Integrative health care model for climacteric stage women: design of the intervention

A need arises when one sees a difference between the situation considered as optimal and the actual observed situation; the difference to be reduced is then the need. In the health field, the felt need relates to the perception people have about their health problems or whatever they want to receive from the health services. Unlike a need that is not felt, there exists a need that people do not perceive, but it must be satisfied to maintain, restore or improve their health [3].

Increase in life expectancy has also caused an increase in the proportion of climacteric stage women with respect to the general population. Traditionally, climacteric stage women seek medical attention when they perceive health problems attributed to this stage such as severe climacteric symptoms, osteoporosis-related fractures, symptoms and/or complications of chronic diseases. Regarding the unfelt and unsatisfied need, most women do not perceive the need to prevent or detect such health problems early. These situations result in delayed health seeking-behavior for these problems, which in turn represent a significant burden for health care systems and for the society due to the high costs of health care, decreased quality of life and premature death [4‐6].

In Mexico, a high proportion of women in the climacteric stage experience important biological, psychological and social changes; 50-70% report climacteric symptoms [7, 8], 45.6% depression and other mood and sleep disorders [9], 31.1% suffer from hypertension, 16.7% suffer from diabetes [10, 11]; the prevalence of hip fractures secondary to osteoporosis is 169 per 10,000 women-years [12], of breast cancer is 27.4 per 100,000 woman-years, and of cervical cancer is 19.2 per 100,000 woman-years [13]. This situation is worsened by women's overall limited knowledge about the potential health problems associated with the climacteric stage, and about the necessary preventive measures, indicated by their low participation in screening programs for chronic diseases and their unhealthy lifestyles (high proportion of physical inactivity and low consumption of fruits, vegetables and foods rich in calcium [8, 11, 14]), which impede a better overall health and quality of life.

Regarding the existing supply of health care for climacteric stage women (how the need is being met), Mexico has a fragmented health system, composed by Social Security institutions, the Ministry of Health (MoH) and private providers. The Mexican Institute of Social Security (IMSS) is a nation-wide social security institution that provides health and social services as well as economic benefits to formal sector workers and their families (approximately 48 million). While the MoH is central authority in charge of the policies and design of programs and while the provision of care is decentralized through the MoH in the 32 states, while granting each a certain autonomy, MoH provides health care to people without social security, mostly through the System for Social Protection of Health [15].

Despite the existence of preventive programs, most health care for climacteric women is based on a biomedical model in which a curative perspective predominates without support or with very limited support from other health professionals, where the relationship between health providers and patients is usually justified by authoritative professional knowledge. This model gives more importance to medical care for biological symptoms and minimizes the relevance of the psychogical and social changes that happen during the climacteric period.

Most interventions for climacteric stage women have focused on informing/educating women about preventing certain diseases. Some studies have developed educational strategies to prevent osteoporosis [16] or to improve healthy diet [17], and have also aimed to improve physical activity in menopausal women, demonstrating the feasibility and effectiveness of moderate and rigorous physical activity, which in turn improves muscle strength, blood pressure, bone density and health-related quality of life (HR-QoL) [18‐20]. Other studies have examined the impact of information about healthy behaviors, stress management and possible treatments during the climacteric stage; these studies have reported the favorable effect of education groups on the participants' knowledge, which is manifested by perceived ease in dealing with the changes of this stage, increase of healthy habits and increased sexual interest, when compared with a control group [21, 22]. In climacteric women, as in the general population, interventions that incorporate cognitive-behavioral strategies, such as individual and group counseling to facilitate changes in lifestyle, have greater positive effect on vasomotor symptoms, psychological distress, self-efficacy, satisfaction with care and cardiovascular risk factors when compared to printed or verbal information [23‐28].

In the 1980 s, the biomedical model was strongly criticized in the middle of severe economic crises in many countries including Mexico. Alternative models that integrated biological, psychological and social areas gained momentum [29]. In 1994, M. Flint [30], highlighted the relationship among the biological, social and psychological factors that women face during menopause, highlighting the need for women to receive bio-psycho-social care at this stage.

