization) | A questionnaire measuring care utilization and absence from work, 12 items. |
| Postoperative Recovery Profile (PRP) | Baseline | Person-reported outcome measure, questionnaire measuring self-reported postoperative recovery. 19 items, 5 dimensions and a cardiac surgery specific module consisting of 7 items at baseline. |
| RAND-36 | Baseline (before randomization) | Swedish version of Short Form-36 (SF-36) a questionnaire measuring health-related quality of life. 36 items, 8 dimensions. |
| Family-Sense Of Coherence (F-SOC) | Baseline (before randomization) | Person-reported outcome measure, questionnaire measuring sense of coherence at family level. 12 items. |
| General Functioning Scale (GFS) | Baseline | Measurement of the persons perceived family functioning, 12 items on a 4-point Likert scale. |
| Family Hardiness Index (FHI) | Baseline | Measurement of the persons perceived hardiness within the family, consisting of 20 items on a 4-point Likert scale. |
Countries
Sweden
Outcome results
None listed