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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
267
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
Department of Cardiovascular and Thoracic Surgery, Örebro University Hospital
Örebro, Närke, Sweden
Thoracic Surgery and Anesthesia, Uppsala university hospital
Uppsala, Uppland, Sweden
Department of Thoracic and Vascular Surgery Linköping university hospital
Linköping, Östergötland County, Sweden
Family-Sense Of Coherence (F-SOC)
Person-reported outcome measure, questionnaire measuring sense of coherence at family level. 12 items.
Time frame: A statistically significant change in F-SOC from baseline at three months after hospital discharge between the trial patient groups.
RAND-36
Swedish version of Short Form-36 (SF-36) a questionnaire measuring health-related quality of life. 36 items, 8 dimensions.
Time frame: Baseline (before randomization)
RAND-36
Swedish version of Short Form-36 (SF-36) a questionnaire measuring health-related quality of life. 36 items, 8 dimensions.
Time frame: 2 weeks after hospital discharge
RAND-36
Swedish version of Short Form-36 (SF-36) a questionnaire measuring health-related quality of life. 36 items, 8 dimensions.
Time frame: 3 month follow up
RAND-36
Swedish version of Short Form-36 (SF-36) a questionnaire measuring health-related quality of life. 36 items, 8 dimensions.
Time frame: 12 month follow up
Family Involvement in Care Questionnaire (FICQ)
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.
Time frame: Family members only: 2 weeks after hospital discharge
Cost-Effectiveness of Heath promoting conversations
A questionnaire measuring care utilization and absence from work, 12 items.
Time frame: Baseline (before randomization)
Cost-Effectiveness of Heath promoting conversations
A questionnaire measuring care utilization and absence from work, 12 items.
Time frame: 2 weeks after hospital discharge
Cost-Effectiveness of Heath promoting conversations
A questionnaire measuring care utilization and absence from work, 12 items.
Time frame: 3 month follow up
Cost-Effectiveness of Heath promoting conversations
A questionnaire measuring care utilization and absence from work, 12 items.
Time frame: 6 month follow up
Cost-Effectiveness of Heath promoting conversations
A questionnaire measuring care utilization and absence from work, 12 items.
Time frame: 12 month follow up
Postoperative Recovery Profile (PRP)
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.
Time frame: Baseline
Postoperative Recovery Profile (PRP)
Person-reported outcome measure, questionnaire measuring self-reported postoperative recovery. 19 items, 5 dimensions and a cardiac surgery specific module consisting of 9 items.
Time frame: 2 weeks after hospital discharge
Postoperative Recovery Profile (PRP)
Person-reported outcome measure, questionnaire measuring self-reported postoperative recovery. 19 items, 5 dimensions and a cardiac surgery specific module consisting of 9 items.
Time frame: 3 month follow up
Postoperative Recovery Profile (PRP)
Person-reported outcome measure, questionnaire measuring self-reported postoperative recovery. 19 items, 5 dimensions and a cardiac surgery specific module consisting of 9 items.
Time frame: 12 month follow up
Family-Sense Of Coherence (F-SOC)
Person-reported outcome measure, questionnaire measuring sense of coherence at family level. 12 items.
Time frame: Baseline (before randomization)
Family-Sense Of Coherence (F-SOC)
Person-reported outcome measure, questionnaire measuring sense of coherence at family level. 12 items.
Time frame: 2 weeks after hospital discharge
Family-Sense Of Coherence (F-SOC)
Person-reported outcome measure, questionnaire measuring sense of coherence at family level. 12 items.
Time frame: 12 month follow up
Family Hardiness Index (FHI)
Measurement of the persons perceived hardiness within the family, consisting of 20 items on a 4-point Likert scale.
Time frame: Baseline
Family Hardiness Index (FHI)
Measurement of the persons perceived hardiness within the family, consisting of 20 items on a 4-point Likert scale.
Time frame: 2 weeks after hospital discharge
Family Hardiness Index (FHI)
Measurement of the persons perceived hardiness within the family, consisting of 20 items on a 4-point Likert scale.
Time frame: 3 month follow up
Family Hardiness Index (FHI)
Measurement of the persons perceived hardiness within the family, consisting of 20 items on a 4-point Likert scale.
Time frame: 12 month follow up
General Functioning Scale (GFS)
Measurement of the persons perceived family functioning, 12 items on a 4-point Likert scale.
Time frame: Baseline
General Functioning Scale (GFS)
Measurement of the persons perceived family functioning, 12 items on a 4-point Likert scale.
Time frame: 2 weeks after hospital discharge
General Functioning Scale (GFS)
Measurement of the persons perceived family functioning, 12 items on a 4-point Likert scale.
Time frame: 3 month follow up
General Functioning Scale (GFS)
Measurement of the persons perceived family functioning, 12 items on a 4-point Likert scale.
Time frame: 12 month follow up
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