The integrative health care model (IHCM) [31] includes a multidisciplinary approach based on a non-hierarchical combination of conventional medicine with complementary and alternative medicine, which promotes the harmonious continuity in decision-making and care that should be focused on the patient. The IHCM is based on a specific set of core values that include the goal of addressing health care in a holistic manner, and promoting personal health and wellbeing. The multidisciplinary approach of the IHCM is based on the collaborative participation of health team members, their mutual respect and a shared vision between them and the patients. This circumstance allows each provider and each patient to contribute their knowledge and particular skills to focus on providing health care to persons within individual care plans. In the experimental field in both developed and developing countries, attempts to implement the IHCM have been made. The study results showed that the IHCM allowed increased use of preventive services, improved health education and health outcomes [32, 33]. The integrative care model is consistent with the empowerment approach. Empowerment is the social process of recognizing, promoting and enhancing the capacity of people to meet their needs, solve their problems, and mobilize the resources needed to take control of their lives [34]. The goal of patient empowerment is to build the patients' capacity for self-care, facilitate the process of obtaining experiences to identify problems (health needs), set goals related to their own health care, identify personal and social obstacles, develop solutions, consider the possible consequences of alternative solutions and make appropriate decisions for themselves [35‐37]. The empowerment approach is linked to the theory of self-determination which supports the empowering of patients to be more independent in their self-care, and raising the possibility of long-lasting changes in health-related behaviors [38]. The counseling focused on the problems perceived and prioritized by the individual considers empowerment as an approach that also includes cultural aspects.

Interventions aimed to potentiate individual (or social) resources to prevent health damage or solve health problems implicitly adopt an empowerment approach to enable people to improve their quality of life by increasing the power to control their problems. For example, it has been shown that individual and group counseling on health-related self-care of patients with chronic diseases based on the empowerment principles, taking their cultural characteristics into account, achieved positive effects on HR-QoL, knowledge about the disease and related self-care, satisfaction with care and metabolic control compared with the control group (telephone counseling on metabolic control and traditional education) [39, 40]. In addition, patients empowered in health-related self-care used fewer medical appointments, resulting in significant savings for health services [41].

This framework sets the groundwork to address the health needs of climacteric stage women through an intervention that comprises, in an integral manner, their bio-psycho-social needs (Figure 1) and allows women to have greater control over the climacteric stage through acquiring knowledge, building on and utilizing individual strengths, making informed choices, setting personal goals, skills and attitudes necessary for better management of their environment and health-related self-care, which is called empowerment.

The characteristics of population, structure and processes of care within social security allows the implementation and testing of an integrative health care model (IHCM) for climacteric stage women (Table 1). The lessons learned from this first intervention that will be implemented in social security settings will provide further elements and evidence to eventually propose a study aimed at the population with social security in other developing countries. This work aims to develop an IHCM applicable in primary care services (family medicine clinics) for climacteric stage women. The effectiveness of the model will be evaluated through the following aspects: a) improved HR-QoL; b-d) increased empowerment, self-efficacy and knowledge regarding climacteric stage, and health-related self-care activities; e) increased use of screening services for breast cancer, cervical cancer, diabetes and hypertension; f-g) improved lifestyles: regular leisure time physical activity and healthy diet.

In both intervention and control clinics the project will be presented to healthcare providers.

All family doctors working in the intervention clinic will be invited to participate in the study. Family doctors, who agree to collaborate, will participate in a training course that consists in reviewing and discussing the proposed model, the roles and responsibilities of health providers involved in the care of climacteric stage women within IHCM. The researchers will deliver this course that will last two sessions of 60 minutes each.

The IHCM with an empowerment approach will address the care that should be given collaboratively by the health team in cooperation with the active participation of women. The IHCM will be provided under the leadership of the nurse who will coordinate with the health team members, promote preventive care, and incorporate cognitive-behavioral strategies, such as individual and group counseling. The IHCM will be provided for three months to each woman, followed by a three-month follow-up. The empowerment of women will work to facilitate women's recognition of their actual or potential health problems, enable them to solve these problems by drawing up an action plan to improve or maintain their health, and develop their autonomous health-related self-care skills.

In the control group, women will continue the usual healthcare consisting of curative care provided by their family doctor and preventive care according to the IMSS prevention programs focused on this age group (chronic disease screening) and provided by nurses according to the women's demand.

In both working shifts (morning and afternoon) family doctors will identify and evaluate those women who meet the inclusion criteria. Family doctors should provide preventive and curative healthcare services, according to womens' individual health needs, and send the candidates to the waiting room where they will be interviewed by study interviewers, who will explain the purpose and content of the study, and obtain the signed informed consent from those women who agree to participate. Once the participant is included in the study, the interviewer will perform the base-line interview then send the woman to the nurse of the study.

