Health-promoting Family Conversations and Open Heart Surgery

Study Overview
=================
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)

Official Title
-----------------
Health-promoting Family Conversations and Open Heart Surgery -An Intervention Model for Families: The HeartFam Intervention

Conditions
-----------------
Thoracic Surgery

Intervention / Treatment
-----------------
* Behavioral: Health promoting conversations


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient and family member of patient undergoing elective open heart surgery- Intervention<br>Family randomized to the intervention group receiving Health-promoting conversation intervention | Behavioral: Health promoting conversations<br>* 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<br>|
| No Intervention: Patient and family member of patient undergoing elective open heart surgery- Control<br>Family of a patient undergoing elective open-heart surgery randomized to the intervention group receiving standard care | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Family-Sense Of Coherence (F-SOC) | Person-reported outcome measure, questionnaire measuring sense of coherence at family level. 12 items. | A clinically significant change in F-SOC from baseline at three months after hospital discharge between the trial patient groups. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RAND-36 | Swedish version of Short Form-36 (SF-36) a questionnaire measuring health-related quality of life. 36 items, 8 dimensions. | 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. | 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. | 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. | 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. | 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. | Baseline (before randomization) | 
| Cost-Effectiveness of Heath promoting conversations | A questionnaire measuring care utilization and absence from work, 12 items. | 2 weeks after hospital discharge | 
| Cost-Effectiveness of Heath promoting conversations | A questionnaire measuring care utilization and absence from work, 12 items. | 3 month follow up | 
| Cost-Effectiveness of Heath promoting conversations | A questionnaire measuring care utilization and absence from work, 12 items. | 6 month follow up | 
| Cost-Effectiveness of Heath promoting conversations | A questionnaire measuring care utilization and absence from work, 12 items. | 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. | 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. | 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. | 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. | 12 month follow up | 
| Family-Sense Of Coherence (F-SOC) | Person-reported outcome measure, questionnaire measuring sense of coherence at family level. 12 items. | Baseline (before randomization) | 
| Family-Sense Of Coherence (F-SOC) | Person-reported outcome measure, questionnaire measuring sense of coherence at family level. 12 items. | 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. | 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. | Baseline | 
| Family Hardiness Index (FHI) | Measurement of the persons perceived hardiness within the family, consisting of 20 items on a 4-point Likert scale. | 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. | 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. | 12 month follow up | 
| General Functioning Scale (GFS) | Measurement of the persons perceived family functioning, 12 items on a 4-point Likert scale. | Baseline | 
| General Functioning Scale (GFS) | Measurement of the persons perceived family functioning, 12 items on a 4-point Likert scale. | 2 weeks after hospital discharge | 
| General Functioning Scale (GFS) | Measurement of the persons perceived family functioning, 12 items on a 4-point Likert scale. | 3 month follow up | 
| General Functioning Scale (GFS) | Measurement of the persons perceived family functioning, 12 items on a 4-point Likert scale. | 12 month follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Family Nursing