Nurses will provide monthly individual counseling to each woman based on the empowerment approach (the first visit being 40 to 60 minutes with subsequent counseling sessions of 20 to 30 minutes). The individual counseling will include the following contents (Table 2): 1) the nurse and the woman collaboratively evaluating the current status of the participant (physical, emotional, cognitive and so forth) within their social environment; 2) the nurse facilitating the women's recognition of her personal health risks and responsibilities for health-related self-care; 3) and 4) the nurse guiding the woman in setting her health goals and laying out a feasible action plan for her health-related self-care, thereby promoting the empowerment of each participant; and 5) the nurse and the woman collaboratively monitoring the progress of the action plan.

The nurse will also schedule appointments for individual and group counseling and refer the woman to the psychologist and to the family doctor, who will provide comprehensive and continuous care consistent with the personal health needs of each participant.

Psychological counseling will be based on the Rational Emotive Behavioral Therapy and its central concept ABC [42]. According to this concept, emotional and behavioral consequences (C) are the result of beliefs (B) on activating events (A). The psychologist and the woman will collaboratively evaluate and restructure the woman's erroneous beliefs about the climacteric stage and her emotional resources, which refer to the ability to positively guide the emotions to achieve a better level of self-esteem and self-efficacy. The psychologist and the woman will define the number of consultations required in accordance to her individual needs and characteristics.

The main themes of group sessions will be: 1) the climacteric stage and the empowerment approach; 2) Emotional well-being, self-esteem and self-efficacy during menopause; 3) Factors that predispose chronic disease development during the climacteric stage and health-related self-care strategies; 4) Physical activity: barriers, benefits, type, frequency and recommended time. How to establish an individual action plan on physical activity and make it feasible (problem solving); 5) Healthy diet during the climacteric stage including increase of intake of fruits, vegetables and dairy products on a daily basis, as well as education about the barriers to and benefits of a healthy diet. How to establish an individual action plan toward a healthy diet and make it feasible; 6-8) Monitoring of the progress of women's action plans. Participants should attend to group sessions one to five, and to sessions six to eight can attend either as a group or individually.

Information on the study variables will be collected on three occasions: when the woman enters to the study (baseline), once intervention is complete (at three months) and after three more months of follow-up (six months).

The main outcome variables will be:

Health-related quality of life (HR-QoL), which will be measured with the revised version of Women's Health Questionnaire (WHQ23) [43]. This is a specific questionnaire for women in perimenopause, menopause and post menopause stages, that comprises six domains: anxiety/depression, well-being, somatic symptoms, memory/concentration, vasomotor symptoms and sleep problems. The WHQ23 also has two optional domains: sexual behavior and menstrual symptoms, which will apply only to women who are sexually active or who have menstrual periods. The highest value for each domain score is 100, which means high HR-QoL, and the lowest is 0, which means low HR-QoL.

Other outcome variables will be:

1) Empowerment of women in relation to their self-care measured by the empowerment scale, which was modified from the diabetes empowerment short scale [44] to be used in climacteric women. The maximum score of empowerment is 5, the minimum is 1.

2) Self-efficacy of women in relation to menopause and its care will be assessed with Perimenopausal Health Self-efficacy Scale (PHS-ES) which consists of 23 items [45]. The maximum score of PHS-ES is 207 (high self-efficacy) and the minimum is 23 (low self-efficacy).

4) The use of screening services for: a) breast cancer by mammography in the last two years; b) cervical cancer by Pap-test in the last three years in women without a history of total hysterectomy; c) diabetes by measuring fasting plasma glucose in the last three years; d) hypertension: by measuring the systolic and diastolic blood pressure in the last year. The use of screening services will be estimated as the sum of the number of screening services that women used, divided by the total number of screening services recommended according to IMSS regulations and multiplied by 100.

5) Percentage of women who practice regular leisure time physical activity (PA), where regular was defined as moderate intensity if done for ≥150 minutes/week or vigorous intensity if done ≥75 minutes/week.

6) Percentage of women who practice a healthy diet, which included the daily consumption of fruits (3-4 servings), vegetables (4-5 servings), and dairy products (2-3 servings).

The covariates will be:

a) Women's general characteristics: Age, schooling, marital and employment status.

b) Smoking status and alcohol consumption. Smoking status will consider former and current smokers and will register the number of cigarettes actually smoked per day. Alcohol consumption will be classified as non-drinkers (never drink alcohol), occasional drinkers (drink rarely or less than once a week), moderate drinkers (from 1 to 14 drinks per week) and heavy drinkers (more than 14 drinks per week).

c) Nutritional status will be measured by body mass index (BMI) and classified into groups of normal weight (BMI of 18.5-24.9 kg/m²), overweight (BMI of 25.0 to 29.9 kg/m²), or obese (BMI ≥30.0 kg/m²).

d) Social support (SS) will be measured by applying the DUKE-UNC-11 questionnaire [46]. This questionnaire evaluates confidential SS (possibility of having people to communicate with) with a minimum score of 7 points (low confidential SS) and a maximum score of 35 points (high confidential SS); and affective SS (demonstration of love, affection, and empathy) with a minimum score of 4 (low affective SS) and a maximum score of 20 points (high affective SS).

e) Medical and reproductive history: Presence of chronic diseases, number of pregnancies and living children, and menopause (one year after the last menstrual period). Type of menopause will be classified as natural or surgical, age at onset of menopause; time elapsed since menopause, presence and type of climacteric symptoms, and number of visits with the family doctor or other health provider in the last three months. The severity of vasomotor symptoms and vaginal atrophy symptoms is classified using the criteria proposed by the Department of Health and Human Services Food and Drug Administration [47], which are based upon women's self-report, and define the symptoms as mild, moderate, or severe.

f) Satisfaction with care received at the FMC will be measured with the general question of how satisfied are you with the care you have received at the clinic? The possible answers are very satisfied, satisfied, neither satisfied nor unsatisfied, unsatisfied, and very unsatisfied.

g) Women's self-esteem will be measured with the Rosenberg Self-Esteem Scale (EAR) [48, 49]. It is a one-domain instrument that consists of 10 questions. The highest score is 30 (high self-esteem) and the lowest is 0 (low self-esteem).

h) Adherence to MAIMC will be defined when the woman attends at least 60% of the planned individual and group counseling sessions.

The sample size for the primary outcome (HR-QoL) was estimated by using the formula to test change in the mean of two normally distributed samples in longitudinal studies [50]. An average increase of at least 10 points in one or more domains of WHQ23 in the intervention group compared with control group women was considered to be clinically relevant. The assumptions included: a mean HR-QoL score of 64.9 points (standard deviation of 23.4 points) in the domain of general well-being [51], α = 0.05 (for one-sided hypothesis) and β = 0.20. The number of women by group, assuming a drop-out rate of 20% will be 107.

We also estimated a sample size for regular leisure time physical activity considering that this is the outcome variable more difficult to achieve. It was assumed that only 17% of women in Mexico engaged in some type of regular leisure time physical activity [11] and a positive increase of at least 10% will be achieved after women participation in the IHCM. For this calculation, we used the formula to test the difference of proportions between two populations [50] with a = 0.05 (one side) and the power of 80%. The total number of women by group to include assuming a drop-out rate of 20% will be 207.

The women characteristics of each intervention and comparison groups will be compared by using the Chi-square test to ascertain whether the groups were equivalent.

The effects of intervention for categorical outcome variables (regular leisure time physical activity, healthy diet) will be measured by comparing the baseline and post-intervention evaluation stages for differences in these variables using Chi-square test. Absolute percentage differences and corresponding 95% confidence intervals will be calculated.

Scores for the HR-QoL on the WHQ23 scale, the self-efficacy on the PHS-ES scale, the empowerment on the short form scale, knowledge about the climacteric stage, and menopause and self-care-related activities will be calculated according to the scoring algorithms. Measures of central tendency and distribution will be examined for these variables at the different measurement periods. The differences in the baseline and post-intervention stages for outcome variables will be compared within each group, and differences between the groups will be compared using the differences-in-differences (D-in-D) estimator [52]. The generalized linear model (GLM) will be used to assess changes in the main outcome variable controlling for baseline measures and other study variables as covariates. The GLM methods allow for modeling the correlation of the repeated observations on the same subjects [53].

The p value <0.05 will be considered as statistically significant. The analysis will be performed with the Stata 11.0 statistical software (Stata 11.0, Stata Corp; College Station, TX).